Tag: antiretroviral therapy

Categories : HIVTags :

Another HIV Treatment Option – but with Less Weight Gain

On By ModernMedia

SA study finds doravirine works as well as dolutegravir to supress HIV viral load, enabling choice for those living with HIV.

Photo by Miguel Á. Padriñán

If you’re a black, 34-year-old South African woman living with HIV, antiretroviral (ARV) treatment options have likely been limited to tenofovir disoproxil fumarate (TDF), lamivudine (3TC) and the ‘gold standard’ dolutegravir (DTG).

Now, another once-a-day, three-drug regimen has been found to be as effective as DTG in supressing HIV viral load.

Not only is the once daily regimen of tenofovir disoproxil fumarate (TDF), lamivudine (3TC) and doravirine non-inferior to DTG, it is associated with significantly less weight gain and has a better lipid profile than the combination favoured and recommended as first-line in many countries, and increasingly in low-and-middle income countries.

These were the end point findings of the South African Opti-DOR study presented at the 2026 International AIDS Society Conference on HIV Science on 31 July and published in the Journal of the American Medical Association (JAMA).

Dr Joana Woods, Senior Research Clinician at Ezintsha at the University of the Witwatersrand (Wits) and lead author, says:“The findings are important because although second-generation ARVs such as dolutegravir and bictegravir are highly effective HIV medicines, they have been consistently associated with substantial weight gain and new onset obesity, particularly among women and black populations and especially when combined with TAF. This has raised concern about long-term cardiometabolic risk, including diabetes and cardiovascular disease.”

In primary healthcare, prevention is better than having to deal with long term consequences. This is why in a country like South Africa with widespread HIV and NCDs, managing weight gain in people living with HIV is critical to their health.

“So if you can start an ARV that’s not going to cause as much weight gain, or not cause weight gain at all, or have an alternative, that would be first prize. And that’s the premise of this study,” says Woods.

About the OPTI-DOR Study

The Africa Health Research Institute (AHRI) ran the rural arm of the Opti-DOR study at the AHRI-Somkhele site in rural northern KwaZulu-Natal province.

“By including participants from both rural KwaZulu-Natal and urban Gauteng, we can be confident that these findings are relevant to people living with HIV in different communities across South Africa,” says Professor Limakatso Lebina, Principal Investigator at the rural AHRI-Somkhele study and Director of Science at AHRI.

The AHRI site enrolled 178 participants between December 2023 and March 2025, with the Johannesburg site enrolling the rest, for a total of 600.

Participants were randomised in a 1:1 ratio to receive either oral daily doravirine (TDF/3TC/DOR) or dolutegravir (TAF/FTC/DTG).

Weight gain differed significantly between the two study groups. Median weight gain at week 48 was 3.0 kg with doravirine (TDF/3TC/DOR) compared with 5.0 kg with dolutegravir (TAF/FTC/DTG).

Increases in total body fat percentage were also significantly lower with doravirine (TDF/3TC/DOR) at 1.5%, versus 2.2%.

“These results add some clarity to a challenge that has frustrated both doctors and patients for years: how to treat HIV effectively without causing significant weight gain,” says Lebina. “For many patients, especially black women who are disproportionately affected by treatment-associated weight gain, this could be a game changer. It offers an important new treatment option that supports long-term health while maintaining excellent HIV control.”

Non-inferior yet drug resistance potential

Woods emphasises that the efficacy of doravirine is dependent on patients’ absolute adherence to taking it. If doravirine is taken properly, HIV viral load will be suppressed. However, failure to adhere can cause drug resistance.

“Doravirine is non-inferior to dolutegravir in the sense that if you take the drug properly, you will suppress it [HIV viral load]. If you don’t take it properly, you will likely become resistant. That unfortunately is one of the downsides of using doravirine.”

In the Opti-DOR clinical trial, seven patients developed resistance to the drug. These participants were then switched over to dolutegravir and successfully suppressed again.

Woods emphasises that doravirine is unlikely to be a replacement for DTG: “It is not a replacement. It has to be targeted to patients who are at risk of gaining more weight – and complications thereof.”

Despite drug resistance, the data prove that doravirine is not inferior to dolutegravir and that it causes less weight gain.

Research into action

Doravarine is already an available and registered drug.

The researchers have alerted the South African National Department of Health and the South African Health Products Regulatory Authority.

“Imagine you’re a diabetic and you only have access to one drug? It’s the same thing with HIV. Yes, the drug they have at the moment is really top of the tops, but it doesn’t suit everybody. You have to have options. Until we can cure HIV, you’ve got to make it as easy as possible for people to take their treatment. That’s what it comes down to.”

Key findings of the Opti-DOR study at week 48

  • Doravirine [TDF/3TC/DOR] was non-inferior to dolutegravir [TAF/FTC/DTG] for viral suppression.
  • Viral suppression was achieved by 89.0% of participants on doravirine [TDF/3TC/DOR] and 90.7% on dolutegravir [TAF/ FTC/DTG].
  • Median weight gain was significantly lower with doravirine [TDF/3TC/DOR]: 3.0 kg versus 5.0 kg.
  • Total body fat percentage increased less with doravirine [TDF/3TC/DOR]: 1.5% versus 2.2%.
  • Lipid changes favoured doravirine [TDF/3TC/DOR].
  • Glycaemic measures and blood pressure were similar between arms.
  • No emergent integrase inhibitor resistance was observed.
  • Bone mineral density declined more with doravirine [TDF/3TC/DOR].
  • Serious adverse events and major laboratory abnormalities were infrequent across and similar between both groups, and not considered treatment related.

Read the full story from Wits University.

Categories : HIVTags :

People with HIV Are Living Longer but Have Fewer Years of Good Health – New Guidelines Aim to Change That

On By ModernMedia
Taking antiretroviral therapy as recommended has expanded the lifespan of people with HIV. (Photo: Unsplash)

By Elna Schütz for Spotlight

South Africa’s first set of clinical guidelines focused on older people living with HIV has been released. They offer practical steps in a resource-strained health system to take care of an ageing patient population.  

The guidelines from the Southern African HIV Clinicians Society were published in the Southern African Journal of HIV Medicine. A dozen experts from institutions around the country gave input from disciplines like infectious diseases and palliative care.  

The guidelines are particularly important in South Africa since the country has an ageing population of people living with HIV. Many of these people would only have started treatment relatively long after they contracted the virus, largely because of the government’s reluctance to make antiretroviral treatment available in the early 2000s. The sooner people start treatment after infection, the better their long-term prognosis tends to be. 

In 2025, there were around 1.9 million people over the age of 50 living with HIV in South Africa, according to Thembisa, the leading mathematical model of HIV in the country. This is 24% of the estimated 7.9 million HIV positive people in the country. The 1.9 million figure is more than double the 800 000 people over 50 who were living with HIV in 2015. This number is projected to rise to over 3.6 million by 2035.  

Most people over the age of 50 who are living with HIV contracted the virus before they turned 50. The increase depicted in this graph is thus mainly a function of people who are already living with HIV ageing into the over 50 age group. Some people over 50 do become newly infected with HIV, but those numbers are comparatively small.

The changing make-up of the population of people living with HIV, coupled with the fact that antiretroviral therapy has been crucial for clearing and suppressing HIV in the body was a core driver for developing the new guidelines, Dr Camilla Wattrus, the Clinical Director at the Southern African HIV Clinicians Society, tells Spotlight. She is one of the guidelines’ authors. 

“Antiretroviral therapy has expanded the lifespan of people with HIV, but we must now also consider how to preserve the ‘health span’ in this group,” says Wattrus.

She explains that this means increasing the years that are spent in good health with a good quality of life.  

