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Daily Maverick
06-05-2025
- Health
- Daily Maverick
Cape Town study brings hope to newborns left behind in HIV treatment advances
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 the passionate clinician-scientist at her office in Cape Town. Two new ways of giving the important HIV medicine dolutegravir to newborns 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 younger than 28 days. 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 10mg, 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 2kg 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 5mg dispersible tablet dissolved in 5ml 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 5mg 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 50mg of dolutegravir twice daily. The findings were presented at the Conference on Retroviruses and Opportunistic Infections in March. Researchers are 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 5mg 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 on Stellenbosch University's medical campus next to Tygerberg Hospital. In examining dosing safety and efficacy, she says, the study found that both formulations 'achieved target concentrations' in the neonates, without the newborns 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. Bekker notes that the film strip 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 to 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 WHO and expects they will be included in the organisation's forthcoming updated dosing guidelines for infants and children. About 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.' Regarding the availability and possible roll-out of dolutegravir for neonates, she adds: 'The generic 10mg dolutegravir, scored, dispersible tablet is already available and being used in children. What we've shown now is that 5mg 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 subspecialist 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 10mg, dispersible tablet that's already available and routinely used to treat children in South African hospitals is more immediately relevant. 'Using this 5mg 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 2kg, 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.' 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 2.5mg 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, among other things, funds research and helps facilitate the more rapid introduction of new health technologies. DM
News24
01-05-2025
- Health
- News24
Cape Town study brings hope to newborns left behind in HIV treatment advances
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. Spotlight met with the passionate clinician-scientist behind the research 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 Organisation (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 two kilogrammes 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 five-milligram dispersible tablet, dissolved in five millilitres of water and given every second day for the first 14 days of life, then once daily until the baby four weeks of age. This was administered with a syringe. The second method involved using a novel five-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 milligrams of Dolutegravir twice daily. The study's findings were presented at the Conference on Retroviruses and Opportunistic Infections in March. Researchers are 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 five-milligram Dolutegravir formulations) was safe, effective, and highly acceptable to mothers, with the Dolutegravir film being particularly easy to administer," Bekker told Spotlight in her office at Stellenbosch University's medical campus next to Tygerberg Hospital. In examining dosing safety and efficacy, she said 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. According to Bekker, 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 noted it was 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 said, 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." According to Bekker, the colourless Dolutegravir film is made by the Indian multinational pharmaceutical company Laurus Labs. Previously, it had only been tested in adults and it 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." READ | Eight million people living with HIV in SA, according to latest estimates She said the research findings were presented to the World Health Organisation (WHO) and they are expected to be included in the organisation's upcoming updated dosing guidelines for infants and children. Commenting on Dolutegravir for neonates, Bekker said: "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 added: "The generic 10-milligram Dolutegravir scored dispersible tablet is already available and being used in children. What we've shown now is that five milligram of Dolutegravir with this dosing strategy is safe for 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," said 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 said 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 use of 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 five 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…" ALSO READ | Experts urge registration of new child-friendly ARV formulation While the study focused on healthy full-term babies weighing at least two kilogrammes, Nuttall noted that many babies born to mothers living with HIV were either premature or had a 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 said. "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 noted that the WHO-led Paediatric Drug Optimisation group identified long-acting Cabotegravir injectables as a high research priority for HIV prevention in neonates. She added 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, among others, funds research and helps facilitate the more rapid introduction of new health technologies.
Eyewitness News
30-04-2025
- Health
- Eyewitness News
Cape Town study brings hope to newborns left behind in HIV treatment advances
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 peadiatric formulations of dolutegravir. The first method involved using a 5 milligram dispersible tablet dissolved in 5 milliliters 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. Related Posts 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. 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. 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.' '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. This article first appeared on Spotlight. Read the original article here.
