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Feature: The Complexities of Traditional and Medical Circumcision in the Eastern Cape

On July 31, 2023July 31, 2023 By ModernMedia

Circumcision rates in South Africa have increased dramatically over the last decade with 62.5% of males aged 15 to 49 who were circumcised as of 2022. PHOTO: Rodger Bosch

By Siyabonga Kamnqa for Spotlight

There is compelling scientific evidence that Voluntary Male Medical Circumcision (VMMC) is both safe and significantly reduces a man’s risk of becoming infected with HIV. While there can also be some protection from traditional circumcision, the protective effect of medical circumcision is thought to be much greater. The World Health Organization (WHO) has recommended medical circumcision for HIV prevention since 2007.

Circumcision rates in South Africa have increased dramatically over the last decade. According to estimates from Thembisa, the leading mathematical model of HIV in South Africa, 62.5% of males aged 15 to 49 were circumcised as of 2022. In 2012, this number stood at 38.8%. Experts ascribe some of the reduction in the country’s rate of new HIV infections to the massive circumcision drive over the last decade.

But the choice between medical, traditional, or no circumcision is often about much more than HIV risk. For one thing, traditional circumcision has great cultural meaning for some groups.

‘From boyhood to manhood’

Spotlight visited Lwazi Mfeka* at his ibhoma (traditional hut) during his last week at an initiate school in the Eastern Cape this winter. The first-year Walter Sisulu University student asked to remain anonymous for fear of victimisation, as talking openly about initiation is taboo in many rural communities.

He said leaving his ibhoma on the last day of his tenure as an initiate is a moment that will forever be etched in his mind. Not only did this signal the end of a “challenging” three-week period at the school, but it was also a symbolic moment where he says he has graduated from boyhood to manhood.

Mfeka said he was supposed to have undergone the ritual in December last year, but due to a bereavement in his family, he couldn’t. “At varsity, I was often mocked and isolated because I was still a ‘boy’. This bothered me a lot and I couldn’t wait to come here (to the mountain) and finally become a man,” he said.

He admits he was gripped by fear in the months leading up to his initiation.

“For starters, many young boys die while undergoing the custom and I didn’t want to add to the numbers. But, fortunately, my dad chose an ingcibi (traditional surgeon) with a good track record. I first had to go and get tested by a doctor for chronic illnesses such as HIV and TB as I had to present a medical certificate to the ingcibi before being circumcised. At the initiation school, everything was done according to the rules. After each cut, the spear gets sanitised to avoid any spread of infections,” Mfeka said.

Botched circumcisions

Mfeka’s fears are not without merit. In recent years, traditional male circumcision has often made headlines for all the wrong reasons, with the lives of young men lost due to botched or unhygienic circumcisions.

According to Mamnkeli Ngam, spokesperson for the Eastern Cape Department of Cooperative Governance and Traditional Affairs, in the 2022 winter initiation season, 11 of 10 794 boys who underwent traditional circumcision in the province died, while in the summer initiation season, 23 of 51 601 died. Ngam says around 20 000 boys went into the mountains to undergo traditional circumcision this winter (2023).

He told Spotlight that some fly-by-night ingcibis, desperate to make a quick buck, are the ones giving the custom a bad name. He says that assisted by the local chiefs and the police, they have been clamping down on illegal initiation schools and arresting bogus traditional surgeons.

“During the period between 1 June to 20 July, nine bogus traditional surgeons have been arrested in the Eastern Cape,” Ngam said.” We have been conducting safety campaigns ahead of the winter circumcision season to educate communities. Circumcising boys without parental consent [and] not having undergone medical examination to perform the procedure is against the law.”

Nkosi Mpumalanga Gwadiso, the Eastern Cape House of Traditional and Khoisan Leaders’ chair, told Spotlight that parents need to be involved throughout the process. “Often, parents leave everything to the amakhankatha (traditional nurses). That’s where things go wrong. As chiefs, we always emphasise the importance of parental involvement from day one until the initiates come back home safely. Some traditional nurses are the reason things go wrong because they neglect the initiates and go drinking. It is therefore the responsibility of the fathers to ensure that they visit the initiation schools regularly and monitor everything,” Gwadiso said.

While numbers vary widely and we haven’t been able to get a full picture, we understand that initiation schools can admit around 100 initiates during each of the winter and summer circumcision seasons. Our informal survey of several initiation camps in the former Transkei suggests the cost is typically around R300.

The medical alternative

While medical male circumcision is a generally available alternative to traditional circumcision, its provision in the Eastern Cape is influenced by cultural factors. For example, according to Eastern Cape Provincial Health Department spokesperson, Yonela Dekeda, the department does not conduct open marketing or demand creation in the communities/public “due to cultural dynamics within the province”.

“Medical Male Circumcision services are actually confined within the health facility level. Therefore, intake depends on the walk-ins, not on demand creation or promoting of the MMC services,” Dekeda said. “MMC is the choice of individual families. However, as the department, we are ensuring that all the designated MMC sites are well equipped with necessary MMC equipment, including training of clinicians such as medical doctors, clinical associates, and professional nurses to provide quality voluntary medical male circumcision services.”

Despite the lack of promotion, some young men, such as Bandile Macetywa*, have opted to go the medical route. He asked that we not use his real name for fear of victimisation from people who disapprove of his decision not to be circumcised in the traditional manner.

Speaking to Spotlight, the 20-year-old from Cofimvaba in the Eastern Cape said he pleaded with his parents, who are staunch traditionalists, to do the custom the medical way. “I know I disappointed my parents, especially my father, but at the end of the day, it was about my safety. I was happy when they respected my decision,” he said.

However, Mecatywa says he is all too aware of the discrimination that awaits him in society. “There are already naysayers. But I’m just glad the whole process went well. For Pete’s sake, we are in 2023. People are free to choose where they get circumcised. Some people had the guts to tell me to my face that I deserved to be abducted and circumcised again the traditional way?” he said.

Mecetywa believes many lives will be saved if rural communities can be educated to accept medical male circumcision. “It is much safer with [fewer] risks of getting infected while undergoing it. I am not saying traditional male circumcision is wrong. But why do initiates continue to die or have botched operations if things are done the right way,” he asked.

While the department does not actively promote medical circumcision, and while Mecetywa is clearly very aware of being in a minority, there are in fact significant numbers of medical circumcisions being conducted in the Eastern Cape. According to Dekeda, 14 637 were performed in the province in 2022, while 14 300 have been performed so far this year.

Medical male circumcision is an elective procedure that is widely available in the public sector, often provided via NGOs. The process typically involves counselling, a pre-assessment to check for anything that may hamper a client’s ability to be circumcised, post-operative care, and follow-up visits. Clients will typically also be offered an HIV test.

VMMC in the Western Cape

Meanwhile, in the Western Cape, the Department of Health and Wellness in collaboration with the City of Cape Town and the Department of Cultural Affairs and Sport has implemented an initiation consent form as a mechanism to uphold ethics. It includes medical screening that helps minimise and mitigate potential risks.

Western Cape Department of Health spokesman Mark Van der Heever told Spotlight, “The initiation consent form is further reviewed to enable alignment to developments as these emerge. Training and capacitation of traditional surgeons is a key element to strengthening partnership following a whole of government and whole of society approach.”

Van der Heever says since 2020, 274 circumcisions were performed by a Medical Officer invited by the traditional healers to perform the circumcisions. A total of 131 977 medical male circumcisions, according to Van der Heever, were performed at the Western Cape health facilities since 2013, with 13 105 performed just last year.

The rest of the stats are as follows:

2013 – 12 581

2014 – 15 990

2015 – 14 131

2016 – 11 982

2017 – 15 127

2018 – 14 557

2019 – 18 000

2020 – 5 750 (COVID)

2021 – 10 754 (COVID)

2022 – 13 105

Van der Heever adds that between April and March 2023, Medical Male Circumcision was reported at 130 public health sites and a total of 12 259 circumcisions were performed across the province.

“The province also has two Men’s Health Clinics (in Karl Bremer and Elsies River). With the intention of increasing access to services, we are in discussions to upskill clinicians to enable service provision at health facilities. Current service provision is based on roving teams in both the metro and rural districts, which limit access to availability of the team.”

Republished from Spotlight under a Creative Commons 4.0 Licence.

Source: Spotlight

Categories : HIVTags : 26/7/23 HIV testing HIV treatment South Africa Spotlight

Opinion: HIV Investments Remain No-brainers, but Some Things Need to Change

On July 26, 2023 By ModernMedia

By Marcus Louw for Spotlight

Making the case for governments and donors to pump money into the HIV response has become more difficult over the last decade. This is partly a result of the notable successes we’ve had – for example, in 2022, HIV-related deaths in South Africa were down to less than a fifth of what it was in 2005. There is clearly some justification for the point of view that HIV simply isn’t the crisis it used to be.

That said, it is also true that about 8 million people in South Africa are living with HIV. This number will continue to rise in the coming years as the rate of new HIV infections is much higher than the rate of HIV-related deaths. Barring a major scientific breakthrough, all these millions of people will require antiretroviral medicines for the rest of their lives, both for their own health and to reduce onward transmission of the virus. In this context, a failure to maintain and improve HIV treatment and prevention programmes will have catastrophic consequences.

