Latest news with #HIV-negative
Scoop
07-07-2025
- Health
- Scoop
Cambodia Is 2nd Asian Country To Rollout Long-Acting Injectable HIV Prevention Option
Press Release – CNS In Cambodia, the first two long-acting and injectable cabotegravir PrEP doses were given to a female sex worker and a transgender person, said Patricia Ongpin, UNAIDS Country Director for Cambodia, Lao PDR and Malaysia. After Thailand, Cambodia becomes the second Asian country to rollout long-acting and injectable options to protect oneself from getting infected with HIV. United Nations health agency (formally known as World Health Organization or WHO) had first issued its guidelines in 2022, asking countries to deliver long-acting injectable Pre-Exposure Prophylaxis (PrEP), using cabotegravir medicine, as part of comprehensive approach to HIV prevention. PrEP is a medicine for HIV-negative people to reduce their risk of getting infected. According to the WHO, long-acting injectable cabotegravir PrEP is a safe and highly effective prevention option for people at substantial risk of HIV infection. In Cambodia, the first two long-acting and injectable cabotegravir PrEP doses were given to a female sex worker and a transgender person, said Patricia Ongpin, UNAIDS Country Director for Cambodia, Lao PDR and Malaysia. Know more about long-acting injectable cabotegravir PrEP Long-acting injectable cabotegravir PrEP is an intramuscular injectable, long-acting form of PrEP. * First 2 injections are administered 4 weeks apart * Followed thereafter by an injection once every 8 weeks. This long-acting injectable PrEP with cabotegravir (CAB- LA) has shown in scientific studies to be safe and highly effective among cisgender women, cisgender men who have sex with men, and transgender women who have sex with men (studies include two randomised controlled trials, HPTN 083 and HPTN 084). These studies found that use of long-acting CAB-LA PrEP, resulted in a 79% relative reduction in HIV risk compared with oral PrEP, where adherence to taking daily oral medication was often a challenge. WHO clearly states that both daily oral PrEP and long-acting injectable PrEP are highly effective. Choice matters Expanding the range of science- and evidence-based HIV prevention options, so that people can choose what works best for them, is very important if we are to empower people towards health seeking behaviour, as well as progress faster towards ending AIDS, she said. 'Evidence is very clear on what works in HIV prevention. But what we need to know is that one size does not fit all. So we really have to understand that a combination of HIV prevention options must be made available in the market for people to choose from – based on their daily life, personal choice, and what they are comfortable with,' said Patricia Ongpin, in an exclusive interview given to CNS in the lead up to 13th International AIDS Society Conference on HIV Science (IAS 2025) – the largest global gathering on HIV science this year. She was also a speaker at IAS 2025 Affiliated Independent Event on the theme: 'Strengthening competencies and capacities in Global South to end AIDS, end TB, and deliver on SDGs.' 'Cambodia is a leader in the HIV response for many reasons. It currently has an HIV prevalence among the general adult population of 0.5%. In 2024, it was estimated that there were 76,000 people living with HIV, 1200 new infections (which roughly translates to 3 new HIV infections a day) and 1000 AIDS related deaths that year in Cambodia,' said Patricia. 'This represents roughly a 45% reduction in new HIV infections as compared to 2010.' Nepal is the only country in Asia Pacific region (and among 4 in the world) to record a decline of over 75% in new HIV infections since 2010, said Eamonn Murphy, UNAIDS Director for Asia Pacific at the 10th Asia Pacific AIDS and Co-Infections Conference (APACC 2025). Cambodia on track to achieve 95-95-95 targets for 2025 95-95-95 targets for 2025 refer to ensuring that at least 95% of people living with HIV know their HIV-positive status, 95% of those who know their status are receiving lifesaving antiretroviral therapy, and 95% of those on therapy are virally suppressed. According to WHO, those people with HIV who remain virally suppressed have ZERO risk of transmitting HIV to anyone else. So, HIV treatment also works as prevention. Not just rich nations like New Zealand, but also low- and middle-income countries like Nepal, Cambodia and Thailand in Asia and the Pacific region are meeting some of the 2025 HIV-related targets. 