Tag: antiretroviral therapy

Categories : HIVTags : Leave a comment

SA Unveils Ambitious New HIV Campaign amid Aid Crisis

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

By Ufrieda Ho

Amid major disruptions caused by aid cuts from the United States government, the health department aims to enrol a record number – an additional 1.1 million – of people living with HIV on life-saving antiretroviral medicine this year. Experts tell Spotlight it can’t be business as usual if this ambitious programme is to have a chance of succeeding.

Government’s new “Close the Gap” campaign launched at the end of February has set a bold target of putting an additional 1.1 million people living with HIV on antiretroviral treatment by the end of 2025.

Around 7.8 million people are living with HIV in the country and of these, 5.9 million are on treatment, according to the National Department of Health. The target is therefore to have a total of seven million people on treatment by the end of the year. Specific targets have also been set for each of the nine provinces.

The initiative is aimed at meeting the UNAIDS 95–95–95 HIV testing, treatment and viral suppression targets that have been endorsed in South Africa’s National Strategic Plan for HIV, TB, and STIs 2023 – 2028. The targets are that by 2030, 95% of people living with HIV should know their HIV status, 95% of people who know their status should be on treatment, and 95% of people on treatment should be virally suppressed (meaning there is so little HIV in their bodily fluids that they are non-infectious).

Currently, South Africa stands at 96–79–94 against these targets, according to the South African National Aids Council (SANAC). This indicates that the biggest gap in the country’s HIV response lies with those who have tested positive but are not on treatment – the second 95 target.

But adding 1.1 million people to South Africa’s HIV treatment programme in just ten months would be unprecedented. The highest number of people who started antiretroviral treatment in a year was the roughly 730 000 in 2011. In each of the last five years, the number has been under 300 000, according to figures from Thembisa, the leading mathematical model of HIV in South Africa. According to our calculations, if South Africa successfully adds 1.1 million people to the HIV treatment programme by the end of 2025, the score on the second target would rise to just above 90%.

The record for the most people starting antiretroviral treatment in a single year was approximately 730 000 in 2011. (Graph by Spotlight, based on Tembisa data.)

The ambitious new campaign launches at a moment of crisis in South Africa’s HIV response. Abrupt funding cuts from the United States government – the PEPFAR funding – has meant that the work of several service-delivery NGOs have ground to a halt in recent weeks.

These NGOs played an important role in getting people tested and in helping find people and supporting them to start and restart treatment. The focus of many of these NGOs was on people in marginalised but high-risk groups, including sex workers, people who use drugs and those in the LGBTQI community. As yet, government has not presented a clear plan for how these specialised services might continue.

“We will need bridging finance for many of these NGOs to contain and preserve the essential work that they were doing till we can confer these roles and responsibilities to others,” says Professor Francois Venter, of the Ezintsha Research Centre at the University of the Witwatersrand.

He says good investment in targeted funding for NGOs is a necessary buffer to minimise “risks to the entire South African HIV programme” and the looming consequences of rising numbers of new HIV cases, more hospitalisations, and inevitably deaths.

Disengaging from care

South Africa’s underperformance on the second 95 target is partly due to people stopping their treatment. The reasons for such disengagement from HIV care can be complex. Research has shown it is linked to factors like frequent relocations, which means people have to restart treatment at different clinics over and over. They also have to navigate an inflexible healthcare system. A systematic review identified factors including mental health challenges, lack of family or social support, long waiting times at clinics, work commitments, and transportation costs.

Venter adds that while people are disengaged from care, they are likely transmitting the virus. The addition of new infections for an already pressured HIV response contributes to South Africa’s sluggish creep forward in meeting the UNAIDS targets.

The health department has not been strong on locating people who have been “lost” to care, says Venter. This role was largely carried out by PEPFAR-supported NGOs that are now unable to continue their work due to the withdrawal of crucial US foreign aid.

Inexpensive interventions

Other experts working in the HIV sector, say the success of the Close the Gap campaign will come down to scrapping programmes and approaches that have not yielded success, using resources more efficiently, strategic investment, and introducing creative interventions to meet the service delivery demands of HIV patients.

Key among these interventions, is to improve levels of professionalism in clinics so patients can trust the clinics enough to restart treatment.

Professor Graeme Meintjes of the Department of Medicine at the University of Cape Town says issues like improving staff attitudes and updating public messaging and communications are inexpensive interventions that can boost “welcome back” programmes.

“The Close the Gap campaign must utilise media platforms and social media platforms to send out a clear message, so people know the risks of disengagement and the importance of returning to care. The longer someone interrupts their treatment and the more times this happens, the more they are at risk of opportunistic infections, severe complications, getting very sick and needing costly hospitalisations,” he says.

Clinics need to provide friendly, professional services that encourage people to return to and stay on treatment, Meintjes says, and services need to be flexible. These could include more external medicine pick-up points, scripts filled for longer periods, later clinic operating hours, and mobile clinic services.

“We need to make services as flexible as possible. People can’t be scolded for missing an appointment – life happens. Putting these interventions in place are not particularly costly, in fact it is good clinical practice and make sense in terms of health economics by avoiding hospitalisations that result from prolonged treatment interruptions,” he says.

The Close the Gap campaign, Meintjes adds, should reassure people that HIV treatment has advanced substantially over the decades. The drugs work well and now have far fewer side effects, with less risk of developing resistance. More patients are stable on the treatment for longer and most adults manage their single tablet once-a-day regime easily.

Insights from our experiences

Professor Linda-Gail Bekker, Chief Executive Officer at the Desmond Tutu Health Foundation, says to get closer to the target of 1.1 million people on treatment by year-end will mean using resources better.

“Additional funding is always welcome, so are new campaigns that catalyse and energise. But we also need to stop doing the things we know don’t have good returns. For instance, testing populations of people who have been tested multiple times and aren’t showing evidence of new infections occurring in those populations,” she says.

