Tag: HIV

Categories : HIVTags :

SA Company Set to Manufacture HIV Prevention Ring

On By ModernMedia

By Catherine Tomlinson for Spotlight

Photo by Miguel Á. Padriñán: https://www.pexels.com/photo/syringe-and-pills-on-blue-background-3936368/

A company headquartered in Johannesburg will start making flexible silicone rings to protect women from HIV. The move signals a strong vote of confidence in an African firm to supply the ring at adequate scale and affordable prices, and a crucial step to making the continent self-reliant, reports Catherine Tomlinson.

A South African company has secured the rights to manufacture a vaginal ring used to prevent HIV infection. The ring, which is inserted and removed by the user, provides protection for a month, after which it has to be replaced with a new ring. The ring contains an antiretroviral drug called dapivirine.

While studies show that the dapivirine vaginal ring is less effective at preventing HIV than HIV prevention pills and injections, it has benefits over other tools that have led the World Health Organization (WHO) to recommend its inclusion in the package of sexual health services available to women.

One advantage of the ring over HIV prevention pills is that it can be used discreetly by women, allowing users to use the ring without having to negotiate or discuss its use and purpose with their sexual partners. This is particularly important in the context of South Africa where women face high rates of gender-based violence, which erodes their autonomy over their bodies and sexual and reproductive health.

“We need to give women more control over their health and bodies and access to a range of safe and effective options, including the dapivirine ring, to choose from so they can decide to use what works best for them at different times of their lives,” wrote several prominent women African activists in 2022.

Limited access

While the WHO recommended that the ring is offered to women, its current price is a barrier to broad use and rollout in South Africa. The only dapivirine vaginal ring approved by the South African Health Products Regulatory Authority that is currently available in the country is called the DapiRing.

The DapiRing is manufactured by a Swedish company, Sever Pharma Solutions, under a licence from the Population Council (formerly the International Partnership for Microbicides). It can be bought in South Africa’s private sector for R320, excluding dispensing fees.

The DapiRing is not available in South Africa’s public sector outside of study and pilot sites, as the National Essential Medicines List Committee, the body that determines which health technologies should be available in the country’s public health facilities, determined that the product is unaffordable at its current price. They estimate that the product will become affordable for South Africa’s public sector at a threshold price of R52 per ring.

Local company to boost access

The Population Council, the entity that owns the intellectual property on the dapivirine vaginal ring, selected South African pharmaceutical company Kiara Health to manufacture and supply the ring across Africa.

Kiara Health’s CEO, Dr Skhumbuzo Ngozwana, told Spotlight that while it is not yet known what the price of the Kiara manufactured ring will be, it is expected to be lower than the current price of the Swedish-manufactured DapiRing.

Licensc to manufacture

The council told Spotlight that the initial focus of the licence and partnership will be to develop manufacturing capacity at Kiara Health to supply the dapivirine vaginal ring across Africa. In the long term it is hoped that Kiara will be able to serve markets outside of Africa where there is a need for the ring.

The Population Council’s selection of an African-based manufacturing partner is notable as holders of intellectual property protections on HIV health technologies have typically sought out companies in Asia, and India in particular, as manufacturing partners.

Professor Linda-Gail Bekker, CEO of the Desmond Tutu HIV Foundation, told Spotlight: “If the “COVID-19 pandemic taught us anything, it is the value of being self-reliant as a region – being able to manufacture the vaginal ring is a step closer to Southern African self-reliance.”

Ngozwana said that Kiara Health appreciates that the Population Council have bucked the trend by not going to the East. “[A]ll these new technologies tend to go to the East, but instead they’ve partnered with an African company”.

Dapivirine vaginal ring. Credit: Columbia University Mailman School of Public Health

He added that future technology transfers to other manufacturers in Africa may be pursued if there is a need.

Exclusive supply licence

The Council told Spotlight that it intends to pursue an exclusive supply licence with Kiara Health for the sole supply of the dapivirine ring in Africa. The pursuit of an exclusive supply licence is a strong vote of confidence by the Population Council in the ability of Kiara Health to supply the ring at adequate scale and affordable prices.

Since Kiara Health’s exclusivity is for the supply of the ring, if there is a need, the company will be able to supply a dapivirine vaginal ring that is made by the Population Council’s Swedish manufacturing partner, Sever Pharma Solutions, that is already widely authorised for use in countries in Africa.

This would also guard against supply shortfalls that sometimes occur when only one manufacturer supplies a market, doctor Brid Devlin, the Population Council’s chief scientific officer, told Spotlight. “We would have two registered manufacturers right out the gate to guard against any shortfalls and have the opportunity to continue the supply as the demand grows.”

Why Kiara Health was chosen

Devlin added that the Population Council did not have a formal bid process through which Kiara Health was selected as the manufacturing partner for the ring, but rather that Kiara Health was selected following years of engagement with the company.

“We had a team that went to Kiara last year to see this site and it was a really impressive operation, both in terms of the staff but also the entire manufacturing operation,” she said.

Ngozwana told Spotlight that Kiara Health has existing manufacturing facilities in Johannesburg where capacity to produce the ring will be established.

Kiara Health’s manufacturing facilities already hold the quality assurance certifications (cGMP certification) required to manufacture medicines and have adequate space in Johannesburg to establish and scale manufacturing capacity for the ring, Ngozwana told Spotlight.

What is needed to manufacture the ring locally?

Critical steps include technology transfer, securing financing, procuring and importing manufacturing equipment, developing validation batches, and seeking regulatory approvals.

At this stage, there are still unknowns regarding the extent of data and testing that will be required to gain regulatory approval of Kiara Health’s dapivirine vaginal ring. To aid regulatory authorisation, Ngozwana and Devlin noted that Kiara Health would use the same manufacturing technology and inputs, including active pharmaceutical ingredients (API) used by Sever Pharma Solutions. This will require Kiara Health to import manufacturing equipment and API from Europe.

