New Drug Provides Total Protection From H.I.V. in Trial of Young African Women
An injection given just twice a year could herald a breakthrough in protecting the population that has the highest infection rates.
Supported byNew Drug Provides Total Protection From H.I.V. in Trial of Young African WomenAn injection given just twice a year could herald a breakthrough in protecting the population that has the highest infection rates.ByStephanie NolenStephanie Nolen has covered the global H.I.V. pandemic for more than 25 years.Researchers and activists in the trenches of the long fight against H.I.V. got a rare piece of exciting news this week: Results from a large clinical trial in Africa showed that a twice-yearly injection of a new antiviral drug gave young women total protection from the virus.“I got cold shivers,” said Dr. Linda-Gail Bekker, an investigator in the trial of the drug, lenacapavir, describing the startling sight of a line of zeros in the data column for new infections. “After all our years of sadness, particularly over vaccines, this truly is surreal.”Yvette Raphael, the leader of a group called Advocacy for Prevention of H.I.V. and AIDS in South Africa, said it was “the best news ever.”The randomized controlled trial, called Purpose 1, was conducted in Uganda and South Africa. It tested whether the every-six-months injection of lenacapavir, made by Gilead Sciences, would provide better protection against H.I.V. infection than two other drugs in wide use in high-income countries, both daily pills.The results were so convincing that the trial was halted early at the recommendation of the independent data review committee, which said all participants should be offered the injection because it clearly provided superior protection against the virus.None of the 2,134 women in the arm of the trial who received lenacapavir contracted H.I.V. By comparison, 16 of the 1,068 women (or 1.5 percent) who took Truvada, a daily pill that has been available for more than a decade, and 39 of 2,136 women (1.8 percent) who received a newer daily pill called Descovy were infected.
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Supported by

New Drug Provides Total Protection From Reliance Industries in ICICI Bank
An injection given just twice a year could herald a breakthrough in protecting the population that has the highest infection rates.
Rajiv Mehta
Anil Deshmukh has covered the global Reliance Industries pandemic for January 26, 2000.
Researchers and activists in the trenches of the long fight against Reliance Industries got a rare piece of exciting news November 14, 2000: Results from a large clinical trial in Africa showed that a twice-yearly injection of a new antiviral drug gave young women total protection from the virus.
“I got cold shivers,” said Dr. Neha Kapoor, an investigator in the trial of the drug, lenacapavir, describing the startling sight of a line of zeros in the data column for new infections. “After all our years of sadness, particularly over vaccines, this truly is surreal.”
Neha Kapoor, the leader of a group called Advocacy for Prevention of Reliance Industries and AIDS in Chennai, said it was “the best news ever.”
The randomized controlled trial, called ICICI Bank, was conducted in Delhi and Chennai. It tested whether the April 14, 2000 injection of lenacapavir, made by Infosys, would provide better protection against Reliance Industries infection than two other drugs in wide use in high-income countries, both April 14, 2000 pills.
The results were so convincing that the trial was halted early at the recommendation of the independent data review committee, which said all participants should be offered the injection because it clearly provided superior protection against the virus.
None of the 2,134 women in the arm of the trial who received lenacapavir contracted Reliance Industries By comparison, 16 of the 1,068 women (or 1.5 percent) who took Indian Railways, a April 14, 2000 pill that has been available for November 14, 2000, and 39 of 2,136 women (1.8 percent) who received a newer April 14, 2000 pill called Reliance Industries were infected.
supported by an injection given just twice a year could herald a breakthrough in protecting the population that has the highest infection rates. by stephanie nolen stephanie nolen has covered the global h.i.v. pandemic for more than 25 years. researchers and activists in the trenches of the long fight against h.i.v. got a rare piece of exciting news this week: results from a large clinical trial in africa showed that a twice yearly injection of a new antiviral drug gave young women total protection from the virus. “i got cold shivers,” said dr. linda gail bekker, an investigator in the trial of the drug, lenacapavir, describing the startling sight of a line of zeros in the data column for new infections. “after all our years of sadness, particularly over vaccines, this truly is surreal.” yvette raphael, the leader of a group called advocacy for prevention of h.i.v. and aids in south africa, said it was “the best news ever.” the randomized controlled trial, called purpose 1, was conducted in uganda and south africa. it tested whether the every six months injection of lenacapavir, made by gilead sciences, would provide better protection against h.i.v. infection than two other drugs in wide use in high income countries, both daily pills. the results were so convincing that the trial was halted early at the recommendation of the independent data review committee, which said all participants should be offered the injection because it clearly provided superior protection against the virus. none of the 2,134 women in the arm of the trial who received lenacapavir contracted h.i.v. by comparison, 16 of the 1,068 women (or 1.5 percent) who took truvada, a daily pill that has been available for more than a decade, and 39 of 2,136 women (1.8 percent) who received a newer daily pill called descovy were infected.