There is also a need for better data collection and more strategic use of data, Bekker says. Additionally, she suggests a status-neutral approach, meaning that if someone tests positive, they are referred for treatment, while those who test negative are directed to effective prevention programmes, including access to pre-exposure prophylaxis (PrEP) for people at high risk of exposure through sex or injection drug use.

But Bekker adds: “We need to be absolutely clear; these people aren’t going to come to us in our health facilities, or we would have found them already. We have to do the work that many of the PEPFAR-funded NGOs were doing and that is going to the last mile to find the last patient and to bring them to care.”

She says the impact of the PEPFAR funding cuts can therefore not be downplayed. “The job is going to get harder with fewer resources that were specifically directed at solving this problem.”

Venter names another approach that has not worked. This, he says, is the persistence of treating HIV within an integrated health system. Overburdened clinics have simply not coped, he adds, with being able to fulfil the ideal of a “one-stop-shop” model of healthcare.

Citing an example, he says: “Someone might come into a clinic with a stomach ache and be vomiting, they might be treated for that but there’s no investigation or follow-up to find out if it might be HIV-related, for instance. And once that person is out of the door, they’re gone.”

Campaign specifics still lacking

The Department of Health did not answer Spotlight’s questions about funding for the Close the Gap campaign; what specific projects in the campaign will look like; or how clinics and clinic staff will be equipped or supported in order to find the 1.1 million people. There is also scant details of the specifics of the campaign online.

Speaking to the public broadcaster after the 25 February campaign launch, Health Minister Dr Aaron Motsoaledi said South Africa is still seeing 150 000 new infections every year. He said they will reach their 1.1 million target through a province-by-province approach. He used the Eastern Cape as an example.

“When you look at the 1.1 million, it can be scary – it’s quite big. But if you go to the provinces – the Eastern Cape needs to look for 140 000 people. Then you come to their seven districts, that number becomes much less. So, one clinic could be looking for just three people,” he said.

Nelson Dlamini, SANAC’s communications manager, says the focus will be to bring into care 650 000 men, as men are known to have poor health-seeking habits. Added to this will be a focus on adolescents and children who are living with HIV.

He says funding for the Close the Gap campaign will not be shouldered by the health department alone.

“This is a multisectoral campaign. Other departments have a role to play, these include social development, basic education, higher education and training, etc, and civil society themselves,” Dlamini says.

The province-by-province approach to reach the target of finding 1.1 million additional people is guided by new data sources.

“Last year, SANAC launched the SANAC Situation Room, a data hub which pulls data from multiple sources in order for us to have the most accurate picture on the status of the epidemic,” says Dlamini.

These include the Thembisa and Naomi model outputs and data from the District Health Information System and Human Sciences Research Council, he says adding that SANAC is working to secure data sharing agreements with other sectors too.

Dlamini however says the health department, rather than SANAC, will provide progress reports on the 10-month project.

Republished from Spotlight under a Creative Commons licence.

Read the original article.

Categories : HIVTags :

#InTheSpotlight | Where are We in the Search for an HIV Cure?

On By ModernMedia

By Elri Voigt

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

Highly effective treatments for HIV have existed since the mid-1990s. But while these treatments keep people healthy, we do not yet have a safe and scalable way to completely rid the body of the virus. In this Spotlight special briefing, Elri Voigt takes stock of where we are in the decades-long search for an HIV cure.

As the science stands, the vast majority of the roughly eight million people in South Africa living with HIV will have to take treatment for the rest of their lives. This is because the antiretrovirals used to treat HIV prevents the virus from replicating but cannot eliminate it from the body. As soon as treatment is stopped, the virus rebounds, resulting in illness and eventually an early death.

A handful of people have been cured of HIV, but these “cures” involve very risky bone marrow transplants given as part of cancer treatment. The harsh reality is that 40 years into the HIV epidemic, and despite major scientific advances, we don’t yet have a viable cure for the roughly 40 million people on the planet who are living with the virus.

The good news, as one will see at any major AIDS conference these days, is that researchers around the world are working very hard to find a cure. In this #InTheSpotlight special briefing, we take a closer look at what progress has been made on this fascinating scientific journey and ask what the possible routes are toward an HIV cure.

What do we actually mean by a cure?

Dr Sharon Lewin, a leading figure in the world of HIV cure research and the inaugural director of the Peter Doherty Institute for Infection and Immunity in Melbourne, explains that a true “cure” for HIV would mean that there is not a single HIV infected cell left in a person’s body.

By contrast, “remission” would mean that the virus is still in the body, but it is being kept under control by the immune system. This could theoretically happen if the amount of HIV infected cells in a person’s body has been reduced to very low levels and the immune system’s ability to control those remaining cells has been enhanced. Basically, Lewin says, it is when the immune system does what antiretroviral therapy (ART) does without needing to take medication. Another term for this is ART-free viral load control.

There are some people living with HIV called “elite controllers” whose immune systems can naturally, without ART, control HIV. There are also extraordinary elite controllers, says Lewin, who through their immune response have been able to get rid of every single piece of the virus that they had in their bodies. Studying what is special about these rare people has been a key area of research in recent years.

Along with concepts like cure, remission, and control, it also helps to understand where vaccines fit in. As Jessica Salzwedel, the senior programme manager for research engagement at New York-based NGO AVAC, explains, a potential HIV vaccine might be therapeutic and not necessarily preventative. A therapeutic vaccine would be given to someone who is already living with HIV, in the hope that the vaccine would prime their immune system to better fight HIV or potentially clear it.

Why don’t we have a viable cure yet?

Finding cures for viral infections is not unheard of. In fact, one of the most consequential medical breakthroughs of the last decade or so was the development of a highly effective cure for hepatitis C. Unfortunately, it seems HIV is a much tougher nut to crack.