However, in the long term, Ngozwana said that Kiara Health would hope to increasingly procure manufacturing inputs, including potentially dapivirine API from the Pretoria-based API manufacturer CPT Pharma. (Spotlight previously reported on CPT Pharma’s work on API production here).

Ngozwana and Devlin told Spotlight that the anticipated time-limiting factors for establishing manufacturing capacity are securing financing and procuring and importing manufacturing equipment.

Funding has long been a challenge for African-based pharmaceutical companies since it has historically been scarce and only available on unfavourable terms. However, Ngozwana told Spotlight that Kiara Health is already engaging potential funders for support and exploring different financing sources, including grants and debt instruments.

Ngozwana and Devlin noted that technology transfer, which is a process for transferring manufacturing skills and knowledge, has already begun.

Can this license boost further domestic manufacturing capacity?

While vaginal rings are a relatively new type of health technology, they have multiple potential applications. A vaginal ring to prevent pregnancy has been available since the early 2000s and work is underway to develop a ring that is effective in combating both HIV and pregnancy. A dapivirine ring that reduces one’s risk of contracting HIV for three months – as opposed to one month – is also under development.

Kiara Health will seek to position itself to manufacture other vaginal rings entering the market, Ngozwana said. He added that in the long term, the company hoped that the partnership with the Population Council will be broadened to allow for local manufacturing of other sexual and reproductive health technologies in their product portfolio.

Republished from Spotlight under a Creative Commons licence.

Source: Spotlight

Categories : HIVTags :

Starting HIV Treatment Early may be Key to Remission

On By ModernMedia
Colourised scanning electron micrograph of HIV (yellow) infecting a human T9 cell (blue). Credit: NIH

Some people with HIV, known as “post-treatment controllers,” have been able to discontinue their antiretroviral treatment while maintaining an undetectable viral load for several years. Starting treatment early could promote long-term control of the virus if treatment is discontinued.

Scientists from the Institut Pasteur and other institutes used an animal model to identify a window of opportunity for the introduction of treatment that promotes remission of HIV infection. The findings, published in Nature Communications, suggest that starting treatment four weeks after infection promotes long-term control of the virus following the interruption of treatment after two years of antiretroviral therapy.

These results highlight how important it is for people with HIV to be diagnosed and begin treatment as early as possible.

Research on the VISCONTI cohort, composed of 30 post-treatment controllers, has provided proof of concept of possible long-term remission for people living with HIV. These individuals received early treatment that was maintained for several years.

When they subsequently interrupted their antiretroviral treatment, they were capable of controlling viraemia for a period lasting more than 20 years in some cases. At the time (in 2013), the team leading the VISCONTI study suggested that starting treatment early could promote control of the virus, but this remained to be proven.

In this new study, the scientists used a primate model of SIV1 infection which allowed them to control all the parameters (sex, age, genetics, viral strain, etc.) that may have an impact on the development of immune responses and progression to disease.

They compared groups that had received two years of treatment, starting either shortly after infection (in the acute phase) or several months after infection (in the chronic phase), or no treatment.

The reproducible results show that starting treatment within four weeks of infection (as was the case for most of the participants in the VISCONTI study) strongly promotes viral control after discontinuation of treatment.

This protective effect is lost if treatment is started just five months later.

“We show the link between early treatment and control of infection after treatment interruption, and our study indicates that there is a window of opportunity to promote remission of HIV infection,” comments Asier Sáez-Cirión, Head of the Institut Pasteur’s Viral Reservoirs and Immune Control Unit and co-last author of the study.

The scientists also demonstrated that early treatment promotes the development of an effective immune response against the virus.

Although the antiviral CD8+ T immune cells developed in the first weeks after infection have very limited antiviral potential, the early introduction of long-term treatment promotes the development of memory CD8+ T cells, which have a stronger antiviral potential and are therefore capable of effectively controlling the viral rebound that occurs after treatment interruption.

“We observed that early treatment maintained for two years optimises the development of immune cells. They acquire an effective memory against the virus and can eliminate it naturally when viral rebound occurs after discontinuation of treatment,” explains Asier Sáez-Cirión.

These results confirm how important it is for people with HIV to be diagnosed and begin treatment as early as possible.

“Starting treatment six months after infection, a delay that our study shows results in a loss of effectiveness, is already considered as a very short time frame compared with current clinical practice, with many people with HIV starting treatment years after infection because they are diagnosed too late,” notes Roger Le Grand, Director of IDMIT (Infectious Disease Models for Innovative Therapies) and co-last author of the study.

“Early treatment has a twofold effect: individually, as early treatment prevents diversification of the virus in the body and preserves and optimises immune responses against the virus; and collectively, as it prevents the possibility of the virus spreading to other people,” adds Asier Sáez-Cirión.

Finally, these results should guide the development of novel immunotherapies targeting the immune cells involved in the remission of HIV infection.

These are the initial results of the p-VISCONTI study, which began in 2015 in collaboration with the institutions cited above and received funding from MSD Avenir and the support of ANRS Emerging Infectious Diseases as part of the RHIVIERA consortium.

1 SIV: simian immunodeficiency virus only affects non-human primates. SIV infection of animals recapitulates the key features of human HIV infection.

Source: Institut Pasteur

Categories : HIVTags :

Opinion: This is How SA can Meet its HIV Targets

On By ModernMedia
Photo by Miguel Á. Padriñán

By Yogan Pillay for Spotlight

“The path to ending AIDS is clear,” states a recent UNAIDS report. “HIV responses succeed when they are anchored in strong political leadership, have adequate resources, follow the evidence, use inclusive and rights-based approaches, and pursue equity. Countries that are putting people first in their policies and programmes are already leading the world on the journey to ending AIDS by 2030,” it reads.

Ending AIDS and the HIV epidemic mean different things to different people.

