Tag: South Africa

Categories : HIVTags :

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

On By ModernMedia
Photo by Sergey Mikheev on Unsplash

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 : Hospitals Surgeries & ProceduresTags :

Cancellation of Operations at the Charlotte Maxeke Johannesburg Academic Hospital

On By ModernMedia

The Charlotte Maxeke Johannesburg Academic Hospital (CMJAH) would like to dismiss the misleading information shared by Mr Jack Bloom regarding cancelled operations.

CMJAH would like to put it on record that there were no “more than 50 elective cases cancelled due to the cold weather conditions”. The statement by Mr Bloom creates the impression that all elective cases were cancelled, which is not true.

There were 53 operations scheduled for Monday, 10 July 2023, and 26 cases were done, while only 15 were cancelled due to low temperatures at theatres and 12 were cancelled for reasons not related to low temperatures.

Out of the 15 cancelled cases, 3 were for Thoracic, 6 were for Trauma Orthopaedic, 2 were for Paeds Orthopaedic, 1 was for Paeds plastics, and 3 were for Ear, Nose, & Throat.

The problem of temperature control has been a challenge for the facility for years, but it became worse in the last two years due to the copper theft which took place during the period when the facility was evacuated for months after the fire incident. This affected the central heating system of the facility, which regulates the level of acceptable temperatures in the entire hospital, but mostly in the theatres.

To remedy the situation, the process of installing Schedule 40 pipes, which are less susceptible to theft as they do not have an attractive market value as copper does, has started. During the installation process, the theatres and intensive care units (ICU) were prioritised. From the date of appointment, 28 June 2023, to date, the contractor has completed the installation of schedule 40 pipes for Blocks 2, 3 and 4. The installation process at Block 5 has already started and the work is progressing well, ahead of schedule.

The water system is currently running, with close monitoring, at all three blocks where the schedule 40 pipes were installed to check for any possible leaks as the system has not been running for the past two years.

The facility would like to apologise to the public for any inconvenience this might have caused. The installation of the schedule 40 pipes is a necessary project that would address the issue of copper theft and the central heating system.

The facility would further like to assure the public that this matter is getting the urgency it deserves, and cancelled cases are being attended to.

News release issued by the Charlotte Maxeke Johannesburg Academic Hospital

Categories : HospitalsTags :

Staff at Chatsworth Hospital Picket over Poor Working Conditions

On By ModernMedia
Staff, including nurses, at RK Khan Hospital in Chatsworth, Durban, picketed on Wednesday over poor working conditions at the facility. Photo: Tsoanelo Sefoloko

By Tsoanelo Sefoloko

Nurses, administration staff and general workers brought parts of RK Khan Hospital in Chatsworth, Durban, to a standstill for about an hour on Wednesday. They protested outside the hospital to highlight what they say are poor working conditions. 

Protesting nurses say they are forced to perform cleaning duties in addition to patient care because the hospital has not employed enough cleaners. Other workers complained of staff shortages in the administration and general units.

Workers say they met with the management in February. Union leaders had asked the facility to commit to resolving their complaints.

Nurse Zizakele Ndlovu said they were told by the union leaders that working conditions would improve. But nothing changed, she said.

“The conditions we work under at the hospital are not good. We end up having to work more hours, and we don’t get paid for overtime. Sometimes I even work as a clerk,” she said.

“The department treats us as if we don’t know our job, and we don’t deserve what we are asking for. We lost many workers to Covid; some retired and others resigned. Those vacancies have not been filled. Even at top management there are lots of vacancies and this leads to poor service.”

Chairperson at the hospital of the National Education, Health and Allied and Workers’ Union (NEHAWU) David Mpongose said they had engaged management and had been promised that the situation would improve.

“Our bosses are arrogant. They really don’t take us seriously. Each time they make empty promises, so we decided to protest for the provincial government to assist us,” said Mpongose.

Xolani Mnguni, a cleaner, said he earned R7800 per month under the hospital’s previous contractor, but now only earns R3000 under the current contractor. He also said he has to do jobs other than cleaning.

Hospital CEO Linda Sobekwa accepted the workers’ memorandum and signed it on behalf of the provincial health department. She promised to ensure that the department responded within ten days as requested.