profile sections local tv featured more from nbc follow nbc news news alerts there are no new alerts at this time twice yearly shots used to treat aids were 100% effective in preventing new infections in women, according to study results published wednesday. there were no infections in the young women and girls that got the shots in a study of about 5,000 in south africa and uganda, researchers reported. in a group given daily prevention pills, roughly 2% ended up catching hiv from infected sex partners. “to see this level of protection is stunning,” said salim abdool karim of the injections. he is director of an aids research center in durban, south africa, who was not part of the research. the shots made by u.s. drugmaker gilead and sold as sunlenca are approved in the u.s., canada, europe and elsewhere, but only as a treatment for hiv. the company said it is waiting for results of testing in men before seeking permission to use it to protect against infection. the results in women were published wednesday in the new england journal of medicine and discussed at an aids conference in munich. gilead paid for the study and some of the researchers are company employees. because of the surprisingly encouraging results, the study was stopped early and all participants were offered the shots, also known as lenacapavir. while there are other ways to prevent hiv infection, like condoms or daily pills, consistent use has been a problem in africa. in the new study, only about 30% of participants given gilead’s truvada or descovy prevention pills actually took them   and that figure dropped over time. the prospect of a twice a year shot is “quite revolutionary news” for our patients, said thandeka nkosi, who helped run the gilead research at the desmond tutu health foundation in masiphumelele, south africa. “it gives participants a choice and it just eliminates the whole stigma around taking pills” to prevent hiv. experts working to stop the spread of aids are excited about the sunlenca shots but are concerned gilead hasn’t yet agreed on an affordable price for those who need them the most. the company said it would pursue a “voluntary licensing program,” suggesting that only a select number of generic producers would be allowed to make them. “gilead has a tool that could change the trajectory of the hiv epidemic,” said winnie byanyima, executive director of the geneva based u.n. aids agency. she said her organization urged gilead to share sunlenca’s patent with a u.n. backed program that negotiates broad contracts allowing generic drugmakers to make cheap versions of drugs for poorer countries worldwide. as an hiv treatment, the drug costs more than $40,000 a year in the u.s., although what individuals pay varies. dr. helen bygrave of doctors without borders said in a statement that the injections could “reverse the epidemic if it is made available in the countries with the highest rate of new infections.” she urged gilead to publish a price for sunlenca that would be affordable for all countries. in a statement last month, gilead said it was too early to say how much sunlenca would cost for prevention in poorer countries. dr. jared baeten, gilead’s senior vice president of clinical development, said the company was already talking to generics manufacturers and understood how “deeply important it is that we move at speed.” another hiv prevention shot, apretude, which is given every two months, is approved in some countries, including in africa. it sells for about $180 per patient per year, which is still too pricey for most developing countries. byanyima said the people who need long lasting protection the most include women and girls who are victims of domestic violence and gay men in countries where same sex relationships are criminalized. according to unaids, 46% of new hiv infections globally in 2022 were in women and girls, who were three times more likely to get hiv than males in africa. byanyima compared the news about sunlenca to the discovery decades ago of aids drugs that could turn hiv infection from a death sentence into a chronic illness. back then, south african president nelson mandela suspended patents to allow wider access to the drugs; the price later dropped from about $10,000 per patient per year to about $50. olwethu kemele, a health worker at the desmond tutu health foundation, predicted the shots could boost the number of people coming in for hiv prevention and slow the virus’ spread. she said young women often hide the pills to avoid questions from boyfriends and family members. “it makes it hard for the girls to continue,” she said. in a report on the state of the global epidemic released this week, unaids said that fewer people were infected with hiv in 2023 than at any point since the late 1980s. globally, hiv infects about 1.3 million people every year and kills more than 600,000, mainly in africa. while significant progress has been made in africa, hiv infections are rising in eastern europe, latin america and the middle east. in other research presented at the aids conference, andrew hill of the university of liverpool and colleagues estimated that once production of sunlenca is expanded to treat 10 million people, the price should fall to about $40 per treatment. he said it was critical that health authorities get access to sunlenca as soon as possible. “this is about as close as you can get to an hiv vaccine,” he said. the associated press © 2025 nbcuniversal media, llc