There is also increasing competition with other areas of urgent need. In recent years, climate change and COVID-19 have understandably made the headlines much more frequently than HIV. There is also a slow shift underway in South Africa’s disease burden, away from HIV and tuberculosis toward non-communicable diseases (NCDs) such as diabetes and hypertension.

Still a no-brainer

Despite these shifts, there is good reason to think that spending money on HIV continues to offer excellent value for money. For example, according to a recent report by Economist Impact (part of the Economist group that also publishes the Economist magazine), for every dollar spent on HIV in South Africa from 2022 to 2030, it is estimated the country will see GDP gains of over $7.

We also have a good idea of the impact and cost-effectiveness of specific HIV-related interventions. According to the most recent version of the South Africa HIV investment case, published in December 2021, condom provision continues to be the most cost-effective intervention in South Africa, followed by antiretroviral treatment, infant testing, pre-exposure prophylaxis for men who have sex with men, and general population testing. Voluntary medical male circumcision has become less cost-effective as coverage levels have risen in recent years, but remains worth it. In fact, the investment case leaves no doubt that most of the key interventions needed to combat HIV in South Africa are both worth it and affordable.

Despite all this, according to a recent UNAIDS report, global investment in HIV has taken a knock in recent years, and in 2022 we were essentially back down to the same level as in 2013. Such reductions constitute a crisis in HIV funding, especially in poor countries that are heavily reliant on donor funds. In South Africa, key interventions like antiretroviral treatment and condoms generally remain funded, but public sector health budgets have been shrinking in real terms, something that is no doubt impacting the HIV programme.

Time to leverage HIV investments

This brings us back to the knotty problem with which we started – while HIV remains a large and serious problem and most investments in combatting HIV remain excellent value for money, making the case for these investments has become more difficult due to competing priorities and the fact that, in South Africa at least, people are not dying of AIDS at nearly the rate they did 20 years ago. How to best make the case in a way that convinces governments and donors to put up the money in this context is a devilishly hard problem.

There are certainly no simple solutions.

What there is, though, is some indications that a too narrow focus on HIV is becoming a harder sell. There is also a risk that as funds for HIV get harder to come by, and the clamour for funding NCDs becomes more pronounced, we may end up pitting diseases against each other in a way that benefits no one.

Given the incredible acuteness of our HIV crisis ten and 20 years ago, a laser focus on HIV was right and necessary. Today, however, the reality is that many people living with HIV are also living with NCDs like diabetes or hypertension, something that will become only more so as the population of people living with HIV grow older. It is clear that we need to start doing a better job of integrating care and treatment for all the different diseases one person might have – the key is to do so in a way that doesn’t drop the ball when it comes to HIV.

In some areas progress is already clear – medicines distribution via pickup points closer to people’s homes were fuelled by the need to get ARVs to people, but is now also being used to distribute medicines for some NCDs. In other areas, such as data systems, integration however remains limited and the systems available for HIV and TB remain superior to those for NCDs.

There appears to be a broader policy shift along these lines. As recently reported on Devex, the Global Fund to Fight HIV, TB, and Malaria’s current five-year strategy explicitly endorses and promises funding for integrating non-communicable disease services with TB and HIV programmes. UNAIDS’s new ‘The path to end AIDS’ report also makes the right noises on the “deeper integration of HIV and other health services”, as does South Africa’s National Strategic Plan for HIV, TB, and STIs 2023 – 2028.

Of course, the road from policy-level ambitions such as these and change on the ground can be a long one – to some extent such integration has been on the cards for over a decade. But, rising NCD rates, an ageing population of people living with HIV and comorbidities, and funding pressures mean that getting integration right is now more urgent than ever.

One of the arguments for HIV-specific funding has always been that HIV investments have benefited healthcare systems more generally, even if that was not the primary intention. Maybe in this next act of the HIV response then, the key will be to stop thinking of health system improvement as a side effect of HIV investments and instead lean into the idea of explicitly leveraging what we’ve done and will continue to do in HIV to improve health systems more generally.

Republished from Spotlight under a Creative Commons Licence.

Source: Spotlight

Categories : General InterestTags : 21/7/23 intimate partner violence medical education South Africa Spotlight University of Cape Town

Going Viral: Dr Chivaugn Gordon on Medical School with a Difference

On July 21, 2023July 21, 2023 By ModernMedia

Dr Chivaugn Gordon, head of undergraduate education at UCT’s Department of Obstetrics and Gynaecology, reflects on her love of teaching future doctors about women’s health issues. PHOTO: Nasief Manie/Spotlight

By Biénne Huisman for Spotlight

With humour and wearing an occasional wig, Dr Chivaugn Gordon teaches medical students about serious women’s health issues. During hard lockdown she delighted students at the University of Cape Town (UCT) with educational videos using household items as props. For example, she created an endometrium (the inner lining of the uterus) from hair gel and red glitter, performed a biopsy on a potato, and showed a chicken hand puppet go into labour.

One video features a patient named Zoya Lockdownikoff – who is a spy – consulting with her doctor about abnormal menstrual bleeding. Gordon, in a blonde wig with round sunglasses, plays Lockdownikoff; and Gordon’s husband, Dr Adalbert Ernst, plays her doctor.

Lockdownikoff explains that the bleeding started when she “did a very complicated backflip to escape a very compromising situation” and that it’s ruining her expensive super-spy coats.

Gordon is head of undergraduate education at UCT’s Department of Obstetrics and Gynaecology, while Ernst is with the university’s Department of Anaesthesia and Perioperative Medicine.

Speaking from her yellow-walled lounge in Cape Town’s Bergvliet, Gordon says: “I became a doctor because I love working with patients. And then I realised, oh cool, I love teaching too. And now I can do these two things together.”

Interest in IPV

For Gordon a driving interest has been intimate partner violence (IPV) which she introduced into her undergraduate curriculum in 2015.

“The aim is to have graduating doctors who are able to recognise intimate partner violence. Everybody thinks that you can’t possibly be abused unless you have a black eye or a fractured arm. But actually, IPV is often more psychological. It’s often psychological abuse. So the challenge is to teach young doctors what are the red flags in someone’s behaviour, or in their clinical presentation, that might indicate IPV.”

Published online in April, Gordon delivered a talk for TEDxUCT called “Tackling IPV, one awkward dad conversation at a time”, in which she notes IPV is “a global pandemic that has been ongoing since time began”. The title refers to Gordon’s father who raised her.

According to a paper published in the journal Lancet Psychiatry last year, IPV is the most common form of violence worldwide; it is most prevalent in unequal societies, and its victims are mostly women and girls. The paper states that worldwide 27% of women and girls aged 15 and older have experienced physical or sexual IPV, but in South Africa the figure is estimated to be much higher, between 33 and 50%.

Gordon contributed to South Africa’s revised Domestic Violence Amendment Act of 2021, through UCT’s Gender Health and Justice Research Unit.

The new legislation broadens the definition of domestic violence to include (above and beyond physical and sexual abuse) emotional, verbal or psychological abuse, which is described as “a pattern of degrading, manipulating, threatening, offensive, intimidating or humiliating conduct towards a complainant that causes mental or psychological harm…including (repeated) insults, ridicule or name calling; (repeated) threats to cause emotional pain; the (repeated) exhibition of obsessive possessiveness or jealousy…”

Gordon highlights the term coercive control. “Because that underpins most serious intimate partner violence. So, somebody who is extremely controlling; they want their partner to do what they want, when they want, and how they want immediately. They normally start isolating you from friends and family so they can spin a narrative of your reality that can’t be contested by anyone else. And it also makes it more difficult to leave.”

Red flags

Gordon highlights some of the IPV red flags that doctors should look for in their patients.

“Depression, anxiety, PTSD, insomnia, [and] things like self-medicating with substances,” she says. “Because when you are living in absolute, abject terror every day of your life, it’s going to manifest in some kind of psychological manner. So, when people have been broken down and worn down and their self-esteem has been eroded it also affects the way they might interact with the healthcare professional.

“Big red flags come out in body language. Usually when someone goes to a doctor, they tell you everything about all their symptoms, because they want you to make them better. So, if you’ve got a patient who is closed off, they’re not making eye contact, they’re avoiding answering your questions, they’re just very reticent and you can’t get anything out of them…then you’ve got to think.”

Gordon stresses that IPV happens across economic strata and in all walks of life. “Every time I run this workshop, a medical student who comes from a very privileged background, from a very financially stable, loving home, comes to me, saying this is happening to her. It happens everywhere. I’ve got medical colleagues, several, who have experienced intimate partner violence. It doesn’t discriminate.”

Republished from Spotlight under a Creative Commons Licence.

