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.
As HIV, TB and other treatments are updated in our public healthcare system, it is critical that healthcare workers and counsellors stay on top of the latest developments. One innovative programme makes use of short lessons delivered over WhatsApp to provide such training.
Over her years working as an information pharmacist at the University of Cape Town’s Medicines Information Centre (MIC), Briony Chisholm noted that many health workers in rural clinics face difficulties accessing training in crucial aspects of their work.
“The lack of easy access to training was in areas where it was really needed, such as the HIV (treatment) guidelines that are constantly being updated,” says Chisholm. “It’s not enough to have training sessions when new guidelines come out; you ideally should be training all the time.”
Drug-drug interactions
At the end of 2019, government introduced new standard first-line HIV treatment that includes an antiretroviral medicine called dolutegravir. As we previously reported, by 2023 around 4.7 million people in South Africa were taking dolutegravir-based treatment.
But the introduction of a new medicine in the public healthcare system, especially at this scale, is rarely straight-forward.
“Dolutegravir is considered as a ‘wonder child’ in ARV treatment, because it provides a high barrier to resistance, is easier to take, and has far fewer side effects than older ARVs. However, it also has interactions with other key drugs, particularly those used for the treatment of TB, diabetes and some anti-epileptic medications,” she says.
Through numerous queries received on the MIC’s National HIV and TB Healthcare Worker Hotline, Chisholm and her colleagues became aware that some healthcare workers were struggling with managing drug interactions. “Some healthcare workers didn’t know about these interactions; others knew about them but not how to deal with them. For example, if a patient is on the TB drug rifampicin, but also needs to take dolutegravir, there’s a need to adjust the dose of dolutegravir. Similarly, adjustments are needed with the diabetes medicine, metformin.”
Chisholm now lives in the Eastern Cape village of Nieu Bethesda. When dolutegravir was introduced, she had just completed her part-time post-graduate Diploma in HIV and TB management through UCT and signed up for her Masters. She and a colleague had, in 2016, done a road trip to about 200 clinics in seven provinces to promote the MIC’s Hotline.
“We saw that most South African healthcare workers are dedicated and keen to learn. You hear all this terrible news about health and corruption, and then you go to these clinics which are ticking along under sometimes difficult conditions, doing amazing work. It’s inspiring!”
A key realisation was the challenges experienced by health workers at these rural clinics to access much-needed training.
“Getting nurses to a central point for training and the need for transport, accommodation and food, as well as having them absent from the clinic for anything between one and five days, is challenging. It’s expensive and involves a great deal of organising,” says Chisholm.
Doing the research
Chisholm then started conducting research on what healthcare workers know about dolutegravir-related drug interactions. Her study, published in 2022, found that about 70 percent of respondents understood that dolutegravir interacts with other drugs, but there were gaps in people’s knowledge of specific interactions and the dosing changes needed to manage those interactions.
The study found that access to guidelines and training were positively associated with knowledge of drug-drug interactions. “There was a clear indication that we needed more accessible training,” Chisholm says.
“The Department of Health offers online training through live webinars, and recordings of these, but they are often one or two hours long. Nurses in busy clinics don’t necessarily have this time to sit through training sessions.”
Testing the efficacy of short training sessions
Chisholm then designed a project to test the efficacy of short training sessions focusing on teaching one or two learning points from the national guidelines in ten to fifteen-minute live lessons using WhatsApp.
“I thought, ‘we’re in a country where not everyone has access to big computer screens, but they all have a cell phone and use WhatsApp – so let’s go as simple as we can’,” she says. “The idea was not to teach the entire set of guidelines but to pick out important parts of them and ensure that if something changes in the guidelines, you get it out to people, quickly.”
Chisholm tested the feasibility of WhatsApp-based microlearning with health workers and counsellors at 50 clinics around Nieu Bethesda. “I ran a range of short case-based lessons on WhatsApp groups and then measured the changes in knowledge and patient care, as well as other factors like uptake, feasibility and accessibility,” she explains.
She found that WhatsApp-based microlearning for healthcare workers is “effective, feasible and well received” and 98 percent of those who participated said they would take part if training sessions were held weekly throughout the year.
While using WhatsApp for medical interactions is not new, Chisholm says a structured syllabus using microlearning for short, punchy sessions is a first.
