This is the first study using a combination of immunotherapies in humans. The results show promise for sustained control of the virus.
Colourised scanning electron micrograph of HIV (yellow) infecting a human T9 cell (blue). Credit: NIH
A new study from UC San Francisco shows it may be possible to control HIV without long-term antiviral treatment – an advance that points the way toward a possible cure for a disease that affects 40 million people around the world.
Treatment with a combination of experimental immunotherapy agents enabled 7 out of 10 participants to keep the virus at low levels for many months after going off antiretroviral therapy (ART).
The results appear on Dec. 1, World AIDS Day, in Nature.
The trial, which relied on a collaboration with nearly a dozen pharmaceutical companies and other partners in HIV research, offers a proof of concept that the approach could work. Although the study was small and did not include a control arm, investigators said the results are extremely encouraging.
“The majority had some evidence of control, which we believe is unprecedented,” said the paper’s co-senior author, Steven Deeks, MD, a professor of Medicine at UCSF who is in the Division of HIV, Infectious Diseases, and Global Medicine at Zuckerberg San Francisco General Hospital. “I do believe we are finally making real progress towards developing a therapy that may allow people to live a healthy life without the need of life-long medications.”
The trial was made possible by the Foundation for AIDS Research (amfAR)’s $20 million, five-year partnership with UCSF to advance AIDS cure research, launched in 2015. It was also supported by the National Institutes of Health (NIH).
Reprogramming the body’s immune system
Antiretroviral therapy (ART) was introduced in the 1990s and turned HIV infection from a death sentence into a chronic disease. But it is not a cure, and the virus stays in the body ready to reawaken as soon as someone stops taking ART.
The study was designed to test whether a triple combination of immunotherapies could reprogram the body’s immune system to control the virus after going off ART. Most of the participants had started ART soon after they acquired HIV, which helped preserve their immune response.
First, participants received a therapeutic vaccine to encourage their T cells to go after the latent HIV in their bodies. Then, they received an antibody cocktail to reduce the amount of HIV in the body. Finally, they were given another round of anti-HIV antibodies before being taken off ART.
Typically, when a person with HIV stops HIV medicines, the virus starts to rebound in about two weeks and then skyrockets. This time, only three of the 10 patients experienced the typical rapid rebound. Six maintained low levels of the virus for months, and one did not rebound at all.
The pouncing cat analogy
The investigators then examined the immune responses of those who controlled the virus to see how they did it.
“It turns out the controllers had T cells that were able to expand dramatically once they ran into the virus,” said Rachel Rutishauser, MD, PhD, an associate professor in UCSF’s Division of Experimental Medicine and co-senior author of the paper. “It’s like they were hanging out waiting for their target, kind of like a cat getting ready to pounce on a mouse.”
The treatment would need to be simplified and proved effective in much larger studies before it could replace standard HIV treatment.
“This is not the end game,” said Michael Peluso, MD, an assistant professor in UCSF’s Department of Medicine and the study’s first author. “But it proves we can push progress on a challenge we often frame as unsolvable.”
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:
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.
Human Sciences Research Council. Sixth South African HIV Prevalence, Incidence, and Behaviour Survey (SABSSM VI). Access.
The cancellation of US aid funding to South Africa is harming the country’s HIV response. Source: Unsplash CC0
By Marcus Low and Nathan Geffen
The number of HIV viral load tests is significantly lower than expected, according to an analysis of data from the National Health Laboratory Service which Spotlight and GroundUp obtained through the Promotion of Access to Information Act.
The number of HIV viral load tests recorded by the National Health Laboratory Service (NHLS) is significantly less than expected since February 2025. We are aware of no compelling reason to explain this except the withdrawal of US aid.
All patients in the public health system with HIV are supposed to get viral load tests regularly, usually once a year. These tests are used to determine if HIV is being suppressed successfully in their blood using ARV medicines. If the number of viral load tests declines, it likely indicates either that patients are being lost to the public health system, they are being monitored less diligently, or the system for recording viral load tests has become less accurate. Any one of these would imply a serious hit to South Africa’s public sector HIV programme.
GroundUp and Spotlight used the Promotion of Access to Information Act to request, among other things, viral load test numbers from the NHLS. We were provided a spreadsheet with the number of tests per month for each province from January 2015 to September 2025.
The current US Administration began taking steps to reduce US aid across the world after Donald Trump was inaugurated as president on 20 January 2025. Billions of rands have been withdrawn from South Africa. This caused some services, especially for vulnerable people — including gay men, sex workers and trans people— to close almost immediately, such as the Ivan Toms Centre in Cape Town and Wits University facilities in Johannesburg. US aid also funded support systems, such as data collection.