'Cambodia is on track to achieve the 95-95-95 HIV-related targets. In 2024, Cambodia had 92% of all people living with HIV who knew their status. Nearly 100% of all those who knew their HIV positive status were on lifesaving antiretroviral treatment, and 98% of those on treatment were virally suppressed. So, this is a fantastic achievement and we are really hoping that Cambodia can achieve the 95-95-95 targets on time for 2025,' said UNAIDS' Patricia Ongpin to CNS (Citizen News Service). She added: 'This is a very strong health response in Cambodia. and it also reflects its strong political commitment, community-led response, and adoption of innovations. But it is not just a health response, it is essentially a multi-sectoral response from Cambodia. This includes provision of social protection for people living with HIV and female entertainment workers, to social protection schemes that allow them access to free healthcare and covers their other out-of-pocket expenses or reimbursements.' Patricia was referring to Health Equity Funds in Cambodia – a social health protection government scheme designed to enable poor people to access free healthcare at public facilities. They aim to improve access to healthcare and reduce financial burdens, particularly for those most vulnerable. 'So, a holistic approach in Cambodia's HIV response has helped the country to become a leader in achieving the 95-95-95 HIV-related targets for 2025, in the hope that it can indeed end AIDS soon after,' said Patricia. 1st ever rollout of long-acting injectable PrEP in Cambodia Patricia shared that long-acting injectable cabotegravir PrEP was launched in the second half of June 2025 in Cambodia. 'A feasibility and acceptability research study was done last year in consultations with communities, so that we can know how will it be perceived by the people who are intended to use it. The government is working hand-in-hand with civil society organisations and communities so that there is more demand generation for long-acting injectable cabotegravir PrEP, and also to stem other challenges like hesitancy etc.' She had a meeting with Cambodian Director of HIV programmes and learnt that the uptake of long-acting injectable cabotegravir PrEP is 'pretty good right now, where we have both: people who are switching from oral PrEP to long-acting injectable PrEP, and also new initiation of PrEP in general.' One dose of long-acting injectable cabotegravir PrEP costs US$36 Thanks to the Global Fund to fight AIDS, TB and Malaria (The Global Fund), long-acting injectable cabotegravir has become possible for eligible people in Cambodia. Treatment for people living with HIV is lifesaving and revolutionary as it has made HIV akin to any other chronic disease. It has been proven that those who are on treatment and remain virally suppressed, live healthy and normal lifespans – comparable to those without the virus – and there is zero risk of any further HIV transmission from them. But oral HIV treatment has to be taken daily without fail. This could be challenging given the fact that HIV treatment is lifelong. Long-acting injectable cabotegravir along with Rilpivirine (CAB/RPV LA) is also available as treatment for people living with HIV who have suppressed viral load (once every two months). But it is not yet rolled out in Cambodia yet. Dapivirine vaginal rings in Cambodia: next breaking news? 'Right now, we have cabotegravir as a PrEP (HIV prevention option), injected once every two months. However, it is likely that soon Cambodia may rollout dapivirine vaginal rings for HIV prevention,' said Patricia of UNAIDS. Dapivirine vaginal ring (developed by International Partnership for Microbicides and acquired by Population Council), is the world's first female-controlled, long-acting, non-systemic, microbicide product that substantially reduces the risk of getting infected with HIV. Thus, it is also referred to as a PrEP ring. The dapivirine vaginal ring is a flexible silicon ring that slowly releases the HIV prevention drug dapivirine into the target cells and substantially reduces the risk of her getting infected with HIV. Any HIV-negative woman, who is at risk of acquiring the infection, can herself put the ring in her vagina, leave it in place for a specified period and then replace it by herself. Patricia informs that Cambodian government began considering dapivirine vaginal rings and long-acting injectable cabotegravir, roughly at the same time. 