Source: Spotlight

Categories : HIVTags : 18/7/23 antiretroviral therapy South Africa Spotlight

Over 4.7m People in SA Placed on New HIV Med in Four Years

On July 18, 2023July 18, 2023 By ModernMedia

By Elri Voigt for Spotlight

In what is likely one of the largest treatment rollouts in South African history, well over four million people living with HIV have started taking the antiretroviral dolutegravir since its introduction around four years ago. Now, according to a recent study published in the Lancet medical journal, use of dolutegravir in South Africa is associated with more people staying on treatment and higher rates of viral suppression.

The use of a three-in-one combination of the antiretroviral drugs tenofovir, lamivudine and dolutegravir (TLD for short) for the treatment of HIV was first recommended by the World Health Organization (WHO) in 2018. A year later it was recommended in the South African treatment guidelines as first line treatment for HIV and a three-year tender was awarded. Since then, dolutegravir has largely replaced another antiretroviral called efavirenz.

Today, TLD is the recommended treatment option for most people living with HIV in the country. The 2023 National antiretroviral (ARV) guidelines also include recommendations for the use of child-friendly formulations of dolutegravir and dolutegravir containing regimens in kids. Spotlight reported on these here.

Around 4.7m people in SA taking dolutegravir

According to Foster Mohale, spokesperson for the National Department of Health, in 2019 the HIV clinical guidelines were revised to include a fixed combination dose of TLD “for all eligible people for use as the first line regimen.”

Based on this, the department set a goal that 90% of those eligible for it should receive TLD as a first line regimen. In terms of meeting this goal, Mohale says that by March 2023, just over four million (4 127 427) people were on TLD. Additionally, about 650 000 (653 884) people were on other dolutegravir based regimens. Altogether, there are thus now over 4.7 million people in the country on treatment combinations that include dolutegravir.

“Based on the March 2023 data, 90% of clients on first line regimen were on TLD. However, performance varies by province,” he says.

Of the total number of people on ART in the public health sector, 75.8% are on TLD, according to Mohale.

Trends in the roll out

While on paper the country’s transition from efavirenz to dolutegravir-based regimens seems to have been smooth, the reality on the ground has been more complex. A study published in the Lancet earlier this year looked at real-world rollout data from 2019 to 2022. The study was conducted in 59 clinics across the country and collected data from two cohorts-one cohort were first time initiators of ART and the other were transitioning from regimens that did not include dolutegravir to ones that did.

In the initiator cohort, just over 45 000 people were initiated on ART between December 2019 and February 2022. Of those, 68.9% were initiated on dolutegravir-based regimens, 31.1% on efavirenz-based regimens, and 0.1% on nevirapine-based regimens.

Those initiated on dolutegravir-based regimens were more likely to still be on treatment a year later and were also more likely to be virally suppressed than those who were initiated on the other regimens.

In December 2019, in the transition cohort, just over 180 000 people were on a non-dolutegravir first line regimen. By February 2022, 67% of them had transitioned to a dolutegravir-based regimen. These people were also more likely to be retained in care at 12 months and be virologically suppressed than those who had not switched to a dolutegravir-based regimen.

“That’s good for a number of reasons. It means that the treatment’s working, people are less likely to get unwell and also, they can’t transmit the virus onto other people,” explains Dr Jienchi Dorward, one of the study authors and an academic clinical lecturer at the University of Oxford and honorary associate scientist at the Centre for the AIDS Programme of Research in South Africa (CAPRISA).

‘Bumpy transition’

Dr Yukteshwar Sookrajh, a Senior Medical Practitioner at the eThekwini Municipality Health Unit who was also involved in the study, tells Spotlight that the rollout quickly gathered momentum.

“But initially there were some issues to navigate around drug interactions; concurrent TB infection and the use of dolutegravir in women of childbearing potential,” he says. “Once those concerns were addressed, the comfort of switching to dolutegravir was increased and we find that the majority of our patients have now safely transitioned across to dolutegravir-based regimens.”

In many ways South Africa was slow in rolling out dolutegravir compared to other African countries, according to Professor Francois Venter, the head of Ezintsha at Wits University. Reasons for this, he says, include an initial concern around the safety of dolutegravir use among pregnant women, and disruption in training due to the COVID-19 pandemic.

He says that the South African Clinicians society was alerted during the COVID-19 pandemic that many patients in the public health sector had still not been transitioned to dolutegravir. An education campaign was then launched to encourage clinicians to start or switch patients to dolutegravir.

However, as it stands now the rollout of the drug in the public sector has been a huge success, despite what Venter calls a “bumpy transition”.

Initial safety concerns

One important reason to conduct the study reported in the Lancet, according to Dorward, was a safety concern regarding the use of dolutegravir by pregnant women. An earlier study conducted in Botswana called Tsepamo found a higher prevalence of neural-tube defects (a type of birth defect) associated with dolutegravir exposure at conception than with other types of antiretroviral exposure. As more data has been gathered since, it has however become clear that dolutegravir does not in fact increase the risk of neural-tube defects.

But the Tsepamo scare did impact who was initiated and transitioned onto dolutegravir in first two years of the rollout.

“The initial concerns around neural-tube defects and the use of dolutegravir in women of childbearing potential clearly hampered rollout of dolutegravir in women – and this has been clearly demonstrated in this study,” says Sookrajh.

The Lancet study found that pregnant women and non-pregnant women were less likely to be initiated on dolutegravir than men early in the rollout, with the biggest difference between women and men aged 15 to 24 years old. This difference decreased with age and by age 55 there was no difference between men and women receiving dolutegravir.

But this changed over time and by September 2021 women were as likely to get initiated on dolutegravir as men. Spotlight previously reported that the rollout was done in two stages. In the first stage men, adolescent boys, women on reliable contraception, and older women were prioritised.

Of those who started treatment during the study period, 46.9% of the pregnant women in the cohort were initiated on dolutegravir-based regimens, while 63.9% of the non-pregnant women and 82.3% of the men in the cohort were initiated on dolutegravir-based regimens.

“In both those groups [cohorts] we found that women were less likely than men to get dolutegravir, but interestingly, this was particularly in younger women,” Dorward explains. “As time went on, the difference between men and women became much less…around June to September 2021 was a time period where we found that women and men pretty much began to equally get dolutegravir.”

Dorward says the data showed an uptick in women in the study being given dolutegravir once the South African guidelines changed to reflect that there was no longer a concern around neural-tube defects. It is thus likely that the safety concern was responsible for the lower initial uptake among young women.

He adds that the messaging around this potential risk was based on the evidence available at the time and was clearly outlined in the guideline document and training for dolutegravir use, but these did not appear to adequately allay these concerns among healthcare workers.

“The risks versus benefits needed to be messaged in a more effective way such that healthcare workers were more comfortable and confident in offering dolutegravir to women,” he says. Based on this experience Sookrajh adds that in future there needs to be more engagement with “practitioners on the ground to determine what type of messaging and supportive materials are required to facilitate better understanding of guidelines at the coal face.”

Another concern for some healthcare workers has been that dolutegravir-based regimens have been associated with greater weight gain than efavirenz-based regimens. But, as argued in a recent editorial in the Southern African Journal of HIV medicine, association is not the same as causation and it may well be that efavirenz inhibits weight gain rather than dolutegravir promoting it. People living with HIV who start taking antiretroviral medicines often gain weight as their health recovers.

New guidelines should further boost uptake

Sookrajh says that the National Department of Health’s antiretroviral (ARV) 2023 guidelines will further improve the uptake of dolutegravir in the public healthcare system.

“With the April 2023 National Department of Health ARV Guidelines, we actually find that further barriers to switching to dolutegravir have been removed and dolutegravir is clearly placed as the preferred drug of choice in almost all scenarios for both first- and second-line antiretrovirals,” he says.

“I think the new [ARV] guidelines hopefully will be a big improvement for people who are on treatment, and part of that is possible because we’re using the drug that is better. You’re less likely to get resistance with dolutegravir so we’re less worried if people don’t take treatment properly that they might get drug resistance, although we still need more research to be sure about that,” Dorward says. “And it’s still very important for people to take treatment consistently to suppress the virus and maintain their own health and prevent onward transmission.”

According to Venter, there needs to be proper resistance surveillance to detect potential dolutegravir resistance.

“We can’t take for granted we’ll never have resistance [to dolutegravir]…eventually there will be the occasional patient that does have resistance, but we need proper surveillance there,” he says. “And then we need to keep an eye on things. There are still patients getting HIV…there’s still a lot of new infections…we need to make that stop…we’ve got amazing PrEP and way too few people getting it. So, we do need to start addressing that.” (PrEP, or pre-exposure prophylaxis, refers to antiretrovirals taken to prevent HIV infection.)

Venter adds that while successful in the public health sector, the uptake of dolutegravir has been extremely slow in the private health sector for reasons unknown to him.

Republished from Spotlight under a Creative Commons licence.

Source: Spotlight

Categories : HIV PaediatricsTags : 5/7/23 antiretroviral therapy HIV treatment South Africa Spotlight

SA AIDS 2023: New Treatments and Guidelines to Benefit Kids, with More Advances on The Horizon

On July 5, 2023 By ModernMedia

By Elri Voigt for Spotlight

Several sessions at the 11^th SA AIDS conference, recently held in Durban, highlighted the worrying fact that key HIV numbers such as treatment coverage are much lower in children than in adults. There is hope, however, that new treatments and new treatment guidelines might help close the gap.