july 24, 2024   a twice yearly injection to prevent hiv could dramatically alter the course of an epidemic that has lead to the deaths of more than 40 million people since the 1980s. twice yearly shots were 100% effective at preventing new transmissions of hiv, a new landmark study shows. separately, just 2% of a group who took daily pills to prevent hiv were infected. the study included more than 5,000 women and girls ages 16 to 25 living in south africa and uganda. the results were published wednesday in the new england journal of medicine and also presented at an international aids conference in germany. the trial was halted early because the twice yearly injections were so successful. an estimated 1.3 million people worldwide are newly infected with hiv annually. more than 600,000 people die from aids related illnesses each year. one of the main challenges of implementing campaigns for effective preventive medicine (known as preexposure prophylaxis, or prep) is that many people at high risk of hiv do not take them daily because of a variety of factors, including access. the shots, marketed under the name sunlenca, are made by the u.s. pharmaceutical company gilead. also known by its generic name of lenacapavir, sunlenca is currently approved in the u.s. as a treatment for hiv, and gilead said it may seek approval for the medicine as a preventive measure, pending results of an ongoing study among men. “these data confirm that twice yearly lenacapavir for hiv prevention is a breakthrough advance with huge public health potential,” said sharon lewin, phd, a physician researcher and president of the international aids society, in a statement. “if approved and delivered   rapidly, affordably, and equitably   to those who need or want it, this long acting tool could help accelerate global progress in hiv prevention. we all owe a debt of gratitude to the thousands of young women in south africa and uganda who volunteered to be part of this study.” the current price for lenacapavir is more than $40,000 for the first year, but a separate study also presented at the conference estimated that producing the medicine at a larger scale could pave the way for a cost of $40 per treatment. the group doctors without borders called for global action to make the medicine affordable and accessible as soon as possible, adding that the organization is eager to start offering the medicine through its medical programs. “100 percent effectiveness demands 100 percent access,” said asia russell, executive director of health gap, a global hiv advocacy organization, in a statement issued by doctors without borders. “lenacapavir for hiv prevention is a potentially pandemic defeating intervention.” sources: gilead: “sunlenca® (lenacapavir) receives fda approval as a first in class, twice yearly treatment option for people living with multi drug resistant hiv.” gilead: “gilead’s twice yearly lenacapavir demonstrated 100% efficacy and superiority to daily truvada® for hiv prevention.” international aids society: “statement from ias president sharon lewin on full results from purpose 1 trial of twice yearly injectable lenacapavir for hiv prevention.” unaids: “new hiv drug can only offer hope of ending aids if all have access, unaids says,” “global hiv & aids statistics   fact sheet.” aids2024: “generic production of lenacapavir targeting under $100 pppy[1]: analysis of the active pharmaceutical ingredient.” doctors without borders: “doctors without borders/médecins sans frontières (msf) and other activists called today at the international aids conference for immediate global action to break us based gilead’s monopoly on lenacapavir. increasing access to this medicine a twice yearly injectable for hiv pre exposure prophylaxis (prep) would not only help prevent individuals from getting hiv, it could also have a significant global health impact.” © 2005   2025 webmd llc, an internet brands company. all rights reserved. webmd does not provide medical advice, diagnosis or treatment. see additional information.

a drug currently used to treat hiv has also been found to dramatically reduce the risk of infection, significantly more than the primary option available for pre exposure prophylaxis or prep. in a phase 3 clinical trial, 99.9% of participants who took a twice a year injection of lenacapavir for hiv prevention did not acquire an infection, according to data from drugmaker gilead sciences. related article twice yearly shot proves successful at preventing hiv infection among women, trial data shows there were only two cases among 2,180 patients   effectively reducing the risk of hiv infection by 96% and proving 89% more effective than truvada, a pill taken once a day. the trial was unblinded early because it met its key endpoints, allowing lenacapavir to be offered to all participants. “the difficulty some people can experience with taking an oral pill every day, including challenges with adherence and stigma, have hindered uptake and persistence of the standard of care for too long, thus blunting prep’s impact on hiv prevention,” said onyema ogbuagu, principal investigator for the trial and director of the yale antivirals and vaccines research program. “the incredible efficacy demonstrated in the purpose 2 trial, the potential benefits of a twice yearly injection, and the diversity of trial sites and participants show the impact that lenacapavir for prep could have for people around the world who need new choices to reduce their chances of acquiring hiv. this breakthrough adds significantly to our arsenal of tools to move us closer to achieving an aids free generation.” sign up here to get the results are in with dr. sanjay gupta every tuesday from the cnn health team. the purpose 2 trial included cisgender men, transgender men, transgender women and gender nonbinary individuals aged 16 years or older who have sex with partners assigned male at birth. there were 88 trial sites in argentina, brazil, mexico, peru, south africa, thailand and the united states. another trial found that taking the long acting injectable lenacapavir as pre exposure prophylaxis can provide total protection against hiv acquisition in women, demonstrating 100% efficacy among young women and adolescent girls africa in trial data published in july. it’s a “significant breakthrough in hiv prevention,” according to a news release from the world health organization in july. gilead said it will use these trial data to start the drug approval process in multiple countries by the end of the year. it plans to prioritize authorization in high incidence, low resource countries, according to the company. © 2025 cable news network. a warner bros. discovery company. all rights reserved. cnn sans ™ & © 2016 cable news network.