Agiza Hlongwane, spokesperson for the KwaZulu-Natal Department of Health, said officials would consider the workers’ demands and respond to them.

Republished under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Source: GroundUp

Categories : Healthcare Politics and RegulationsTags :

High Court Ruling Paves the Way for Affordable Medical Scheme Benefits in South Africa

On By ModernMedia
Photo by Bill Oxford on Unsplash

The recent judgement by the Pretoria High Court in favour of the Board of Health Funders (BHF) carries substantial implications for medical schemes in South Africa. This follows BHF’s court application, which sought to compel the Council for Medical Schemes (CMS) to give a complete record, providing light on the LCBO’s decision-making process thus far.

The Court ordered the Minister of Health and the CMS to provide all of the papers listed in Rule 30A within 10 days of receiving the applicant’s notice of motion. The completion of this crucial milestone hinges on the provision of several documents, which we eagerly await.

This significant victory brings us closer to the ultimate goal of granting Medical Schemes exemptions to offer Low-Cost Benefit Options (LCBOs), which aim to provide greater access to affordable medical scheme benefits for low-income earners. The BHF’s success aligns with the mission of improving
healthcare accessibility and advancing progress towards universal healthcare coverage (UHC) in the country.

In the main application lodged on 8 August, the BHF requested the High Court to:

  • Lift the moratorium that prevents medical schemes from offering LCBOs when the Council for Medical Schemes (CMS) refuses to grant applications for exemptions to medical schemes, pending the finalisation of LCBO guidelines.
  • Declare the failure by the respondents to develop and implement LCBO guidelines as irrational, unreasonable, and unlawful, as per Section 6 of the Promotion of Administrative Justice Act and Section 1(c) of the Constitution.

The BHF represents the majority of the country’s medical schemes and healthcare funders, encompassing schemes and administrators serving nearly 4.5 million individuals.

According to Charlton Murove, the protracted process of crafting a framework for Low-Cost Benefit Options has taken over seven years and is yet to be finalised. Many policymakers have criticised medical schemes for their lack of affordability. The proposed solution aims to address these concerns and move closer to the principles of UHC, ensuring that the healthcare system grants everyone access to quality and affordable healthcare.

Murove stated, “This application seeks to drive a progressive agenda for the public and private healthcare sectors, fostering collaboration to alleviate the current challenges in our healthcare system. The Council for Medical Schemes and the Minister have pivotal roles in implementing policies that enhance access to healthcare. However, progress with LCBOs has been hindered by the CMS’s failure to take the necessary steps for reform, despite the publication of demarcation regulations in 2016.”

The BHF’s victory in the High Court represents a significant step forward in the pursuit of affordable and accessible medical scheme benefits. By addressing the current burdens faced by the state and ensuring that medical scheme premiums remain affordable, we can strive towards a healthcare system that benefits all South Africans.

Categories : Healthcare Politics and RegulationsTags :

Funding the NHI: ‘Political Suicide’ and Tax Revolts

On By ModernMedia
Photo by Jp Valery on Unsplash

According to a 27-page ‘factsheet’ purportedly produced by the Department of Health and the Presidency, the National Health Insurance (NHI) scheme would be funded through a payroll tax and additional personal income taxes. There are however better ways to go about this, according to a number of experts who weighed in on the topic.

Professor Alex van den Heever said that the payroll tax plan is misguided, according to Daily Investor. In the same vein as Unemployment Insurance Fund (UIF) payment, both employers and employees would make contributions to a payroll tax.

But Van den Heever criticised this, saying that those who suggested this do not have the qualifications to make financial comments such as NHI funding.

“They talk of introducing payroll taxes. You don’t introduce payroll taxes for a general government allocation,” he explained. “Payroll taxes are for contributory systems where you get a specific benefit or entitlement for what you contribute.”

The term “payroll taxes” in relation to funding NHI does not make sense, he said. Discussions on raising taxes and a new payroll tax shows that the government does not know how to fund the NHI.

He called them an “incredibly naïve set of fiscal proposals that you cannot even consider implementing,” and that they were “incoherent from a public finance perspective.” Introducing them as is would be politically suicidal: the tax base is already overburdened, and raising taxes beyond a certain point results in a reduction in taxes actually collected.