'So, Cambodia is in the final process of settling down the standard operating procedures (SOPs) and training. We are hoping that in the next month or two, dapivirine vaginal ring will also be added to the range of combination HIV prevention options people can choose from. We hope this would reduce the number of new HIV infections in Cambodia.' Public health warrants infection prevention but would we sustain it? UNAIDS' Patricia Ongpin puts the spotlight on sustainability of HIV prevention as well as global AIDS response in context of competing priorities. 'It is a real issue,' she rightly points out. She calls on governments to have optimal political commitment which should match the services, legal reforms and policy harmonisation, policy framework, health and development financing, and systematic integration which are critical if we are to end AIDS by 2030. 'Multi-sectoral approach towards ending AIDS is key,' she said. Health financing varies between countries. For example, Malaysia has almost all (99%) of its HIV response domestically-funded, whereas Cambodia has roughly 36%, informs Patricia. IAS 2025 message of UNAIDS' Patricia Ongpin 'HIV is not over and we need to stand together in solidarity to support governments, communities, and development partners in making sure that HIV responses stay alive,' said Patricia. She called for ensuring effective collaboration between different partners, such as governments, communities and development partners – so that not only innovative financing can be fully harnessed, but we are also able to rollout all combination HIV prevention options along with other critical cog-in-the-wheels to end AIDS by 2030. Shobha Shukla – CNS (Citizen News Service) (Shobha Shukla is the award-winning founding Managing Editor and Executive Director of CNS (Citizen News Service) and is a feminist, health and development justice advocate. She is a former senior Physics faculty of prestigious Loreto Convent College and current Coordinator of Asia Pacific Regional Media Alliance for Health and Development (APCAT Media) and Chairperson of Global AMR Media Alliance (GAMA received AMR One Health Emerging Leaders and Outstanding Talents Award 2024). She also coordinates SHE & Rights initiative (Sexual health with equity & rights). Follow her on Twitter @shobha1shukla or read her writings here
Scoop
06-07-2025
- Health
- Scoop
Cambodia Is 2nd Asian Country To Rollout Long-Acting Injectable HIV Prevention Option
After Thailand, Cambodia becomes the second Asian country to rollout long-acting and injectable options to protect oneself from getting infected with HIV. United Nations health agency (formally known as World Health Organization or WHO) had first issued its guidelines in 2022, asking countries to deliver long-acting injectable Pre-Exposure Prophylaxis (PrEP), using cabotegravir medicine, as part of comprehensive approach to HIV prevention. PrEP is a medicine for HIV-negative people to reduce their risk of getting infected. According to the WHO, long-acting injectable cabotegravir PrEP is a safe and highly effective prevention option for people at substantial risk of HIV infection. In Cambodia, the first two long-acting and injectable cabotegravir PrEP doses were given to a female sex worker and a transgender person, said Patricia Ongpin, UNAIDS Country Director for Cambodia, Lao PDR and Malaysia. Know more about long-acting injectable cabotegravir PrEP Long-acting injectable cabotegravir PrEP is an intramuscular injectable, long-acting form of PrEP. * First 2 injections are administered 4 weeks apart * Followed thereafter by an injection once every 8 weeks. This long-acting injectable PrEP with cabotegravir (CAB- LA) has shown in scientific studies to be safe and highly effective among cisgender women, cisgender men who have sex with men, and transgender women who have sex with men (studies include two randomised controlled trials, HPTN 083 and HPTN 084). These studies found that use of long-acting CAB-LA PrEP, resulted in a 79% relative reduction in HIV risk compared with oral PrEP, where adherence to taking daily oral medication was often a challenge. WHO clearly states that both daily oral PrEP and long-acting injectable PrEP are highly effective. Choice matters Expanding the range of science- and evidence-based HIV prevention options, so that people can choose what works best for them, is very important if we are to empower people towards health seeking behaviour, as well as progress faster towards ending AIDS, she said. "Evidence is very clear on what works in HIV prevention. But what we need to know is that one size does not fit