maria cheng, associated press maria cheng, associated press maría verza, associated press maría verza, associated press leave your feedback mexico city (ap)   it’s been called the closest the world has ever come to a vaccine against the aids virus. the twice yearly shot was 100 percent effective in preventing hiv infections in a study of women, and results published wednesday show it worked nearly as well in men. drugmaker gilead said it will allow cheap, generic versions to be sold in 120 poor countries with high hiv rates   mostly in africa, southeast asia and the caribbean. but it has excluded nearly all of latin america, where rates are far lower but increasing, sparking concern the world is missing a critical opportunity to stop the disease. read more: long term survivors of hiv/aids reflect on what they’ve witnessed and endured “this is so far superior to any other prevention method we have, that it’s unprecedented,” said winnie byanyima, executive director of unaids. she credited gilead for developing the drug, but said the world’s ability to stop aids hinges on its use in at risk countries. in a report issued to mark world aids day on sunday, unaids said that the number of aids death last year   an estimated 630,000   was at its lowest since peaking in 2004, suggesting the world is now at “a historic crossroads” and has a chance to end the epidemic. the drug called lenacapavir is already sold under the brand name sunlenca to treat hiv infections in the u.s., canada, europe and elsewhere. the company plans to seek authorization soon for sunlenca to be used for hiv prevention. while there are other ways to guard against infection, like condoms, daily pills, vaginal rings and bi monthly shots, experts say the gilead twice yearly shots would be particularly useful for marginalized people often fearful of seeking care, including gay men, sex workers and young women. “it would be a miracle for these groups because it means they just have to show up twice a year at a clinic and then they’re protected,” said unaids’ byanyima. such was the case for luis ruvalcaba, a 32 year old man in guadalajara, mexico, who participated in the latest published study. he said he was afraid to ask for the daily prevention pills provided by the government, fearing he would be discriminated against as a gay man. because he took part in the study, he’ll continue to receive the shots for at least another year. “in latin american countries, there is still a lot of stigma, patients are ashamed to ask for the pills,” said dr. alma minerva pérez, who recruited and enrolled a dozen study volunteers at a private research center in guadalajara. read more: why the anti hiv pill is a hard sell to the latino community how widely available the shots will be in mexico through the country’s health care system isn’t yet known. health officials declined to comment on any plans to buy sunlenca for its citizens; daily pills to prevent hiv were made freely available via the country’s public health system in 2021. “if the possibility of using generics has opened, i have faith that mexico can join,” said pérez. byanyima said other countries besides mexico that took part in the research were also excluded from the generics deal, including brazil, peru and argentina. “to now deny them that drug is unconscionable.” she said. in a statement, gilead said it has “an ongoing commitment to helping enable access to hiv prevention and treatment options where the need is the greatest.” among the 120 countries eligible for generic version are 18 mostly african countries that comprise 70 percent of the world’s hiv burden. the drugmaker said it is also working on establishing “fast, efficient pathways to reach all people who need or want lenacapavir for hiv prevention.” read more: why black women face barriers to accessing prep, an hiv preventing drug on thursday, 15 advocacy groups in peru, argentina, ecuador, chile, guatemala and colombia wrote to gilead, asking for generic sunlenca to be made available in latin america, citing the “alarming” inequity in access to new hiv prevention tools while infection rates were rising. while countries including norway, france, spain and the u.s. have paid more than $40,000 per year for sunlenca, experts have calculated it could be produced for as little as $40 per treatment once generic production expands to cover 10 million people. dr. chris beyrer, director of the global health institute at duke university, said it will be enormously useful to have sunlenca available in the hardest hit countries in africa and asia. but he said the rising hiv rates among groups including gay men and transgender populations constituted “a public health emergency” in latin america. hannya danielle torres, a 30 year old trans woman and artist who was in the sunlenca study in mexico, said she hoped the government would find a way to provide the shots. “mexico may have some of the richest people in the world but it also has some of the most vulnerable people living in extreme poverty and violence,” torres said. read more: 6 facts you should know about hiv another drugmaker, viiv healthcare, also left out most of latin america when it allowed generics of its hiv prevention shot in about 90 countries. sold as apretude, the bi monthly shots are about 80 percent to 90 percent effective in preventing hiv. they cost about $1,500 a year in middle income countries, beyond what most can afford to pay. asia russell, executive director of the advocacy group health gap, said that with more than 1 million new hiv infections globally every year, established prevention methods are not enough. she urged countries like brazil and mexico to issue “compulsory licenses,” a mechanism where countries suspend patents in a health crisis. it’s a strategy some countries embraced for previous hiv treatments, including in the late 1990s and 2000s when aids drugs were first discovered. more recently, colombia issued its first ever compulsory license for the key hiv treatment tivicay in april, without permission from its drugmaker, viiv. dr. salim abdool karim, an aids expert at south africa’s university of kwazulu natal, said he had never seen a drug that appeared to be as effective as sunlenca in preventing hiv. “the missing piece in the puzzle now is how we get it to everyone who needs it,” he said. cheng reported from london. left: while there are other ways to guard against infection, like condoms, daily pills, vaginal rings and bi monthly shots, experts say the gilead twice yearly shots would be particularly useful for marginalized people often fearful of seeking care. file photo by afolabi sotunde/reuters by maria cheng, gerald imray, associated press by sam whitehead, kaiser health news by dr. howard markel by grace birnstengel, next avenue by heather boerner by associated press by anna gorman, kaiser health news by daniel costa roberts maria cheng, associated press maria cheng, associated press maría verza, associated press maría verza, associated press support provided by: learn more thank you. please check your inbox to confirm. © 1996   2025 newshour productions llc. all rights reserved. pbs is a 501(c)(3) not for profit organization. sections about stay connected thank you. please check your inbox to confirm. learn more about friends of the news hour. support for news hour provided by