HIV works largely by invading a type of immune cell called a CD4 cell. Once inside, HIV writes its own genetic information into the cell’s DNA and then uses the cell’s machinery to produce more HIV. Eventually, the infected CD4 cell bursts and dies. Different types of antiretrovirals work by gumming up different stages of this process by which HIV invades and exploits CD4 cells. Most antiretroviral treatment regimens used today contain two drugs that target two different stages of this process. These medicines can drive HIV replication in the body down to near zero – which is why people who are stable on ART can live essentially normal, healthy lives.

Unfortunately, that is not the full story. As Lewin explains, the virus has a range of “tricks” that allows it to stay in someone’s body for much longer. One of those tricks is that HIV uses one of the immune system’s greatest assets against it. A person’s immune system contains cells that function as an immunological memory – essentially memory cells – which are designed to survive for a very long time. These memory cells, which include special CD4+ (CD4 positive) T-cells, contain information about which antigens it has encountered during a person’s lifetime. This helps the immune system recognise and kill those antigens faster the next time they enter the body.

HIV writes its own genetic code into some of these memory cells, which helps it stay in the body for as long as that person is alive. Lewin explains that once someone is on treatment, these immune system cells infected with HIV go silent and the virus stops replicating. These silent cells that contain infectious virus are rare, about one in every million, and can’t be found easily by the immune system, allowing the virus to hide in an inactive state but still able to release virus should the cell one day be activated.

These memory cells are found mainly in the lymph nodes, although they can also hide away in the gut, the spleen, and even the brain. Collectively, these HIV-infected cells in hiding are known as the latent reservoir. Should someone stop taking antiretroviral treatment, some of the cells in this latent reservoir could reactivate and start replicating again.

Lewin says researchers are getting better at finding these latent HIV-infected cells, but there still isn’t a way to easily tag these cells and destroy them.

Three lines of investigation

According to Lewin, researchers are exploring three broad strategies in search of an HIV cure.

Firstly, with a strategy called “shock and kill”, researchers try to reactivate (shock) the virus in the cells where it is hiding and then destroy (kill) it once it is flushed out. Such an approach will likely require at least two medicines – one to shock and one to kill. Unfortunately, attempts to find treatments that reliably shock HIV-infected cells out of their slumber has not borne much fruit so far.

Secondly, with “block and lock”, researchers hope to permanently silence the HIV that is hiding away in a person’s body. The aim here is to keep HIV latent for good, so that we never need to worry about killing it. This approach might involve using ART together with a latency promoting agent, of which several are currently being researched. “Block and lock” approaches have been picking up momentum in recent years.

Thirdly, with gene editing, researchers aim to “edit” cells to make them resistant to HIV or remove HIV from them. For example, CD4 cells can be modified to not have the specific receptor called CCR5 that HIV requires to gain entry into the cell. Essentially, if you remove the CCR5 receptor from a cell, HIV has no way in and the cell becomes immune to HIV. In this area, there have been some tantalising developments, but nothing yet that amounts to a workable cure. For example, in one study, people had their blood drawn, the CCR5 receptors removed from the CD4 cells in the blood, and then had the blood reinfused. It worked somewhat, but not nearly well enough to call it a cure.

These three categories are not the only way to think about potential cures.

Broadly, we can think about there being two big “buckets” of approaches for an HIV cure, says Salzwedel. The first “bucket” of approaches targets the virus, and those approaches are trying to remove HIV from the cell or “silencing” it so even if it is still present there is no replication. The other “bucket” of approaches looks at the host – or the person living with HIV – and improving their immune system so it can adequately kill HIV or make the cells that have HIV in them easier to spot so these cells can’t hide from the immune system. She says a combination of approaches from both “buckets” will probably need to be used for a cure.

A resource of HIV cure trials maintained by Treatment Action Group, a New York-based advocacy organisation, lists hundreds of clinical trials currently underway that are trying these different approaches or combinations of approaches.

What about the people who have been cured?

As mentioned earlier, one area of research has involved trying to understand “elite controllers”. Another critically important group of people in the search for a cure are the seven or so people who were living with HIV, but who have been cured. Some of these people, like Timothy Ray Brown and Adam Castillejo, have become minor celebrities in the HIV world.

Lewin explains that people like Brown and Castallejo, both of whom have essentially no HIV left in their bodies, had to go through interventions that can’t be replicated in everyone. Both had a type of blood cancer and were living with HIV. They had to undergo chemotherapy which wiped out their bone marrow, including the cells that had HIV in them. They were then given a whole new bone marrow system through a donation from someone who was naturally resistant to HIV since their CD4 cells do not have CCR5 receptors. This allowed the latently infected cells to be “flushed out” of their bodies. One of the other people cured of HIV received a bone marrow transplant from umbilical cord blood.

Such transplants are not things you can do for everyone who is living with HIV, its expensive and the severe risks of the procedure can only be taken in people living with both HIV and certain cancers. Even so, these cases, says Salzwedel, has shown us that it is possible to cure HIV and made us aware of some of the challenges.

Lewin says that cases like those of Brown and Castallejo helped advance gene editing approaches because they showed that not having CCR5 receptors makes CD4 cells essentially immune to HIV. This led to studies using special gene scissors – a technique called CRISPR – to find the gene for the CCR5 receptor in cells and remove it. CRISPR has also been used experimentally to remove HIV from cells.

So far only a small number of studies have been conducted using CRISPR-based gene editing approaches in an attempt to cure HIV – and these were mostly in the lab or in mice and monkeys. The first human gene editing study for CCR5 was done ex vivo – meaning cells were taken out of the body, edited, and then reinfused into the body. The first clinical trial of CRISPR for HIV in vivo – meaning it is done inside the body –  is currently underway and early results were presented in July at the AIDS 2024 conference. While initial results in monkeys were promising, the early findings in humans were disappointing. EBT-101, the specific type of CRISPR treatment, did not prevent HIV from returning once treatment was stopped – although one study participant’s HIV only started replicating again after 16 weeks. A longer follow-up study is currently open in the United States for enrolment.