all. So we really have to understand that a combination of HIV prevention options must be made available in the market for people to choose from - based on their daily life, personal choice, and what they are comfortable with," said Patricia Ongpin, in an exclusive interview given to CNS in the lead up to 13th International AIDS Society Conference on HIV Science (IAS 2025) - the largest global gathering on HIV science this year. She was also a speaker at IAS 2025 Affiliated Independent Event on the theme: "Strengthening competencies and capacities in Global South to end AIDS, end TB, and deliver on SDGs." "Cambodia is a leader in the HIV response for many reasons. It currently has an HIV prevalence among the general adult population of 0.5%. In 2024, it was estimated that there were 76,000 people living with HIV, 1200 new infections (which roughly translates to 3 new HIV infections a day) and 1000 AIDS related deaths that year in Cambodia," said Patricia. "This represents roughly a 45% reduction in new HIV infections as compared to 2010." Nepal is the only country in Asia Pacific region (and among 4 in the world) to record a decline of over 75% in new HIV infections since 2010, said Eamonn Murphy, UNAIDS Director for Asia Pacific at the 10th Asia Pacific AIDS and Co-Infections Conference (APACC 2025). Cambodia on track to achieve 95-95-95 targets for 2025 95-95-95 targets for 2025 refer to ensuring that at least 95% of people living with HIV know their HIV-positive status, 95% of those who know their status are receiving lifesaving antiretroviral therapy, and 95% of those on therapy are virally suppressed. According to WHO, those people with HIV who remain virally suppressed have ZERO risk of transmitting HIV to anyone else. So, HIV treatment also works as prevention. Not just rich nations like New Zealand, but also low- and middle-income countries like Nepal, Cambodia and Thailand in Asia and the Pacific region are meeting some of the 2025 HIV-related targets. "Cambodia is on track to achieve the 95-95-95 HIV-related targets. In 2024, Cambodia had 92% of all people living with HIV who knew their status. Nearly 100% of all those who knew their HIV positive status were on lifesaving antiretroviral treatment, and 98% of those on treatment were virally suppressed. So, this is a fantastic achievement and we are really hoping that Cambodia can achieve the 95-95-95 targets on time for 2025," said UNAIDS' Patricia Ongpin to CNS (Citizen News Service). She added: "This is a very strong health response in Cambodia. and it also reflects its strong political commitment, community-led response, and adoption of innovations. But it is not just a health response, it is essentially a multi-sectoral response from Cambodia. This includes provision of social protection for people living with HIV and female entertainment workers, to social protection schemes that allow them access to free healthcare and covers their other out-of-pocket expenses or reimbursements." Patricia was referring to Health Equity Funds in Cambodia - a social health protection government scheme designed to enable poor people to access free healthcare at public facilities. They aim to improve access to healthcare and reduce financial burdens, particularly for those most vulnerable. "So, a holistic approach in Cambodia's HIV response has helped the country to become a leader in achieving the 95-95-95 HIV-related targets for 2025, in the hope that it can indeed end AIDS soon after," said Patricia. 1st ever rollout of long-acting injectable PrEP in Cambodia Patricia shared that long-acting injectable cabotegravir PrEP was launched in the second half of June 2025 in Cambodia. "A feasibility and acceptability research study was done last year in consultations with communities, so that we can know how will it be perceived by the people who are intended to use it. The government is working hand-in-hand with civil society organisations and communities so that there is more demand generation for long-acting injectable cabotegravir PrEP, and also to stem other challenges like hesitancy etc." She had a meeting with Cambodian Director of HIV programmes and learnt that the uptake of long-acting injectable cabotegravir PrEP is "pretty good right now, where we have both: people who are switching from oral PrEP to long-acting injectable PrEP, and also new initiation of PrEP in general." One dose of long-acting injectable cabotegravir PrEP costs US$36 Thanks to the Global Fund to fight AIDS, TB and Malaria (The Global Fund), long-acting