Yahoo
12-03-2025
- Health
- Yahoo
Gilead to launch Phase III once-yearly HIV PrEP trial after Phase I success
Gilead is set to launch a Phase III trial of its once-yearly lenacapavir pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) following the success of a Phase I study. The Phase I trial investigated two single 5,000mg doses of the yearly injection in 40 healthy participants at low risk of acquiring HIV. One formula contained 5% ethanol, the second contained 10% ethanol. Both groups achieved and maintained plasma concentrations above the 95% efficacy threshold for 56 weeks. The data, presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025) as well as in The Lancet, showed lenacapavir plasma trough concentrations for both formulations of once-yearly lenacapavir at week 52, 57.0ng/mL and 65.6ng/mL, were higher than those from twice-yearly lenacapavir in the Purpose 1 and Purpose 2 trials (NCT04994509 and NCT04925752) after 26 weeks, an average of 23.4ng/mL. The Purpose 1 programme saw 100% prevention of HIV cases while Purpose 2 showed a 99.9% prevention in lenacapavir-treated patients. Twice-yearly lenacapavir is currently under priority review by the US Food and Drug Administration (FDA) with a decision expected by June 19. The most common adverse event (AE) for both cohorts was injection site pain, which was mostly mild in severity and resolved within one week. Medication-emergent AEs were similar between the two cohorts and mostly mild to moderate in severity. The study was designed to evaluate the safety and pharmacokinetics (PK) of the therapy. Participants had to be found to be negative for HIV prior to the trial. Data from the trial confirmed that both once-yearly formulations of lenacapavir warrant further investigation, according to Gilead, with the company set to launch Phase III trials of the therapy in the second half of 2025. Gilead Sciences's senior vice president and virology therapeutic area head Dr Jared Baeten said: 'Gilead is continuing to innovate in our work to develop additional person-centered long-acting injectable and oral options to help people find an HIV prevention choice that is right for them. Once-yearly lenacapavir, if approved, could become an important new HIV prevention option that could help address PrEP adherence and persistence challenges for individuals who need or want PrEP around the world.' Alongside its Phase III plans, Gilead also presented more data from its Purpose clinical programme at the California conference. This included data from adolescents, aged 16 and 17 who were enrolled in the Purpose 1 study, with lenacapavir plasma concentrations being comparable between adolescent and adult trial groups. The therapy was also able to show 100% no incidence of HIV infections across the adolescent group, the same as the adult group in the same study. Participants in both groups experienced the same most common AEs. Gilead now intends to submit data to agencies to support the use of twice-yearly lenacapavir in adolescents. Gilead also revealed quantitative and qualitative survey data from the Purpose 1 trial, with approximately two-thirds of survey respondents preferring twice-yearly lenacapavir compared to once-daily pills. Additionally, 61% of respondents reported they would feel more protected from HIV with twice-yearly PrEP injections compared with once-daily pills, and 61% of respondents also reported they would feel more confident about not missing a PrEP dose with twice-yearly injections. According to UNAIDS, 39.9 million people globally were living with HIV in 2023, with 1.3 million new infections in the same year. After Gilead presented the flagship Purpose trial data, UNAIDS executive director Winnie Byanyima called upon Gilead Sciences to make twice-yearly lenacapavir available to people from developing countries. Byanyima said that people in Africa could be 'freed from the stigma and fear of being attacked' that they face if they are seen swallowing tablets. Gilead responded by stating it had provided royalty-free voluntary licensing agreements with six generic manufacturers to increase access to lenacapavir for HIV prevention in high-incidence, resource-limited countries. "Gilead to launch Phase III once-yearly HIV PrEP trial after Phase I success" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
The Independent
11-03-2025
- Health
- The Independent
HIV prevention medication ‘could one day be a yearly jab'
An annual jab to protect against HIV 'shows potential', according to an early study. Millions of people around the world are deemed to be at high risk of contracting the human immunodeficiency virus (HIV). But only 3.5 million take pre-exposure prophylaxis (PrEP), which reduces a person's risk of getting HIV. Researchers believe that giving people the option for long-lasting treatment could help reduce the number of new HIV infections, citing potential problems with 'adherence and persistence' among people taking daily tablets. The new study, published in The Lancet, found that a yearly injection lenacapavir, made by Gilead Sciences, was 'safe and well tolerated'. The study, which has also been presented to the 2025 Conference on Retroviruses and Opportunistic Infections, was a phase one clinical trial examining data on 40 people aged 18 to 55, who were given a single dose of the treatment. Concentrations of the annual medication remain in the body for at least 56 weeks, researchers found. They said that average concentrations 'exceeded those associated with efficacy' in the trial which assessed the jab at a twice-yearly interval. 'These data show the potential for biomedical HIV prevention with a once-yearly dosing interval,' experts wrote in The Lancet. More studies will be needed to confirm the efficacy of the treatment, they added. 'There were 1.3 million new HIV infections globally in 2023,' the authors wrote. 'However, despite the availability of multiple pre-exposure prophylaxis (PrEP) options, only 3.5 million of the 21.2 million people who would benefit from PrEP were receiving it in 2023. 'Although daily oral PrEP options are highly effective when used as directed, challenges with adherence and persistence have limited their overall effect. 'Longer-acting options can overcome some of the key challenges with daily oral PrEP by avoiding the requirement for adherence to daily dosing.' They added: 'Yearly dosing of lenacapavir has the potential to further decrease current barriers to PrEP by increasing the uptake of, persistence on, and, therefore, scalability of PrEP.' A long-acting injectable PrEP has been approved in the US, but it is not yet available in the UK. Experts at the National Institute for health and Care Excellence (Nice) are currently considering whether or not to approve a PrEP injection which is given once every two months. Commenting on the new study, Richard Angell, chief executive of Terrence Higgins Trust, said: 'PrEP as a daily pill has been a game-changer in our HIV response, the prospect of 'safe' annual injectable PrEP is as exciting as it is transformational. 'It's great to see these early results that suggest injectable PrEP might be effective for up to 12 months, we need to get ready for its roll out now and fund sexual health clinics to do so. 'PrEP has been characterised by delays — and in turn, inequalities — and this cannot continue. 'The oral pill is still not available in prisons, online or in community pharmacy. 'The Scottish Medicines Consortium has finally approved two monthly PrEP injections for use in Scotland, but we are waiting for Nice approval for use in England. 'Thanks to rapid HIV testing, PrEP and the fact that a person living with HIV on effective treatment can't pass it on, we can end new HIV cases by 2030—all without a vaccine or a cure. Increasing access to PrEP—including making oral PrEP accessible beyond sexual health services through a digital service and community pharmacies and getting injectables to be routinely commissioned—will be crucial to realising this historic goal.'