Public health experts have accused the government of being in denial about the consequences of the withdrawal of US aid. Health Minister Dr Aaron Motsoaledi has responded defiantly. In May, he stated that a record number of people had been initiated on ARVs over the previous months, a claim disputed by epidemiologists.
We asked a biostatistician to examine the NHLS data we received. She analysed the change in viral load tests by month and province over time. She found that the number of viral load tests for the period February to September this year is statistically significantly lower than what one would expect based on previous years. This confirms the view of public health experts: the withdrawal of US aid from South Africa has hit the HIV programme badly.
The decline in viral load numbers was previously reported by the Daily Maverick and Reuters for March and April. This was inevitable given the sudden withdrawal of US aid. But the new data shows that the decline has been sustained until September. The decline has occurred in every province except Limpopo.
How Viral Load Testing Performed Against Expectations, Feb–Sept 2025
Province
Predicted
Actual
Difference
% Difference
p_value
Eastern Cape
545,061
463,510
-81,551
-15
0.0007
Free State
285,423
234,671
-50,752
-18
0.0002
Gauteng
1,210,891
1,006,833
-204,058
-17
0.0002
KwaZulu-Natal
1,475,360
1,284,008
-191,352
-13
0.0001
Limpopo
419,357
441,314
21,957
5
0.1550
Mpumalanga
532,713
450,495
-82,218
-15
0.0007
North West
326,907
292,150
-34,757
-11
0.0002
Northern Cape
64,855
58,746
-6,109
-9
0.0017
Western Cape
324,074
290,011
-34,063
-11
0.0205
National
5,184,640
4,521,738
-662,902
-13
0.0003
*This table presents the expected and actual numbers of viral load tests conducted by the National Health Laboratory Service in South Africa from February to September 2025.
By looking at the change in viral load tests since 2015, a biostatistician estimated the number of viral load tests that there should have been for the period February to September 2025 using a standard linear regression model. She found that the actual number of tests declined significantly. A p-value less than 0.05 is considered statistically significant. Except for Limpopo, the p-values are substantially less than 0.05 for every province. The analysis takes into account that the NHLS suffered a data hack in 2024, and consequently, there is missing data for a few months.
An even simpler analysis also raises red flags. The absolute number of viral load tests conducted from February to September 2025 (4,521,738) is slightly lower than it was over the same period in 2023 (4,554,463) (due to a cyber attack, the NHLS’s 2024 figures are not a reliable comparison). Given that the number of people on HIV treatment is expected to increase over time and that everyone should be getting at least one viral load test per year, one would expect the number of viral load tests to have increased by a few hundred thousand since 2023.
These results show that the HIV programme has been set back. It is possible that tens of thousands of people have been lost to care. Also possible is that they are disproportionately the most vulnerable patients treated at specialist US funded facilities that closed as a consequence of the funding cuts.
Nevertheless the HIV programme is still successfully treating millions of people and South Africa is far better off than other African countries, such as Mozambique, whose response to HIV is almost entirely paid for with foreign aid.
Fewer patients have viral rebound. But is it a silver lining?
People with HIV who are on ARVs should have, after a few weeks, an undetectable amount of virus in their blood. This is what the viral load test measures. But if the ARVs stop working or a person stops taking their ARVs regularly, the virus will rebound in their blood.
The NHLS counts the number of viral load tests for which patients have more than a thousand copies of HIV per drop of blood. For these patients, the virus has rebounded in their blood.
The percentage of viral rebound cases has come down in 2025.
This might be because the standard ARV regimen has improved. A drug called dolutegravir is now part of the regimen, and it is known to do a better job of suppressing HIV than the drug it replaced a few years ago. This would be the good-news explanation, a silver lining in the data.
But it’s also possible that it’s because vulnerable patients treated in specialist clinics funded by US aid are more likely to have viral rebound and they are the ones who have been lost to the HIV programme. This would be the bad-news explanation.
At this point, we don’t have data to know which explanation of the viral rebound improvement is correct. The situation also varies substantially by province. The real picture might be a complex interaction of multiple factors.
Pretoria, 27 October 2025 – The South African Health Products Regulatory Authority (SAHPRA) is pleased to announce the registration of Lenacapavir. Lenacapavir is an antiviral medicine that is recommended, in combination with safer sex practices, for pre-exposure prophylaxis (PrEP) to prevent HIV-1 infection in adults and adolescents weighing at least 35kg.
An application by Gilead was submitted to SAHPRA in March 2025. The SAHPRA review process was done in collaboration with the European Medicines for All Procedure (EU-M4all). This procedure enables the European Medicines Agency (EMA), together with the participating regulatory authorities, to provide scientific opinions on high-priority medicines, such as Lenacapavir, intended for markets outside the European Union. The benefits of this pathway are to strengthen regulatory systems and accelerate access to essential medicines.