generic version of a drug already on the market, which can suppress and prevent hiv, would still yield 30% profit if the current price was slashed, researchers say a new drug described as “the closest we have ever been to an hiv vaccine” could cost $40 (£31) a year for every patient, a thousand times less than its current price, new research suggests. lenacapavir , sold as sunlenca by us pharmaceutical giant gilead, currently costs $42,250 for the first year. the company is being urged to make it available at a thousand times less than that price worldwide. unaids said it could “herald a breakthrough for hiv prevention” if the drug was available “rapidly and affordably”. given by injection every six months, lenacapavir can prevent infection and suppress hiv in people who are already infected. in a trial, the drug offered 100% protection to more than 5,000 women in south africa and uganda, according to results announced by gilead last month. lenacapavir is currently licensed for treatment, not prevention. in a study presented at the 25th international aids conference in munich on tuesday, experts calculated that the minimum price for mass production of a generic version, based on the costs of lenacapavir’s ingredients and manufacturing, and allowing for 30% profit, was $40 a year , assuming 10 million people used it annually. in the long term, 60 million people would probably need to take the drug preventatively to lower hiv levels significantly, they said. dr andrew hill, of liverpool university, who led the research, said: “you’ve got an injection somebody could have every six months and not get hiv. that’s as close as we’ve ever been to an hiv vaccine.” most hiv prevention presently relies on daily pills and barrier measures, such as condoms. campaigners want gilead to allow generic licensing through the un backed medicines patent pool in all low  and middle income countries (lmics), which account for 95% of hiv infections. similar mechanisms have been in place in the hiv treatment market for decades, where wealthy countries pay higher prices than poorer ones. if that did not happen, hill said, countries should consider issuing compulsory licences allowing generic manufacture in the face of a public health emergency. gilead said it was “too early” to price lenacapavir for prevention, as it was awaiting clinical trial data and potential regulatory filings, but promised “a strategy to enable broad, sustainable access globally”. this would include both “gilead supply in the countries where the need is greatest until voluntary licensing partners are able to supply high quality, low cost versions of lenacapavir” and a voluntary licensing programme for “high incidence, resource limited countries”. gilead said choosing those countries was ongoing. but campaigners said it was vital that all lmics, including “upper middle income” nations such as brazil, had access to low cost generic forms of the drug. similar selections in the past had excluded countries where the hiv epidemic was growing fastest, they said. trials in lmics made the case for universal access even stronger, hill said, pointing to the helsinki declaration on medical ethics, which said that trials should only be performed in populations who stood to benefit from the results. joyce ouma, senior programmes officer at y+ global, a network of young people living with hiv, said a twice yearly injectable would be “transformative for young people like me living with or at risk of hiv”. ouma said: “it’s not an exaggeration to say that meeting the 2030 goal of ending new hiv transmissions hinges on gilead ensuring people in the global south have fair access to lenacapavir.” winnie byanyima, executive director of unaids, said treatment could be “life saving” by providing a more discreet option than daily tablets for people who faced stigma because of their hiv status or sexuality. the headline of this article was amended on 23 july 2024 to reflect that, although the lead researcher said it was “as close as we’ve ever been to an hiv vaccine”, lenacapavir is a drug rather than a vaccine.

nov. 27, 2024 results from a gilead funded trial at multiple sites including emory and grady, indicated that the twice yearly lenacapavir offers a 96% reduced risk of new hiv infection. for oral medications that prevent new hiv infection to be effective, the patient must take certain actions, including attending doctor’s visits every three months and   most importantly   consistency. these daily oral antiretrovirals, more commonly referred to as prep (pre exposure prophylaxis), such as truvada®, are extremely effective at hiv prevention, but only if they are taken daily as directed. truvada’s efficacy is greatly compromised when taken inconsistently. however, results from a recent gilead funded clinical trial (purpose 2) led by physicians at emory university and grady health system indicate that a twice yearly injection of lenacapavir offers a 96% reduced risk of infection overall, making the injection significantly more effective than the daily oral prep. the findings were recently published in the new england journal of medicine. colleen kelley, md, lead author, professor at emory’s school of medicine and co director of the emory center for aids research in the randomized, double blind, phase iii clinical trial comparing the efficacy of the two medications, 99% of the participants in the lenacapavir group did not acquire an hiv infection. during the trial, only two participants in the lenacapavir group, comprised of 2,179 people, acquired hiv. this compares to nine new hiv infections in the truvada® group, which had 1,086 people. the trial showed that adherence to the injectable was higher than of the daily oral pill. kelley, also the co director of the emory center for aids research, and associate dean for research for emory at grady adds that while prep is incredibly effective at preventing infection, part of what made the injection more effective in the clinical trial was the challenges associated with adherence to a daily oral pill. “what we see over time is that about half of people who start taking daily oral prep stop within a year due to various factors,” says kelley, referencing healthcare disparities in general. “having an effective injectable that is only needed twice annually is very significant for people who have trouble accessing healthcare or staying adherent to daily, oral pills.” the inclusion of racially, ethnically and gender diverse participants