Gene editing could also potentially be used to strengthen the immune system. This could work, Lewin explains, by inserting a new gene that produces an antibody against HIV into cells and then putting those cells back into the body. “So instead of giving an infusion of an antibody, your own body makes the antibody. And that’s been done successfully in people with HIV on ART in two separate clinical trials and more recently in infant monkeys where ART was stopped,” she says. “The investigators injected CRISPR that delivered two different antibodies to infant monkeys who are infected with a monkey adapted form of HIV virus and on ART. The infant monkey’s muscle cells then start making the antibodies, and when they stopped ART, the antibodies kicked in and kept the virus under control, so that’s the most successful type of gene therapy,” Lewin says.

Boosting the immune response

Another promising avenue is broadly neutralising antibodies (bNAbs) – the broadly refers to the ability of these antibodies to neutralise a range of different HIV viral strains. Broadly neutralising antibodies can work as an antiviral while present in the body, but they can also trigger the immune system to control the virus and, according to Lewin, figuring out how bNAbs do this is a very important part of current cure research. Broadly neutralising antibodies that are HIV specific, work by binding with the virus and eliminating it while also enhancing a person’s immune system so it can control the virus that remains in the body by hiding in the immune system’s memory cells. Broadly neutralising antibodies potentially have this beneficial effect on immune control by activating CD4 and CD8 responses – part of the immune system’s defence – to kill HIV cells. There have been several clinical trials where a subset of participants who have been given bNAbs have been able to control the HIV virus for six months after stopping ART and when the bNAbs are no longer detected in blood. The scientific challenge is that this beneficial effect was only seen in a subset of participants and the duration of control is not fully understood as most clinical trials only assess participants up to 24 weeks off of ART.

Lewin says a small study has also looked at using anti-PD1, an antibody that reverses immune system exhaustion and essentially “revs” up the immune system to keep fighting HIV. Early study findings were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) this year. Participants stopped ART and were given four doses of the antibody, called Budigalimab, or placebo over 29 weeks. Six out of the nine people who received the antibody had delayed viral rebound and/or ART free control, and two people had viral control off ART for over 29 weeks. The antibody will now be evaluated in a larger study.

Additional approaches, according to Dr Daniel Douek, an expert in immunology and the Chief of the Human Immunology Section at the National Institute of Allergy and Infectious Diseases in the United States, include HIV vaccines, which so far have not generated a strong enough immune response to be considered successful. Douek was speaking on an IAS webinar on HIV cure research. Another promising approach is to start someone on ART as quickly as possible after infection in the hope of preventing the establishment of the latent reservoir.

YouTube video

Suppressing the immune system with a drug has also been tried, says Douek, and research so far in this area warrants further investigation. While it seems counterintuitive, the researchers wanted to see if suppressing immune system cells might stop or reduce HIV replication because the virus likes to replicate in activated immune cells. People living with HIV, even when on treatment have a lot of activated immune cells. The drug Ruxolitnib, which is used to treat graft-versus-host disease in transplant patients, was given to 60 people living with HIV alongside their HIV treatment. After five weeks, there was a decrease in markers of immune activation and cell survival. And between five and 12 weeks of using this combination, those with large viral reservoirs displayed signs that their reservoirs were reducing in size. However, Douek cautioned that much more work needs to be done before we can draw firm conclusions about the value of this approach .

What comes next?

Though we don’t yet have a viable cure for HIV, Lewin says a lot of progress has been made, especially over the decade and a half since Brown was cured. We now know a lot more than we did about the virus and how it hides away in cells. Today, she says, we have cure interventions that work well in monkeys and some interventions being investigated in human clinical trials have induced ART-free viral control in some participants. But she is also clear that it will probably be “a very long time” before you can go to your doctor and get an HIV cure.

In this #InTheSpotlight special briefing, we have focused on the science, but as we have learnt from the new hepatitis C cures and from HIV prevention injections, the journey from the lab to your local clinic can be a very long one and involves far more than just the science.

According to Lewin, a successful HIV cure will have to tick several boxes. She says one needs an intervention that is durable, so that it leads to ART-free viral load control over a prolonged period of time. At this point, an intervention that allows for control over two, three or five years, is seen as worthwhile. Although the ideal would be to give something once and have ART-free viral load control over a lifetime. The intervention also needs to be scalable, so it can be given to a lot of people. It also needs to be cheap.

And if there is one insight we’ve gained over our many years covering HIV, it is that affordability and sufficient supply are not things we can take for granted. Given that many of the potential cures involve treatments that are substantially more complicated to produce and administer than antiretrovirals, the challenges here might be more acute than what we’ve seen before.

That we will eventually get a cure is also by no means inevitable. This is why it is critically important that governments and philanthropies continue to invest in cure research and support programmes such as the International AIDS Society’s Toward an HIV Cure initiative. Among others, this initiative is helping to build the capacity needed to conduct cure research in low-and-middle income countries.

Right now, even under a best-case scenario, a world without a cure will mean that many millions of people will still be living with HIV until late in the 21st century. A successful cure could change this trajectory. Ultimately, Salzwedel is right when she says: “We can’t really end an epidemic without a cure”.

Republished from Spotlight under a Creative Commons licence.

Read the original article

Categories : HIV PaediatricsTags :

Iron Supplements for Children with HIV may Aid Brain Development

On By ModernMedia
Photo by Miguel Á. Padriñán

A University of Minnesota Medical School research team has found that giving iron supplements to children living with human immunodeficiency virus (HIV) in sub-Saharan Africa could be an important first step in optimising brain development. 

The study, published in Lancet HIV, demonstrates that iron, while often withheld from children with HIV due to fear of increasing infection risk, is in fact beneficial. This finding paves the way for future research examining iron’s role in neurodevelopmental outcomes in children with HIV. 