In a plenary session, Dr Sandile Buthelezi, Director General of the National Department of Health, told delegates that on UNAIDS’ 95-95-95 targets, children in South Africa are at 81-65-68. This means that 81% of children living with HIV have been diagnosed, 65% of those diagnosed are on antiretroviral treatment, and 68% of those on treatment are virally suppressed. For the South African population as a whole, the numbers are at 94-76-92.

Throughout the conference, various speakers highlighted the fact that only 65% of children who have been diagnosed are on treatment as a particular concern. To close the gap and reach UNAIDS’ target of 95%, just over an additional 88 000 children would need to be initiated on treatment.

Professor Lee Fairlie, Director of Maternal and Child Health at Wits RHI, said in a presentation that only 52% of children younger than 14 living with HIV are on treatment. Fairlie also pointed out that children lagged behind substantially when it comes to viral suppression, and this is particularly challenging in the youngest age groups.

Not all bad news

But it was not all bad news at this year’s conference. One piece of good news is that new and better child-friendly antiretroviral formulations are being rolled out in South Africa. These new treatments should make it easier for children to start and stay on treatment – children often find it difficult to take medicines formulated for adults, due to factors like incorrect dosing, large pills, and bad taste.

The National Department of Health recently updated the country’s antiretroviral treatment guidelines to allow for the use of several of these new formulations and better HIV treatment regimens for children. Most notable is the introduction of a new regimen consisting of the medicines abacavir, lamivudine and dolutegravir (ALD for short).

Speaking at the conference, Dr Leon Levin, a paediatrician who has been treating infants, children, and adolescents living with HIV for almost three decades, pointed out that the availability of new paediatric formulations had a major impact on the new treatment guidelines. (Spotlight previously reported on the registration of some of these new formulations here.) Levin is also the Senior Technical Advisor in Paediatrics at the NGO Right to Care.

One such child-friendly formulation is a 120/60mg scored, dispersible tablet of abacavir and lamivudine that can be taken in patients who weigh between 3 and 25kg. It is given once daily and two generics are registered with the South African Regulatory Authority (SAHPRA). “It’s going to literally replace all the other paediatric Abacavir+3TC formulations. You can swallow it, chew it, crush it, or dissolve it in water. So [it’s] very versatile,” he said.

Also important is a paediatric formulation of the antiretroviral dolutegravir – a medicine that forms the backbone of HIV treatment in adults. According to Levin, the child-friendly version of dolutegravir is not available to everyone yet, and many clinicians still need to undergo training on how to use it. It is a 10mg dispersible, scored tablet given once daily that can be used at 3kg and higher and from four weeks of age onward. There are two generic versions of this product registered with SAHPRA.

The introduction of paediatric dolutegravir is likely to overshadow the introduction of a four-in-one formulation of abacavir, lamivudine, lopinavir/ritonavir. The four-in-one combination has to be taken twice daily, is strawberry flavoured and comes in a powder form. “Unfortunately, this product to nobody’s fault was launched at the same time as paediatric dolutegravir. Which means paediatric dolutegravir is going to take centre stage and this product unfortunately is not going to be used much,” Levin said.

Updated guidelines

Levin explained that the changes to South Africa’s treatment guidelines focused on doing two main things when it comes to children living with HIV, the first is to implement an optimised regimen – the ALD regimen and the second is to create an “enabling environment to support engagement in care and adherence”. He said that with the new guidelines, we can expect “much improved [viral] suppression, optimised regimens, improved synchronisation of clinic visits, happier patients and their families and clinicians as well”.

A big change to the guidelines is that now children who weigh 3kg and are four weeks of age should be started on the ALD regimen, instead of the abacavir, lamivudine, and lopinavir/ritonavir regimen that was previously recommended. “This is a major change. It’s a fantastic, well-tolerated regimen. It’s potent and you’re going to get around a lot of the issues you had with these younger children,” Levin said.

Once the children on this regimen get to 30kg, they will be switched to a regimen containing tenofovir, dolutegravir, and lamivudine (TLD for short). TLD is also the regimen adults living with HIV in South Africa are offered when starting treatment for the first time.

For children who are already on treatment, the new guidelines recommend that all children who are four weeks of age and older and weigh 3kg or more should be transitioned to a dolutegravir-containing regimen. For children with suppressed viral loads, the switch to ALD or TLD is straightforward, while for children without viral suppression, it can get more complicated.

Another important change is that children over five years of age are now eligible for Repeat Prescription Collection Strategies (RPCs) if they are virally suppressed and had an age-appropriate disclosure, which means that their HIV status has been explained to them in a way that is appropriate for their age, as outlined in the guidelines. For children under five, they can be given a three months supply at a time, providing they are at least six months old. Levin pointed out that whenever RCPs or a three months supply is considered for children, it is essential to look at where and how the parents may be receiving their own antiretroviral treatment so that it can be co-ordinated, and parents don’t have to go to two different places to collect the medications.

New options in the pipeline

While the paediatric formulations included in the new guidelines are a step forward, there are experimental treatments in the pipeline that may make treatment yet more convenient for children.

“There’s a rich pipeline of new combinations and drug delivery developments. Hopefully, this will further improve access, clinical and virological outcomes,” Fairlie said in a conference presentation. “Obviously, the paediatric market is extremely small and then one has to maintain enthusiasm for manufacturers to actually continue to look at the paediatric population. And so, merging of treatments and prophylaxis regimens is really what would work going forwards.”

In her presentation, she specifically referred to long-acting formulations of cabotegravir (CAB-LA) and rilpivirine (RPV). CAB-LA has already been approved by SAHPRA for HIV prevention in adults and, as Spotlight reported last week, pilot projects evaluating how to best provide the CAB-LA injection in South Africa are set to start soon. The combination of CAB-LA and rilpivirine injections has been approved for the treatment of HIV in adults by the United States Food and Drug Administration, but not yet by SAHPRA. The injections are administered every two months.

Fairlie says that currently there are several studies either ongoing or set to start soon for the use of these agents in the paediatric and adolescent age groups. In addition, there are also trials planned to test another long-acting medication called lenacapavir in adolescents and broadly neutralising antibodies (bNAbs) in children.

She also highlighted several improved delivery methods that are in the pipeline for paediatrics. These include a mechanism that doesn’t require water, like oro-dispersible tablets, also known as fast melts, which disintegrate in the mouth as well as oral films that stick to the mouth, disintegrate there, and dissolve. There are also various tablet options that are small enough for children to swallow easily. Like multi-particulates, which are small and solid, multiple-unit dosages that can take the form of granules, pellets, or beads. Mini-tablets are also a prospect – these are compressed tablets no larger than 4ml. Finally, there are novel mechanisms like long-acting oral drug delivery systems and micro-array patches. Fairlie explained that long-acting oral drugs are where a drug is stored in the centre of a capsule that has a number of “arms”, which are able to keep the capsule in the stomach and slowly dissolve and release the drug into the stomach. This allows for slow-release dosing. The “arms” tend to break down after about seven days.

Republished from Spotlight under a Creative Commons Licence.

Source: Spotlight

Categories : General Interest Medical Research & TechnologyTags : 3/7/23 South Africa Spotlight University of Cape Town

Face to Face: “Fail your way to success”, Says Prof Behind Pioneering Drug Discovery Group at UCT

On July 3, 2023July 3, 2023 By ModernMedia

Technical work on the discovery of new medicines is not commonly done in Africa, but Kelly Chibale, a professor in organic chemistry and founder of H3D at the University of Cape Town is changing this. PHOTO: Nasief Manie/Spotlight

By Biénne Huisman for Spotlight

Inside Professor Kelly Chibale’s office the bookshelves are packed with awards. On the walls, framed photographs include his class photo at Cambridge University in the United Kingdom, dated 1989.

Chibale is a professor of organic chemistry and founder of the pioneering Holistic Drug Discovery and Development Centre – H3D – at the University of Cape Town. While many important clinical trials have been conducted by Africans in Africa, the kind of drug discovery work that Chibale is doing is rare on the continent.

Chibale relays how he sees molecules everywhere – in hair, in clothes, in all of life around us. His animated voice fills the space as he speaks. “With organic chemistry, we are very visual. We look at chemical structures. If you give me a chemical structure, oh my goodness, my head starts racing about what I can do with it, or how I can change it to create new properties or new materials.”

H3D has 76 staff members investigating novel chemical compounds that could become new lifesaving medicines, with a focus on malaria, tuberculosis, and antibiotic-resistant microbial diseases.

Effectively a small biotech company embedded within the university, to date, H3D’s most notable discovery was a compound in 2012 which they named MMV390048, which had the potential to become a single-dose cure for malaria. Phase I clinical trials saw MMV390048 tested on human volunteers in South Africa and in Australia.

“In Australia, the testing model used is a volunteer infection study where human beings volunteer to be injected with the malaria parasite, which they know can be treated using available medicines,” says Chibale. “And then a section of those are given the experimental drug. And it worked beautifully there.”