This very ambitious language is found in Sustainable Development Goal 3.3: “By 2030, end the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases and combat hepatitis, water-borne diseases and other communicable diseases”. The global target is to reduce the newly HIV infected population (per 1 000 uninfected population) to 0.05 by 2025 and to 0.025 by 2030.

Another version is “ending AIDS as a public health threat by 2030” which has been characterised as being “consistent with the three zeros vision: zero deaths, zero new infections and zero discrimination, operationalized as a 90% reduction of annual new HIV infections and AIDS-related deaths in 2030 compared to 2010”.

A third approach calls for countries to reach the 95-95-95 targets – 95% of people living with HIV are diagnosed, 95% of those that have been diagnosed are on antiretroviral treatment and 95% of those on treatment are virally suppressed – by 2025.

A fourth, more realistic approach, is to reduce the number of new HIV infections below the number of deaths from HIV – labelled ‘epidemic control’ – to an endemic status beyond 2030.

Regardless of the definition of ‘ending AIDS’, what should South Africa do in determining its path towards reducing the burden of HIV?

First, let’s start with what we think the HIV epidemic will look like in 2030. Whilst we do not have a crystal ball, we do have a well-recognised mathematical model – the Thembisa model, which is also used as the basis for UNAIDS’s HIV estimates for South Africa. The latest Thembisa model outputs, published last year, include projections up to 2030.

The model projects that in 2030 there will be around 128 535 new HIV infections with the bulk of these, over 54% (70 412) being young women between the ages of 15 and 24 years. Using the definition of a 90% decrease in new infections between 2010 and 2030, South Africa is projected to reach 65.7%.

The model projects that in 2030 around 8.1 million people will be living with HIV with 6.4 million being on antiretroviral treatment. The total number of AIDS deaths projected by the model in 2030 is 40 486 compared to 149 257 deaths in 2010. (This is a 72.9% reduction – not quite the 90% expected by one of the definitions noted above).

How well is the country doing in reaching the 95-95-95 targets?

According to the Thembisa model, the percentage of people ever tested for HIV stood at 83.7% in 2022 (projected to reach 86.1% in 2030). The percentage of people living with HIV who had been diagnosed was at 94.5% in 2022 and projected to reach 96.4% in 2030. The percentage of diagnosed people on treatment in 2022 stood at 77.4% and is projected to reach 81.1% in 2030.

The percentage of all people living with HIV who were virally suppressed was at 65.4% in 2022 and projected to reach 71.3% in 2030. (These percentages are slightly higher if a viral load cut-off of 1000 copies/mL rather than 400 is used). This means only one of the 95s (percent diagnosed) is expected to be reached. (If the third 95 is defined as percentage of people on HIV treatment who are virally suppressed, rather than percentage of all people living with HIV who are virally suppressed, it will also be met.)

A more optimistic picture has been reported by the Human Sciences Research Council (HSRC) through their recently completed national survey. This survey found that 90% of 15-year-olds and older living with HIV knew their status (this included self-reported status), with 91% of them on treatment, and 94% of those on treatment being virally suppressed (at the 1000 copies/mL threshold).

Based on the Thembisa projections, South Africa is not expected to reach epidemic control by 2030. So, what needs to be done to achieve significantly fewer new infections and deaths?

What to do

In his address to the 2023 South African AIDS conference, the Minister of Health outlined what the Department of Health considered as necessary. He noted that the country has achieved 94:77:92 against the UNAIDS targets – far lower than the HSRC survey found. This means that, according to the Department’s data, there are over two million people who are living with HIV but not on treatment and a further 1.6 million people who are on treatment but are not virally suppressed. This is far higher than the 1.9 million that the HSRC survey suggests are not on treatment and not virally suppressed.

Regardless of which data is correct, it is urgent that these patients are found, initiated on treatment and supported to reach viral suppression.

While the Minister did not quantify the number of people living with HIV who are not being reached, he did outline the following interventions that he proposed should be prioritised:

  • Immediate implementation of the revised and consolidated ART Clinical Guidelines, which includes an integrated approach on prevention of vertical transmission, a focus on TB/HIV given high levels of coinfection, and differentiated service delivery.
  • A focus on the 100 identified health facilities which are lagging in reaching the 2nd and 3rd 95s (treatment coverage and viral suppression).
  • The need to close the testing and treatment gaps for men and children through HIV self-testing and index testing (an approach whereby the exposed contacts of an HIV-positive person are notified and offered an HIV test).
  • A focus on re-engaging those who have stopped taking treatment and scaling up of community treatment, 3-month dispensing of treatment medication as well as the use of community health workers in tracking and tracing people living with HIV.
  • A greater effort on combination prevention, using all currently available prevention methods as well as Cab-LA, which is an antiretroviral HIV prevention injection that provides two months of protection per shot.

These are well known interventions and if health workers and communities are committed to their urgent and full implementation, it is possible to achieve further reductions in new HIV infections, as well as further reductions in death. However, as most deaths in people living with HIV are due to TB, a greater focus should be placed on testing people living with HIV for TB  – given the estimated 59% co-infection rates; and ensuring that they are successfully treated and initiating those that test negative for TB, on TB preventive therapy.

How do the Minister’s prescriptions align with the recently completed HIV investment case?

As recently reported in Spotlight, the only HIV intervention found to be cost saving for the health system in South Africa was condoms. However, the recent HSRC survey found that reported condom use at last sexual encounter declined in all age categories. The 2017 survey found that 68% of males aged 15-24 years reported condom use, compared to 50.6% in the latest report. Similarly, 53.4% of males aged 25-49 years reported condom use in 2017 compared to 44% in 2023.

Whilst the Minister noted in his speech at the South African AIDS conference the availability of Cab-LA for HIV prevention, the investment case found that at the current price, this was not a good investment and unaffordable! The investment case outputs suggest that it was most cost effective to increase HIV self-testing, focusing on improving linkage to treatment, as well as increasing the rate of testing infants for HIV at 10 weeks after birth.  It is therefore important to prioritise HIV interventions, as noted in the investment case, given that the National Treasury has reduced the HIV conditional grant by R1 billion and that the National Strategic Plan for 2023-2028 is not fully funded!