injectable cabotegravir has become possible for eligible people in Cambodia. Treatment for people living with HIV is lifesaving and revolutionary as it has made HIV akin to any other chronic disease. It has been proven that those who are on treatment and remain virally suppressed, live healthy and normal lifespans - comparable to those without the virus – and there is zero risk of any further HIV transmission from them. But oral HIV treatment has to be taken daily without fail. This could be challenging given the fact that HIV treatment is lifelong. Long-acting injectable cabotegravir along with Rilpivirine (CAB/RPV LA) is also available as treatment for people living with HIV who have suppressed viral load (once every two months). But it is not yet rolled out in Cambodia yet. Dapivirine vaginal rings in Cambodia: next breaking news? "Right now, we have cabotegravir as a PrEP (HIV prevention option), injected once every two months. However, it is likely that soon Cambodia may rollout dapivirine vaginal rings for HIV prevention," said Patricia of UNAIDS. Dapivirine vaginal ring (developed by International Partnership for Microbicides and acquired by Population Council), is the world's first female-controlled, long-acting, non-systemic, microbicide product that substantially reduces the risk of getting infected with HIV. Thus, it is also referred to as a PrEP ring. The dapivirine vaginal ring is a flexible silicon ring that slowly releases the HIV prevention drug dapivirine into the target cells and substantially reduces the risk of her getting infected with HIV. Any HIV-negative woman, who is at risk of acquiring the infection, can herself put the ring in her vagina, leave it in place for a specified period and then replace it by herself. Patricia informs that Cambodian government began considering dapivirine vaginal rings and long-acting injectable cabotegravir, roughly at the same time. "So, Cambodia is in the final process of settling down the standard operating procedures (SOPs) and training. We are hoping that in the next month or two, dapivirine vaginal ring will also be added to the range of combination HIV prevention options people can choose from. We hope this would reduce the number of new HIV infections in Cambodia." Public health warrants infection prevention but would we sustain it? UNAIDS' Patricia Ongpin puts the spotlight on sustainability of HIV prevention as well as global AIDS response in context of competing priorities. "It is a real issue," she rightly points out. She calls on governments to have optimal political commitment which should match the services, legal reforms and policy harmonisation, policy framework, health and development financing, and systematic integration which are critical if we are to end AIDS by 2030. "Multi-sectoral approach towards ending AIDS is key," she said. Health financing varies between countries. For example, Malaysia has almost all (99%) of its HIV response domestically-funded, whereas Cambodia has roughly 36%, informs Patricia. IAS 2025 message of UNAIDS' Patricia Ongpin "HIV is not over and we need to stand together in solidarity to support governments, communities, and development partners in making sure that HIV responses stay alive," said Patricia. She called for ensuring effective collaboration between different partners, such as governments, communities and development partners - so that not only innovative financing can be fully harnessed, but we are also able to rollout all combination HIV prevention options along with other critical cog-in-the-wheels to end AIDS by 2030. Shobha Shukla – CNS (Citizen News Service) (Shobha Shukla is the award-winning founding Managing Editor and Executive Director of CNS (Citizen News Service) and is a feminist, health and development justice advocate. She is a former senior Physics faculty of prestigious Loreto Convent College and current Coordinator of Asia Pacific Regional Media Alliance for Health and Development (APCAT Media) and Chairperson of Global AMR Media Alliance (GAMA received AMR One Health Emerging Leaders and Outstanding Talents Award 2024). She also coordinates SHE & Rights initiative (Sexual health with equity & rights). Follow her on Twitter @shobha1shukla or read her writings here
India Today
19-06-2025
- Health
- India Today
Lenacapavir becomes first FDA-approved HIV preventive drug: All about it