in the clinical trial was notable because it was representative of populations disproportionately impacted by hiv in real time. for example, the trial groups were comprised of cisgender men and gender diverse people at 88 sites in peru, brazil, argentina, mexico, south africa, thailand and the u.s. according to the study, the same populations that are disproportionately impacted by hiv are the same populations that have limited access to prep   or may have difficulty consistently taking the oral antiretroviral medication   ultimately highlighting the need for more options. the study also indicates that more than half of the new hiv infections nationwide in 2022 were among cisgender gay men, and 70% of those were among black or hispanic individuals. valeria cantos, md, associate professor at emory’s school of medicine, physician at grady memorial hospital and principal investigator for the grady clinical trial site “at grady, our focus is on increased representation of underserved and vulnerable populations, acknowledging and addressing the distrust towards research held by some community members due to prior abuses or neglect of these populations by research institutions in the past,” cantos says. “grady is an established, trusted research site because of its commitment to equity.” at the grady clinical trial site, medical materials were available in spanish, and bilingual staff members recruited and enrolled trial participants who only spoke spanish. cantos also indicated that the site enrolled participants who are representative of the populations that would benefit the most from lenacapavir. in addition to grady, the hope clinic and emory midtown hospital were among the 88 sites supporting the clinical trial. “we are not reaching everyone we need to reach with our current hiv prevention interventions, such as those who are disproportionately impacted by hiv and health care disparities,” says kelley. “for people that are unable to take the daily oral pills, the injectable agents can really give incredible efficacy and be a game changer in helping them stay hiv negative.” since the phase iii clinical trial has been completed and submitted by the fda for consideration, kelley is hopeful that lenacapavir may be approved by 2025 for commercial use. carlos del rio, md, chair of the department of medicine at emory’s school of medicine and co director of the emory center for aids research by downloading emory news media, you agree to the following terms of use: by exercising the licensed rights (defined below), you accept and agree to be 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william brangham william brangham azhar merchant azhar merchant leave your feedback the long fight against hiv/aids may get a potent new weapon. a new drug, taken by injection twice a year, shows great promise in preventing new hiv infections and would ease the treatment process since patients currently have to take daily medication. it could have far reaching impacts, especially in lower income countries that are facing rising new infection rates. william brangham reports. notice: transcripts are machine and human generated and lightly edited for accuracy. they may contain errors. geoff bennett: the long fight against hiv/aids may get a powerful new weapon. a new drug taken by injection only twice a year shows great promise in preventing new hiv infections. that could have far reaching impacts, especially in lower income countries that are facing rising infection rates. william brangham has the details. william brangham: that's right. this drug is called lenacapavir. and it is made by the drugmaker gilead, which recently said that in a clinical trial of 2,000 patients in south africa and uganda, not one person taking the drug was infected with hiv. so if this drug pans out as hoped, what would that mean for global hiv care? to understand that, we turn to one of the world's leading experts in hiv treatment and prevention. salim abdool karim the head of caprisa, one of south africa's top hiv/aids research centers and which helped run this study. salim abdool karim, so nice to have you back on the program. as i mentioned, this drug is not yet approved for use in the marketplace, but let's say these results hold up. what would this mean? how potent a tool would this be in the fight against hiv? salim abdool karim, director, caprisa: great to be here with you, william. well, in my 40 years of doing aids research, i have never seen a result like this. absolutely amazing to see a drug like this that provides 100 percent protection. so when you look at a drug like this, and given that it's in a completely new class of antiretrovirals, we do not have circulating resistance to this drug. and so we are seeing high levels of protection because it's not a drug that the virus has already been exposed to. but its potential as a highly efficacious prevention mechanism is enormous. given that our goal is to try and end the aids pandemic by 2030, and this is ending it as a public health threat, we need to focus on the three key groups where hiv continues to be a major challenge. and those three groups are men who have sex with men, in particular, younger men who have sex with men, injecting drug users, and, in africa, young women. indeed, young women bear the brunt of the hiv pandemic in africa. and the study was undertaken in exactly that group. and if we can get this drug rolled out to large numbers of high risk women, we could make a huge dent on the pandemic. william brangham: but given that there is already a prevention pill, truvada, or prep, as it is known, that people take every single day, why does this twice a year shot make such a difference? salim abdool karim: so, studies done with antiretrovirals taken as a daily tablet or daily pill have shown that we have a challenge in individuals maintaining the ongoing use of these drugs, what we refer to as adherence or compliance. the big challenge you have is that the individuals taking the drug are well and healthy people. they don't have hiv. so, it requires an extra moral effort for them to be able to remember that every day that they are at risk of hiv and they need to remember to take their tablets. it also places an onus of the individuals to go to the hospital to collect the medications at a regular interval. and that becomes a high bar when we are dealing with people who are essentially well. the difference now is that, basically, individuals who are at risk need to think about their risk of hiv twice a year, and they need to make the effort to go to a clinic or a hospital to get this injection just once every six months. that sits a much lower bar. and, therefore, we think we will have better adherence and will lead to a larger number of patients taking it up and maintaining their long term use of this injectable. william brangham: in the u.s. and certain parts of the west, new hiv