“This type of learning is equally accessible to a rural clinic as to one in central Hillbrow. We can access people wherever they are. Nobody has to spend money getting anywhere and clinical services are not disrupted. And it doesn’t matter if they’re not in the live session: when they have a moment, they can go into their WhatsApp and read back on the lesson,” she says.
Working with the department of health on 6MMD
Chisholm has been working with the National Department of Health on their Six-Month Multi-Month Dispensing (6MMD) programme. The programme allows people living with HIV who are doing well on treatment and have suppressed viral loads to get a six-month supply of ARVs in one go. This makes life considerably easier for people, since they only need to go to the clinic twice a year; whilst also reducing workloads in the clinics. The programme started in August 2025 and is still being phased in across the country.
“In the pilot phase, the Department of Health did some really good online training and they used our WhatsApp training as an add-on to the longer form training,” says Chisholm.
“We started with one group and ran an eight-week course of 15-minute lessons once a week on WhatsApp. Sessions were case-based and included which patients are eligible for 6MMD, and which patients are not,” she explains. By the end of 2025, around 2 000 healthcare workers had been reached through these sessions.
Lynne Wilkinson, a technical expert with the International AIDS Society which supports the Department of Health on 6MMD, says the microlearning is “a great way to ensure we get to all the clinicians in the country and explain how the 6MMD programme works”.
She adds: “When a new policy comes out, it takes a long time for implementation to be scaled because ground level clinicians aren’t always aware of the changes or don’t have an opportunity to engage with how to implement the changes.”
Daniel Canham, a professional nurse and facility team lead for the NGO, TB HIV Care, at Idutywa Village Community Health Centre in the Eastern Cape, says they’ve found the microlearning sessions for 6MMD very useful. “It’s no secret that the waiting times in clinics are quite extensive, so we are trying to enrol all those qualified for 6MMD as quickly as possible to ease the burden on the clinic,” he says.
“The microlearning on 6MMD has been very helpful. Our staff don’t have to be out of the facility to attend it. They can run their normal activities and attend sessions of ten minutes maximum,” says Canham.
“Our professional nurses joined the WhatsApp microlearning sessions in September last year,” says Faith Maseko, a nurse lead based at Phola Park Clinic in Thokoza in Gauteng who works for the WITS Research Health Institute (RHI). The RHI supports the health department in the management of HIV and employs more than 30 nurses.
“When nurses are trained virtually, some of the information is forgotten, but when you’re on WhatsApp, you can go back and access the information that was shared. The scenarios provided are very useful. If you see a patient, with a similar scenario you can go back and see what was discussed and apply it to your own situation,” she says.
Department of Health backing
Foster Mohale, spokesperson for the National Department of Health, says the WhatsApp-based microlearning has been “an effective low-cost, high-reach supplement to formal 6MMD training”.
He adds: “Training gaps translate directly into service gaps, affecting quality, retention, and progress toward epidemic control. Microlearning addresses this risk by enabling continuous, bite-sized reinforcement of policy and implementation guidance, rather than relying solely on once-off training events. This approach supports frontline healthcare workers in applying 6MMD consistently under real-world service pressures.”
Mohale says evidence from the department’s broader capacitation strategy shows that lifelong, continuous learning, rather than episodic training, is essential for resilient health systems.
“WhatsApp microlearning aligns with this principle by supporting rapid dissemination of updates, peer learning, and sustained mentorship. When integrated with structured models and aligned to national guidelines, it can be effectively applied across HIV, TB, maternal and child health, non-communicable diseases, and health systems strengthening more broadly,” he says.
Professor Adrie Bekker explains the findings of a study on two novel formulations for the administration of dolutegravir in babies born to mothers living with HIV. (Photo: Biénne Huisman/Spotlight)
By Biénne Huisman
Research led by Professor Adrie Bekker is paving the way for an important HIV medicine to be made available to neonates in a way that is both safe and much more convenient than previous options. Spotlight met with the passionate clinician-scientist at her office in Cape Town.
Two new ways of giving the important HIV medicine dolutegravir to newborn babies have been found to be safe and effective, according to new research done in Cape Town. The new findings support for the first time the broader use of dolutegravir in infants who are less than 28 days old.