‘Fail your way to success’

He adds, “People don’t realise this – there’s no medicine that will be given to people if it wasn’t tested on people first. Even me as an African. Oh man, I suffered from malaria as a child in Zambia many times. Thanks to our government then I’d be taken to a health facility and get malaria tablets, which I took and got well again. Otherwise, I would have died. Malaria kills very quickly. Now this is something I didn’t know then, something I took for granted. Only much later in life did I realise, goodness the medicine I took – someone somewhere invested in its research and development. And someone, somewhere, another human being, volunteered for that drug to be tested on them for my benefit.”

In 2017, the compound made it to Phase II clinical trials in patients with the disease, but further development was halted in 2020 when extensive further tests showed toxicity signals in rats – not rabbits though, Chibale says, adding that they had to err on the side of caution.

“In drug discovery, you have to kiss many frogs before you meet the prince,” he says. “Many drugs fail to progress. People focus on one product that makes it onto the market, right? But there are many failures that don’t even see the light of day. In this industry, you fail your way to success.”

H3D’s most notable discovery was a compound in 2012 which they named MMV390048, which had the potential to become a single-dose cure for malaria. PHOTO: Nasief Manie/Spotlight

Their work continues. In April last year at a function at Cape Town’s Vineyard Hotel, multinational pharmaceutical company Johnson & Johnson announced H3D as one of its three satellite centres for global health discovery. The other centres are in London and Singapore. At the time, Johnson & Johnson stated, “Driven by some of the leading researchers in Africa and discovery science, the satellite center [H3D] is focused on outpacing the rising threat of antimicrobial resistance by accelerating innovation against multidrug-resistance gram-negative bacteria.”

Seated at a boardroom table in his office, Chibale laughs deep from his belly. “We associate Johnson & Johnson with baby powder, but there’s much more…”

His left arm is in a sling following shoulder surgery – an injury stemming from lockdown when he slipped and fell while hiking on Table Mountain. “It happened just here, above the university,” he gestures, with his other arm.

Chibale and his wife Bertha live on the university’s campus, where he has served as warden of student residence Upper Campus Residence, formerly Smuts Hall, since 2015. Here he weathered the #rhodesmustfall and #feesmustfall protests, which saw students torch vehicles and police deploy stun grenades a stone’s throw away from his home.

Referring to his injured arm, he says at least his writing arm wasn’t hurt and that he can still type with one hand.

From a village in Zambia

Mentions of gratitude underpin the story of his journey, which starts in a village without electricity or running water in Zambia’s Mpika district. His father died when he was two months old. Laughing, he relays how hearing in his one ear is still impaired after being ambushed as a kid while stealing mangoes.

“This was a township,” he says. “So I’m climbing up a tree to steal mangoes and I was coming down. This gang, or well guys who were playful, had surrounded us. There were only about four of us, of who three managed to escape. And I was the only one left. Oh my goodness. And they took a big rock and smashed it to my ear. And then, when they saw me bleeding, they actually ran away. They were so scared of the damage they had done. Oh, that day! Anyway, so I went home and lied to my mother and said, no I went to school and tripped over a hole.”

During high school classes, thanks to an excellent teacher, he became fascinated with chemistry experiments. He went on to study organic chemistry at the University of Zambia, where he fell in love with the logical nature of organic molecules. “These things cannot be planned. I simply fell in love with organic chemistry, in the same way I fell in love with my wife Bertha,” he says.

From early on he realised education was a way out of poverty. “To get out of poverty, you either play sport or you follow education,” he says. “So I started applying for scholarships, writing letters to universities around the world. And I got rejected. I kept applying and kept on being rejected. But I didn’t give up. I kept applying.”

His first job was at Kafironda Explosives in the mining town Mufulira, on Zambia’s Copperbelt, where he made detonators, dynamite, and other explosives for use in Zambian mines. Laughing, he says this would come to haunt him later while applying for a visa to enter the United States. “There was a section on the form where you had to declare whether you’ve worked with explosives,” he says. “Of course, I said ‘yes’, and fortunately nothing happened.”

During two years at Kafironda, he continued applying for scholarships. “And I remember this,” he says. “It was January of 1989. I got a letter saying you have been shortlisted for a Cambridge Livingstone Trust Scholarship. Please present yourself for an interview on the 26th of January at the Anglo-American Corporation offices in Harare, Zimbabwe… So that was my first time out of Zambia. The first time to fly on an aeroplane.”

‘This was my turn’

Competition for the scholarship was tight, with shortlisted candidates from several African countries. “So in that year, there were six of us from Zambia, from different disciplines. I was the only scientist. And of course, I’d been failing all this time, getting rejected. But this was my turn. It was God’s appointed time for me. Actually, I was the only successful candidate.”

At Cambridge, without having completed an honours or master’s degree, Chibale enrolled for a PhD under the late organic chemist Professor Stuart Warren. “So Stuart, this amazing, incredible man, just gave me a chance. I mean there was such a gap between me and my colleagues who had all done their undergraduates at Cambridge. But in life, you can moan and complain about a disadvantage, or you can turn it into a challenge. I mean, the first three to six months were rough. Stuart would recommend to me that I sneak into first-year undergraduate classes to catch up. Stuart, he saw something in me that I didn’t even see in myself, and really gave me a chance.”

Chibale’s work at Warren’s lab, developing new synthetic methods for optically active molecules, helped secure his first post-doctoral position at the University of Liverpool, in the United Kingdom, after which he joined the Scripps Research Institute in La Jolla, California, funded through a Wellcome Trust International Prize Travelling Research Fellowship.

“That was another miracle,” he says. “I was eligible for this fellowship only because I had lived in England for three years, which was a minimum requirement. And the scholarship was so good, it even gave me an allowance for my family. I haven’t forgotten. It was 1 000 pounds per month. In those days, the pound was much stronger than the US dollar. So I went from rags to riches. In Liverpool, I was walking most of the time while in California, I actually had a car!”

Over the years, he was gaining insight into the pharmaceutical sector – the science but also the entrepreneurial side that pushes innovation, all the while longing to bring this knowledge to Africa. Peers suggested he consider South Africa, and particularly the University of Cape Town [UCT]. Around 1994, then UCT Department of Chemistry head, Professor James Bull actually made Chibale an offer to pursue postdoctoral research – which he declined. “Because I thought there was going to be a civil war in South Africa! I remember watching the release of Nelson Mandela on TV in England, quiet, just watching.”

Towards the end of 1995, inside a copy of the British scientific journal Nature, Chibale found an advertisement for a position as a lecturer in organic chemistry at UCT and applied. “It was a calling,” he says. The family moved to Cape Town.

Then in 2010 at UCT, with five post-doctoral staff, Chibale founded H3D. At the time his mentors included Dr Anthony Wood, former Pfizer senior vice-president, now head of GlaxoSmithKline’s Research and Development, who arranged for Chibale to have a four-month sabbatical with Pfizer in the United Kingdom to learn about the practicalities of innovative pharma. Thirteen years later, H3D has blossomed.

Chibale says he is a Christian as well as a soccer and boxing fan. His wife Bertha runs a Cape Town catering business called Hearts and Tarts. They have three sons.

As the interview draws to a close, he looks up at his 1989 Cambridge class photo. “You won’t believe it,” he says. “Last year I visited my college at Cambridge with my wife and second son and they pulled out a copy of my handwritten scholarship application letter, written to them from Zambia all those years back.”

This precious relic of Chibale’s journey is not in his office. He keeps it on his desk at home.

Republished from Spotlight under a Creative Commons 4.0 Licence.

Source: Spotlight

Categories : Gender HIVTags : 30/6/23 HIV treatment opinion piece public health South Africa Spotlight

OPINION: With the Right Interventions We can Help Many More Men Start and Stay on HIV Treatment

On June 30, 2023June 30, 2023 By ModernMedia

By Shawn Malone for Spotlight

June is Men’s Health Month and while the focus is mostly on men’s attitudes about their health, it is also worth reflecting on the health sector’s attitudes toward men.

We hear many stereotypes about men and health, but how many of those are actually true?

A few years ago representatives of The Mpilo Project spoke to more than 2 000 men in KwaZulu-Natal and Mpumalanga to understand why many find it hard to engage with HIV testing and treatment. We uncovered several myths and misperceptions in the process.

One common myth is that men are stubborn and apathetic about HIV – that they aren’t listening and don’t care. While many men may indeed wear a mask of indifference, HIV leaves many of them feeling paralysed by fear and anxiety. This is why we need a health service delivery approach rooted in encouragement and reassurance, not scolding and pressure.

Another common misconception is that men are mainly just workers who need practical solutions like convenient clinic hours and quick service. The reality is that men are complex human beings who face social and emotional barriers as well as practical ones. We need solutions that address both practical and psychosocial barriers.

There is also a view that sources of support are available and that men just fail to access them, perhaps because “they don’t really want support”. In fact, many men are hungry for support but see no sources that feel safe or relatable. They experience counselling as scripted, one-directional, overly technical, and often judgmental. The key is to give men the right sources of support and to speak empathetically to their individual issues and concerns.