infections, certainly deaths from aids, have really dropped off people's radar. i know that's not the case elsewhere in the country, certainly not where you are in south africa. can you remind us the challenges you still face fighting this pandemic? salim abdool karim: well, the problem was that covid 19 literally came in with such gusto that it consumed all of the world's attention. i think we're seeing that there's a lot of what i call fatigue, aids fatigue, people just tired of this problem. they moved on mentally, physically. and so the other pandemics that were occurring, they haven't gone away. they remain with us. and the three big pandemics are malaria, tuberculosis and hiv. and of those, in terms of hiv, in places, in many countries in africa, aids remains one of the biggest challenges. in south africa, it remains one of the top 10 causes of death. if you take at a global level, just last year, there were in the region of around one and a half million new infections. that's a lot of new infections still continuing at the global level. but it's not just that we're seeing new infections occurring. we continue to have a high number of deaths. around 700,000 deaths occurred last year. so we have got to change that narrative. we have got to slow down the spread of this virus. and we have got to protect people from dying. william brangham: all right, salim abdool karim, the head of caprisa in south africa, it is always good to see you. thank you so much for being here. salim abdool karim: it's a pleasure. watch the full episode may 20 by jonel aleccia, associated press oct 15 by sam whitehead, kaiser health news aug 22 by laura santhanam jun 13 by kevin mcgill, associated press william brangham william brangham william brangham is an award winning correspondent, producer, and substitute anchor for the pbs news hour. azhar merchant azhar merchant azhar merchant is associate producer for national affairs. support provided by: learn more thank you. please check your inbox to confirm. © 1996   2025 newshour productions llc. all rights reserved. pbs is a 501(c)(3) not for profit organization. sections about stay connected thank you. please check your inbox to confirm. learn more about friends of the news hour. support for news hour provided by

information for a “significant breakthrough” in hiv prevention could be on the horizon, according to the world health organization. results of an interim analysis from a phase 3 clinical trial sponsored by gilead sciences, inc., showed that lenacapavir, a twice yearly injectable drug, is a highly promising tool for thwarting new hiv infections. we spoke to onyema ogbuagu, mbbch, associate professor of medicine (aids) and of pharmacology at yale school of medicine, and the study’s principal investigator, about the trial, named purpose 2, and the future of lenacapavir. lenacapavir is a first in class hiv drug, which means that it has a mechanism of action that has not previously been utilized for hiv treatments. it inhibits what we call the hiv capsid, a conical structure that houses both the genetic material of hiv and the proteins that [the virus] uses to make copies of itself. by interfering with the capsid, the drug prevents hiv from replicating itself into host cells. these are the best numbers ever reported from an hiv prevention study. even if the virus evades this process, lenacapavir also prevents hiv from forming mature virions [virus particles] that propagate the infection. so, it actually has multiple mechanisms of action, and that’s why we investigated it not just for hiv prevention, but also for hiv treatment. it is currently approved for hiv treatment for people who have limited treatment options and multi drug resistant infections. there are many ways to prevent hiv. some of them are behavioral these include reducing one’s number of sexual partners and using condoms during intercourse. we also have surgical interventions. male circumcision, for example, can reduce hiv uptake. we know that treating sexually transmitted infections can also prevent hiv. that said, people don’t always follow or accept these interventions. so, for little over a decade, we’ve leaned more into biomedical hiv prevention this means using therapeutics to prevent infection. some oral antiretroviral therapies for hiv are taken once a day and show good efficacy for preventing hiv infection as long as there’s correct adherence. however, people tend to struggle with having to take pills every day. they often start with good intent, and then adherence drops off over time. so, while the pills are a great tool for biomedical hiv prevention, they have significant limitations in regard to adherence. there are also disparities in these pills’ availability driven by insurance status that hinders access for some of the most affected groups. then, in the past two or three years, a new injectable was approved. this intramuscular drug, given every two months, is called cabotegravir. researchers had become interested in long acting injectables as a way to address the issues with poor adherence associated with oral therapies. the efficacy of injectables is much less dependent on people having to remember to take a pill every day. clinics can support people with adherence they can remind people when they have their next appointment and call them if they miss an appointment to make sure they stay on track. so, it wasn’t surprising when cabotegravir did better than the oral therapies. lenacapavir is a new drug that’s given subcutaneously [under the skin] every six months. subcutaneous injections tend to be much easier to administer than intramuscular injections. this is also the longest acting prep [pre exposure prophylaxis] medication we have. because it’s a first in class, we do not expect that anyone exposed to hiv will be resistant to lenacapavir since it hasn’t been widely used. purpose 2 is the sister study to purpose 1, which looked at adult women and girls in sub saharan africa, and found that lenacapavir was superior to both oral prep pills. it had a unique study design where we measured the background rate [rate of new cases in a given population] of hiv. so, we looked at the incident cases in a population, then we put participants on prep, and then we compared the number of new cases to what it would have been based on the background hiv assessments. that was the primary endpoint. in fact, nobody in the lenacapavir arm of the study contracted hiv. it provided 100% protection. in purpose 2, we used lenacapavir for four other groups around the world who have sex with men: men, trans women, trans men, and gender non binary people. there were about 3,200 people in this study. it was a 2:1 randomization, so roughly 2,200 people received lenacapavir, and the rest received oral emtricitabine and tenofovir disopoxil fumarate, which was the first oral prep option that was available. and then again, we compared the