This product, developed to prevent new HIV infections, is a six-monthly injection. There is an initiation dose of a subcutaneous injection (administered just under the skin) with tablets (taken on days 1 and 2). It is used to reduce the risk of HIV in adults and adolescents who weigh at least 35kg, are HIV negative, and are at risk of getting HIV. Lenacapavir for PrEP should always be used in combination with safer sex practices, such as using condoms, to reduce the risk of getting other sexually transmitted infections.
“The registration of Lenacapavir is a game-changer, given the high prevalence rate of HIV in South Africa. This product is the most effective HIV prevention measure thus far,” indicated Dr Boitumelo Semete-Makokotlela, CEO: SAHPRA.
Avian Bell, CEO of Quantumed South Africa, has welcomed the announcement that South Africa will begin rolling out the long-acting HIV prevention jab by March 2026. The injectable, which offers six months of protection per dose, is a major step forward in the country’s efforts to curb new HIV infections.
“This is a landmark moment for South Africa’s public healthcare landscape,” says Bell. “We are thrilled that the jab will soon be available to those who need it most. It represents a powerful tool that will help reduce the burden of HIV, especially among adolescent girls, young women, sex workers, and other high-risk communities.”
The jab, which has shown promising results in clinical trials, is expected to be a game-changer in HIV prevention. Its long-acting nature means fewer doses and improved adherence, which has historically been a challenge with daily oral PrEP (pre-exposure prophylaxis). Quantumed applauds the Department of Health’s commitment to making this innovation accessible to the public.
However, Bell cautions that while the jab is a significant advancement, it must not lead to a false sense of security. “The jab is designed to prevent HIV, but it does not offer protection against other sexually transmitted infections (STIs) such as HPV, syphilis, gonorrhoea, or chlamydia, nor does it prevent unintended pregnancies,” he explains. “We must continue to promote safe sex practices, regular STI screenings, and comprehensive sexual health education.”
Quantumed urges the public and healthcare providers to view the jab as part of a broader strategy, not a standalone solution. “We cannot afford to let our guard down,” Bell adds. “Complacency could reverse the gains we’ve made in STI prevention and reproductive health. We must continue to educate communities about the importance of condoms, routine testing, and open conversations about sexual health.”
In addition to the vaccine rollout, South Africa recently secured a $115 million emergency funding package from the United States under the PEPFAR Bridge Plan. This funding is intended to support critical HIV/AIDS services and ensure continuity of care for millions of South Africans.
“This emergency aid is a vital lifeline,” says Bell. “It will help stabilise programmes that have been under immense pressure and allow healthcare providers to continue delivering essential services, from testing and treatment to counselling and community outreach.”
However, Bell also acknowledges the broader context of this funding. Earlier in 2025, significant cuts to US aid disrupted HIV-related initiatives across South Africa. These cuts led to the closure of clinics, the suspension of research trials, and the loss of thousands of healthcare jobs. Vulnerable communities were left without access to life-saving services, and the ripple effects are still being felt.
“We must recognise that while the emergency funds are welcome, they do not undo the damage caused by earlier funding cuts,” Bell says. “We need long-term, sustainable investment in HIV prevention and treatment, not short-term fixes. The fight against HIV/AIDS is ongoing, and it requires consistent support from both local and international partners.”
Quantumed calls on government, civil society, and global stakeholders to remain steadfast in their commitment to ending HIV/AIDS. “We’ve come a long way, but the journey is far from over,” Bell concludes. “Let’s celebrate the progress, but let’s also stay focused. Innovation must be matched with education, access, and accountability. Together, we can build a future where HIV is no longer a threat — but that future depends on our actions today.”
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.
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.”
Colourised scanning electron micrograph of HIV (yellow) infecting a human T9 cell (blue). Credit: NIH
For over three decades, HIV has played an elaborate game of hide-and-seek with researchers, making treating – and possibly even curing – the disease a seemingly insurmountable obstacle to achieve.
But scientists at Case Western Reserve University have made a breakthrough discovery that could fundamentally change strategies for treating HIV.
The team identified for the first time how HIV enters a dormant state in infected cells that allows the virus to “hide” from the immune system and current treatments.
The researchers believe the finding, just published in Nature Microbiology, challenges decades of scientific assumptions and opens a new approach to possibly eliminating the deadly virus.
“This discovery rewrites what we thought we knew about how HIV goes into this stealth mode in the human body,” said study lead Saba Valadkhan, an associate professor in the Department of Molecular Biology and Microbiology at the Case Western Reserve School of Medicine. “We’ve shown that HIV actually orchestrates its own survival by reprogramming host cells to create the perfect hiding place.”