“With the success and widespread availability of antiretroviral therapy (ART), children with HIV in sub-Saharan Africa are living longer, and optimising their brain development is a new public health imperative,” said Sarah Cusick, PhD, associate professor at the U of M Medical School and a member of the Masonic Institute for the Developing Brain.

Between May 2018 and November 2019, researchers enrolled 200 children with HIV and anaemia who had received ART for at least six months. The study participants were randomly chosen to receive either iron supplements or a placebo for three months. Children who received iron had higher haemoglobin concentrations and better markers of iron nutrition than those who received the placebo. There also was no evidence of increased risk of infection. 

According to Dr Cusick, further research is needed to assess brain development and infection risk over a longer period of time.

Source: University of Minnesota Medical School

Categories : HIVTags :

Medicines Stockouts Persist in North West as Tide Turns Slowly

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

By Nthusang Lefafa

Despite some improvement over the past three years, the North West province continues to experience medicine shortages, according to a survey by a community clinic monitoring initiative. We unpack the latest findings and ask why shortages persist in the province.

Some people in need of HIV or tuberculosis (TB) medicines were sent home empty handed after visiting clinics in the North West. This is according to the latest survey of public healthcare services in the province published by community-led clinic monitoring group Ritshidze. The survey data was collected in April and May this year.

Of the roughly 490 000 people living with HIV in North West, around 380 000 (77%) are on antiretroviral treatment, according to figures from Thembisa, the leading mathematical model of HIV in South Africa. Antiretroviral treatment is recommended for everyone living with the virus.

According to Ritshidze, besides HIV and TB medicines, other commonly reported stockouts at clinic-level include pain medicines (such as Paracetamol and Ibuprofen), cardiac medicines (such as Aspirin), contraceptives, dry stock (gauze, bandages, needles), maternal health medicines, psychiatric medicines, and different vaccines.

Out of the 72 facilities surveyed in the province, medicine stockouts lasting one to three months were reported at 20 and stockouts lasting three to six months were reported at six.

‘Failed to comply’

The North West health department, according to Ritshidze, has failed to comply with national guidelines recommending that people living with HIV should be provided with a three or more month supply of antiretrovirals at a time. They found that 71% of people surveyed in 2024 received antiretroviral refills of three to six months – in each of the previous three years this number was below 30%. There was large differences between districts, with 97% of people surveyed in Bojanala district reporting getting a 3 month supply of ARVs — compared to 37% in Dr Kenneth Kaunda.

Giving people longer antiretroviral refills like this means people do not have to visit health facilities as often to collect their medicines.

Various factors influence giving more people longer antiretroviral refills, Tebogo Lekgethwane, Director of Media and Communications in the province’s health department, told Spotlight.

A crucial factor, he said, is that patients must have a good track record of collecting their medication as well as a history of a documented undetectable viral load. “There’s therefore a criteria for multi-month supply which includes the fact that patients should have been on treatment for six months, they are compliant and clinically stable,” said Lekgethwane.

No “crisis” of medicine shortages

While the year-on-year comparisons should not be overinterpreted – Ritshidze themselves advise caution – the numbers nevertheless provide some indication that when it comes to medicines stockouts things are trending in the right direction. The total number of stockouts in the province reported to Ritshidze plunged from 895 in 2021 to 148 in 2024 – over the same period stockouts of HIV medicines went from 115 to 19 and stockouts of TB medicines from 28 to 7.

Lekgethwane was at pains to point out that Ritshidze’s findings do not necessarily represent the actual picture of the entire province. He said that the department believes that the Ritshidze report is subjective and relies on isolated incidents. These incidents, Lekgethwane said, are often quickly addressed.

“The current provincial medicine availability report shows that medicine availability has stabilised above 80%. As at the end of June 2024, ARV stock was at 89.5%, Expanded Programme on Immunisation and Contraceptives remained above 90%, TB treatment at 79%, Oncology treatment at 81.7% and Diabetes Mellitus at 85.8%. Therefore the province does not have a crisis of medicine shortages,” he said.

Asked what exactly these percentages mean, Lekgethwane said that it indicates the actual medicines stock available in the province in relation to what is required.

A pharmacy expert consulted by Spotlight further explained that the percentage indicates the percentage of medicines on a list or in a class that is available in the province.

The way these numbers are tracked is somewhat tricky. Firstly, if a clinic is supposed to have 10 different HIV medicines in stock, but they only have 8 in stock, then its HIV medicines availability would be at 80% (having a single pack of a medicine counts as having it in stock). When many facilities are considered together, as with an entire province like North West, the key indicator looks at what percentage of those facilities have medicines availability above 90%. We thus understand the figures shared by Lekgethwane to mean that 89.5% of facilities, depots and so on in the province have HIV medicines availability above 90%.

Catching up with payments

Past medicine shortages in the province were partly attributed to companies ceasing delivery of medicine due to non-payment of invoices. While the North West health department was under National Department of Health administration in 2020, the offices at the Mmabatho Medical Depot was raided. The search uncovered a number of unpaid invoices worth millions, some dating back to 2014. One unpaid invoice was for more than R16 million.

Bolstered by a Pharmaceutical Intervention Team to address medicine shortages, Lekgethwane said the department’s payments system is now in top shape.

“Payment of suppliers has remained a priority and the finance unit has assisted the team by making good progress on payments of supplier accounts. The unit continues to investigate and intervene when suppliers indicate their account status to the pharmacies.

“This has led to an increased number of deliveries from suppliers to the depot and increased direct deliveries to pharmacies from contracted companies as well as deliveries of main orders, allocation of orders and emergency orders from the depot to the pharmacies,” he said.

“The Department can confidently confirm that the financial management of pharmaceuticals has been improved resulting in 97% of 2024/2025 accruals being paid and remaining with only two accounts that are on hold. The two accounts that are on hold will only be paid once their compliance requirements are sorted,” said Lekgethwane.