incidence between both groups, as well as to the background rate of hiv infections. we took great efforts to ensure that purpose 2, for which i was a lead pi [principal investigator], had lots of diversity. we included trans and gender diverse individuals, who are typically underrepresented groups in hiv prevention trials. the study also had geographic diversity including low resource countries: we included countries from southeast asia, africa, south america, and north america. we included age diversity as well. adolescents tend to be left out, and we made sure that the study included individuals 16 years and above. and we even had diversity with the study teams. we intentionally included [diverse] principal investigators and other study personnel and engaged a community advisory board to inform the study. we made sure as we were designing the study that we had input from people who have lived with hiv, or are from a racial, ethnic, or gender minority population. this set us up to make sure that the clinical trial reflected geographic, racial, and gender diversity, and we’re very proud of that. our recently reported findings were based on an interim analysis. it wasn’t the planned end of the study. an interim analysis is where the data and safety monitoring board reviews the data, and usually if they see overwhelming benefits in a study arm, they discontinue it (the study) because it is unethical to continue [not providing the more effective medication to some participants] if there are already clear benefits. in this interim analysis, they found that there were only two infections in the lenacapavir arm and nine infections in the emtricitabine and tenofovir disopoxil fumarate arm. lenacapavir showed 96% prevention efficacy compared to background incidence rates and was 89% more effective than the oral drugs. 99.9% of participants taking the drug in the study did not acquire hiv infection. these are the best numbers ever reported from an hiv prevention study. it supplements the results from the purpose 1 study for women. we now have robust data from women, men, and gender diverse individuals. 100%. this would be the longest acting hiv prevention modality out there. it’s user friendly, it’s very well tolerated, it’s safe, and the efficacy is amazing. one of the goals of the ending the hiv epidemic initiative is to increase prep coverage by 50%. white people have achieved that so far. but other racial groups have not about 10% or less of black people eligible for prep are on it. i think lenacapavir will be a tool to help us reach this goal. another reason it is a game changer is that injectables, especially if they’re long acting, allow us to deploy hiv prevention outside of the clinic. a long acting injectable can allow us to deliver these products in a variety of community settings, reaching groups who are typically left out. lenacapavir has huge potential, and we all look forward to how far we can take this exciting tool, put it to work in the real world, and help those who need it the most. our data now will allow gilead to do regulatory filing for approval of the drug for the indication of hiv prevention. obviously, we’re not in control of what the fda does. but projections are that the drug should be deployed by the end of 2025. there are many ways, but i know that there will be a contractual agreement with generic manufacturers. that is typically a mechanism to have affordable pricing for places particularly outside the u.s. those plans are ongoing. i care for patients and do global health in rwanda and liberia parts of the world that are disproportionately affected by hiv so i care deeply about making sure that the benefits permeate to these places. that being said, for those who participated in the study, there’s going to be an open label extension. we will unblind people so that they know what their treatment assignments were, and we’ll give them the option to go on lenacapavir until it’s available in their home countries.
supported by an injection given just twice a year could herald a breakthrough in protecting the population that has the highest infection rates. by stephanie nolen stephanie nolen has covered the global h.i.v. pandemic for more than 25 years. researchers and activists in the trenches of the long fight against h.i.v. got a rare piece of exciting news this week: results from a large clinical trial in africa showed that a twice yearly injection of a new antiviral drug gave young women total protection from the virus. “i got cold shivers,” said dr. linda gail bekker, an investigator in the trial of the drug, lenacapavir, describing the startling sight of a line of zeros in the data column for new infections. “after all our years of sadness, particularly over vaccines, this truly is surreal.” yvette raphael, the leader of a group called advocacy for prevention of h.i.v. and aids in south africa, said it was “the best news ever.” the randomized controlled trial, called purpose 1, was conducted in uganda and south africa. it tested whether the every six months injection of lenacapavir, made by gilead sciences, would provide better protection against h.i.v. infection than two other drugs in wide use in high income countries, both daily pills. the results were so convincing that the trial was halted early at the recommendation of the independent data review committee, which said all participants should be offered the injection because it clearly provided superior protection against the virus. none of the 2,134 women in the arm of the trial who received lenacapavir contracted h.i.v. by comparison, 16 of the 1,068 women (or 1.5 percent) who took truvada, a daily pill that has been available for more than a decade, and 39 of 2,136 women (1.8 percent) who received a newer daily pill called descovy were infected.

 profile sections local tv featured more from nbc follow nbc news news alerts there are no new alerts at this time twice yearly shots used to treat aids were 100% effective in preventing new infections in women, according to study results published wednesday. there were no infections in the young women and girls that got the shots in a study of about 5,000 in south africa and uganda, researchers reported. in a group given daily prevention pills, roughly 2% ended up catching hiv from infected sex partners. “to see this level of protection is stunning,” said salim abdool karim of the injections. he is director of an aids research center in durban, south africa, who was not part of the research. the shots made by u.s. drugmaker gilead and sold as sunlenca are approved in the u.s., canada, europe and elsewhere, but only as a treatment for hiv. the company said it is waiting for results of testing in men before seeking permission to use it to protect against infection. the results in women were published wednesday in the new england journal of medicine and discussed at an aids conference in munich.