Another co-author of the guidelines, Nomathemba Chandiwana, Chief Scientific Officer at the Desmond Tutu Health Foundation, points out that after antiretroviral treatment was introduced in South Africa, the life expectancy of people living with HIV increased dramatically. “We didn’t think people would live as long as they have now, so that’s been a big success,” she says. “But now we have new problems.” 

Chandiwana says that older people living with HIV have around 16 fewer years in good health than people without HIV. The 16-year figure (technically 15.3) seems to originate in a study published in 2020 in the JAMA medical journal that compared the health and lifespans of insured people with and without HIV in the United States. For people with HIV who started antiretroviral treatment when they were still healthy (CD4 countes above 500), the difference in healthy years was 9.5 years.  

Another broad concern is that clinicians may be focused on HIV-related issues like viral suppression for these patients and not be sufficiently aware of other ageing-related developments. People with HIV get the same ageing related diseases as other people, but there is evidence that they tend to get them earlier. 

We know from Thembisa model outputs that on average, people living with HIV today are slightly more likely to die of non-HIV-related causes than AIDS. According to the model, there were 53 000 HIV-related deaths in the year from mid-2024 to mid-2025. This is a thousand fewer than the 54 000 people with HIV who died of non-HIV-related causes over the same period.  

What is in the new guidelines  

The new guidance states that it is designed to:  

  • Raise healthcare workers’ awareness of the needs and concerns of the population of people living with HIV who are 50 years and older.  
  • Inform healthcare workers about an ageing-related approach to older people with HIV.  
  • Highlight good practices to help healthcare workers provide optimal care for this population. 
  • Provide resources about ageing with HIV for healthcare workers, their patients and their patients’ carers.  
  • Guide clinical settings in implementing geriatric care into HIV clinical practice.  

The clinical advice in the guidelines follow the World Health Organisation’s (WHO) principles for Integrated Care for Older People (ICOPE), which emphasises prevention prior to frailty, person-centred assessment, and the involvement of healthcare workers other than doctors.  

The guidelines cover a thorough list of challenges faced by older people with HIV that need to be monitored and addressed. For instance, physiologically, there is a risk of comorbid conditions like hypertension and cancer, and an increased risk of complications from polypharmacy, when more than five medicines are used concurrently. Social and behavioural challenges include that older people are perceived to be less likely to get infected with HIV and therefore have lower rates of HIV testing and use of HIV prevention tools. 

This population is also at risk of being disregarded or not fully cared for in the healthcare system. The guidelines give examples such as restricted mobility access to health facilities and healthcare workers being unaware of the HIV-related risks in older people. “The health system needs to be equipped to manage their needs in a holistic and integrated way, and that is what this guideline aims to support,” says Wattrus. 

The guidelines include a comprehensive schedule of what need to be assessed and screened and at what regularity. There is a particular focus on geriatric syndromes like frailty, cognitive impairment, and managing comorbid non-communicable diseases. 

“The idea is that every visit with an older patient involves more than just routine HIV care and that it becomes a conversation about how that person is functioning and living,” says Wattrus.  

The guidelines also emphasise how care can be offered by a variety of healthcare providers, depending on the resources available. “Recommendations enable task-shifting, which is a practical necessity in a country where specialists such as geriatricians are scarce, and the bulk of HIV routine care is delivered by healthcare workers at primary care level,” says Wattrus.  

Even though the guidelines focus on overall health in older people living with HIV, managing HIV is, of course, a part of this. It cautions that “CD4 recovery may be slower and blunter compared to younger individuals,” but viral suppression is still the primary treatment goal.  

The crucial factor here is to choose the correct antiretroviral treatment regimen for the patient. For instance, popular tenofovir disoproxil fumarate (TDF) combinations should be avoided in people at risk of or with osteoporosis, bone fractures, or renal impairment. Regimens with tenofovir-alafenamide or abacavir may be better, though the latter is contraindicated if there is high cardiovascular risk. 

The new local guidelines hit largely the same notes as a major commission on HIV and ageing that was published by the journal Lancet HIV to coincide with the AIDS 2026 conference taking place in Rio de Janeiro, Brazil. 

“Supporting healthy ageing requires more than sustained viral suppression; it requires care that is informed by what matters most to the individual, with attention to maintaining physical and mental function, minimising healthcare complexity, and addressing multimorbidity, polypharmacy, stigma, and social determinants of health,” the commission found. 

Simple systems, big change   

Apart from giving healthcare workers a framework for giving better care to older people living with HIV, the guidelines advise how this larger change in the health system can happen for this growing older population. “What is great is that most of the recommendations are not complicated or expensive,” says Wattrus.  

She explains that the sensitisation and training of healthcare workers, especially in primary care, is a crucial first step. If they know how to, they can easily incorporate brief screenings, such as those for frailty, into normal appointments. For example, as Chandiwana points out, several geriatric tests need only a chair for the patient to sit down on and get up from. She says it is easier to do these things for people with HIV during their existing appointments, compared to people without HIV who may not be visiting health facilities for regular screenings. 

Another relatively easy adaptation is to simply make healthcare services easier to access. “This can be done by having appointments aligned across conditions, fewer unnecessary referrals and genuine attention to broader aspects of their health such as poverty, isolation and limited mobility,” she says. 

Chandiwana also suggests that one could consider rolling out geriatric care health cards to track screening, as is often done with children. She would also like to see more community buy-in, in a similar way as there was during the earlier part of the HIV treatment roll-out. For instance, she suggests community health clubs and increased health literacy efforts around ageing.  

Avoiding problematic polypharmacy, says Wattrus, is another low-cost, high-yield strategy that does not require specialist input. “Routinely reviewing medication lists, identifying unnecessary drugs, and checking for interactions is straightforward and can make a significant difference,” she says. 

More specialists would of course help. Chandiwana says there are fewer than 50 geriatric specialists in the country. She says there is also a much wider need for geriatric-specific training across the healthcare system, including for primary care nurses and community healthcare workers. 

Lastly, Chandiwana says the guidelines offer a much-needed look into the unique challenges and needs of older people with HIV as an opportunity for the government to act to prevent a future problem. “So that investment in having scalable, simple systems for people who are ageing, both with HIV and without, I think, would be fantastic, but that needs money,” she says.

*This story was published by Spotlight – health journalism in the public interest. Sign up to the Spotlight newsletter.

Categories : HIVTags :

Positive Interim Findings on New Once-weekly HIV Treatment Pill

On By ModernMedia
Researchers have found that a new once-weekly antiretroviral formulation appears to be as effective as the daily pills. Photo by Danilo Alvesd on Unsplash

By Marcus Low and Elri Voigt

A new antiretroviral combination pill that is taken only once a week appears to work as well as daily pills at treating HIV. This is according to interim study findings to be presented next week at the AIDS 2026 conference in Rio de Janeiro, Brazil.

Almost all of the over six million people in South Africa who are currently taking HIV treatment are taking it in the form of one tablet taken once a day. These tablets contain a combination of three different antiretrovirals, most commonly dolutegravir, lamivudine or emtricitabine, and tenofovir.

Now researchers have found that a new once-weekly antiretroviral formulation appears to be as effective as the daily pills. The new pill contains only two antiretrovirals, islatravir and lenacapavir. A different formulation of lenacapavir is used in the six-monthly HIV prevention injections being rolled out at around 10% of public sector clinics in South Africa.

“I think this is the next treatment blockbuster,” Professor Francois Venter told Spotlight this week when asked about the new once-weekly pill. Venter is the Executive Director of the Ezintsha Research Centre at the University of the Witwatersrand. He was not involved in the studies of the once-weekly pill.

“Patients are crying out for less frequent dosing, and it does not have the fiddliness and complexity, the supply line, healthcare worker training, or resistance issues of the current or immediate next generation of injectables. Imagine dispensing the same number of tablets for 6 months as previously for a month. It looks cheap to make. Low- and middle-income countries really should be taking note,” he said.