The team discovered that HIV uses a clever survival trick that explains why it’s been impossible to cure. After HIV invades a cell, it sneaks its genetic code into the cell’s DNA, then tricks the cell into going to sleep, which also puts the virus to sleep, making both completely invisible. This tactic makes the infected cell invisible to the immune system and unreachable by even today’s most advanced HIV drugs. The virus stays hidden in these dormant cells until the right moment to “wake up” and spread again, creating an undetectable reservoir that ensures HIV never goes away completely.
“What we’ve uncovered is that HIV doesn’t just randomly go dormant – it actively manipulates the host cell to create conditions for its own survival,” said study collaborator Jonathan Karn, Distinguished University Professor and chair of the Department of Molecular Biology and Microbiology. “This gives us specific targets to attack.”
The findings may extend far beyond HIV treatment. The researchers believe similar dormancy actions could be triggered by other viruses – including herpes, hepatitis and other retroviruses – potentially leading to new therapies for many viral diseases.
“We may have uncovered new tactic viruses use to trick the host cells to do their bidding,” Valadkhan said.
This discovery is also important for protecting public health worldwide because viruses like HIV – which can permanently insert themselves into a person’s DNA – could potentially be used as future viral threats and pandemic preparedness.
A dire picture for HIV/Aids funding emerged at the 12th South African AIDS Conference, raising the call for resilience, adapting and also for government to raise its game.
The what-next of South Africa’s HIV response will have to be centred on getting back to basics, leveraging on advances in treatment options and learning fast about adapting in a world without US aid for health services.
These were among the key takeaways from speakers at a plenary session at the 12th Southern African Aids Conference held in Kempton Park last week.
Professor Linda-Gail Bekker, executive officer of the Desmond Tutu Health Foundation, in her address took stock of “the incredible devastation around the world” from the virtual overnight shutting off of funds and human resources as Donald Trump returned to the US presidency in January 2025.
“It was $460 million into the wood chipper for us. And the worrying thing is that it could take us back to the harrowing scenes of 2000 [the height of Aids deaths in the country],” she said.
This comes against what she called the two largest challenges for South Africa’s HIV response: sub-optimal 12-month retention in care and viral suppression. Meaning the struggle to keep patients on treatment beyond a year and helping them stay on antiretrovirals that reduce the amount of virus in the body to a minimum.
The picture painted by Bekker and others is bleak, with much uncertainty remaining as to how South Africa might plug the funding holes left by the abrupt US aid cuts.
Bekker shared research by the Health Economics and Epidemiology Research Office (HE²RO), a division of the Wits Health Consortium at the University of the Witwatersrand. Their research shows that the fallout in the next three years could see South Africa experience a 29% to 56% increase in new HIV infections, or an additional 150 000 to 295 000 cases by 2028. Unless the South African government is able to take over services, there could be a 33% to 38% increase, or an additional 56 000 to 65 000 AIDS-related deaths in that period. (Spotlight previously reported on the HE²RO modelling in more detail here.)
The modelling also suggests that government will need additional funding of between $620 million and $1.4 billion (roughly R10 billion to R24 billion) between 2025 and 2028 to replace the local services that received US government funding.
In July, Treasury allocated R763 million in emergency funding to fill the gap, a fraction of what the HE²RO researchers estimate is needed. In addition, the Gates Foundation and the Wellcome Trust pledged R100 million each for research to the South African Medical Research Council on condition that the South African government doubled their contributions, which government committed to over three years. This added up to an R600 million bailout for research, also a fraction of the amount of research funding that has been lost.
Throughout the conference, there was also strong calls from attendees and speakers for government to be more transparent about its plans to mitigate the funding cuts and to provide credible data and information about monitoring and measuring of the success of their interventions. This includes details on how it plans to provide all stable patients with enough medicines for six months at a time. Such multi-month supplies mean people have to travel less to collect medicines, thus making it easier to stay on them. Rollout of multi-month dispensing has been very uneven across the country.
Questions were also raised over a lack of full transparency regarding the price of lenacapavir, a breakthrough HIV prevention injection that provides six months of protection per shot. As we recently reported, the South African government will be paying $60 per person per year for the jab, with other donors paying the rest – it is not publicly known how much this “rest” is. The deal was setup by the Global Fund to Fight AIDS, Tuberculosis and Malaria, Gilead Sciences – the company that makes lenacapavir – and several private donors. Last week, Spotlight published an op-ed in which activists questioned the lack of full transparency about the price.