He said that the intervention team has the capacity to assess and intervene, in among others, pharmaceutical supply chain issues, system effectiveness, distribution and delivery processes, storage capacity, human resource capacity and safety issues.

Lekgethwane said the team’s first priority was to assess the Mmabatho Medical Depot before moving onto pharmacies in hospitals and clinics across the province.

Getting medicines to rural areas

While Ritshidze also raised concern around transportation for the delivery of medicines, the department said transportation has never been a challenge.

“There are contracted service providers who deliver to the Mmabatho Medical Depot and the depot delivers to hospitals. Clinics receive their medicine from their referral hospital,” said Lekgethwane.

“However, the department is currently implementing the bulk pharmacies for districts to bring medicines closer to facilities”, he added. A bulk pharmacy is a medicine storage facility which serves as a medical depot. It is situated in the districts and helps with bringing medicines closer to rural areas so that medicines do not have to be transported from major towns.

In this regard, Lekgethwane said the Dr Kenneth District Bulk Pharmacy was recently opened and soon the General De la Rey Bulk Pharmacy will open.

He said the department is confident that the use of these bulk pharmacies will improve medicine storage and distribution capacity.

Shortage of pharmacists and pharmacy assistants

The Ritshidze report found that only 9% of surveyed facilities had a pharmacist and only 18% had a pharmacist assistant. Government regulations state that either pharmacists or pharmacy assistants should be responsible for stock receiving orders and updating the stock visibility system. However, Ritshidze found that enrolled nurses, enrolled nurse assistants, facility managers, and even cleaners acted in that capacity at some clinics.

The province has a 6% vacancy rate for pharmacists while 342 are currently employed, according to the 2024/2025 health department annual performance plan tabled in the North West Provincial Legislature earlier this month. The plan states that the department’s organisational structure makes provision for 10 pharmacists to be appointed in the province for every 100 000 uninsured individuals.

The DA’s Hendriette van Huyssteen says there is a challenge of pharmacists and pharmacy assistants where there are clusters of less than 10 000 uninsured individuals (where one pharmacist would be allocated for 10 000 uninsured individuals) and the clinics servicing them are far removed from one another.

“With the NHI [National Health Insurance] being signed into law, the number of pharmacists will become only a greater challenge. The cost per pharmacist employee stands at R765 000.00 per annum. It is unclear as to where the funding would come from for the remuneration of the additional pharmacists needed under the NHI, as even the NHI Act is unclear in this regard,” she said.

Notwithstanding the issue of budget constraints, the training of more pharmaceutical staff is integral to having fully functional health systems, said Professor Andrew Robinson. He is a deputy dean in the Faculty of Health Sciences at North West University (NWU). He was previously a deputy director general in the North West health department.

“To improve the pharmaceutical skills in the province, the NWU must ensure it aligns its pharmacy training to address the skill needs of the provincial health department to ensure equitable health service delivery to all, which is necessary for successful implementation of the NHI,” he said.

Republished from Spotlight under a Creative Commons licence.

Read the original article

Categories : HIVTags :

New Drug Shows Promise in Clearing HIV from the Brain

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

An experimental drug originally developed to treat cancer may help clear HIV from infected cells in the brain, according to a new study published in the journal Brain. For the first time, researchers at Tulane University found that a cancer drug significantly reduced levels of SIV, the nonhuman primate equivalent of HIV, in the brain by targeting and depleting certain immune cells that harbour the virus.

This discovery marks a significant step toward eliminating HIV from hard-to-reach reservoirs where the virus evades otherwise effective treatment.

“This research is an important step in tackling brain-related issues caused by HIV, which still affect people even when they are on effective HIV medication,” said lead study author Woong-Ki Kim, PhD, associate director for research at Tulane National Primate Research Center. “By specifically targeting the infected cells in the brain, we may be able to clear the virus from these hidden areas, which has been a major challenge in HIV treatment.”

Antiretroviral therapy (ART) is an essential component of successful HIV treatment, but the virus persists in “viral reservoirs” in the brain, liver, and lymph nodes, where it remains out of reach of ART.

The brain has been a particularly challenging area for treatment due to the blood-brain barrier preventing treatments from reaching the virus. In addition, macrophages are extremely long-lived, making them difficult to eradicate once they become infected.

Infection of macrophages is thought to contribute to neurocognitive dysfunction, experienced by nearly half of those living with HIV. Eradicating the virus from the brain is critical for comprehensive HIV treatment and could significantly improve the quality of life for those with HIV-related neurocognitive problems.

Researchers focused on macrophages, a type of white blood cell that harbours HIV in the brain. By using a small molecule inhibitor to block a receptor that increases in HIV-infected macrophages, the team successfully reduced the viral load in the brain. This approach essentially cleared the virus from brain tissue, providing a potential new treatment avenue for HIV.

The small molecule inhibitor used, BLZ945, has previously been studied for therapeutic use in amyotrophic lateral sclerosis (ALS) and brain cancer, but never before in the context of clearing HIV from the brain.

The study, which took place at the Tulane National Primate Research Center, utilised three groups to model human HIV infection and treatment: an untreated control group, and two groups treated with either a low or high dose of the small molecule inhibitor for 30 days. The high-dose treatment lead to a notable reduction in cells expressing HIV receptor sites, as well as a 95-99% decrease in viral DNA loads in the brain .

In addition to reducing viral loads, the treatment did not significantly impact microglia, the brain’s resident immune cells, which are essential for maintaining a healthy neuroimmune environment. It also did not show signs of liver toxicity at the doses tested.

The next step for the research team is to test this therapy in conjunction with ART to assess its efficacy in a combined treatment approach. This could pave the way for more comprehensive strategies to eradicate HIV from the body entirely.