“It is very dangerous to overstress your tax bases. We are hitting the limit on the amount you can fund the government and the public health system from taxes.”

Huge tax increases needed to fund NHI

Van der Heever’s viewpoint is shared by Connie Mulder, Solidarity Research Institute head and Ryan Noach, Discovery Health CEO.

Mulder said trying to fund NHI through additional taxes is unfeasible because of the tremendous amount of money needed.

Mulder said that the massive additional taxation would “crush South Africa’s economic outlook.”

It is naive for the Department of Health to assume that medical aid contributions will be funnelled into a national health insurance scheme, said Noach. The NHI scheme would force South African taxpayers to pay much higher taxes but cut their healthcare entitlement by 72%, and would provoke a tax revolt.

South Africa has a unique situation where a very small tax base of 5.5 million people funds nearly all government expenditures, accounting for 80% of public healthcare funding, he said. Notably, their after-tax disposable income is used to pay medical aid and private healthcare.

The single-funder model described in the NHI Bill would not be able to achieve the government’s goal of equitable access to healthcare, Noach told Daily Investor. This is a model which Discovery Health does not endorse, calling it not only “risky and inefficient” but also not likely to be equitable because “cross-subsidies cannot be properly managed”.

He reiterated earlier comments where he said that the NHI Bill would have no immediate impact on medical schemes, but once it is fully implemented (with “implemented” remaining undefined), medical aid schemes would only be allowed to offer what is not covered under the NHI – at the discretion of the Health Minister. This would make NHI a single monopolistic funder for the NHI package of services, which he had said in an earlier interview with Newzroom Afrika was without a parallel anywhere in the world. 

Even though implementation is a decade away, this is going to drive off health sector investment, Noach said.

Noach recommended a multi-fund framework, which he described as “not only less risky and faster to implement, but also ensures that cross-subsidies are managed to ensure that social solidarity is achieved”.

Collaboration between the private and public sectors is the only way financial integrity and sustainability is achievable, something which has been built on the successful COVID-19 partnerships.

NHI ‘charade’ – but Obamacare offers an alternative

Business Leadership South Africa CEO Busi Mavuso has a similar view – and didn’t mince her words. According to Mavuso, NHI as currently envisaged, was a “charade” without any thought to funding, according to Moneyweb. One that would leave all South Africans worse off, and recommends instead a private-public partnership.

She also pointed to the public–private partnership behind South Africa’s COVID-19 response. The two entities sourced resources, rolled out vaccines and funded other interventions.

“It was a clear demonstration that national health outcomes are achieved faster and more efficiently when government and business work together, drawing on their respective strengths,” she said.

“With the right incentives, the private sector can complement government efforts, speed up the investment needed and reduce costs to the state and users.” 

One viable alternative to the NHI’s single buyer model was the US’ Affordable Care Act (aka Obamacare) in the US, wherein health insurers provide minimum cover, with the state subsidising those below a certain level. Insurers are however able to compete to offer coverage.

One other disadvantage of South Africa effectively ending the private sector was that it would discourage internationally mobile businesspeople from working in the country.

Categories : Ageing Mental HealthTags :

SA Retirement Home Study Reveals the Mental Health Benefits for Residents Interacting with Children

On By ModernMedia

A small South African study published in the open-access journal PLOS ONE suggests that programmes promoting interaction between retirement home residents and children may provide quality of life improvements and could help manage residents’ anxiety and depression.

Among retirement home residents, previous research has shown that common mental health conditions often go undetected and untreated. These conditions, which include anxiety and depression, are typically treated with a combination of drugs and non-pharmacological interventions.

One intervention is the Eden Alternative, which identifies loneliness, helplessness and boredom as key challenges to overcome provide a higher quality of life. Evidence suggests that programmes that enable older adults to regularly interact with children may improve mental health, but these have mostly been done outside of retirement homes and few have looked at such programmes in South Africa.

To deepen the understanding of potential benefits of intergenerational interactions, Elizabeth Jane Earl and Debbie Marais of Stellenbosch University, South Africa, conducted a study at a retirement home in South Africa. Residents were able to regularly interact with children who attend an onsite preschool. Activities include playing games, doing puzzles, reading, or singing with the children.