Dr Sandile Buthelezi, director-general for the National Department of Health, told attendees about the possibility of bringing forward the rollout date for lenacapavir from April next year, to possibly as soon as November this year. He did not answer questions about the price negotiations. He did however confirm that negotiations with The Global Fund has seen them commit to ringfencing US$29 million for procurement of lenacapavir over the next two and a half years.
Doing more with less
Having to do more with less, Bekker said at the conference, will mean the need to build a “resilience bridge”. For her, this means preserving the “two most important interventions” of providing continued access to antiretroviral treatment and to HIV prevention treatments – both long-acting injections and prevention pills.
She added that it also means better efforts to reach the population of people living with HIV who have been diagnosed but are not on treatment. In February 2025, government launched its ‘Close the Gap’ campaign aimed at placing an additional 1.1 million people on treatment by the end of this year. Bekker said the number of people living with HIV who are not on treatment is closer to 2 million people. According to Thembisa, the leading mathematical model of HIV in the country, of the roughly eight million people living with HIV in South Africa, around 6.2 million are on treatment.
How South Africa is progressing against the 1.1 million target is not clear. Figures previously shared by Health Minister Dr Aaron Motsoaledi indicated that over half a million people had been initiated on treatment in a matter of months. This raised eyebrows since, on the face of it, it means that people had been started on treatment this year more quickly than at any other time in South Africa’s HIV response. It also wasn’t clear whether the number of people who had stopped treatment had been subtracted from the number starting treatment. Questions Spotlight previously sent to the health department seeking clarification of the numbers went unanswered. Similar questions were also raised in an open letter and an op-ed published by Spotlight and GroundUp. As yet, Spotlight has not seen answers to the questions raised about the numbers shared by the Minister.
“We need to make services [more] amenable to retention so it means multi-month dispensing and differentiated care,” Bekker said. Differentiated care refers to treating people differently based on their needs – for example by not requiring healthy people living with HIV to visit the clinic as often as sicker people.
“Bad policies that reflect ideology and bias, mean the most vulnerable are deterred from assessing the services they need, and this includes our key populations,” she added of the challenges that people like sex workers, members of the LGBTQI+ community and people who use drugs face in clinics where they are judged, harassed or discriminated against.
Dr Lise Jamieson, a senior researcher at HE²RO, echoed Bekker’s sentiments and said a first priority remains to arrest any backsliding of care as South Africa restructures its HIV programme to match the money it has currently. “It is clear that the one thing that we absolutely cannot drop is our HIV treatment programme – it saves lives,” she said.
For Yvette Raphael, the co-founder and co-director of Advocacy for the Prevention of HIV and Aids (APHA), the undergirding socio-economic factors that have given HIV its stranglehold in South Africa remain largely unchanged.
She said: “I am one of the people who are ageing with HIV and suffering from other non-communicable diseases that come with this”, highlighting the need to address the evolving nature of HIV in the country and the need to address it alongside conditions such as diabetes and heart disease.
But she added that it is still teen girls and young women who are at a disproportionately high risk of acquiring HIV. Her message was for better youth-targeted responses that are community-level responses not top-down strategies.
“Make HIV a priority sustained by local and district government structures, not up here in our national and province centres,” she said.
“Make HIV prevention harder to ignore and weave HIV intervention services with skills training and income generating programmes. We know that employment in this country is low, so young people cannot be expected to continue a healthy life without spaces where they can generate income for themselves, this will [in turn] reduce their vulnerability and dependency on older men.”
She added that government had to step up to what should always have been their role as Pepfar funding was never meant to substitute the work of government. Raphael said: “Pepfar was here to support the government in the early days of HIV. However, some of our government officials saw that as a way of evading their responsibility, and we are now here.”
Note: The Gates Foundation is mentioned in this article. Spotlight receives funding from the Gates Foundation, but is editorially independent – an independence that the editors guard jealously. Spotlight is a member of the South African Press Council and subject to the South African Press Code.
By Fatima Hassan, Leena Menghaney, and Bellinda Nkoana
A new HIV prevention jab has the potential to bring an end to the AIDS epidemic. But a lack of ambition and unjustifiable secrecy over pricing is holding it back, argue three leading health activists.
Imagine a new HIV prevention tool existed that could – if it reached the right people – flick the switch to prevent almost all new HIV cases across the world. You would expect every health system and government to be doing all they can to roll it out to everyone as quickly as possible, regardless of the challenges, right?
The good news is that this scenario is not merely in our imagination because we actually have that tool today. The bad news? The rollout of this breakthrough HIV prevention jab is moving at a glacial pace.