In a major breakthrough in the fight against HIV, the US Food and Drug Administration (FDA) has approved lenacapavir, under the brand name Yeztugo, a long-acting injectable drug developed by Gilead Sciences, as a preventive treatment for HIV. It has been in the making for over two for HIV prevention is not approved by any regulatory authority outside the US. There is currently no cure for HIV or makes Yeztugo the first and only HIV pre-exposure prophylaxis (PrEP) option in the United States that is required just twice a year. The injectable drug is approved for use in adults and adolescents weighing at least 35 kg who are at risk of acquiring HIV through sexual trial data show over 99.9% of people who received Yeztugo remained HIV-negative during the study period, highlighting its strong potential to prevent HIV infections.'This is a historic day in the decades-long fight against HIV. Yeztugo only needs to be given twice a year and has shown remarkable results. It could transform HIV prevention,' said Daniel O'Day, CEO of Gilead FOR HIV PREVENTIONThe first PrEP medication, also made by Gilead, was approved in 2012. But as of 2022, only about 1 in 3 people in the US who were eligible for PrEP were actually prescribed it, according to the Centers for Disease Control and Prevention (CDC).advertisementMany people, especially women, Black and Latino communities, and people in the US South, continue to face challenges such as stigma, lack of awareness, and difficulties in sticking to daily oral medications.'Yeztugo could be the transformative option we've been waiting for. A twice-yearly shot could help overcome key barriers like adherence and stigma,' said Dr. Carlos del Rio, Professor of Medicine at Emory YEZTUGO WORKSYeztugo contains lenacapavir, a unique antiretroviral that works by blocking HIV (Human Immunodeficiency Virus) at multiple stages of its life cycle, unlike most drugs that target just one. The injectable drug is approved for use in adults and adolescents weighing at least 35 kg who are at risk of acquiring HIV through sexual contact. () It is not a complete treatment for people who already have HIV, and people must be tested for HIV before starting the company has also highlighted certain safety warnings of the drug:People must be confirmed HIV-negative before starting or continuing Yeztugo. Taking it unknowingly while already infected with HIV can lead to drug-resistant strains of the side effects include injection site reactions, headache, and the drug stays in the body for up to 12 months, missed doses or improper use can increase the risk of infection and drug should not be used by individuals who are HIV-positive or whose status is IT'S GIVENYeztugo is given as a subcutaneous injection every six months, but starts with a loading dose that includes two injections and oral a patient misses a scheduled injection, temporary oral tablets may be taken weekly until injections TRIAL SUCCESSThe FDA approval is based on two large Phase 3 trials, led by researchers from Emory University and Grady Health 1 Trial: Conducted in cisgender women in sub-Saharan Africa, this trial showed zero HIV infections among the 2,134 people who received Yeztugo, demonstrating 100% effectiveness compared to daily oral PrEP (Truvada).PURPOSE 2 Trial: Involved cisgender men and gender-diverse people across various countries. Out of 2,179 participants, only two HIV infections were recorded in those on Yeztugo, showing 99.9% effectiveness. Yeztugo is given as a subcutaneous injection every six months, but starts with a loading dose that includestwo injections and oral tablets. () advertisementBoth trials found Yeztugo to be superior to daily oral PrEP and it was generally well-tolerated, with no new safety light of this breakthrough, the peer-reviewed journal Science named lenacapavir its 2024 "Breakthrough of the Year."MAKING IT WIDELY ACCESSIBLE IN THE USTo make Yeztugo widely accessible, Gilead is working with insurers and health systems to include the drug in insurance uninsured individuals, Gilead's assistance program will provide Yeztugo free of cost, based on EXPANSION PLANSGilead has already filed for regulatory approval in Australia, Brazil, Canada, South Africa, and submitted applications to the European Medicines company is also preparing applications in countries like Argentina, Mexico, and Peru, which rely on FDA approvals for their own of now, Yeztugo is only approved in the United States for HIV prevention. There is no cure for HIV or AIDS, but preventive tools like Yeztugo bring the world closer to controlling the this FDA approval, the drug can help those who have struggled with traditional prevention methods, making the prevention more manageable.