Dolutegravir is recommended by the World Health Organization (WHO) for infants, children and adults and is the preferred HIV medicine in South Africa. It exists in a scored 10 milligram child-friendly dispersible tablet. But until now, there hasn’t been any guidance on how to safely use it for newborns in their first four weeks of life. A study called PETITE-DTG aimed to bridge this critical gap in neonatal HIV care.
Forty-one full-term babies, each weighing at least 2 kilograms and born to mothers receiving dolutegravir-based HIV treatment, were enrolled in the study at Tygerberg Hospital to test two paediatric formulations of dolutegravir.
The first method involved using a 5 milligram dispersible tablet dissolved in 5 millilitres of water and given every second day for the first 14 days of life, then once daily until the baby was four weeks old. This was administered with a syringe.
The second method involved using a novel 5 milligram mint-flavoured film the size of a fingernail that dissolves on the tongue in seconds. It followed the same dosing schedule as the first method.
Findings showed that both formulations were safe and effective, achieving drug concentrations comparable to adults receiving 50 milligram of dolutegravir twice daily.
The study’s findings were presented at the Conference on Retroviruses and Opportunistic Infections in March. Researchers are currently writing up the final results of the study for publication in a peer-reviewed medical journal.
Professor Adrie Bekker, a neonatologist from the University of Stellenbosch is co-principal investigator of the PETITE-DTG study alongside Dr Tim Cressey, a clinical pharmacologist from the University of Chiang Mai in Thailand.
“The study results confirmed that the regimen [both 5 milligram dolutegravir formulations] was safe, effective, and highly acceptable to mothers, with the dolutegravir film being particularly easy to administer,”
says Bekker, speaking to Spotlight in her office at Stellenbosch University’s medical campus next to Tygerberg Hospital.
In examining dosing safety and efficacy, she says that the study found that both formulations “achieved target concentrations” in the neonates, without the newborn babies experiencing any adverse effects related to the medicine. All neonates were HIV negative at the end of the study.
Babies born to a mother living with HIV may need antiretroviral medicines for the prevention or treatment of HIV. Bekker explains that neonates are currently given an older type of liquid HIV medication that doesn’t taste good, costs more than dolutegravir, is harder to give properly, and can’t be stored for long.
The novel film method was popular with mums in the study, who cited its simplicity of administering and dose accuracy as highly advantageous, with no risk of the medicine being spit out or other spillage.“I wash and dry my hands and I cut the paper, it’s quick. As soon as I put it on his tongue, it just dissolves in a few seconds, he enjoys it,” said one mother, as quoted on a poster highlighting the results of the study.
Commenting on the film strip, Bekker notes it is one of the least disruptive ways to give medication.
“So what has been amazing to me is that the babies seem to be completely oblivious of what is happening when the mother puts the film in their mouth,” she says pointing out a video clip on her desktop of a film strip being placed in a tiny baby’s mouth.
“If they were crying, they would just keep on crying. If they were sleeping, they would just keep on sleeping. If they were happy, they would just keep on being happy. It really is the most unintrusive way of administering medication.”
Bekker says the colourless dolutegravir film is made by the Indian multinational pharmaceutical company Laurus Labs. Previously, it had only been tested in adults and is not yet commercially available. “It’s actually never even been used in children…And so our study for the first time tested the dolutegravir film in newborns to see what drug levels are found in a baby when you use it,” she says.
She says the research findings have been presented to the World Health Organization (WHO) and expects they will be included in the organisation’s upcoming updated dosing guidelines for infants and children.
Commenting on dolutegravir for neonates, Bekker says: “I think the first step is to actually get this recommendation into the WHO guidelines. As soon as the WHO releases their updated HIV guidelines, then countries can decide whether they want to adopt it or not.”
Commenting on the availability and possible roll-out of dolutegravir for neonates, she adds: “The generic 10 milligram dolutegravir scored dispersible tablet is already available and being used in children. What we’ve shown now is that 5 milligram of dolutegravir with this dosing strategy is safe for neonates…The film is a bit more complicated because it is not yet commercially available. And we don’t know the price of the drug; all of that will need to be discussed and negotiated with the company and relevant parties before it can become available.”
The PETITE-DTG research has been welcomed by fellow scientists.