Source: Tulane University

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 : General Interest HIVTags :

Interview: “I Used That Anger to Feed My Activist’s Soul,” Says Former TAC General Secretary

On By ModernMedia
Dr Vuyiseka Dubula-Majola, the former General Secretary of the Treatment Action Campaign, reflects on her journey and new role at the Global Fund. PHOTO: Joyrene Kramer

By Biénne Huisman for Spotlight

Dressed in a dark jacket, rain is pelting Vuyiseka Dubula-Majola’s face as she rushes past bare trees in Geneva, Switzerland. Along with her two children, Dubula-Majola has newly moved into a house in nearby Genthod, from where she commutes to work by train.

In October, the Global Fund to Fight AIDS, Tuberculosis [TB] and Malaria, appointed Dubula-Majola as head of their community, rights and gender department. The Global Fund has allocated tens of billions of dollars around the world to fight HIV since its inception in 2002.

Five weeks into the job, Dubula-Majola tells Spotlight that a big challenge for her will be to hone a new tool – that of diplomacy.

Laughing, the former General Secretary of the Treatment Action Campaign (TAC) says that in the past, diplomacy has not been her greatest strength.

“In this new job, I am required to be diplomatic,” she says. “Basically, diplomacy is being nice in the face of atrocities, and I am not that person. So it will be a huge challenge for me, it’s going to take a shift. I will have to keep asking myself, ‘what value I can add in this position?’ While developing new tools and new ways of fighting, without being the noisy person in the room.”

The power of collective action

Known for not mincing her words, the activist-scholar is talking to Spotlight over Zoom while walking to the Global Fund’s offices in central Geneva. She adds: “Activists don’t like bureaucracies by nature, but you have a voice here. You have political currency to shift things. It’s a tough one, but I’m there.”

In a 2014 TedX talk hosted in London, an inflamed Dubula-Majola told the audience that she is angry – angry with her father, angry with her government, angry at everyone. But that she was using her anger to fuel her work.

Vuyiseka Dubula-Majola was recently appointed at head of the Global Fund’s community, rights and gender department. PHOTO: Supplied

While she is in Switzerland, Dubula-Majola’s heart still brims with African proverbs, such as: “When spider webs unite, they can tie up a lion.” She has experienced the power of such collective action first-hand at the TAC, but now she’ll be applying it on a different stage. Indeed, her new job is “to ensure that the Global Fund strongly engages civil society and promotes human rights and gender equality”, with a particular focus on supporting community led organisations.

As a role model for her new diplomatic duties, Dubula-Majola cites American public health official Loyce Pace. “Loyce Pace who runs the health program in the United States government, she is very effective in what she does while hardly saying anything in public. But she is shifting norms – bringing priority to black and poor people. She uses her allies and many other people similar to her to say things louder than she could…I guess this is another step of growth in my activist journey – to still be as effective, as radical, the very same eagerness and passion, but silently.”

‘There was no time to dream’

Dubla-Majola grew up in a village near Dutywa in the Eastern Cape. Aged 22 in Cape Town in 2001, she spiralled with depression after being diagnosed with HIV. But instead of resigning herself to what was then still a death sentence for most people, she joined the TAC – working night shifts at the McDonalds drive-through in Green Point, while by day she joined the fight to bring antiretrovirals and other medicines to South Africa.

“As a 22-year-old, I did not have fun, there was no time to dream,” she recalls. “I was fighting for my life and the lives of others. I never thought I would have children, I never thought I would get married, I never thought I would love again. Because there was also the issue of who infected me, how did this happen? You start resenting relationships.”

At the forefront of social justice activism for most of South Africa’s young democracy – a role model for people living with HIV, and for those fighting inequality – Dubula-Majola lead the TAC from 2007 to 2013, after which she joined Sonke Gender Justice as director of policy and accountability. She holds an MA in HIV/AIDS management from Stellenbosch University; her PhD from the University of KwaZulu-Natal examined “grassroots policy participation after a movement has succeeded to push for policy change,” using MSF’s [Médecins Sans Frontières] pioneering antiretroviral sites in Khayelitsha and Lusikisiki as samples.

‘Build and regain the dignity of poor people’

In 2018, when Stellenbosch University offered her a job as director of its Africa Centre for HIV/AIDS Management, Dubula-Majola was circumspect. Why take up appointment at a white male-dominated institution shackled by slow transformation, in an elitist town? But she took on the challenge to become the transformation she wanted to see.

Dubula-Majola tells Spotlight that while relishing the privilege of academia – a space to reflect – it saw her away from “the heat of the activist fire” for too long. Five years later, a new challenge awaits.

Reflecting on Stellenbosch, she says: “This [job at the Global Fund] is even harder, because it’s not just one country, one university. This is all the continents of the world. All of them facing the same thing, the struggle here is to build and regain the dignity of poor people around the globe.”

Despite her early misgivings about relationships, Dubula-Majola married fellow TAC activist, Mandla Majola. Their children, now aged 10 and 16, are HIV-negative. Presently Majola is helping with their friend Zackie Achmat’s independent campaign for the 2024 general elections, after which he will join his wife in Geneva. The family will unite in Switzerland for Christmas though – “which will be the most miserable and cold Christmas,” says Dubula-Majola, laughing. “It will be our first winter Christmas and our last. As we just arrived a month ago, it doesn’t make sense to travel back to South Africa for the holidays.”

Overall she says she remains hopeful, adding that movements like #MeTo are lessons in global solidarity.

Her thoughts on continuing the fight against HIV: “It is up to HIV positive people, and those who want to remain HIV negative, to steer towards an AIDS-free generation. We must stop complaining, thinking politicians will do everything for us, and do it ourselves.”

Meanwhile, Global Fund representatives have voiced confidence in Dubula-Majola’s ability to lead. Marijke Wijnroks, head of the organisation’s strategic investment and impact division, said in a statement: “Following an extensive search process, I am delighted to say that we found the ideal person for this role. As a person living with HIV, Vuyiseka’s lived experience and leadership style are well aligned to what we need from this critical role.”