In UNAIDS’s path to ending AIDS, the organisation suggests what countries can do to intervene. These include: political commitment to ending AIDS, respecting human rights, engaging affected communities, removing criminalising policies and laws, addressing gender inequities, stigma and discrimination, as well as a focused approach to prevention. Some of the barriers to ending AIDS are listed as: inadequate prevention programmes, large treatment gaps, and lack of sufficient funding.

In summary, to respond to the call to end AIDS by 2030:

Firstly, it is critical to agree on its definition.

Secondly, it is important to have accurate data, including at sub-national level given that national averages hide variability by province and district. District level data by sex, age and by key populations will allow a more targeted approach to reaching those that the health system typically does not reach.

While South Africa largely funds much of its HIV response – despite the reduction noted above, the possibility of reduced external funding – through PEPFAR (a US government’s effort to address HIV globally) and The Global Fund (an international financing and partnership organisation to fight AIDS, TB and Malaria) in the future, requires the country to move to a more efficient HIV response, with more precise targeting and with greater levels of accountability. For this more granular and real time data will be required.

*Dr Pillay is extraordinary professor at the Department of Global Health, Stellenbosch University and director for HIV and TB delivery at the Bill and Melinda Gates Foundation.

Note: Spotlight receives funding from the Gates Foundation, but is editorially independent and a member of the South African Press Council. The views expressed in this opinion piece are not necessarily shared by Spotlight.

Republished from Spotlight under a Creative Commons licence.

Source: Spotlight

Categories : General Interest HIVTags :

The Good Doctor: Mark Blaylock on Finding Meaning Back at Manguzi

On By ModernMedia
Dr Mark Blaylock, medical manager at Manguzi Hospital. PHOTO: Supplied.

By Sue Segar for Spotlight

There was a time, about 20 years ago, when, at the Manguzi district hospital in Northern KwaZulu-Natal, (and, of course, at hospitals throughout South Africa too) mothers and their babies were dying of AIDS at shockingly high rates.

“We used to get these patients who were slow progressors,” Mark Blaylock, medical manager at Manguzi, tells Spotlight. “Then there were the rapid progressors – babies who were HIV-positive who would get sick very quickly. There wasn’t much we could do for them. We’d give them vitamins and Bactrim, but ultimately they died. Then we had the ones who got sick a bit later, and those were even worse because now mum has had this baby for five years and they’ve bonded, and are a little family and now they are coming in with AIDS. Obviously, a huge number of mums died too. It was heartbreaking.

“It was the pregnancies that knocked their vulnerable immune systems. We’d watch it over and over again. The mums would come in looking ok and then they’d get pregnant and just go downhill. This was in the pre-ARV era. Pregnancy was a death sentence. I think people have forgotten what it was like in those days.”

Blaylock is talking to Spotlight from Northern KwaZulu-Natal, relaying how things have changed for the better since that terrible era. “It’s quite astounding,” he says. Blaylock returned to the hospital ten years ago after having been away for four.

“I was going through the stats recently, and in those days, 40 percent of all mothers who delivered were HIV positive, and about 40 percent of those babies born to HIV- positive mothers ended up with HIV either from birth or breastfeeding. About 20 percent would pick up HIV at birth and another 20 percent would pick it up subsequently through breastfeeding.

“These days, if we have one baby who is delivered HIV-positive or who picks up HIV, we get really upset. Our six-month HIV-positive rate now for babies is less than 0.6 percent and that is a dramatic change. It makes me so happy. Unfortunately, the young girls are still positive, but at least their babies are not becoming positive.”

Blaylock puts the changes down, “purely”, to prevention of mother-to-child transmission (PMCT) using antiretroviral therapy (ART). “Remember how, at one stage, we only gave HIV treatment if a patient was below a certain CD4 count? That was changed to test-and-treat, so regardless of their CD4 count, patients will get HIV treatment which brings the viral load down dramatically,” he says. “And now we have dolutegravir (an ARV), which is the backbone of our current HIV treatment. The success is due to prevention of mother-to-child transmission (PMTC) as well as the test-and-treat policy.”

‘A mixed bag’

It’s Sunday, a day off for Blaylock, and he’s speaking from a place with the best reception near his house on the edge of the Shengeza Lake. He lives here with his wife, Liz and their 13-year-old home-schooled daughter, Una. The sound of birds in the background makes it hard to hear him on the call. “It’s peaceful. There are hippos all around and lots of birds. It’s Eskom-free, which is even better. I love it. We live with three dogs, three cats, a genet, and I can’t tell you how many snakes. It’s paradise.”

It’s taken a long time to clinch this interview, but Blaylock has finally relented and forwarded us the provincial health department’s media protocol he has to adhere to. On problems in KwaZulu-Natal’s health system, he is reticent, saying only that it’s a “mixed bag”. “There’s a lot of dead wood, but there are real areas of excellence,” he says.

His reticence is understandable.

There was a time, also about 15 years ago, amidst the noise and turmoil of the last few years of state-backed AIDS denialism, when Blaylock was going through his own personal trauma. In April 2008, whilst working as chief medical officer at Manguzi, he was suspended for throwing an official photograph of then-Health MEC Peggy Nkonyeni into a dustbin in the hospital’s foyer. He did this out of anger and frustration, after his colleague at the hospital, Colin Pfaff was charged with misconduct for sourcing funding for antiretroviral drugs for pregnant women, and for implementing dual antiretroviral therapy to save babies from HIV – because politicians were not doing so.

He was also furious about comments made by Nkonyeni, questioning the integrity of rural doctors and suggesting they were racist. The South African National AIDS Council soon after asked the Human Rights Commission to probe the ‘racial tone’ of Nkonyeni’s remarks and to curb her ‘harassment’ of Manguzi doctors.