“Adrie Bekker and her colleagues at Tygerberg Hospital and in Thailand have done great work and are really moving the field forward for neonatal antiretroviral treatment,” says Associate Professor James Nuttall, a paediatric infectious diseases sub-specialist at the Red Cross War Memorial Children’s Hospital and the University of Cape Town.
He says the research “provides really nice information about how we could use our existing drugs to treat neonates, potentially”.
Nuttall described the new film as extraordinary, and suggested that it might eventually replace the current drug formulations.
For Nuttall though, making provision for using a pill like the scored 10 milligram dispersible tablet that’s already available and routinely used to treat children in South African hospitals is more immediately relevant. “Using this 5 milligram dispersible tablet in neonates and working out the dosing schedule for that, that’s the real advance of this study to me, the big win.”
He anticipates these findings to be implemented in South Africa in the next few years. “From what I understand, she [Bekker] has presented this to WHO already. And once it gets accepted and included into WHO guidelines, then countries tend to really take note and follow, that’s when it makes its way into national guidelines…”
While the study focused on healthy full-term babies weighing at least two kilograms, Nuttall noted that many babies born to mothers living with HIV are either premature or have low birth weight. “So this dosing and safety information doesn’t yet apply to those children,” he said.
Bekker already has her eye set on assessing dosing safety for pre-term newborns. “So obviously our dream is to extend this to pre-term babies,” she says. “And there is a possibility that a 2.5 milligram dolutegravir film may be a good dose for pre-term neonates. Obviously, that will have to be studied very rigorously first.”
Other research goals include the hope of being involved in studies assessing long-acting antiretroviral drugs in neonates. Bekker notes that the WHO-led Paediatric Drug Optimisation group identified long-acting cabotegravir injectables as a high research priority for HIV prevention in neonates. She adds that developing patches with tiny microneedles that deliver HIV medication could hold great promise for treating newborns in the future.
Commenting on the PETITE-DTG study, Dr Moherndran Archary, who has been at the forefront of South Africa’s HIV response for children, said: “Professor Bekker’s research has directly impacted access to life-saving HIV medication for newborn infants – the most vulnerable of populations who have not traditionally benefited from the significant advances in HIV treatment.”
The PETITE-DTG study is one of many under the Unitaid-funded BENEFIT Kids project aiming to improve treatment for children with HIV or multidrug-resistant tuberculosis. UNITAID is a global health initiative that, amongst others, funds research and helps facilitate the more rapid introduction of new health technologies.
The South African HIV Clinicians Society (SAHCS) have recently announced a clinical update on the dolutegravir (DGT)-based regimens for first- and second-line antiretroviral therapy. This comes in the wake of positive findings from a number of clinical trials.
“Based on data from several recent trials, we now recommend that all patients > 10 years old and 35 kg on tenofovir/emtricitabine (or lamivudine)/efavirenz (TEE/TLE) or NVP-based regimens be switched to tenofovir/lamivudine/dolutegravir (TLD) regardless of the viral load (VL) result. In addition, all patients > 10 years old and > 35 kg on a regimen of two nucleoside reverse transcriptase inhibitors (NRTI) with a boosted protease inhibitor (PI) (eg, lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r)) and a suppressed VL can be switched to TLD, regardless of prior resistance patterns or treatment history.”
In South Africa, pre-treatment resistance to nonnucleoside reverse transcriptase inhibitors (NNRTI)-based antiretroviral therapy regimens has been rising. Meanwhile, DTG has a higher barrier to resistance and reduced side effects. This prompted the Department of Health to recommend that patients on NNRTI-based ART regimens be switched to DTG-based regimens. This transition is slower than desired partly because a documented suppressed VL is required prior to switching from TEE/TLE to TLD. Since this recommendation was first made, evidence from several trials (NADIA, VISEND and ARTIST) has demonstrated that tenofovir with lamivudine can be safely and effectively recycled from a first- to a second-line regimen. Therefore, the SAHCS has stated that “in patients with virological failure on a TEE or TLE regimen a single drug can be switched (efavirenz to dolutegravir ie, TLD as secondline), resulting in virological suppression comparable to or better than alternative second-line options.”
The guidelines also outline the results of the NADIA, VISEND and ARTIST trials conducted in southern African countries, as well as the single-arm DAWNING trial.