Lenacapavir, a twice-yearly antiretroviral-containing injection, is one of the most promising tools yet in the fight to end AIDS. Data from two major trials released last year showed it offers near-complete protection against HIV infection for some of the most vulnerable groups: young women, men who have sex with men, sex workers, and transgender and gender-diverse people. Trials that test the effectiveness of the jab as prevention in people who inject drugs are also underway. For communities still bearing the brunt of new infections, it could be a game-changer.
Take South Africa as a case in point. Modelling studies suggest the impact could be transformative. If two to four million HIV-negative people here used lenacapavir annually over the next eight years, new infections could dramatically fall, with rates low enough that experts would consider it significant enough to end AIDS.
And yet, the current rollout targets look worryingly timid, particularly for vulnerable communities.
According to the National Department of Health, South Africa’s projected initial target for the first two years of the roll out (April 2026 – March 2028 and subject to registration or interim approval by the South African Health Products Regulatory Authority) of just under 500 000 people, includes the general population and certain vulnerable or key risk population groups – for the latter, the targets are woefully low: 69 799 sex workers, 37 857 transgender people, and 155 946 gay, bisexual, and other men who have sex with men.
This barely scratches the surface of the actual need in vulnerable populations. At this rate, access will be severely rationed, and the epidemic will continue to outpace us.
One reason the roll out cannot be on a mass scale, is not just due to an absent political will, but also because the company that holds the patent, Gilead Sciences, is rationing access. And until a sufficient number of generics come on to the market, voluntarily or through compulsory measures, Gilead will call the shots.
The Trump administration’s funding cuts earlier this year left ambitious plans to roll out lenacapavir in several countries in the Global South in the dust. In response, South Africa, in consultation with the Global Fund for AIDS, Tuberculosis, and Malaria (Global Fund) and indirectly with Gilead, announced plans to repurpose R520-million from an existing Global Fund grant to buy lenacapavir for HIV prevention.
But despite South Africa being asked by the Global Fund to budget $30 per dose ($60, roughly R1 050, per person per year) as its contribution, no one knows the total price the Global Fund is paying Gilead.
Such pricing secrecy is unacceptable, especially when health ministries in low- and middle-income countries are already squeezed by the massive US government funding cuts and debt crises.
Countries excluded from the Global Fund’s supply agreement and Gilead’s inadequate mechanisms for allowing generic competition (they exclude several countries and only a few companies were licensed) will be left to negotiate directly with Gilead, facing the prospect of unaffordable “tiered” prices designed to maximise profit – eerily similar to the COVID vaccine inequitable access debacle. Millions who need HIV prevention could face rationing, with health providers forced to leave the most vulnerable populations behind.
The Global Fund’s willing decision to shield Gilead’s pricing from public disclosure undermines accountability and risks reversing years of hard-won progress towards transparency in medicine pricing in the Global South and elsewhere. This is a dangerous precedent for the global HIV movement as pharmaceutical multinational companies are finding new ways to normalise price secrecy – and the Global Fund has just approved that tactic. While civil society in Global South countries such as South Africa are defending the right to know how public funds are spent, global institutions like the Global Fund in Geneva, are enabling practices that give pharmaceutical corporations a free pass.
The push to normalise secrecy, particularly when public or donor money is involved, should ring alarm bells. If international actors are serious about equitable access, then price transparency must be non-negotiable. Anything less erodes public trust and hands undue power to pharmaceutical companies at the expense of public health. Transparency is also necessary to ensure that the price we pay is fair and justified, because public money should not subsidise Gilead’s profiteering.
All this comes at a time when global health financing is under severe strain. Deep cuts in HIV/AIDS funding have already cost tens of thousands of lives across multiple countries. But rationing prevention is a false economy because the cost of new infections, in lives and long-term treatment, will far outweigh the investment required to scale up prevention now.
As delegates convene this week at the SA AIDS Conference, they must publicly call out the demand for price secrecy from Gilead and the Global Fund for what it is: bullying. It must also raise the funds, domestically and internationally, to pay for lenacapavir for all who need it. Two million people at minimum should be the national target – four times the glacial rollout pace the Global Fund is proposing at present.
The lesson from history is clear: When lifesaving HIV treatment was delayed, millions died needlessly. We cannot afford the same mistake with HIV prevention.
*Hassan, Menghaney, and Nkoana are all part of the global LEN-LA for All Coalition, a grouping that includes the organisations Health GAP, Health Justice Initiative, Sankalp Rehabilitation Trust, Just Tx, and ABIA.
Note: Spotlight aims to deepen public understanding of important health issues by publishing a variety of views on its opinion pages. The views expressed in this article are not necessarily shared by the Spotlight editors.
The health department has plans to roll out lenacapavir, a twice-yearly HIV prevention injection, in a select group of public sector clinics by April 2026. Meanwhile, little progress has been made towards rolling out a two-monthly prevention injection, despite the four-year head start this product had on lenacapavir.