Finally, there is a view that healthcare providers are helping men by taking proactive approaches like provider-initiated testing and tracking-tracing. But these often leave men feeling hunted and ambushed by the health system. We need proactive approaches that leave men feeling like they still have control over their own lives and decisions and help them develop their own internal motivation to start and stay on treatment.

These and other misconceptions can lead healthcare providers to conclude that men are simply difficult if not impossible to reach. But once we understand their barriers, that picture changes dramatically.

The 11^th SA AIDS Conference concluded last week and in one of the plenary sessions we had the opportunity to respond to the question: “Strategies for reaching men—are we seeing a return on investment?”

The short answer is yes!

Since 2017, the percentage of men with HIV in South Africa who know their status has increased from 78% to 94%, nearly on par with women. We can attribute that in part to approaches like HIV self-testing that have made it quick, easy, and private for men to learn their status.

We’ve also seen good progress on viral suppression, which has increased from 82% to 93%, again comparable to the rate among women – proof that men on treatment are fully capable of being adherent.

Yet only 70% of men who know they have HIV are currently on treatment – hardly any increase at all from 68% in 2017.

Given the progress we’ve seen in men testing for HIV and achieving viral suppression, the persistent gap in men on treatment suggests that something is wrong – not with men but with the HIV treatment services and support we are offering them.

The good news

The good news is that we know much more than we did a few years ago about what works. Here are three examples.

The MINA campaign aims to reach men with “the new HIV story” by featuring stories from real men living a healthy, happy life with HIV on social media, television, radio, billboards, etc. The campaign also helps men feel more welcome in the clinic, using signage and materials to send the signal to men that “this is your space too”. MINA-supported districts and facilities have seen strong growth in testing and linkage, as well as modest improvement in retention in care.

The Coach Mpilo model employs men who are thriving with HIV as coaches of men at risk of non-initiation or disengagement. Coaches provide a safe, relatable source of support and serve as living proof that HIV is not the end of the road. Piloted in 2020 and currently implemented in 18 districts, the model is achieving 97% linkage to care and 94% retention.

The B-OK bead bottles are a simple visual tool for helping people to understand the benefits of HIV treatment and viral suppression and, more importantly, to build the motivation to start and stay on treatment. Red beads are HIV; black beads are healthy cells. A mixed bottle represents most people upon diagnosis. A red bottle represents the virus multiplying uncontrolled in the absence of treatment. A black bottle with one red bead represents viral suppression achieved through treatment adherence. In an evaluation of the tool, understanding of how HIV treatment works increased from 12.5% to 92.5%.

Men are not indifferent about their health and they are not inherently poor health-seekers. If many of them are avoiding healthcare services, let’s consider that it may be because they are not getting what they need from these services.

We have seen that men do engage when we in the public health sector meet them where they are rather than where we want them to be; when we speak to their needs and priorities rather than ours; when we give them the right sources of support rather than one-size-fits-all, and when we help them build understanding and motivation rather than simply instructing.

When we invest, we see returns. Let’s keep investing in scaling what works.

*Malone is the Project Director of The Mpilo Project, PSI.

Reproduced from Spotlight under a Creative Commons 4.0 Licence.

Source: Spotlight

Categories : Antibiotics PaediatricsTags : 13/6/23 antibiotic resistance neonates Spotlight

Antibiotic-resistant Bugs Claim Over 200 000 Infants Globally per Year, Finds Major Study

On June 13, 2023June 13, 2023 By ModernMedia

By Adele Baleta for Spotlight

“The death of a child affects us all. Witnessing the loss of a newborn baby who has sepsis is terribly traumatic, especially so when antibiotics used to treat the child are ineffective,” says neonatologist Professor Sithembiso Velaphi.

“It’s very heavy for a mother to carry her baby, give birth, watch as her newborn gets seriously sick from infection, suffers while being pricked with drips and pumped with drugs to try and save the child – only for her to leave the hospital empty handed. It’s painful,” says Velaphi, who is the head of Paediatrics at Chris Hani Baragwanath Academic Hospital in Johannesburg.

***Professor Sithembiso Velaphi, head of Paediatrics at Chris Hani Baragwanath Academic Hospital in Johannesburg. PHOTO: Kim Cloete for GARDP***

Nurses and doctors feel sad and crushed too when they cannot save a newborn’s life because of antibiotic resistance to bacterial infections. “We need to prioritise the development of antibiotics to treat these babies. For us, success is seeing a baby get better and going home,” he says.

Velaphi was speaking to Spotlight about a landmark global observational study published in the journal Plos Medicine (June 8) which found that many neonates (within 60 days of birth) get life-threatening bloodstream infections, or sepsis, and are dying because the antibiotics used to treat them are not effective. This is the first global overview to assess the extent of the problem. Spotlight last year reported on interim findings from the same study.

The study, called NeoOBS, led by the Global Antibiotic Research and Development Partnership (GARDP) recruited more than 3 200 babies in 19 hospitals in 11 countries – South Africa, Kenya, Uganda, Thailand, Vietnam, India, Greece, Italy, Bangladesh, Brazil, and China.

The researchers reported great variability in mortality rates of babies with sepsis across the 19 hospitals, ranging from 1% to 27.3%.

Sepsis affects up to 3 million babies a year globally. Importantly, the study’s 80 authors estimate that 214 000 newborns die every year from sepsis that has become antibiotic resistant, and this is mostly in low- to middle-income countries (LMIC). Many survivors suffer from neurodevelopmental problems. Treatment options have become increasingly limited as about 40% of infections are reported to be resistant to standard antibiotic treatments.

Many infections acquired in hospital

Almost 60% of infection-related deaths were due to infections acquired at the 19 hospitals under review. Klebsiella pneumoniae was the most common pathogen isolated.

Of the 40 antibiotics approved for use in adults since 2000, only four have included dosing information for neonates in their labelling. Currently, 43 adult antibiotic clinical trials are recruiting patients, compared to only six trials recruiting neonates, researchers say.

New antibiotic treatments are urgently needed, especially in LMICs where almost 1 in 5 babies with sepsis died. Premature babies are particularly vulnerable to infections because of their immature immune systems.

More than 200 different antibiotic combinations were used by hospitals included in the NeoOBS study, with repeated switching of antibiotics due to high resistance to treatments. This showed a pattern of limited use of the World Health Organization’s recommended first-line treatment.

Many doctors have had to opt for last-line antibiotics such as carbapenems because of the high degree of antibiotic resistance in their units or because they were the only treatment available.

Outlining various challenges, Velaphi says the risk of infections is very high in hospital settings where there is often a shortage of nurses, beds, and space between patients making it difficult to stop the spread of infection. Chris Hani Baragwanath has an 18-bed Intensive Care Unit (ICU) that is almost always full and when the situation is desperate there is a spillover of patients into the high-care area. The pressure on the facility is huge and the influx of people from other countries has made it even more challenging, he says.

“There is a major problem of infection control, specifically related to high-risk babies – sick babies with complications who need interventions such as drips and even surgery. This increases the chances of infection. “More than 70% of all deaths ascribed to prematurity at the hospital were due to hospital-acquired multi-drug resistant infections,” he says.

The NeoSep 1 trial

The authors say the NeoOBS study has yielded “a wealth of high-quality data” needed to design trials for much-needed and appropriate treatments for sepsis in babies. Encouragingly, and building on from the observational study the first global hospital-based neonatal sepsis trial called NeoSep 1 is underway in Kenya and South Africa. Chris Hani Baragwanath is taking part in the trial together with Tygerberg Hospital in Cape Town and KEMRI, Kilifi County Hospital in Kenya. It’s planned that the trial will be expanded to other countries and regions in 2024 with the aim of recruiting 3 000 newborns.

A Personalised Randomised Controlled Trial (PRACTical) design will be used. According to GARDP and partners the design is a new way of comparing antibiotic treatments for neonatal sepsis. In addition, doctors can choose treatment regimens that are likely to work well for newborns in their specific hospital settings.

Researchers say the development pipeline for new antibiotic treatments is limited and the lack of a universal, effective standard of care creates huge challenges in conducting research to tackle neonatal sepsis. The PRACTical design has been specifically developed to address these challenges in important public health emergencies such as neonatal sepsis. (You can read more about how this type of trial works in the Lancet.)

The trial will compare the safety and efficacy of three new combinations of older antibiotics (fosfomycin-amikacin, flomoxef-amikacin, and flomoxef-fosfomycin) against the current standard of care. It will also assess and validate the doses of two antibiotics (fosfomycin and flomoxef) for use in newborns. The trial will also evaluate new combinations of generic antibiotics.

“We are hoping the trial will provide robust evidence that the antibiotic combinations are safe and effective and that this will lead to a change in both WHO and local treatment guidelines,” says Christina Obiero, Principal Investigator for the NeoSep1 trial for KEMRI at Kilifi County Hospital in a statement.

Severity and recovery scores

Principal Investigator for the NeoSep1 trial at Tygerberg Hospital, Professor Adrie Bekker tells Spotlight, “We have so few antibiotics that work effectively against these very sick babies. And even for those that we have, we are still not 100% sure how to dose these drugs to get accurate concentrations in the blood and to also make sure that the outcomes in these babies are as good as can be. This trial will help give us confidence that we are delivering more effective treatment.”