At the time, Blaylock (and Pfaff) were hailed by many working in the health sector as heroes with a deep commitment to their patients. In a letter to the provincial health department at the time, Blaylock said he had given his “heart and soul” to the under-resourced hospital, going beyond the call of duty.

Needing a change

Blaylock was reinstated but, in December 2008, he decided to leave, saying he needed a change and because the KwaZulu-Natal Department of Health was in “absolute disarray”. He says his old colleague Pfaff went to work as a missionary doctor in Malawi.

There was more to Blaylock’s decision to leave Manguzi than just the public disagreement with Nkonyeni. In our interview, he describes those days as “a really tough decade”. “Working in paediatrics, as I did for my first couple of years at Manguzi, I couldn’t take it anymore, emotionally. I just couldn’t do it, so I taught myself surgery. That was easier, as you could fix people. We were also so broken from losing so many friends, colleagues, and patients from HIV at the time. It was definitely traumatising and emotionally exhausting, not just for me but for Liz.

“There’s no doubt most of us were burnt out,” he says. “We kind of knew it, but we pushed on anyway. We were also quite a bit wilder and younger. We’d blow off steam by recklessly taking tiny boats across the lake, in the big waves, with lots of hippos – or we’d go for runs along the beach or naked midnight swims.”

The years outside SA

After leaving Manguzi, Blaylock moved to Ghana, where he took up a position as a general doctor at ABA Hospital in Tarkwa, north-east of Accra. “The hospital was part of the national health system but contracted to a mine, so we would treat people and then try and charge the government, fairly unsuccessfully, for the treatment,” he says. “I’d always fancied the idea of Ghana. I had this fantasy about Kwame Nkrumah and it being the first country to throw off Britain in Africa – but I didn’t enjoy it as much as I’d hoped. Everywhere you went, the police were pulling you over and asking for bribes.”

A defining moment was when Blaylock says he noticed the anti-malaria medication the hospital was giving patients was “just not working”. “Our malaria patients kept coming back full of parasites. I knew there were similar drugs in South Africa which were fantastic, so there was definitely something wrong.” He says he sent a sample to South Africa for testing and realised that “they weren’t as full of the good stuff as they were meant to be”. “I handed in the report and said ‘deal with it.”

From Ghana, where he married Liz and where his daughter Una was born, the family moved to the Kansanshi Mine Hospital in Zambia where they lived on a “beautiful golf estate, surrounded by poverty”.

“It didn’t feel right at all and was quite unfulfilling work,” he recalls. “I did GP work and there was lots of babbalaria – that’s when mostly the expat wives have a hangover on a Monday morning and they think they have malaria.”

Being “medically bored” in Zambia, Blaylock returned to Newcastle in KZN with the aim of specialising in anaesthetics. He worked in Madadeni Hospital’s anaesthetics department, before getting into a registrar’s programme on the anaesthetics circuit at various hospitals in Durban.

‘Like walking back home’

Then, in 2012, his friend and colleague Etienne Immelman, then working as medical manager of Manguzi, suggested that Blaylock should “come home”. “Etienne had been at Manguzi for more than 20 years when he retired six years ago. We’d always had a friendship and a mutual loyalty. He wanted someone to take over.”

Blaylock decided that indeed, it was time. It meant losing the opportunity to specialise, but he says it “felt right”. He went back as medical officer, before becoming manager.

“When I first arrived back, we were a small team, working hard. We all had the same commitment. It gave me a sense of purpose and belonging which hasn’t left.”

Blaylock said the hospital went through a “wonderful period” with a core team of great doctors. “But I burnt them all out during COVID – we had 164 deaths, but we pulled a lot of people through and many of the doctors have moved on. We have a young team now and they are getting there, but we don’t have the broad skill range we used to have. That is common across most district hospitals nowadays.”

So, is he happy to have come full circle, back to the place that was once a source of deep distress to him? “Yes,” he says. “For me, it’s about the community. This place gives me that, as well as a sense of stability and purpose. If you go into a little shop in Manguzi, everyone knows who you are. You say hallo to each other. You shout at a taxi driver and he says, ‘Hey Mark, don’t be so naughty’. When I came back ten years ago, it was like walking back home. It’s just a nice feeling.”

He says a lot has changed in the area. “People say there’s been no development, but when I first arrived at Manguzi in 2002, we knew every car on the road. Today, the town is overwhelmed with vehicles. There’s more money around. We almost never see malnutrition anymore. A lot of government programmes are working, as much as we like to diss them.”

Taking a stand

Given the toll that taking a stand has taken on doctors like Blaylock and Pfaff, one might be forgiven for wondering whether it was all worth it.

Did it make a difference to how things turned out? “Absolutely,” says Blaylock. “There were people scattered people around South Africa at the time who were doing great things. In our part of the world, it was Victor Friedland at Mseleni Hospital and Colin Pfaff (at Manguzi) who were the big drivers, pushing for the right actions to provide the services that the HIV Clinicians Society at the time thought was the correct one and was affordable. The Western Cape had already started, so we weren’t doing anything that groundbreaking except that it hadn’t been official policy yet,” he says.

“Can you believe that when HIV treatment first came to South Africa, it was going to be done at tertiary hospitals only? Imagine the repercussions for us sending a patient to Durban – in those days the Hluhluwe road was 160 kilometres of dirt road – to go and get their HIV treatment once a month. It was not sustainable.

“The HIV (Clinicians) Society pushed hard to get it decentralised to all hospitals. Then it was just going to be done by doctors and they said we absolutely cannot do it just with doctors. It has to be a nurse-run programme. Their vision became our current system. They weren’t the only people, but they were at the forefront of it at the time.”