Injections that provide months of protection at a time against HIV infection have been hailed by several leading experts as game-changers with the potential to help end the HIV epidemic.
The two antiretroviral-containing injections leading the field are long-acting cabotegravir (CAB-LA) and lenacapavir. Both have been shown to effectively eliminate the risk of contracting HIV in large clinical trials. The main difference between the two shots is that CAB-LA provides two months of protection at a time, while lenacapavir provides six.
CAB-LA captured global attention back in 2020 when pivotal trial results showed that the two-monthly injection was more effective than daily prevention pills in preventing HIV infection. Lenacapavir was thrust into the spotlight four years later in 2024 when two large trials demonstrated that the twice-yearly injection provided almost perfect protection against HIV.
There are still no clear plans for providing CAB-LA in South Africa’s public sector clinics, despite the four-year head start that it had on lenacapavir. By contrast, lenacapavir injections could be available in some select public sector clinics by April of next year, according to reporting by Bhekisisa.
How CAB-LA fell behind
In July 2022, the World Health Organization (WHO) recommended CAB-LA as a tool to prevent HIV and by December 2022 it was registered for use in South Africa.
In February 2023 though, South Africa’s National Essential Medicines Committee stated that it could not recommend the use of CAB-LA in the country because the medicine’s manufacturer, ViiV Healthcare, had yet to share how much it would charge the country for the shots.
It was only in late 2023 that ViiV provided pricing details for public sector procurement in certain low-and middle- income countries, including South Africa. That price was around R540 ($30) per dose or R3 240 ($180) per person per year, which the health department said was unaffordable for the country.
The price has since dropped slightly to around R2 880 ($160) per person per year, Mitchell Warren, from the US-based HIV advocacy organisation AVAC, told Spotlight.
In 2024, the health department requested further details from ViiV on its CAB-LA pricing but there is no indication that any progress has been made towards securing a lower price and enabling local procurement of CAB-LA for public sector facilities.
Khadija Jamaloodien, the top official for health products procurement in the National Department of Health, told Spotlight the department could not comment on whether there have been any developments towards local procurement of CAB-LA.
A spokesperson for ViiV told Spotlight: “We have not received any orders to date for CAB-LA for PrEP to supply to South Africa”. PrEP, or pre-exposure prophylaxis, refers to taking an injection to prevent HIV infection.
What about CAB-LA in the private sector?
For those using private healthcare in South Africa, CAB-LA also remains inaccessible. ViiV has not launched CAB-LA in the private sector or disclosed the price at which it will sell CAB-LA through private pharmacies.
ViiV did not respond to Spotlight’s questions regarding its plans and timelines for launching CAB-LA in the country’s private sector.
PEPFAR steps in, but doesn’t deliver
After the health department balked at ViiV’s CAB-LA price for the public sector, the United States President’s Emergency Plan for AIDS Relief (PEPFAR) announced plans to kick start the rollout of CAB-LA in South Africa and some other African countries.
PEPFAR pledged to buy CAB-LA from ViiV for donation to ten African countries during 2024 and 2025. The largest donation of 231 000 CAB-LA doses was designated for South Africa.
While some of the PEPFAR-donated stock began reaching countries before the Trump administration halted foreign aid on 20 January, according to Warren, South Africa never received any of the promised doses.
These donations are no longer expected, given cuts to the agency’s capacity and budget under the Trump administration.
The US State Department did not respond to Spotlight’s questions seeking confirmation that the CAB-LA donations would no longer be delivered, but our health department told Spotlight it doesn’t expect to receive this donation.
Gilead leapfrogs ViiV
Amid the delays and uncertainty surrounding CAB-LA’s pricing and rollout, Gilead, the company that manufactures lenacapavir, has positioned their product to become the first long-acting injectable form of HIV prevention available at any real scale in South Africa.
While lenacapavir is not yet registered in South Africa, Hasina Subedar, the senior technical advisor for HIV prevention in the National Department of Health, told Bhekisisa that it plans to start rolling out lenacapavir in 300 public clinics by April 2026 – less than 10% of the well over 3000 clinics in the country.
SAHPRA authorisation is expected to be granted in the coming months, as lenacapavir has already been recommended for marketing authorisation through the EU medicines for all (EU-M4All) initiative – a process which includes regulators from South Africa. In addition to securing local registration, lenacapavir must also receive a positive recommendation from South Africa’s National Essential Medicines List Committee to enable its rollout.
Gilead has secured a deal with the Global Fund for HIV, TB and Malaria, as well as private donors, that will allow lenacapavir to be rolled out in eight African countries, including in South Africa at a cost to country of R1080 ($60) per person per year.