Two studies

The findings to be presented in Rio are from the first 48 weeks of two relatively large, multi-country, phase 3 studies called ISLEND-1 and ISLEND-2. Both studies will continue for another 48 weeks. The final study findings will only be reported after the full 96 weeks are completed.

The two studies have similar designs. Both started out with people who were already on antiretroviral therapy and doing well on treatment (607 people in ISLEND-1 and 624 in ISLEND-2). The researchers then switched roughly half of the people in each study over to the weekly islatravir/lenacapavir pill. The outcomes of those who switched to the weekly pill were then compared to those who didn’t switch and simply kept taking the treatment they had been taking before.

A key difference between the studies is in the control groups. In ISLEND-1, the researchers specifically recruited just people who were taking the antiretroviral combination of bictegravir, emtricitabine, and tenofovir alafenamide. In ISLEND-2, they recruited people who were taking whatever the local standard of care was (which often differs between countries). Some of the many ISLEND-2 clinical trial sites are in South Africa where the standard of care is dolutegravir, lamivudine or emtricitabine, and tenofovir.

Another notable difference between the studies is that ISLEND-1 is double-blinded, whereas ISLEND-2 is an open label study. This means that in ISLEND-1 neither study participants or their doctors know which study arm they are on – this is achieved by also giving people on the weekly arm daily placebo pills and people on the daily arm pills that look like the weekly placebo. In ISLEND-2, people know what study arm they are on and there is no need for placebos.

Both studies have a non-inferiority design, which is to say their main aim is to establish whether the weekly pill is roughly as safe and effective as existing treatments. Such designs are commonly used in HIV treatment trials given that existing treatments are already very safe and effective. The potential step forward in this research is the weekly dosing, not improved safety or efficacy against HIV.

“Developing new antiviral HIV medications remains important in order to address pill fatigue, adherence challenges, broaden treatment, with the goal of ending the HIV epidemic,” Professor Jürgen Rockstroh, lead author of the presentation of the ISLEND-1 results at AIDS 2026, told Spotlight by e-mail.

What the researchers found

The short version, as described in a conference media release, is that in both studies the weekly pill was found to be “efficacious and well tolerated and statistically non-inferior” to the controls it was measured against. In other words, based on the 48-week data, the weekly pill is passing the test so far. The findings have also been summarised in a media statement by pharmaceutical company Gilead Sciences.

The key indicator that the researchers looked at was the proportion of people whose HIV viral load was not suppressed at 48 weeks (they used a cut-off of 50 copies per millilitre of blood). If antiretroviral treatment is working well in someone’s body, one’s viral load is typically suppressed below this level.

In ISLEND-1, zero of the people on the weekly pill had a viral load above the cut-off, while one person on the bictegravir, emtricitabine, and tenofovir alafenamide study arm was above the cut-off. In ISLEND-2, one person taking the weekly pill had a viral load above the cut-off, while four people on the standard of care arm were above the threshold. Given that outcomes on the weekly pill were technically better than for the controls, it should come as no surprise that the non-inferiority thresholds were met.

Though the once-weekly pill was well-tolerated, there are some interesting nuances in the safety data. In ISLEND-1, treatment-related adverse events were very similar between the two study arms. In ISLEND-2, however, treatment-related adverse events were reported in 18% of participants treated with the once-weekly pill compared to less than 1% receiving standard of care antiretroviral regimens. Among those receiving the weekly pill in ISLEND-2, the most common treatment-related adverse events reported were headache (5%), nausea (3%) and diarrhoea (3%). There were no red flags regarding more serious treatment-related adverse events.

“It is not uncommon to see a higher rate of treatment related adverse events in the experimental arm of an open label switch study due to reporting bias. That is, when someone knows they are on a new drug, they may be more apt to believe that any new symptoms are caused by the new drug,” Dr Amy Colson, a principal investigator for both ISLEND studies at a study site in Boston in the United States, explained to Spotlight. “Of note, all treatment related adverse events in ISLEND-2 were grade 1 or grade 2.  And importantly, the rate of treatment related adverse events in the ISLEND 1 study – which was a double-blind study – was nearly identical in the islatravir/lenacapavir and bictegravir/emtricitabine/tenofovir alafenamide arms which further supports that the discrepancy in ISLEND 2 may indeed be due in part to reporting bias in the open label study.” (Adverse events are graded from 1 to 4, with 1 being the least severe. Only grade 3 and 4 adverse events are considered severe.)

“It is too early to comment on how any safety signals from the ISLEND 1 and ISLEND 2 trials will impact eligibility for future studies or eligibility for treatment outside of clinical trials.  However, safety data at week 48 from both trials was reassuring.  The overall rates of adverse events, grade 3 adverse events, serious adverse events and discontinuations due to adverse events was highly comparable between islatravir/lenacapavir and comparator groups in both trials,” Colson said.

The early data from ISLEND-2 suggests that people who switched to the once-weekly pill prefer it to the daily treatments they were taking before. According to Colson, 78% reported that they were more or much more satisfied with the weekly pill relative to their prior daily treatment and 64% reported that their prior daily treatment was more of a burden than the weekly pill. More extensive data on people’s self-reported experience of the treatment will be reported on at a future conference.

The new weekly pill is not the first long-acting form of HIV treatment, although it is the first long-acting HIV treatment in pill form. HIV treatment injections administered every two months have been available in the United States for around four years. Spotlight has previously explored in depth why we do not have these HIV treatment injections in South Africa.

Next steps

In a media statement released early in June, pharmaceutical companies Gilead Sciences and Merck (called MSD outside of the United States and Canada) indicated that they plan to file the once-weekly pill with medicines regulators “globally”. Spotlight asked both companies whether this will include filing with the South African Health Products Regulatory Authority, but neither company answered this question. Gilead has the patent on lenacapavir and Merck on islatravir. ISLEND-1 and ISLEND-2 were sponsored by Gilead. Gilead has already filed a weekly lenacapavir pill, used for HIV prevention rather than treatment, for registration with the United States Food and Drug Administration.

The companies didn’t provide details in response to Spotlight’s questions on their pricing plans and whether they would license other companies, directly or through the Geneva-based Medicines Patent Pool, to produce generic versions of the pill.

“Merck and Gilead are committed to supporting global efforts to reduce the incidence and burden of HIV by bringing forward new treatments. This includes our joint investigational long-acting oral treatment option, ISL/LEN. The single-tablet regimen represents a potential step-change in HIV treatment by offering a once-weekly oral regimen that may broaden choice for people living with HIV,” a Merck spokesperson told Spotlight by e-mail. “We remain focused on advancing the development program. If approved, our decades of experience collaborating with a range of stakeholders will help us explore pathways with the goal of facilitating rapid uptake and broad access around the world.”

Republished from Spotlight under a Creative Commons licence.

Read the original article.

Categories : Healthcare Politics and RegulationsTags :

Why Pharmacists Still Can’t Prescribe ARVs, Months After Court Gave the Green Light

On By ModernMedia
Specially trained pharmacists will soon be allowed to dispense antiretrovirals without a doctor’s script. Photo by National Cancer Institute on Unsplash

By Catherine Tomlinson

A Supreme Court of Appeal ruling in October 2025 cleared the way for specially trained and permitted pharmacists to dispense antiretroviral medicines without a doctor’s script. Seven months later, no pharmacists are yet providing these services. Spotlight explores the reasons for the delay.

After a three-and a half year court battle between a group of private doctors and the South African Pharmacy Council (SAPC), the Supreme Court of Appeal (SCA) cleared the way for the SAPC to implement pharmacist-initiated management of antiretroviral treatment (PIMART) in October 2025.