Bekker who is also Professor in the Division of Neonatology, Department of Paediatrics and Child Health at Stellenbosch University says a positive outcome of the NeoOBS study is the development of two important tools which can be used in ICUs globally.

The first is the NeoSep Severity Score which is a compilation of common symptoms and signs that can occur in a baby with clinical sepsis. The second is the NeoSep Recovery Score, which will assist clinicians in deciding if they can stop antibiotics earlier.

The tools are expected to help prevent the often excessive and inappropriate use of antibiotics for over too long a period, which compounds the problem of antibiotic resistance globally.

Diagnosis in older age groups, children, and adults, is generally easier.

“It’s sometimes difficult for a clinician to know whether a baby actually has neonatal sepsis because it can present very subtly and not always with the same symptoms,” Bekker explains.

The blood culture is the gold standard for diagnosing neonatal sepsis, but Bekker says only around 10% of blood cultures will grow an organism even if the baby has sepsis, making it very difficult to get a diagnosis. “And because it’s such an aggressive disease and a baby can die very quickly from it, clinicians tend to rather over-treat than under-treat. That is correct but, just as important as it is to start antibiotics quickly, it’s important to stop them if they are not necessary. The NeoSeps Severity score will help doctors identify babies that are at very high risk from sepsis and those that would need treatment immediately.

Velaphi says a major challenge is the time it takes for an outcome of the blood culture and the general protocol is to start antibiotics immediately. Waiting between 24 to 48 hours can be too late for a child who may have sepsis and could die. On the other hand, antibiotics may be given to children who do not have sepsis and this adds to the frequency of antibiotic resistance. “So, you are damned if you do and you are damned if you don’t.”

He says we need new diagnostic tests that are reliable and that have a high degree of sensitivity and specificity. “We need antibiotics that work to reduce mortality,” he adds.

Republished from Spotlight under a Creative Commons NoDerivatives 4.0 Licence.

Source: Spotlight

Categories : Respiratory DiseasesTags : 6/6/23 HIV liver disease public health South Africa Spotlight

The Complex Interplay Between TB and Liver Problems

On June 6, 2023 By ModernMedia

By Tiyese Jeranji for Spotlight

People in South Africa who fall ill with tuberculosis (TB) often also have other health issues. HIV, which drives much of the TB epidemic in South Africa, is the most obvious co-infection, but people who fall ill with TB are also more likely to have diabetes and mental health problems than the general public.

Another issue that is often mentioned at conferences and in journal articles, but that doesn’t often make the headlines, is the complex set of links between TB and liver problems. With the World Health Organization estimating that in the region of 300 000 people fall ill with TB in South Africa every year, the scale of the issue is likely to be substantial, although we do not have particularly good data on liver problems in South Africa, and even less so on people experiencing TB and liver problems together.

Complex interactions

Broadly speaking, the link between TB and the liver can be divided into two categories. First, there are the liver-related side effects of some TB treatments, and second, there is the interaction between TB and liver conditions such as viral hepatitis. In some cases, TB itself can also cause liver problems directly.

Start with hepatitis. Dr Louisa Dunn, Think TB Provincial TB Technical Lead in KwaZulu-Natal, explains that hepatitis is a general term meaning inflammation of the liver. She says that there are many causes of hepatitis, such as infections, alcohol, or an overdose of certain medications. There is also autoimmune hepatitis, where a person’s own immune system is attacking the liver. “Even lifestyle can cause inflammation in the liver from a build-up of fatty tissue, which is more common in people who are overweight and obese,” she says.

Infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are thought to cause significant illness and death in South Africa. According to a study published in 2022, over 1.9 million people in South Africa are living with chronic HBV infection – earlier research put the number at 3.5 million. HBV can be treated and there is an effective childhood vaccine for it that has been used in South Africa since 1995.

Estimates for HCV are less certain than for HBV – an estimate of 400 000 chronic infections was quoted in an HBV and HCV investment case for South Africa. Highly effective cures for HCV infection have been developed over the last decade, although access to these cures remains limited. The Department of Health published viral hepatitis treatment guidelines in December 2019.

Given these numbers, some people in South Africa would simply, by chance, get both TB and hepatitis. But since there are common risk factors, co-infection will be higher than what one would expect purely through chance. HIV infection, for example, increases both a person’s risk of TB and HCV.

“There is no data from South Africa about viral hepatitis and TB co-infection that I am aware of,” says Dr Andrew Scheibe, a Technical Advisor for TB HIV Care and an infectious disease specialist at the University of Pretoria. He points out that people who use drugs and other groups of people who are marginalised, including people experiencing homelessness or people in prison, are at increased risk for these co-infections. The risk of HCV transmission is particularly high when people who inject drugs share needles.

In addition, as Dunn points out, TB itself can also cause hepatitis.

Hepatotoxicity

The picture is further complicated by the fact that several of the medicines used to cure TB have liver-related side effects. Drug-sensitive TB is treated with a combination of four different medicines, while drug-resistant TB is treated with anything from three to eight different medicines.

“Medications used to treat both drug-sensitive and drug-resistant TB can cause hepatitis through drug-induced liver toxicity (hepatotoxicity),” says Dunn. “The presence of other risk factors may further increase the risk of hepatitis in TB patients. These risk factors could be alcohol use, older age, malnutrition, co-infection with HIV or viral Hepatitis B, and taking other potentially hepatotoxic drugs with TB treatment.”

Wieda Human, project coordinator and communications officer at TB advocacy group TB Proof says 3 to 28% of people with TB may experience hepatotoxicity and other side effects. “Those who are already infected with the hepatitis B infection are at an increased risk for hepatotoxicity,” she says.

She refers to a study done in Ethiopia that found having hepatitis B and hepatitis C infection made having TB disease more severe. “This study also found that people with TB who have hazardous alcohol use have a 1.5 times increased risk of developing hepatitis C,” says Human.

What it means for treatment

Dunn says although it is less straightforward to treat a person with TB and hepatitis than a person with just TB, it is important to understand treatment is still available. “It involves establishing the cause for hepatitis and treating this where possible, for instance, treating a viral hepatitis [and TB] co-infection at the same time or [providing] support to reduce alcohol intake. It may involve closer monitoring and follow-up, changes to medications, including stopping treatments either permanently or temporarily, and using alternative more ‘liver-friendly’ treatment regimens,” she says.

“If the hepatitis is stable, then TB can be treated,” Scheibe says. He explains hepatitis B requires long-term treatment (there is no cure), while hepatitis C can be cured with direct-acting antivirals (recently registered in SA, but not yet on the Government Essential Medicines List, so not easily available in the public sector). He says HCV treatment may be delayed until the TB is cured.

No routine screening

South Africa’s National Strategic Plan for HIV, TB, and STIs 2023-2028 under Goal 2 sets out to reduce viral hepatitis morbidity through scale-up of prevention, diagnostic testing, and treatment. However, according to Dunn, screening for viral hepatitis infections, such as HBV, is not part of the current drug-sensitive or drug-resistant TB guidelines.

But she says everyone should be assessed for symptoms and risk factors for liver disease at the start of TB treatment – a sentiment Scheibe shares. According to them, these screenings are however performed at diagnosis of HIV infection before a person is commenced on antiretroviral treatment for HIV, as chronic hepatitis B infection has specific implications for HIV treatment.

“During [TB] treatment, it is critical that clinicians assess people for signs and symptoms that may suggest hepatitis at each visit and educate them on recognising these side effects as well,” says Dunn. “This includes loss of appetite, feeling tired and unwell, nausea, vomiting, abdominal pains, yellowing of the eyes and skin, and darkening of urine.”

Treatment guidelines for drug-induced liver injury are available here. The guidelines focus on the management of suspected drug-induced rash, kidney injury, and liver injury for patients on TB treatment and or antiretroviral treatment.

Scheibe adds that people at high risk for HCV should receive TB screening regularly due to potential exposure to TB (eg if living in closed settings with many people in contexts of high TB prevalence and /or with HIV co-infection).

Republished from Spotlight under a Creative Commons 4.0 Licence.

Source: Spotlight

Categories : Hospitals Surgeries & ProceduresTags : 31/5/23 Gift of the Givers Groot Schuur Hospital public health South Africa Spotlight

Groote Schuur Hospital Clears Backlog of 1 500 Surgeries

On May 31, 2023May 31, 2023 By ModernMedia

By Elri Voigt for Spotlight

Much of South Africa’s public health sector is plagued by long waiting times for surgery, a situation that was made much worse by the COVID-19 pandemic. Now, an inspiring project at Groote Schuur Hospital in Cape Town has reached the target of slashing its backlog by 1 500 elective surgeries – two months ahead of target.

At the end of March, a small team of healthcare workers completed the project called ‘Surgical Recovery’. The project ran from May 2022 and was originally planned to conclude 12 months later.