‘Keeping it going’

Apart from the many advances in HIV treatment, much else has changed at Manguzi over the last 15 years. Blaylock says these days the hospital’s gastro wards are empty “thanks to the rotavirus vaccine”. “We’ve also seen a turnaround in acute respiratory tract infection,” he says. “The pneumococcal conjugate vaccine has changed that dramatically. We have also seen the pushing out of Continuous Positive Pressure Airway Ventilation (CPAP) for neonatal respiratory distressed newborns to district hospitals. This is a non-invasive way of ventilating babies with immature lungs,” he says.

“Our next great hope is the HPV vaccine, which will be a groundbreaker. It’s been rolled out in the past couple of years, but we’ll only see the effects in ten years or so because cervical cancer takes a few decades to come about. The other thing I really want to get in,” he insists, “is that our therapy department (offers occupational therapy, speech and hearing, and physiotherapy) at Manguzi is astonishingly fantastic. There are a lot of good things happening,” he says. “It is so easy to sit on the things that irritate you, but it is worth trying to remember the wins.”

As with several other rural doctors Spotlight has interviewed over the years, Blaylock seems deeply committed to building on what works at Manguzi and simply getting things done. As he says, “When you’ve invested so much into a hospital, you want to keep going as much as you can.”

Republished from Spotlight under a Creative Commons Licence.

Source: Spotlight

Categories : Healthcare Politics and Regulations HIVTags : 1 Comment

In-depth: The Court Ruling that Gives Qualifying Pharmacists the Green Light to Provide HIV and TB Meds Without a Script

On By ModernMedia
Photo by National Cancer Institute on Unsplash

By Catherine Tomlinson for Spotlight

Specially trained and accredited pharmacists in South Africa will now be allowed to provide people with medicines to prevent HIV and tuberculosis (TB) and to treat uncomplicated HIV without a doctor’s script. This is because the North Gauteng High Court this week ruled against an application by the IPA Foundation (an association of private doctors) attempting to block the implementation of Pharmacist-Initiated Management of Antiretroviral Therapy (PIMART).

PIMART involves the introduction of a legislative framework, a specialised training course, and an accreditation process to allow pharmacists to supply HIV and TB medicines to people visiting pharmacies, under certain conditions, without a doctor’s script.

The ruling in the case of IPA Foundation versus the South African Pharmacy Council (SAPC) was handed down by Judge Elmarie van der Schyff on 14 August 2023 – almost two years to the day exactly after legislation introducing PIMART was published by the SAPC. Board Notice 101 of 2021 was published on 13 August 2021 (at the time, Spotlight published an in-depth article on the case for PIMART).

While PIMART has been delayed for two years by the IPA Foundation’s legal challenge, Judge van der Schyff’s ruling now clears the way for the SAPC to proceed with its implementation.

Steve Letsike, Chair of the SAPC’s Health Committee and PIMART Task Team, said in a media conference on Thursday that the IPA Foundation has until 8 September to appeal the High Court’s decision. Speaking at the same media conference, Mogologolo Phasha, President of the SAPC, indicated that if the IPA Foundation appeals the ruling, the SAPC will continue to fight to preserve the initiative in higher courts.

Spotlight asked the IPA Foundation whether they plan to appeal the decision, but no response was received by time of publication.

The background

The introduction of PIMART was proposed by the SAPC in 2018 in response to a request from the National Department of Health for the SAPC to develop an intervention to enable pharmacists to help get HIV prevention treatment to more people quicker.

Pharmacists trained and accredited under the PIMART initiative will be able to provide preventative therapy for HIV (both post-exposure and pre-exposure prophylaxis – PEP and PrEP), TB preventive therapy, and first-line antiretroviral treatment for uncomplicated HIV.

According to Phasha, around 900 pharmacists, or 5% of pharmacists on the register have already undertaken specialised, supplementary training to enable them to provide PIMART services. He noted, however, that before trained pharmacists would be able to start providing PIMART services they would need to receive accreditation in the form of a permit granted by the National Department of Health under Section 22(A)15 of the Medicines and Related Substances Act.

The court’s response to the IPA Foundation’s arguments

In February 2022, the IPA Foundation filed an affidavit with the North Gauteng High Court seeking review and dismissal of the SAPC’s decision to implement PIMART and related legislation.

In its affidavit, the IPA Foundation argued that the provision of PIMART services falls within the domain of medical doctors and that pharmacists do not have the required training and competencies to provide these services. The IPA Foundation further argued that the SAPC does not have the legislative mandate to introduce PIMART, that the SAPC’s reasons for implementing PIMART were not adequately explained, and that the SAPC’s procedures for implementing PIMART were not procedurally fair and did not provide adequate opportunity for interested parties to comment.

The IPA Foundation warned of a “slippery slope” resulting from PIMART’s introduction, adding “this objection essentially warns of the opening of the floodgates or perhaps an anticipated negative precedent setting occurrence relevant to the provision of medication… without prescription”.

In her ruling, Judge van der Schyff noted that while tension between healthcare cadres regarding their scopes of practice is common, the World Health Organization calls for “a collaborative approach to primary healthcare issues and the embracing of task-shifting”.

She added that “competition, per se, does not limit or curtail the rights of medical practitioners to continue providing the services that they currently provide,” further stating that “even if the assumed competition is regarded to affect family practitioner’s rights adversely, the alleged adverse effect it holds for medical practitioners has to be considered against the need to expand primary healthcare services aimed at preventing and treating HIV”.

Judge van der Schyff dismissed the IPA Foundation’s argument that the SAPC is not mandated to introduce PIMART, stating that “the SAPC is empowered to prescribe the scope of practice of the various categories of persons registered in terms of the Pharmacy Act”. She added, “The development and implementation of PIMART, does not expand the existing scope of practice of pharmacists that generically provides for PIT [pharmacist-initiated therapy] and PCDT [primary care drug therapy]. It introduced a specialised category of PIT and PCDT focused on preventing and treating HIV.”