The SAPC welcomed the ruling with a bullish press conference promising rapid implementation of PIMART. “The South African Pharmacy Council, together with stakeholders and the Department of Health, will work with speed to ensure that PIMART-trained pharmacists join other primary healthcare practitioners in providing primary care in relation to HIV and Aids,” said Mogologolo Phasha, president of the SAPC, at the time.

Vincent Tlala, CEO and Registrar of the SAPC, also in October 2025, said that the SAPC aimed to issue an e-note inviting pharmacists to apply for the PIMART permits in November. However, seven months later, this has still not happened and no pharmacists in the country are yet permitted to provide PIMART services.

What is PIMART?

PIMART stands for pharmacist-initiated management of antiretroviral treatment. It is a form of task-shifting that allows pharmacists to provide some limited HIV services that are currently only provided by doctors and nurses. The programme seeks to better utilise pharmacists in the country’s HIV response and relieve some of the burden on overcrowded and under resourced public clinics. It will also offer a route into treatment for people who are not willing or able to visit clinics.

It is intended that, under the PIMART programme, pharmacists that have completed a dedicated training programme and have received a special permit from the Director-General of Health will be authorised to provide first-line antiretroviral treatment to people with uncomplicated HIV without a doctor’s script. They will also be allowed to dispense HIV prevention medicines without a doctor’s script – this includes both pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP). PrEP is taken prior to sex to prevent potential infection while PEP is taken shortly after a possible HIV exposure to prevent infection.

Why is PIMART needed?

PIMART was proposed by the SAPC in response to a request from the health department for the SAPC to design an intervention to enable pharmacists to take on a greater role in the country’s HIV response.

South Africa has adopted the UNAIDS 95-95-95 targets that aim to ensure that 95% of people living with HIV know their status, 95% of people diagnosed with HIV are on treatment, and 95% of people on treatment are virally suppressed (and therefore cannot transmit HIV onwards).

According to new estimates from Thembisa, the leading mathematical model of South Africa’s HIV epidemic, 7.9 million people are living with HIV in South Africa. Ninety six percent of people living with HIV know their status, yet only 82% of people who know they are HIV positive are on antiretroviral treatment.

While South Africa’s health system should be commended for the fact that around 6.2 million people are taking HIV treatment, it is concerning that 1.7 million people living with HIV are not yet on treatment. In recognition of this problem, the health department has launched the “Close the Gap” campaign.

The thinking behind PIMART is that pharmacies can help close the gap by providing an important third option to people who are disinclined or unable to access HIV treatment from public clinics or private sector doctors.

More urgent than ever following US funding cuts

While PIMART was always intended to help identify patients falling through the gaps between South Africa’s public and private health sectors and to link them to care, the need for this third option is now more urgent than ever. US funding cuts over the last 15 months or so have led to the closure of many NGO-run clinics that previously provided HIV treatment and prevention services to populations at high risk of HIV who often face stigma at traditional health facilities. These groups include sex workers, men who have sex with men, and people who inject drugs.

In addition to expanding access to HIV treatment, PIMART aims to increase access to PrEP and PEP to prevent new HIV infections. While the full impact of US funding cuts on these services remains unclear, the cuts likely contributed to the slight decline in PrEP use in South Africa seen in 2025, following seven years of steady growth in PrEP uptake.

Graph by Spotlight. Data courtesy of the Thembisa model.

Finger pointing and lack of accountability

Seven months after the Supreme Court of Appeal ruled that the SAPC could implement PIMART and the SAPC promised to move rapidly in implementing PIMART, pharmacists have still not been invited to apply for permits and no PIMART permits have yet been issued to pharmacists.

When asked why the programme remains unimplemented, the SAPC pointed to the Southern African HIV Clinicians Society’s (SAHCS) PIMART training course as the cause of the delay.

SAHCS is the only entity in the country providing PIMART training to pharmacists. In October 2025, Mokoena said several groups had expressed interest in becoming accredited to provide PIMART training. However, on 14 May 2026, Tlala told Spotlight: “While we have invited existing providers of pharmacy education in South Africa to offer (the course), the South African Pharmacy Council is yet to receive applications for the accreditation of the PIMART supplementary training course.”

He added: “Currently, the Southern African HIV Clinicians Society are the only approved provider for the PIMART short course.”

So, what’s going on with SAHCS’ PIMART training?

PIMART used to be on a very different timeline before it got tangled up in the court processes that led to the October 2025 SCA judgment. Back in July 2021, Spotlight reported that the launch of PIMART was imminent, and indeed, that was roughly the timeline the SAHCS training had been working toward.

In fact, the SAHCS has offered a PIMART training course for pharmacists that want to provide PIMART services since 2019. Professor Natalie Shellack, chairperson of the SAPC Education Committee, said in October 2025 that this course was developed jointly by SAHCS and SAPC.

Over a thousand pharmacists have completed SAHCS’s original PIMART training course as continuous professional development (CPD) training. But after the October 2025 SCA ruling, Lizeth Kruger, Dischem’s Clinical Executive, told Spotlight that due to the time lapse between the initial training and court ruling, Dischem pharmacists “will need to do a refresher course to ensure compliance and up-to-date knowledge”.

While SAHCS’s PIMART course has not yet been accredited by the SAPC as a PIMART course, it is accredited as a CPD course for pharmacists. Tlala told Spotlight in May that it has not been accredited as a PIMART course because of an identified “gap” in the course.

“The gap identified between the short course and the approved qualification standard meant that the approved provider of the short course, the Southern African HIV Clinicians Society, had to conduct a gap analysis and develop a bridging course to enable pharmacists trained in the short course to access the full PIMART scope of services,” said Tlala.

In response to questions about the “gap” in their training course identified by the SAPC, SAHCS’s CEO Dr Fiona Storie told Spotlight on 19 May: “SAHCS has completed a full review and update of the PIMART training course in line with the requirements for accreditation as a supplementary training course (i.e. not just a CPD accredited course).”

“As PIMART training was originally provided from 2019, there is a need for pharmacists to undergo refresher training since the field of HIV medicine is evolving and clinical recommendations change over time,” said Storie. She added: “SAHCS’ recommendation is that pharmacists undertake the newly updated PIMART training course as either a refresher/bridging course or, if not previously trained, as a new course.”

“SAHCS is engaging with SAPC to finalise the accreditation of the updated PIMART course as a refresher course and a new supplementary training course to make it available as soon as possible,” Storie said.

Limiting PIMART’s scope

Tlala told Spotlight that because of the “gap” in SAHCS’s training course, the SAPC has asked the Director-General of Health to grant limited scope PIMART permits.

“The Director-General: Health has been requested to issue a limited scope permit granting PIMART-trained pharmacists’ access to those services fully addressed in the short course previously delivered by the South African HIV Clinicians Society,” he said.

The health department confirmed to Spotlight that this request was received on 23 April 2026.

Neither the SAPC nor the Department of Health responded to Spotlight’s requests for clarification on which PIMART services the SAPC had proposed for inclusion in the limited-scope permits.

Angela Tembo, director of pharmacy health at the research centre Ezintsha, told Spotlight that she understands that the limited scope permits that the SAPC has requested the Director-General of Health to grant “will be limited to HIV prevention (PrEP and PEP) and not treatment”.

“Our understanding is that the delays [in implementing PIMART] relate to ongoing discussions around training requirements, accreditation processes, and the practical implementation pathway following the SCA ruling,” she added.

Tlala said as soon as the Director-General of Health approves the limited-scope permits, the SAPC will publicly communicate the launch of the PIMART programme and the services that may be accessed under such a permit.

“The full PIMART scope of services will only be available once the Southern African HIV Clinicians Society has finalised and submitted a bridging course following gap analysis or, alternatively, once another training provider is accredited to provide the PIMART Supplementary Training course,” he added.

Republished from Sptolight under a Creative Commons licence.

Read the original article.