While this hasn’t cleared the entire backlog of people waiting for surgery at Groote Schuur, it has helped the hospital return to about the same waiting list level as it had before the COVID-19 pandemic, according to Professor Lydia Cairncross, the head of general surgery at Groote Schuur. (Spotlight previously reported on the human cost of surgical waiting lists and on what could be done about it.)

The surgeries took place mainly in the E4 Surgical Day Ward at Groote Schuur. Cairncross explains that ward E4 was built as a Day Ward – meaning it handles surgeries where patients don’t require an overnight stay pre- or post-surgery – with the aim of increasing daycare surgery capacity for the hospital. And for the last 12 months, it has been the host of the Surgical Recovery Project.

E4 has 16 patient beds, four recovery beds, and two theatres, which were completed just as the COVID-19 pandemic hit the country. During the third wave of the pandemic, it was used as a COVID High Care Unit.

According to Dr Shrikant Peters, a public health specialist and the medical manager of theatre and ICU services at Groote Schuur, the hospital’s CEO Dr Bhavna Patel “had the foresight to request provincial use of COVID funding to develop the space as COVID High Care, and eventually to be used long-term as an Operating Suite and High Care Ward in line with prior hospital plans”.

The Surgical Recovery Project

By the end of the third wave of the COVID-19 pandemic, according to Cairncross, there were discussions about how to catch up on the surgeries that had to be postponed because of COVID-19.

“The backlog in surgery comes on top of a pre-existing backlog. So, it’s not that the backlog was created by COVID, but it made it much, much, much worse,” she says, “In November 2021, we did an audit of how many patients were just physically waiting for surgery at the hospital. It was around 6 000 plus. We don’t actually have a baseline for pre-COVID, but we knew that we lost about 50% of our operating capacity,” Cairncross says.

“So, the idea was really to find a way to utilise this theatre space so that we could catch up with some of that backlog.”

From here, the Surgical Recovery Project for Groote Schuur was born with the ambitious target of performing 1 500 surgeries in 12 months.

Funds from the project came from three sources. Kristy Evans, head of the Groote Schuur Hospital Trust, tells Spotlight that fundraising for the project was kick-started by a R5 million donation from Gift of the Givers. The recently established Groote Schuur Hospital Trust focused on Surgical Recovery as their first project to fundraise for. An additional R1 million was raised by the Trust from over 500 corporate and private donors.

“People are always willing… [they] give what they can. We had donations from people who would transfer R10 into the account, sometimes people transfer R180 000,” Evans says.

She adds that the Project will continue into its second year, but the details regarding targets had not yet been finalised by the time of publication.

The Western Cape Provincial Department of Health also donated around R6.5 million to the project from their budget for surgical recovery post-COVID-19. According to Mark van der Heever, the provincial health spokesperson, this money was part of the R20 million that the department allocated to various surgical backlog recovery initiatives.

“[The] COVID-19 pandemic meant that elective surgical services had to be significantly de-escalated, as staff were deployed to COVID services, and this resulted in an increase in the backlog of operations. Hence, a specific practi[cal] plan to address this backlog in the short and long term has been developed,” says van der Heever. “Similar projects and initiatives across hospitals have already taken shape and also yielded success, such as at Karl Bremer Hospital, which also received a portion of the R20 million from the department. The hospital was able to perform an extra 328 procedures since August last year.”

Working around difficulties

At Groote Schuur, the project had to find a way to work around the difficulties of surgical catch-up. According to Cairncross, with any surgical catch-up, the challenges don’t just come from needing a physical space to operate in but also from having the appropriately trained staff. Not having enough trained staff in the public health sector, like theatre and surgery nurses, makes it hard to implement a surgical catch-up programme, even if there is money to do so.

To work around these difficulties, they came up with a centralised model for surgical recovery, where one theatre team of nurses could be employed on a contract rate for the 12 months. This team, led by Sister Melinda Davids, the nursing operations manager for the E4 theatre, would work Monday to Thursday in one of the E4 theatres and occasionally other theatres in the hospital for each of the 1 500 surgeries.

According to Cairncross, many surgeons, herself included, would come and operate on patients in addition to their normal surgeries and other duties. The funds, a total of about R 12.5 million, were used to pay the staff involved in the surgeries. The day-to-day operations were run by Davids and Peters.

According to Peters, the 1 500 operations occurred across all surgical specialities, ranging from cataract to cardiothoracic.

Success factors

Cairncross attributes the success of the project to the existing systems at Groote Schuur, supportive management, and the dedication of the surgical team and surgeons that gave their time to the project.

She says that because the hospital has a relatively functional system to start off with and a supportive management team, it allowed for “enough of a regulatory environment to keep things safe and above board but not to the extent where you can’t move”.

It was also about having the right person in charge of the team, she adds, gesturing to Davids.

Davids, who started her nursing career in 1989 and qualified as a theatre nurse in 2009, started working at Groote Schuur six years ago. She explains that the surgical team at E4 consisted of about 18 people. This includes herself, five scrub nurses, three anaesthetic nurses, three floor nurses, a registered nurse who assists in recovery, and a clerk. Peters adds that there are also two surgical medical officers and two anaesthetic registrars.

According to Davids, when the project started, several of the nurses had not worked in a theatre before so had to be trained and upskilled by her and some of the specialist nurses who make up the scrub nurse team. She also had to get creative about having the right equipment for each surgery, which sometimes meant she had to borrow equipment from other theatres.

“It’s been a challenge, but it’s a good challenge that’s kept me going,” she says. “We’re a good team.”

“Trust [in staff] has been fundamental to this,” says Peters, “I mean, the ability to trust junior staff to upskill themselves to become scrub nurses, to hand surgeons the right instrument when they asked for it. That’s been really heart-warming.”

‘Behind every number on the list is a patient’

When asked why it was so important to do this kind of catch-up, Cairncross says the surgeries that were postponed during the COVID-19 pandemic were ones that weren’t urgent or emergent, but those patients who were bumped still struggled physically because of the delays.

“Behind every number on the list is a patient with a story of either progressive blindness, invasive skull tumours, or tumours around the auditory canal that result in hearing loss, chronic pain from joint problems and urinary retention with recurrent infections and admissions or having a stoma bag [a colostomy bag] with them for months longer than needed,” Cairncross says. “Heart-breaking stories and often these were the patients who kept getting cancelled [on]. They would come in and if something urgent would come up, they would be cancelled or the COVID wave would come.”

She adds that at the time when the idea for Surgical Recovery came about, the morale amongst the surgical teams was at a real low. Patients would be coming to the outpatient clinics and asking, for the umpteenth time, “when am I going to have my operation?” to which the healthcare workers had to keep responding that they don’t know.

“It’s just a terrible thing and so people [staff] started to feel disempowered and disillusioned and I really think that the project helped them to at least see some progress. That there were some changes or some shift in what they were dealing with,” Cairncross says. “It hasn’t cleared our entire backlog, and a once-off project will not do that, but it has reset us pretty close to where we were pre-COVID-19.”

Peters adds that while the backlogs haven’t been fully cleared, “for every case that we’ve done in the project, it’s someone off of a waiting list”.

Health system at a ‘precipice’

While the COVID-19 pandemic caused many surgeries to be postponed and added tremendously to surgical waiting lists, it isn’t the only factor contributing to backlogs. According to Peters, the issue of a shrinking health budget for tertiary services is and will continue to add to the existing backlogs across the country.

“There’s this building backlog coming up against the shrinking budget. And that’s going to be with us for multiple years going into the future and if the clinicians aren’t protecting the budget for these patients that get missed, we’re going to focus on as we have been the emergency patients that come through the door,” he says. “But it’s always difficult for tertiary academic services because to keep up the skills of surgeons to maintain the quality of care, they do need to be managing waiting lists of booked patients. And so, I think across the country we’re going to be struggling with that across all tertiary services.”

Cairncross tells Spotlight that the project is just a temporary measure. In the long term, healthcare systems need to be fixed in order to address issues like surgical backlogs.

“The lesson, I suppose, is that these are temporising measures. We can do them, but fundamentally we need to fix the health system at a core, structural level. And we can’t work in isolation from the rest of the country because we are one health system and tertiary hospitals are only a part of that ecosystem,” she says. “The services at Groote Schuur Hospital, for example, cannot be sustained if the health systems from primary care to district health facilities, in urban and rural facilities, and across provinces are not supported and strengthened.”

The health system is at a precipice, according to Cairncross, and big academic hospitals need to be anchoring elective surgical services together with emergency services, as the problem with emergency services will only get bigger down the line if electives aren’t dealt with now.

“We know that postponed elective surgery just becomes emergency surgery over time, making cancelling elective surgery a false economy. We need to plan robust systems that ensure all types of surgical services are maintained,” she says.

“The strongest voice [in defence of the health system] is a conscious and motivated health workforce. So, where the nurses and doctors and managers are standing and defending patient services, they are supporting the health system,” she says. “I think this is an example of health workers standing up and saying, we can’t allow this deterioration in services. We’ve got to do more. We really want to tell the story, so that people can see it can be done.”

Republished from Spotlight under a Creative Commons 4.0 Licence.

Source: Spotlight

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