Judge van der Schyff also rejected the IPA Foundation’s arguments that PIMART’s introduction was procedurally unfair and the decision for its implementation was not properly explained, arbitrary, or capricious. She says that “through its collaboration with the Southern African HIV Clinicians Society, whose members include numerous medical doctors, the development of PIMART was given great exposure”.

“The need to widen access to first-line ART [antiretroviral therapy] and TPT [TB preventative therapy] on a community level is not a figment of SAPC’s imagination, but a dire need that is also evinced in other countries,” held van der Schyff.

Finally, Judge van der Schyff rejected the argument that pharmacists are not adequately trained to provide PIMART services, stating, “The PIMART training course was developed to ensure that pharmacists who successfully completed the training would be ‘suitably qualified to safely and effectively assist in providing ART’.” She adds that the PIMART training course was “developed by suitably qualified experts in the field, which experts include medical practitioners”.

The ruling was welcomed by the SAPC and several HIV groups.

“The superior court yesterday (Wednesday) confirmed what has been our long-held view that PIMART is a necessary and competently designed intervention programme to support South Africa’s efforts in providing access to patients diagnosed with HIV and AIDS,” said Phasha. “The programme may also arrest and lower the ballooning HIV budget, which is nearly half the national health budget, by reducing the rate of new infections.”

Nelson Dlamini, Head of Communications at the South African National AIDS Council (SANAC), told Spotlight that SANAC welcomes the court ruling.

“The magnitude of South Africa’s HIV burden requires innovative ways of accessing HIV treatment, care, and support. PIMART is one such approach that will improve access to antiretroviral therapy for people living with HIV and those requiring PEP & PrEP,” said Dlamini.

Sibongile Tshabalala, Chairperson of the Treatment Action Campaign (TAC), said the organisation also welcomes the ruling. “The challenges that we are facing in the country include one of people queuing for a long time in facilities… and also the attitude of nurses in facilities which chases away so many people from facilities. We also have the issue of key populations that are not comfortable to go in public health facilities to access medication… so if a pharmacist is able to issue and prescribe ARVs and TB medication it will mean that we will be able to cover a lot of people.”

*NOTE: A representative of the TAC is quoted in this article. Spotlight is published by SECTION27 and the TAC, but is editorially independent – an independence that the editors guard jealously. Spotlight is a member of the South African Press Council.

Republished from Spotlight under a Creative Commons Licence.

Source: Spotlight

Categories : Cardiovascular Disease HIVTags :

Daily Statin Reduces Risk of Major Cardiovascular Events in People Living with HIV

On By ModernMedia
Photo by Towfiqu Barbhuiya on Unsplash

A new study published in the New England Journal of Medicine found that statins, a class of cholesterol-lowering medications, may offset the high risk of cardiovascular disease in people living with HIV by more than a third, potentially preventing one in five major cardiovascular events or premature deaths in this population. People living with HIV can have a 50–100% increased risk for cardiovascular disease.

“This research suggests that statins may provide an accessible, cost-effective measure to improve the cardiovascular health and quality of life for people living with HIV,” said Gary H. Gibbons, MD, director of the National Heart, Lung, and Blood Institute (NHLBI), a study funder. “Additional research can further expand on this effect, while providing a roadmap to rapidly translate research findings into clinical practice.”

For the double-blinded phase 3 trial, known as Randomised Trial to Prevent Vascular Events in HIV (REPRIEVE) study, researchers randomised participants into either a treatment group, where they received pitavastatin calcium daily or a control group receiving placebo. The researchers followed participants for about five years, but ended the trial early when they discovered the treatment benefits outweighed potential risks.

To understand the benefits, the researchers compared how often participants in each group experienced major cardiovascular events, including heart attacks, strokes, or surgery to open a blocked artery. They found participants who took daily pitavastatin had 35% fewer major cardiovascular events than those who took a placebo. The researchers also measured the number of deaths in combination with major cardiovascular events during the study period and found participants in the treatment group were 21% less likely than those in the placebo group to experience these events. Additionally, those taking pitavastatin had a 30% reduction in their low-density lipoprotein (LDL) cholesterol levels.

“Lowering LDL cholesterol levels reduces risks for cardiovascular events, like having a heart attack and stroke, but these findings suggest there may be additional effects of statin therapy that explain these reduced risks among people living with HIV,” said Steven K. Grinspoon, MD, the study chair. “Ongoing research about how statin therapy may affect inflammation and increased immune activation among people with HIV may help us better understand the additional benefits we’re seeing with this treatment approach.” 

To support optimal health outcomes among the study participants, normal liver and kidney function were an enrolment criteria. They were also required to take antiretroviral therapy, which itself is critical to reducing the risk of HIV complications and related comorbidities, including cardiovascular disease.

Beginning in 2015, REPRIEVE enrolled 7769 adults, ages 40–75, from 145 sites in 12 countries. Adults in the study were an average age of 50 and had low-to-moderate risks for cardiovascular disease, which meant they normally would not have been prescribed statins. Women accounted for 31% of participants. Approximately 41% of study participants identified as Black, 35% as white, 15% as Asian, and 9% as another race.

Source: National Insitutes of Health

Categories : Respiratory DiseasesTags :

The Complex Interplay Between TB and Liver Problems

On By ModernMedia
Tuberculosis bacteria. Credit: CDC

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 : HIVTags :

Khayelitsha Trial Shows Single-dose Dolutegravir May Suffice in HIV-associated Tuberculosis

On By ModernMedia
Tuberculosis bacteria. Credit: CDC

In the RADIANT-TB randomised controlled trial carried out in Khayelitsha, researchers found that tuberculosis (TB) patients with HIV taking a double dose of dolutegravir had similar viral suppression to those taking a single dose plus placebo. The findings, published in The Lancet HIV, suggest that a only once-daily dolutegravir is feasible in patients with HIV-associated tuberculosis.