Categories : HIVTags :

Most Cases of HIV Persistence in Blood After Treatment Explained by Defective Copies

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Study strongly suggests that most persistent cases of viral detection, despite ideal HIV drug therapy, are not due to virus transmission or a rebound of active disease

Colourised transmission electron micrograph of an HIV-1 virus particle (yellow/gold) budding from the plasma membrane of an infected H9 T cell (purple/green).

Antiretroviral drugs for HIV infection have enabled most people living with the virus to live long and healthy lives. However, a small portion of people experience detectable – and worrisome – traces of the virus that causes AIDS despite strict adherence to long-term treatment regimens and the absence of symptoms. New findings published in Nature Communications suggest that most cases of this phenomenon, which is called non-suppressible viraemia, are explained by defective and noninfectious copies of the virus. The research was partially supported by grants from the National Institutes of Health (NIH).

The study, which involved more than 50 people, found that while traces of HIV-1 RNA can persist in blood after optimal therapy, cases of non-suppressible viraemia are driven by HIV-1 RNA with defects in a piece of the RNA known as 5’-leader.

“From a clinical perspective, this is important because people with HIV are taught that the absolute goal of their medication is to achieve undetectable viral load and they worry,” says Francesco R. Simonetti, MBChBD, PhD, the senior study author and an assistant professor of medicine in the Division of Infectious Diseases at Johns Hopkins University School of Medicine. The new findings, says Simonetti and his team, should provide relief to many people living with HIV who fear a viral rebound or who are concerned about transmitting the virus to partners despite taking effective treatment.

For the study, the investigators examined blood samples from 52 people living with HIV who had detectable loads of the virus despite taking long-term antiretroviral drug therapy.

These samples, which were assessed from 32 people and compared to an additional 20 samples, were collected between 2021 and 2025. The majority of participants were white men, between ages 58 and 68, and received care in the U.S., Canada and Denmark. The researchers found that most detectable forms of the virus, around 95%, were due to defective copies, and most defects were due to mutations or deletions in the 5’-leader region of HIV-1 RNA. This region is known to orchestrate the production of copies of the virus, but in this case the defects prevented the generation of infectious virus.

Modern antiretroviral therapies, which date back to 1996, prevent HIV from infecting new populations of immune system cells, but aren’t able to retroactively prevent previously infected cells from releasing HIV viral particles. Since those cells usually represent a small portion of infected cells after a person is on stable therapy, most people who take antiretroviral therapies are able to bring their viral loads to clinically undetectable levels in their blood. 

However, in some cases, which are estimated to occur less than 1% of the time, people may experience clinically detectable levels after taking long-term antiretroviral drug therapy. This could happen years later, or, in less frequent cases, they may have never achieved undetectable levels.

This new study offers evidence that clinicians can now study the virus in blood plasma and confirm if clinically detectable levels are due to defective copies released from one or a few T-cell clones, says Simonetti. If so, he adds, this could eliminate the need for extra medications and could prevent related complications. It could also help people living with HIV have access to surgeries or other procedures, such as hip or knee replacements or organ transplants, and participate in clinical studies if they know they have HIV under control.

The assay taht the researchers created and used to confirm the defective copies of the virus for this study is cost-effective and can be broadly used in HIV clinics and research settings. Similar to using a liquid biopsy to detect cancer mutations in DNA, the assay, which is called CLAWS (Capturing 5′ Leader Anomalies Without Sequencing), uses advanced technology to identify detectable viral loads that are due to defective copies.

“We know that these defective proviruses cannot infect new cells, but they are still clinically relevant,” says Simonetti. “Think of how many extra visits, extra drugs, extra costs and tests they’ve been causing.”

“It’s also clear from the new study that, over time on treatment, intact proviruses that make virus are pruned away, while defective ones escape the immune system,” he says. “Now we want to understand these differences in immune recognition to uncover HIV’s vulnerabilities.”

Source: John Hopkins Medicine

Categories : HIV NeurologyTags :

Early Treatment Helps Protect the Brains of People Living with HIV

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If someone living with HIV is not on antiretroviral therapy, the virus can cause inflammation in, among other places, the brain. Photo by Anna Shvets

By Biénne Huisman

Antiretroviral therapy has shifted HIV from a fatal to a chronic condition. But neuropsychiatrists say it is imperative for people living with the virus to start treatment immediately as the “duration of untreated exposure” may cause irreversible brain damage and impact long-term cognitive health. 

It has been recognised for decades that cognitive impairment is a potential complication of HIV infection. Questions over how likely and how serious this potential complication is have become more urgent over time as the population of people living with HIV ages – ageing after all also increases the risk of cognitive decline.

There were around 1.75 million people over the age of 50 living with HIV in South Africa in 2024, according to Thembisa, the leading mathematical model of HIV in the country. This is just over 20% of the estimated eight million HIV positive people in the country. A study published in the Lancet medical journal also has the number at around 20% in sub-Saharan Africa.

This is a delicate field of enquiry as researchers walk a tightrope to avoid “the burden of double stigma”, while conceptualising the necessary tools to best diagnose brain problems and suitable interventions.

Within as little as two weeks

At Groote Schuur Hospital’s Neuroscience Institute, Professor John Joska, director of the University of Cape Town’s (UCT’s) HIV Mental Health Research Unit, explains that HIV can enter the brain within as little as two weeks after the initial infection – primarily through infected white blood cells, such as lymphocytes. If a person is not on antiretroviral therapy, the virus can cause inflammation in the brain and possibly also tissue damage.

“The brain is a protected compartment,” says Joska. “A theory as to how the virus, which is a protein particle, gets into the brain is through infected lymphocytes. This doesn’t directly infect nerve cells, what we call neurons. It infects other supporting tissues and cells in the brain, causing an inflammation which damages typically the white matter of the brain. Over time, that inflammation can cause loss of neurons, but indirectly.”

While antiretroviral therapy is crucial for clearing and suppressing HIV in all body compartments, including in the brain, he says that it does not reverse damage that occurred before the treatment was started.

“Today, people with HIV are living near normal lifespans,” he says. “The question is, will the fact that they’ve had HIV, with some duration of untreated exposure and potential loss of brain tissue, cause them to be at higher risk than the average person for developing dementias of old age – which really are mainly Alzheimer’s disease or vascular dementia.” It is these longer-term effects that are the main concern when it comes to the impact of HIV on the brain.

Part of the problem is that South Africa not only has an ageing population of people living with HIV, but many of these people would only have started treatment quite long after they contracted the virus. One key reason for this is the South African government’s reluctance to make antiretroviral treatment available in the early 2000s. It has been estimated that those delays resulted in over 300 000 avoidable deaths – they may also be contributing to brain health issues now and in the future.

From efavirenz to dolutegravir

Apart from HIV itself, some of the medicines used to treat the infection have also had an impact on the brain.

In 2019, the standard HIV treatment in South Africa changed from a three-drug combination containing an antiretroviral drug called efavirenz, to a combination containing the drug dolutegravir. This shift had mental health benefits, as evidenced in research lead by Joska’s fellow UCT Neuro-HIV researcher, Associate Professor Sam Nightingale.

Joska says: “The study looked at the period from 2017 to 2020 and the switch from efavirenz to dolutegravir based treatment. It was well known that efavirenz caused, certainly for the first two months, a bunch of psychotropic or psychological issues like nightmares or anxiety, even psychosis for some people. But our findings showed people who switched to dolutegravir actually do very well. They look more like people without HIV after eight months. So dolutegravir has been a huge advantage, not only because it’s robust, but because it’s neuro-protective.”

New models for HIV and cognitive impairment

A shift is underway in how experts are thinking about cognitive impairment in people with HIV. Some neuropsychiatrists, including Joska, are recommending a shift away from the 2007 HIV-Associated Neurocognitive Disorders model, arguing that its cognitive test scores do not adequately account for variables such as education and socioeconomic background, and that it can overdiagnose impairment. The argument is set out in an article, lead-authored by Nightingale, that was published in the journal Nature Reviews Neurology in 2023.