Time Magazine
18-06-2025
- Health
- Time Magazine
FDA Approves a Twice-Yearly Shot to Prevent HIV
On June 18, the U.S. Food and Drug Administration (FDA) approved the first medicine to prevent HIV that only has to be taken twice a year. People who are at high risk for HIV can now take the injection—called lenacapavir and sold as Yeztugo—just once every six months. The approval is a milestone in the fight against HIV and could transform the epidemic. While anti-HIV drug treatments have helped millions of people suppress the virus to undetectable levels so that they don't spread it to others—and have also allowed people who are HIV-negative to maintain their status when used to prevent infection—a regimen of daily pills means that compliance, and therefore effectiveness, is often not as strong as it should be. In two studies, scientists at Gilead, which developed lenacapavir, showed that the drug was 96% effective at protecting cisgender women from becoming HIV positive as compared to daily oral pills (called PrEP, short for pre-exposure prophylaxis). In men who have sex with men and gender-diverse people, the drug was 100% effective. 'Lenacapavir used by itself for prevention is a huge breakthrough,' says Dr. David Ho, professor of microbiology, immunology, and medicine at Columbia University who pioneered combining anti-HIV drugs to suppress the virus and its ability to mutate to become resistant to treatment. 'Its potential is great in curtailing the epidemic.' But advocacy groups and global AIDS organizations raise concerns about whether that potential will be fully realized, given recent cuts to U.S.-supported programs for HIV treatment and prevention around the world. From treatment to prevention Lenacapavir was approved by the FDA in 2022 to treat people with HIV whose virus has become resistant to other antiviral drugs. As they were developing that treatment, Gilead's scientists noticed that lenacapavir had two important properties that could make it potentially useful in preventing HIV as well: its ability to remain in the body for a longer time than other antiviral drugs, and its power to interfere with several steps in the process that the virus uses to make copies of itself. 'We observed a fantastic effect after a single injection," says Tomas Cihlar, senior vice president of virology at Gilead. "Basically, it protected non-human primates from acquiring HIV. That's when we realized we really needed to get full speed and full force behind the prevention idea.' But because people taking a drug to prevent infection are HIV negative, 'the bar for safety for people who don't have the disease is quite high,' says Jared Baeten, vice president of HIV development at Gilead. 'Still, based on all the pharmacology, science, and demonstrated antiviral activity and safety in the HIV treatment sphere, by the end of 2020 we made the decision to move lenacapavir into prevention,' he says. While it's the same drug, when doctors use lenacapavir to treat HIV, they often combine it with other drugs to limit HIV's potential for developing resistance. But to prevent disease in people who are HIV negative, lenacapavir can be used alone, since there isn't already an actively reproducing population of virus in the body. How lenacapavir could quash HIV vaccine efforts Lenacapavir is not an HIV vaccine, but its effect in preventing infection is similar to one. Vaccines enlist and train the immune system to recognize and target pathogens like viruses, so the body becomes a factory for generating the appropriate defenses to fight infections. Lenacapavir's ability to fend off infection comes from having circulating levels of the drug in the body to fight off any virus that might enter. Whether it's the immune system or the drug, the effect is very similar—which is a huge advance. In the more than 40 years since HIV was discovered, scientists have not been able to develop a vaccine against it. 'So far the candidate vaccines do not show this kind of promise for preventing HIV infection,' says Ho. 'We're nowhere close to an efficacious vaccine.' With lenacapavir approved to prevent HIV, the bar for developing a vaccine becomes even higher. It could be ethically difficult to justify asking people to take a placebo to establish the effects of a vaccine, since both oral PrEP and now lenacapavir as PrEP are so effective in protecting against HIV infection. Depriving those in a vaccine trial from taking lenacapavir by assigning them to receive a placebo would be problematic. 'This might take a bit of the wind out of the sails of vaccine research, because there is something so effective at preventing HIV infection,' says Ho. The future of HIV treatment and prevention The long-acting nature of lenacapavir represents a new direction for anti-HIV drugs that could make preventing infections more tenable and accessible to more people, says Hui Yang, head of supply operations of the Global Fund to Fight HIV, TB, and Malaria. 