WHO’s preferred first-line antiretroviral therapy (ART) regimen for adults and adolescents with HIV is dolutegravir, combined with tenofovir and lamivudine or emtricitabine. A disadvantage of dolutegravir is substantial drug–drug interaction with rifampicin, which is important as tuberculosis is the most common cause of hospitalisation and mortality among people living with HIV.

The drug–drug interaction between rifampicin and dolutegravir can be overcome by supplemental dolutegravir dosing, but is a challenge in resource-constrained settings. The researchers sought to investigate whether virological outcomes with standard-dose dolutegravir-based ART are acceptable in people with HIV on rifampicin-based antituberculosis therapy.

RADIANT-TB was a phase 2b, randomised, double-blind, non-comparative, placebo-controlled trial in Khayelitsha, Cape Town, South Africa. Participants were aged over 18 years, with plasma HIV-1 RNA >1000 copies/mL, CD4 count > 100 cells/μL, ART-naive or first-line ART interrupted, and on rifampicin-based antituberculosis therapy for less than three months. Participants were assigned (1:1) to receive either tenofovir disoproxil fumarate, lamivudine, and dolutegravir plus supplemental 50mg dolutegravir 12h later or the same drugs but with placebo in place of the supplemental dolutegravir. Participants received standard antituberculosis therapy (rifampicin, isoniazid, pyrazinamide, and ethambutol for the first two months followed by isoniazid and rifampicin for four months). The primary outcome was the proportion of participants with virological suppression (HIV-1 RNA <50 copies/mL) at week 24 analysed in the modified intention-to-treat population.

No treatment-related dolutegravir resistance emerged in the trial, and though not significant, an increase in insomnia was noted in the supplemental dolutegravir arm. In terms of future research, it is questionable whether a phase 3 trial would be needed given the significant time required for a policy change. Limitations included the study not being powered to compare efficacy.

The authors concluded, “Our findings suggest that twice-daily dolutegravir dosing might be unnecessary in people with HIV-associated tuberculosis. More evidence, from cohort studies or possibly a phase 3 trial, might be necessary to change policy on the need for a supplemental dolutegravir dose with rifampicin-based antituberculosis therapy.”

Categories : HIVTags :

Tuberculosis Weakens HIV Antibody Response in Those with HIV

On By ModernMedia
Tuberculosis bacteria. Credit: CDC

According to new research findings published in iScience, people living with HIV with a history of pulmonary tuberculosis had broader and more potent HIV antibody responses and differences in HIV sequences predicted to be antibody-resistant as compared to those without tuberculosis. The study suggests that concomitant tuberculosis disease has a significant impact on HIV immune responses and the viruses circulating in people living with HIV.

Tuberculosis infects more than 2 billion people in the world, and although tuberculosis is the most common co-infection in people living with HIV, previous studies have not examined how tuberculosis impacts HIV immune responses and virus characteristics.

This study suggest that tuberculosis may impact the efficacy of antibody based prevention and therapeutic strategies. Vaccines to elicit antibodies and antibodies are also being investigated as a means to treat and cure HIV. Higher prevalence of antibody resistant strains along with tuberculosis disease implies that these antibody-based interventions are more likely to in fail in these individuals.

“Tuberculosis is extremely common, especially in regions of the world with high levels of ongoing HIV transmission, and impacts both the immune responses and the characteristics of the circulating virus in people living with HIV so it is imperative we understand the relationship between the two,” said Manish Sagar, MD, an internist at Boston Medical Center and Professor of Medicine at Boston University Chobanian & Avedisian School of Medicine. “These studies have implications for HIV vaccines and antibody based HIV therapeutics.”

Researchers worked closely with investigators in Uganda and at the AIDS Clinical Trial Group (ACTG) to collect samples from people newly diagnosed with HIV that either did or did not have tuberculosis. From these individuals, they examined samples collected prior to and about 6 months after the start of HIV medications. Researchers compared antibodies, plasma inflammatory markers, and HIV sequences in the baseline and in treatment samples.

Tuberculosis disease is associated with higher prevalence of the some antibody-resistant HIV. High ongoing HIV transmission in areas of the world with frequent tuberculosis disease suggest that a potential vaccine that elicits broad and potent antibodies may not work because these geographic regions are more likely to have antibody resistant strains.

This has implications for HIV vaccine strategies as they aim to generate antibodies that can block the virus after exposure. Generating broad and potent HIV antibodies remains a monumentally difficult goal. Understanding the biological pathways behind the broadly potent antibody responses generated by tuberculosis could provide insight into how tuberculosis enhances HIV antibody responses. This in turn could be leveraged to develop novel strategies for eliciting broad and potent HIV antibodies.

Source: Boston Medical Center

Categories : Cardiovascular Disease HIVTags :

Statins Trial in HIV Patients Ended Early Due to Efficacy

On By ModernMedia
Colourised scanning electron micrograph of HIV (yellow) infecting a human T9 cell (blue). Credit: NIH

A large randomised controlled trial into using statins in people with HIV and low-to-moderate cardiovascular risk was stopped early due to clear benefits, according to an update posted online in JAMA Network. Participants, who were taking 4mg pitavastatin calcium daily, saw a 35% reduction in risk with no significant difference in adverse events compared to placebo, according to the National Institutes of Health.

This recommendation came after a planned interim analysis of data from the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) study, which enrolled 7769 participants, across 12 countries across Asia, Europe, North America, South America and Africa. Participants were aged 40–75 years, had 100 cells/mm3 of blood at enrollment, and had low-to-moderate traditional cardiovascular disease risk that would not typically be considered for statin treatment. 

It was not clear if statins would have the same effect in people living with HIV and who have premature cardiovascular disease despite having low-to-moderate traditional risk. The interim analysis was compelling enough that the study’s independent Data Safety and Monitoring Board recommended at its latest regular meeting that it be halted early given adequate evidence of efficacy.

The study participants are being notified of the findings and will continue to be monitored for several months. Study results from the review are expected to be published in the coming weeks.