The authors argue that a label of cognitive impairment might cause a “double burden of stigma” for people living with HIV – affecting self-esteem, inciting fear and prompting further discrimination against persons already subject to stigma as it stands. To illustrate the point, they point out how, up until recently, people with HIV in the United Kingdom could not become airline pilots due to concerns over cognitive impairment. However, following a campaign by a pilot living with HIV, the United Kingdom’s Civil Aviation Authority removed the ban in 2022.

Nightingale and his colleagues argue that traditional test scores be used in conjunction with real-life symptoms and medical evidence of brain problems. It introduces the conceptual model of HIV-Associated Brain Injury, which refers specifically to damage caused by the virus. This distinguishes it from other causes of cognitive impairment such as depression, substance abuse, diabetes and cardiovascular disease. As Spotlight previously reported, HIV is also associated with an increased risk of depression, though this is at least partially driven by social factors.

Lower cognitive function associated with late diagnosis

At the 2026 Conference on Retroviruses and Opportunistic Infections hosted in Denver in the United States in late February, these issues were tabled at a discussion titled “When I’m 64: Neurodegeneration, Epigenetic Aging, and Cognition in Older People With HIV.”

Professor John Joska is the director of the University of Cape Town’s HIV Mental Health Research Unit. (Photo: Biénne Huisman/Spotlight)

In his presentation, Professor Alan Winston of Imperial College London, also a member of the International HIV-Cognition Working Group, and a frequent co-author alongside Joska and Nightingale, relayed existing research findings that on average, people living with HIV have lower cognitive function – including memory, attention span and executive function like planning – compared to people who don’t have HIV of the same age. He said that this manifests as an increased risk of lower grade early dementia.

Like Joska, Winston stressed that the most deteriorated cognitive function in people living with HIV is associated with untreated HIV and late HIV diagnosis. He reiterated that starting HIV treatment soon after diagnosis is protective, and that viral suppression is associated with better cognition. In groups of patients with HIV well controlled on dolutegravir-based HIV treatment, cognition appears similar to HIV negative groups, he said.

HIV clinicians need to pay better attention to the brain

In an impassioned presentation, Dr Shibani Mukerji, Associate Professor of Neurology at Harvard Medical School, argued that protecting the brain is an overlooked frontier in effective HIV treatment, and that clinicians need to pay more attention to it.

“By the time patients and clinicians notice cognitive decline – generally and in HIV – the damage to the brain is done and lives are affected negatively. People don’t raise cognitive concerns early enough due to stigma, fear, [and] lack of recognition of the issues. It is seen as ‘just getting old’,” she said.

Mukerji emphasised the need to prioritise brain health. “HIV doctors and treatment programmes are focused, almost exclusively, on viral load as the marker of successful treatment. They may be thinking laterally and consider TB and other infections, maybe cardiovascular disease – but they are definitely not paying enough attention to brain health. HIV doctors aren’t aware enough of brain health issues in people living with HIV, and even when they are, they often don’t feel comfortable diagnosing or managing it, so it is under recognised and under diagnosed.”

The perception that there is no way to manage or treat cognitive decline –generally and in people living with HIV – is wrong, she said, adding that optimising physical, mental and social health is critical for brain health.

“Almost half of dementia risk [in people in general] is linked to preventable causes,” she told conference delegates, along with a slide listing preventable causes including loss of hearing, social isolation, cardiovascular disease and depression.

She explained: “If someone has cognitive decline and for example you improve their hearing – if they have hearing issues – and you work on their social isolation, and treat their vascular disease, and treat their depression, you can see a marked improvement in their cognition.”

Ending her presentation with a twist of humour, Mukerji’s last slide referred to the session’s title, a reference to the Beatles song on aging “When I am 64”. She printed the song’s lyrics: “When I get older, losing my hair, many years from now…”, closing her talk by saying: “It’s okay to stand up and sing, in fact your doctor might prescribe it.”

Categories : HIV Medical IndustryTags :

Cipla Confirms Continued Support for ARV Supply Following Changes in Supplier Landscape

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Photo by Towfiqu barbhuiya

Cipla Medpro South Africa reaffirmed its commitment to ensuring the uninterrupted supply of critical antiretroviral (ARV) medicines to the Department of Health. It is essential that people living with HIV have uninterrupted access to these life-saving medicines. Any disruption of supply puts patients at risk of developing resistance to the drugs or adversely affecting health outcomes. According to Statistics South Africa, the number of people living with HIV in the country is estimated to be approximately 8 million (12,7% of the population)[1].

Recently, two suppliers who were awarded the current antiretroviral (ARV) tender, Barrs Pharmaceuticals Industries (Pty) Ltd and Innovata Pharmaceuticals (Pty) Ltd (subsidiaries of Avacare Health), have entered business rescue.

Cipla acknowledges the uncertainty this may create within the ARV supply chain and underscores its readiness to assist in maintaining stability and continuity.

Cipla has been manufacturing tenofovir/lamivudine/dolutegravir (TLD) for the government for the past 7 years, and has been one of the main suppliers of ARVs to the government for more than 12 years. Cipla has made significant investments in its local manufacturing facility, upgrading the capacity of the ARV production line with the installation of a new Countec bottle line and have increased its tablet filing capacity by 190%. The company is able to locally produce 475 million tablets annually and has upscaled its manufacturing capabilities to ensure sufficient capacity to meet current demand and support near‑term growth, while reinforcing Cipla’s commitment to secure and reliable ARV supply.

“We have mobilised resources to help maintain equitable access to quality, affordable critical medication. Cipla confirms its willingness to support national requirements under the current tender agreement and, if needed, contribute meaningfully to any supplementary procurement processes to safeguard patient access to essential treatment. We want people to live a long and healthy life as part of our commitment to caring for life,” said Paul Miller, CEO of Cipla Africa.

“In addition, we believe this tender presents an opportunity to further advance government’s commitment to strengthening local manufacturing capacity. By ensuring greater support for locally produced medicines, future allocations could meaningfully contribute to South Africa’s industrial development agenda while maintaining continuity of supply,” said Miller.

The total ARV tender is for a period of three years, and is worth an estimated R15.5bn, of which the TLD component comprises R12.6bn.

Categories : HIVTags :

HIV Funding Still Falls Short of Targets After Pledges: What’s at Stake

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Photo by Miguel Á. Padriñán

Melanie Bisnauth, University of the Witwatersrand

The US government paused all foreign assistance in January 2025. This abrupt decision affected the delivery of life-saving HIV medicines and the provision of HIV prevention services to millions of people. A UNAIDS report estimates there could be an additional 6 million new HIV infections and 4 million Aids-related deaths by 2029 if the world does not act.

In November 2025, a global health initiative, The Global Fund, raised US$11.34 billion for HIV/Aids, tuberculosis and malaria. Melanie Bisnauth, a public health professional in healthcare systems strengthening and HIV/Aids leadership, discusses how far this latest funding could go and how African nations can tackle the dwindling funding for HIV/Aids control.

What is the funding status for HIV/Aids?

Raising US$11.34 billion is significant but it falls short of the US$18 billion target. The Global Fund is trying to raise US$18 billion for its work from 2027 to 2029. The Global Fund is a worldwide partnership to end the epidemic of HIV/Aids, tuberculosis and malaria and ensure a healthier, safer and more equitable future for all.

It is only a partial response to the global funding gaps.

The US pledged US$4.6 billion to the Global Fund during the fund’s summit in November 2025, on the side of the G20 meeting in South Africa. It was a reduction from its previous pledge of US$6 billion to support prevention, treatment, care and related services for the three diseases. But it is also an indication that the US has not abandoned all multilateral global health efforts. It remains the largest single contribution to the Global Fund 2027 to 2029 cycle.