Ten female residents were recruited and invited to complete a questionnaire evaluating their anxiety and depression levels, as well as asking them to describe their experiences with the children. Four of the participants were screened as possible having anxiety, depression, or both. The participants all took part in the same interactions, though to varying degrees of participation.

Generally, the participants reported positive experiences with the children. Analysing their responses, the researchers found that the interactions fostered a sense of purpose and belonging, fond reminiscences of their own childhood and a positive influence on mood and emotions. Recollections of childhood also sparked a sense of playfulness and positive self-evaluation. They noted that the participants differed in their preconceptions of children, which might have affected their experiences.

The authors wrote that, “Interactions with children promote a sense of belonging and purpose, evoke reminiscence, and positively influence the mental well-being of older persons.”

Based on their findings, Earl and Marais concluded that intergenerational interaction programmes may help manage the mental health conditions that are common for retirement home residents. They suggest that trained staff facilitate the interaction, preparing the children and residents, and should be voluntary, which helps preserve the residents’ agency. Running the interaction as a regular programme should help build bonds and give the residents something to look forward to. Additionally, there should be an educational aspect for the children, giving the residents a sense of purpose.

Looking to the future, they wrote that larger studies would be able to better outline the benefits of such programmes.

Categories : Medical IndustryTags :

iNova Launches New Supplement To Reduce Symptoms Of Osteoarthritis

On By ModernMedia

A new joint health supplement has been launched in South Africa by iNOVA Pharmaceuticals which supports healthy joints and helps reduce the symptoms of osteoarthritis such as joint pain and stiffness1. Unlike other osteoarthritis supplements on the market, POSTEON™ has been shown to start working in as little as five days1.

According to scientifically based research, the ingredients in Posteon™ may help reduce the symptoms of osteoarthritis such as joint pain and stiffness, as well as improving range of motion and mobility1.

Boswellia serrata gum resin extract has traditionally been used to relieve symptoms of osteoarthritis. Taken once a day, Posteon™ contains 100mg of 3-O-Acetyl-11-keto-beta- boswellic acid (AKBA), the most active compound of Boswellia extract which is an inhibitor of 5-lipoxygenase (5-LOX). This is a key enzyme in the biosynthesis of leukotrienes from arachidonic acid in the cellular inflammatory cascade1.

It also contains 300mg of Avocado soy unsaponifiables (ASU), a dietary supplement consisting of one-third avocado oil and two-thirds soybean oil. Studies have found that ASU can reduce the production/action of various joint inflammatory substances which can prevent the destruction of joint cartilage and also help in its repair1.

Osteoarthritis is the most common form of arthritis2 and affects between 55.1% and as many as 82.7% of adults aged over 65 years in South Africa3. Globally, the prevalence of osteoarthritis is increasing, and is expected to continue to escalate4.

POSTEON™, which is now available at leading pharmacies, may reduce these symptoms1 which can significantly impact day-to-day functioning2.

References:

  1. Posteon PI. June 2022
  2. Centers for Disease Control and Prevention (CDC). Osteoarthritis (OA) (2022) at https://www.cdc.gov/arthritis/basics/osteoarthritis.htm# (website accessed on 4 May 2023).
  3. Usenbo, A et al. Prevalence of Arthritis in Africa: A Systematic Review and Meta-Analysis. A Systematic Review of Arthritis Prevalence in Africa (2015) at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4524637/ (website accessed on 4 May 2023).
  4. Osteoarthritis Research Society International (OARSI) Osteoarthritis: A Serious Disease, Submitted to the U.S. Food and Drug Administration (2016) at https://oarsi.org/oarsi-white-paper-oa-serious-disease (website accessed on 4 May 2023).

DISCLAIMER: This editorial has been commissioned and brought to you by iNova Pharmaceuticals.

Content in this editorial is for general information only and is not intended to provide medical or other professional advice. For more information on your medical condition and treatment options, speak to your healthcare professional.

Categories : HIV PaediatricsTags :

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

On By ModernMedia
Photo by Sergey Mikheev on Unsplash

By Elri Voigt for Spotlight

Several sessions at the 11th 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 :

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

On 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 :

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

On 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 11th 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