Under this deal, private donations from the Children’s Investment Fund Foundation (CIFF) will also contribute toward procurement of lenacapavir. CIFF contributions will be above and beyond the $60 contributed by countries per person per year.
While the amount that Gilead will recoup for a year’s supply of lenacapavir under the deal has not been disclosed, it is speculated to be between R1800 ($100) and R2 160 ($120), according to Warren.
He added that Gilead’s deal with the Global Fund will allow countries to begin budgeting and planning for lenacapavir’s rollout using Gilead’s product while they await availability of more affordable generic products in a few years’ time.
The lack of transparency around Gilead’s pricing is uncommon in South Africa, which has strong legal requirements for medicine price transparency. Despite transparency concerns, the National Department of Health has indicated that they will participate in Gilead’s Global Fund arrangement.
By keeping the price secret, two advocacy groups, the Health Justice Initiative and Health Gap, have argued that the deal will undermine efforts in countries not included in the arrangement to negotiate and secure affordable pricing of lenacapavir.
Are HIV prevention injections cost effective for South Africa?
Local researchers have crunched the numbers to establish whether CAB-LA and lenacapavir offer good value for money.
These analyses compared the cost-effectiveness of HIV injections to the widely available prevention pills in public clinics, Lise Jamieson, senior researcher at WITS HE2RO, told Spotlight
The prevention pills provided by the National Department of Health are purchased for R1000 per person per year, said Jamaloodien.
Jamieson said that, according to modelling, prevention injections will avert more HIV infections than prevention pills. Generally speaking, products that provide protection for longer periods are more effective since their efficacy is less dependent on people regularly taking pills or going to the clinic to get an injection. We can thus accept a higher price for lenacapavir (providing six month of protection) than for CAB-LA (only two months of protection) because modelling indicates that this product will avert more HIV infections and delivers more treatment cost savings over time.
Jamieson said according to the latest iteration of their cost-effectiveness modelling, which has not yet been published, CAB-LA needs to be capped around R1800 ($100) per person per year to be cost effective, while lenacapavir needs to be capped around R3600 ($170) per person per year.
Based on this analysis, for South Africa to roll out lenacapavir at $60 per person per year is highly cost-effective, while buying CAB-LA at $160 per person per year is not cost-effective.
Lenacapavir use also requires fewer clinic visits per year than CAB-LA (two versus six) which places less of a strain on health facilities and providers.
Cheaper generic versions of lenacapavir and CAB-LA are expected to become available in 2027.
Lenacapavir generics, Warren said, are expected to enter the market around the same time as generic CAB-LA despite CAB-LA’s initial head start. This is because Gilead was quicker to license generic manufacturers and used a faster licensing approach than ViiV, he added.
Compared to CAB-LA, Warren said it would be faster to show that the generic version of lenacapavir works the same as the original – a necessary step before generic products can be approved. Added to this, he noted that generic companies would likely move faster to bring lenacapavir to market because buyers showed more interest in it.
How will procurement of lenacapavir be funded?
While lenacapavir is cost effective for South Africa at $60 per person per year, purchasing it may nevertheless be challenging given the country’s tight healthcare budget.
HIV prevention pills are procured domestically in South Africa, but Jamieson said the country will need additional funds or donor support to roll out lenacapavir.
The National Department of Health and the Global Fund agreed to allocate R520 million of the country’s Global Fund grant towards buying lenacapavir, Bhekisisa reported in July. This allocation will allow more than 450 000 people in the country to access lenacapavir over the next three years.
Can lenacapavir turn the tide on the epidemic?
In addition to looking at the cost-effectiveness of long acting injectables, Jamieson and her colleagues have modelled how the rollout of injectable HIV prevention options will impact new HIV infections in the country.
Jamieson said if South Africa initiates roughly 1 million people on lenacapavir over the next year and then increase access to reach 4 million people in the next 20 years, HIV incidence could fall below 0.1% by 2038 – with a projected 3.5 million people on lenacapavir by then. At this level, the country would effectively end the HIV epidemic.
Scaling up lenacapavir to this level will require significant political will and additional investment above and beyond what has already been committed by the Global Fund.
Meanwhile, researchers are working on new versions of lenacapavir and CAB-LA that could double the length of protection offered by each.
As Spotlight previously reported, there are promising signs for a lenacapavir formulation that could provide 12 months of protection as opposed to the current six, and a CAB-LA formulation that could provide four months of protection rather than two. HIV prevention tablets that provide a month of protection at a time are also under development. It however remains to be seen whether these new formulations will succeed in the pivotal clinical trials testing their safety and effectiveness.