The shortfall may strain existing programmes and delay expansion of life-saving interventions for HIV/Aids, tuberculosis and malaria.

HIV remains a major global public health issue, having claimed an estimated 44.1 million lives to date. An estimated 40.8 million people were living with HIV at the end of 2024, 65% of whom are in the WHO African region.

Job losses could create inefficiencies or service reductions. Building a sustainable HIV response and meeting key goals was already challenging before the sharp funding decline in 2025. Over 11 million people had unsuppressed viral loads in 2024.

Overall, while the funds raised demonstrate continued global solidarity, they are insufficient to fully compensate for the US withdrawal and broader declines in donor support.

There are potentially long-term consequences. Reduced funding and service disruptions threaten to reverse years of progress. Infections could rise, especially in communities where viral suppression was already low. Lack of service delivery and supply of treatment will weaken trust in health systems and can lead to treatment interruptions, drug resistance and poorer health outcomes.

As the Global Fund’s executive director said at the Replenishment Summit, “the old model” of development funding is over. This model is the heavy reliance on international funding like USAID and other donor organisations.

It’s essential for countries to become more self-reliant. But the statement warned that too abrupt a transition could be dangerous.

I fear that the COVID-19 pandemic has already taken a toll on the quality of care provided. Healthcare systems are already overburdened.

National governments have to step up and locally support their healthcare systems, collaborate and build together, and strengthen their health funding structures.

What should the response be for better HIV funding in Africa?

Africa’s HIV response should be multi-pronged.

After attending the Africa Summit in Geneva in May 2025, stakeholders, country representatives, donor agencies and NGOs expressed a key message: those involved in the sector should not reinvent the entire wheel. There is value in the knowledge gained from programming, technical expertise, data insights, partnerships, communities and global health networks should be used to strengthen, adapt and scale what already works.

This will ensure that Africa’s HIV response remains community-centred, evidence-driven, and resilient in the face of emerging challenges.

The global health climate has changed and communities have lost trust because of severely disrupted or even completely cut programmes. African governments must allocate their own resources for HIV programmes, through budget prioritisation, health insurance schemes, and innovative financing such as public-private partnerships. Improvements, such as integrating HIV services into primary care, using data-driven targeting, and negotiating lower drug costs can maximise impact.

Strengthening regional collaborations and pooled procurement through organisations like the African Union or regional health bodies can improve bargaining power and reduce dependency on external aid. A balanced mix of donor support, domestic financing and operational efficiency is essential to maintain gains and expand access to treatment for all in need.

It is important not to rely solely on international support or one funding body. Diversifying funding portfolios is critical.

What effects has the withdrawal of US funds had?

Reduced US contributions led to immediate financial shortfalls, threatening ongoing HIV prevention and treatment programmes.

For example, some clinic supply and services faced disruption in delivery and supply of antiretroviral therapy, and stock-outs of treatment and malaria nets.

The world is still likely to feel the impact in the coming months. For example:

  • Progress towards epidemic control could slow, potentially increasing illness and death.
  • Programmes that relied heavily on US support have already scaled back services or will do so.
  • Funding uncertainty remains a major concern. Governments will have to reallocate limited domestic resources or seek alternative donors.
  • Global health co-ordination, technical assistance and advocacy efforts may be weakened. In the past these supported robust HIV responses in Africa in progress toward the UNAIDS targets.
  • Reliance on fragmented funding streams will increase.

How can African countries better fund their HIV programmes?

They can take steps that involve a mix of domestic revenue generation, efficiency gains and strategic partnerships:

  • diversify funding through raising domestic revenue, such as earmarked taxes
  • expand the reach of social health insurance coverage
  • leverage corporate investment and innovation through public-private partnerships
  • negotiate pooled procurement of drugs and diagnostics regionally to reduce costs
  • involve communities in decision making, which will help strengthen sustainability
  • integrate HIV programmes into broader health systems – it improves efficiency, reducing duplication and operational costs.

Melanie Bisnauth, Doctoral Researcher, School of Public Health and Public Health Technical Advisor, Anova Health Institute, University of the Witwatersrand

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Categories : HIVTags :

Trial Results Shows the Value of Patient Navigation in Humanising HIV Care

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Eastern Cape HIV Programme demonstrates success in resource-constrained setting

Photo by Pexels on Pixabay

A new randomised controlled trial conducted in the Eastern Cape has shown that adding structured patient navigation to same-day antiretroviral therapy (ART) can make a meaningful difference for people newly diagnosed with HIV. The trial found that patients who received support from trained navigators were far more likely to stay in care and keep their viral load low over six months. Those with navigator support had a 79% retention rate, compared with 64% under standard care.

Among patients who achieved a viral load of fewer than 50 copies per millilitre, 64% remained in care, compared to just 39% without this extra support(1). Patient navigation combines personal support, such as home or virtual check-ins and WhatsApp reminders, with practical help like linking people to services and monitoring their progress. It was especially effective for people who started treatment on the same day as their diagnosis.

“This approach humanises HIV care. It builds a bridge between the clinic and the community, helping patients stay connected to treatment and ultimately saving lives,” said lead author Siyakudumisa Nontamo, Facility Team Lead: Care & Treatment Programme at TB HIV Care.

In August 2024 the Human Sciences Research Council released findings from the Sixth South African HIV Prevalence, Incidence, and Behaviour Survey (SABSSM VI) for the Eastern Cape. The results show that HIV prevalence in the province stabilised, moving from 15.9% in 2017 to 13.7% in 2022. This is an estimated 980 000 people living with HIV, down from about 1 million in 2017. Access to treatment has improved significantly. ART coverage increased from 67.8% in 2017 to 83.5% in 2022, meaning about 723 000 people in the province are now receiving treatment. However, gaps remain among young people: only 70.9% of adolescents and youth aged 15–24 living with HIV are on ART, compared to 84.8% of adults aged 25-49. Among females, coverage is much lower for young women (68.7%) than for women aged 25-49 (88.2%). ART use also varies across districts, ranging from 69.4% in Nelson Mandela Bay to 92.0% in Alfred Nzo(2). Nationally, the proportion of people living with HIV who are currently on antiretroviral treatment (ART) rose to 80.9% in 2022, up from 63.7% in 2017.

Despite major advances in antiretroviral therapy, retention in care remains a persistent challenge within South Africa’s HIV programme, especially in rural provinces such as the Eastern Cape. Many patients initiate treatment but later disengage due to stigma, transport difficulties, and limited ongoing support. The study shows that low-cost, human-centred interventions can significantly strengthen treatment outcomes. The trial, titled “Impact of Patient Navigation on Retention in Care and HIV Viral Load Suppression Among Newly Diagnosed Persons Living with HIV in the Eastern Cape,” compared standard HIV care to an approach where trained patient navigators provided ongoing support to patients starting antiretroviral therapy (ART). Beyond improved retention and viral suppression, the trial also showed that patients supported by navigators experienced fewer deaths and dropouts, with substantially lower losses to follow-up and reduced mortality than those receiving standard care, ultimately strengthening HIV programmes(1).

Patient navigation, in particular, helps bridge the gap by pairing practical healthcare coordination with empathy and community-based follow-up. Navigators assist patients with managing appointments, maintaining adherence, and accessing psychosocial services, thereby fostering trust, continuity, and sustained engagement in care. This approach aligns with South Africa’s national HIV strategy, which prioritises differentiated, patient-centred models of care to achieve the UNAIDS 95-95-95 targets.