Note: Dubula-Majola is a former General Secretary of the TAC. 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 : HIV PaediatricsTags :

Treating Newborns with HIV in 1st 48 Hours may Result in Medication-free Remission

On By ModernMedia
Photo by Christian Bowen on Unsplash

An unexpectedly high percentage of children, who were born with HIV and started treatment within 48 hours of life, exhibit biomarkers by two years of age that may make them eligible to test for medication-free remission, according to a multinational study published in The Lancet HIV.

“Moving away from reliance on daily antiretroviral therapy (ART) to control HIV would be a huge improvement to the quality of life of these children,” said Protocol Co-Chair and senior author Ellen Chadwick, MD, at Ann & Robert H. Lurie Children’s Hospital.

Conducted in 11 countries including South Africa, the proof-of-concept study was charged with replicating the case of HIV remission as seen in the “Mississippi baby” that was reported in 2013. In that case, the infant started ART at 30 hours of life, was treated for 18 months, and achieved 27 months of ART-free remission before the virus rebounded. Typically, if ART is stopped, the virus rebounds within a month.

The study included a three-drug ART regimen initiated within 48 hours of life, with the fourth drug added within 2-4 weeks. This is very early treatment compared to the standard of care where three-drug ART may not begin until 2-3 months of age.

In the US, however, based on earlier findings from this study, very early treatment is now the norm for infants at high risk of acquiring HIV infection from their mother.

“With earlier treatment, we hope to limit or prevent the establishment of viral reservoirs in the body. These viral reservoirs hold small amounts of hidden virus which are hard to reach with ART. By shrinking these reservoirs, we expect to increase the amount of time that patients can be in remission, without needing daily ART,” said co-author and Protocol Co-Chair Jennifer Jao, MD, MPH, from Lurie Children’s.

Dr Chadwick adds: “Another benefit of smaller viral reservoirs might be that newer treatments such as long-acting antibody therapies or therapeutic vaccines could potentially be used instead of daily ART.”

“Our results show a higher percentage of children might be eligible to interrupt therapy than we expected, and the next step is to stop ART and see how many children actually achieve remission,” said Dr Chadwick.

“If even one child achieves remission, that would be considered a success. Today, newer more effective and better tolerated HIV medications are available for infants than when the study began, strengthening the prospect of limiting viral reservoirs and testing for possible remission in infants and children with HIV. Overall, this is an exciting advancement and an opportunity to change the course of pediatric HIV infection.”

The study was conducted in 11 countries – Brazil, Haiti, Kenya, Malawi, South Africa, Tanzania, Thailand, Uganda, USA, Zambia and Zimbabwe.

Source: Ann & Robert H. Lurie Children’s Hospital of Chicago

Categories : HIVTags :

An Injectable Hydrogel could Deliver Long-term ART for HIV Patients

On By ModernMedia
Photo by Raghavendra V Konkathi on Unsplash

A new injectable solution that self-assembles into a gel under the right conditions could help manage HIV unlike any currently available methods, researchers report in the Journal of the American Chemical Society. Developed by John Hopkins University researchers, the new gel releases a steady dose of the antiretroviral lamivudine over six weeks, suggesting people living with HIV could have an alternative to the daily pill regimen.

“The primary challenge in HIV treatment is the need for lifelong management of the virus, and one way to address this is to reduce dosing frequencies to help patients stick to medical regimens,” said lead researcher Honggang Cui, a chemical and biomolecular engineer. “This new molecular design shows us a future in which drug hydrogelation can do that to improve HIV treatment.”

In plasma-like conditions, Cui’s team showed the gel quickly separates into molecules of lamivudine. By injecting the gel in the backs of mice, the researchers found one injection was sufficient to maintain effective and lasting drug concentrations for 42 days with nearly no side effects.

“Our goal is to help improve people’s quality of life,” Cui said. “The antiviral substance can be injected under the skin and remain in place over an extended period, releasing the therapeutic compound slowly and consistently – a critical need for individuals with HIV.”

For people living with HIV, the key is maintaining bloodstream drug levels at concentrations that suppress virus load in the body. But that can be difficult with traditional approaches because the body naturally rids itself of these chemicals, Cui said, which is why different treatments require different dosages and dosing frequencies to work.

Most antiretroviral therapies use a combination of drugs, so the researchers plan to include other drugs in tests. Because lamivudine is an FDA-approved drug to treat HIV and hepatitis B, the researchers said the hydrogel could also help manage hepatitis B.

“This is a novel way to deliver anti-HIV meds, and this platform has the advantage that a single polymer can be programmed to deliver several different drugs simultaneously,” said co-author Charles W. Flexner, a professor of medicine, pharmacology, and molecular sciences in the Johns Hopkins School of Medicine. “One of the drawbacks of the approved injectable HIV treatments is that none have activity against hepatitis B virus, which is a common co-infection with HIV, especially in Asia and Africa. This formulation delivers lamivudine, a drug active against both HIV and HBV, but can also be modified to deliver tenofovir, which is the current standard of care for HBV treatment.”

The team envisions their hydrogel working as a preventive measure, similar to how some people take anti-HIV drugs to avoid infection.

“Keeping the high drug levels in plasma for 42 days is very impressive,” Cui said. “But in the future, we hope it will be even longer.”

Hydrogels have unique water-absorbing properties that give them a jellylike consistency resembling biological tissue. The new gel undergoes self-formulation, stays close to the site of injection, and separates into molecules that can fend off the virus without the need for additional carriers or delivery materials.

“The most exciting aspect of these gel filaments is that they consist entirely of the therapeutic agent itself,” Cui said. “Everything originates from the same compound after injection, and this simplest drug formulation could streamline the regulatory approval process once clinical efficacy is demonstrated.”

The team tweaked the molecular properties of lamivudine to act as the building blocks of a supramolecular polymer, a large chain of repeating molecules that can either stick together tightly or come apart, depending on temperature, pH, and other external conditions.

Source: Johns Hopkins University

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