'We learned from decades-long experience that in prevention programs, adherence is a big issue. And that is an aspect we are hoping to address with the introduction of lenacapavir for PrEP.' The Global Fund's goal is to get two million more people in prevention programs over the next three years, and lenacapavir could accelerate reaching that target. But the shot still must be administered by a health care provider, and people need to test negative for HIV before receiving each shot. Those are hurdles for many of the most vulnerable populations in low- and middle-income countries, many of whom are young adults. To further increase access, Yang says, a form of lenacapavir that people could inject themselves with twice a year would be even more appropriate for such settings. 'It could become something like an insulin injection that people can do themselves,' she says. Gilead is working on a once-a-year version of lenacapavir that would cut down on the need for multiple clinic visits. The unrealized potential of lenacapavir While the advance is scientifically exciting, the drug may take years or even decades to significantly curb the global HIV epidemic. 'We just built the best plane in the world, but unfortunately tore up all the runways,' says Kevin Frost, CEO of amfAR, the Foundation for AIDS Research. 'Lenacapavir is coming at the worst moment in the last 30 years of the AIDS epidemic. We are seeing ourselves time traveling back decades because of the dismantling of the infrastructure around the treatment and prevention of HIV." Cuts to USAID, PEPFAR, and the National Institutes of Health "mean lenacapavir will never have a shot coming out of the gate. The very architecture that could deliver lenacapavir on a global scale to be transformative is being dismantled." While Gilead would not specify a price for lenacapavir, a company spokesperson said it would likely be 'in line with existing branded PrEP options.' Still, that could be out of reach for those in lower income countries who could benefit the most, says Frost. Addressing cost and other issues related to access will be critical to realizing the full potential of the drug. In the U.S., states that offer and cover PrEP options have reported a 38% decrease in new infections, whereas states that don't make PrEP as available saw a 27% increase in infections from 2012 to 2022, according to a recent report published in the Lancet HIV. Gilead has negotiated royalty-free licensing deals with six generic manufacturers to manufacture lenacapavir for prevention for 120 low- and middle-income countries. 'Hopefully in those places where they have that kind of manufacturing capacity, we will see cheap, inexpensive lenacapavir," says Frost—but given that the normal distribution channels are newly gutted programs like USAID and PEPFAR, "I still expect access will be extraordinarily limited.'
9 News
18-06-2025
- Health
- 9 News
Rule change means gay and bisexual men can donate plasma without wait times
Your web browser is no longer supported. To improve your experience update it here LIVE Rockets activate third country's air defences Sexually active gay and bisexual men will be able to donate plasma under a change in rules by Australian Red Cross Lifeblood. Under the previous rules, any gay or bisexual men and transgender women who have sex with men cannot donate blood or plasma if they have had sex in the last three months. But from July 14, Lifeblood will remove most sexual activity with times for plasma donations for gay and bisexual men and transgender women, meaning they can donate plasma at any time. Sexually active gay and bisexual men will be able to donate plasma in a change of rules. (Lifeblood) It means over 100,000 additional people can donate much-needed life-saving plasma, Lifeblood said. "We're excited to be able to welcome more people from across the community into our donor centres from next month," Lifeblood's chief medical officer Dr Jo Pink said. "With more than 600,0000 people estimated to be covered by the previous wait times, we now anticipate an extra 24,000 donors and 95,000 extra donations of plasma to be made each year." They will also accept plasma donations from people taking PrEP, an antiviral taken by people who are HIV-negative that protects them from contracting the illness. The Therapeutic Goods Administration (TGA) has also approved a submission to remove gender-based sexual activity rules from blood and platelet donation eligibility. The change means all people with a single sexual partner for six months or more will be eligible to donate blood. It means over 100,000 additional people can donate much-needed life-saving plasma, Lifeblood said. (9NEWS) Most people with new or multiple partners will also be able to dontate blood under the new laws, as long as they haven't had anal sex in the past three months. The rule change means men will not be asked if they have had sex with another man but rather everyone will be asked the same questions regardless of their gender or sex. "This is a significant milestone in being able to safely reduce wait times and make it easier for more people in the LGBTQIA+ community to donate," Pink said. "Blood safety is and always will be our top priority, but we know the current donation rules have been very difficult for many people in the LGBTQIA+ community. "While they were put in place to ensure a safe blood supply in the past, we know that they've contributed to the stigma faced by the community. "We hope as we move through the process of seeking to have both these changes introduced, that this will be a turning point for both Lifeblood and the LGBTQIA+ community." People taking PrEP still won't be able to donate blood despite the changes. CONTACT US