At scale, TB HIV Care’s programmes are grounded in person-centred, integrated service models that reflect the real lives and needs of people affected by HIV and TB. This study reinforces TB HIV Care’s belief that support beyond clinic walls is essential for achieving lasting impact. In the 2024/25 reporting period, the organisation reached more than 1.9 million people with HIV testing services and initiated 27,873 individuals on ART, achieving a 95% viral suppression rate among clients in care.

“By bridging the gap between diagnosis and ongoing care, patient navigation aligns with our outreach for key populations and our shift toward holistic service delivery. We look forward to translating this evidence into practice, ensuring fewer people fall through the cracks and more sustain treatment success”, said Professor Harry Hausler, CEO at TB HIV Care.

Additional findings from the Sixth South African HIV Prevalence, Incidence, and Behaviour Survey (SABSSM VI) for the Eastern Cape.

  • In the Eastern Cape, HIV remains most common among adults aged 25-49, with a prevalence of 27.7%, and women in this age group are especially affected at 35.4% compared to 17.1% for men.
  • The survey also found geographic differences: HIV prevalence among men was highest in urban areas (8.7%), while among women it was highest in rural informal or tribal areas (19.8%).
  • By district, prevalence was highest in Chris Hani (14.4%), Amathole (14.1%), Alfred Nzo (13.9%), and lowest in Nelson Mandela Bay (9.7%).
  • At a national level, the survey showed that 81.4% of all people living with HIV were virally suppressed. The survey found encouraging progress in the Eastern Cape, where viral load suppression (VLS) among people living with HIV rose to 79.3% in 2022, up from 66.3% in 2017. However, children aged 0-14 years had much lower suppression levels, at 61.4%. Among people aged 15-49 years living with HIV, 78.6% were virally suppressed. Within this group, women had far higher suppression rates (83.9%) than men (65.4%).

About the Randomized Controlled Trial

The randomised controlled trial involved participants from HIV testing sites in the O.R. Tambo District (Flagstaff, Mthatha Gateway, and Tsolo Clinics). It was approved by the Eastern Cape Health Research Committee and Walter Sisulu University’s Ethics Committee. The study was supported by the Chemical Industries Education and Training Authority (CHIETA) and the South African Medical Research Council’s Strategic Health Innovation Partnerships (SHIP).

References:

  1. Nontamo, S., Kamsu, G.T., Ndebia, E.J., et al. Impact of Patient Navigation on Retention in Care and HIV Viral Load Suppression Among Newly Diagnosed Persons Living with HIV in the Eastern Cape – South Africa. Access.
  2. Human Sciences Research Council. Sixth South African HIV Prevalence, Incidence, and Behaviour Survey (SABSSM VI). Access.

Categories : Ethics and Law HIVTags :

Pharmacists Can Treat People with HIV, Appeal Court Rules

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“Legitimate and compelling public interests” to allow pharmacists to initiate antiretroviral treatment, says judge

By Tania Broughton

Pharmacists can initiate people with HIV on antiretroviral treatment, the Supreme Court of Appeal has ruled. Photo: GroundUp Staff

The Supreme Court of Appeal (SCA) has dismissed, with costs, an appeal by a doctor’s organisation, the IPA Foundation, aimed at stopping specially trained pharmacists from treating people with HIV and TB.

The IPA first took its dispute with the South African Pharmacy Council (SAPC) to the Gauteng High Court in Pretoria. In 2023, Judge Elmarie van der Schyff ruled in favour of the pharmacists, giving a judicial go-ahead for the council to introduce its Pharmacy-Initiated Management of Antiretroviral Treatment (PIMART) initiative.

However the IPA Foundation, intent on having the initiative set aside, took this ruling on appeal to the SCA. In that court, five judges this week ruled against it. The ruling came nearly 11 months after the case was heard, far more than the three months that judicial norms provide for when a judgment is reserved.

Read the judgment

Justice Tati Makgoka, writing for the court, said the initiative was created in response to a persistent rise in new HIV infection rates.

The SAPC, at the department’s request, deemed PIMART suitable for addressing this issue.

“As the high court correctly found, the SAPC evaluated the risks associated with pharmacists initiating first-line ART [antiretroviral treatment] and TPT [tuberculosis preventive therapy] as well as providing medicines for PrEP [Pre-Exposure Prophylaxis of HIV] and PEP [Post Exposure Prophylaxis of HIV], considering the risks when deciding to approve the PIMART training.

“The uncontested evidence presented by the SAPC demonstrates that the approved accreditation process for PIMART was rigorous and thorough,” Makgoka said.

In her previous judgment, Van Der Schyff had noted that a pilot project had emphasised the value of the initiative, which was in line with the World Health Organisation’s vision to promote widely accessible primary health care.

“The untapped value of pharmacists in fighting HIV was also emphasised by the efficient role pharmacies played in meeting health care needs and providing health care services during the Covid-19 pandemic,” she said.

“The need to widen access to first line ART and TPT therapy on a community level is not a figment of SAPC’s imagination but a dire need that is also evinced in other countries.”

The IPA Foundation had approached the Pretoria court, under the Promotion of Administrative Justice Act (PAJA), seeking to review and set aside the SAPC’s decision to implement PIMART.

IPA claimed that the SAPC had failed to give interested parties an adequate opportunity to comment before the initiative was implemented. It further contended that PIMART unjustifiably encroached on the domain of medical practitioners and was in conflict with legislation.

On appeal, the IPA persisted with these arguments.

Dealing with the background, Justice Makgoka said the SAPC had published a notice in the government gazette in March 2021 regarding the proposed adoption of PIMART, giving interested parties 60 days to comment. This resulted in government approval later that year.

It was only after this that the IPA submitted its comments and objections.

Following engagements, the IPA lodged the review application in the high court.

On the issue that the IPA and its members claimed they were not given sufficient notice of PIMART, because it was advertised in the government gazette during the Covid-19 pandemic – Makgoka said there was no suggestion that the pandemic had “paralysed the administrative functions” of the IPA.

Remarkably, the judge said, the IPA had not suggested that the notice did not come to its attention, finding that adequate notice had been given. Makgoka said that several other organisations had submitted comments during the prescribed period.

He said the IPA had also not challenged the validity of the Pharmacy Act, which specified publication in the gazette and in the absence of that, it was not open for it to say the publication was inadequate.

Makgoka said the IPA had introduced the issue of “rationality” only in its notice of appeal. However, the court had dealt with this because there was no prejudice to the SAPC.

In ruling on this issue, he said PIMART was a crucial intervention in the public interest, which had been devised by a group of medical experts.

“Through PIMART, the SAPC aimed to improve access to healthcare. Contrary to the IPA’s contentions, PIMART is an essential intervention in the fight against HIV/AIDS. Its introduction constitutes a rational legislative and practical measure with the competence of the SAPC as an organ of the state in enhancing access to healthcare for HIV treatment, in fulfilment of the state’s obligation under the Constitution,” Makgoka said.

“These are legitimate and compelling public interests.”

He said the IPA was wrong in believing that PIMART was a blanket licence for pharmacists to treat HIV patients.

“Its scope is limited and applies only to accredited pharmacists. It will not alter the scope of practice for medical practitioners. The fact is that medical practitioners do not have the exclusive rights to care for people living with HIV/AIDS. This is a collaborative effort involving various health professionals.”

The IPA had also submitted that pharmacists were not authorised to prescribe schedule 3, 4 and 5 medicines without a prescription.

However, the judge said, the Medicines Act carved out an exception to this with authorisation of the Director-General. It was through this that PIMART-accredited pharmacists could apply for permits to prescribe schedule 3 – 5 substances.

The appeal was dismissed with costs.

Certainly not all doctors oppose the idea of pharmacists initiating patients with HIV on treatment: the South African HIV Clinicians Society stated: “We look forward to supporting the rollout of PIMART which will further contribute to South Africa’s HIV response and progress towards the 2030 target of eliminating HIV as a public health concern.”

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

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