{"id":2237,"date":"2024-07-26T15:10:33","date_gmt":"2024-07-26T15:10:33","guid":{"rendered":"https:\/\/healthyretirementnews.com\/index.php\/2024\/07\/26\/twice-yearly-shot-proves-successful-at-preventing-hiv-infection-among-women-trial-data-shows\/"},"modified":"2024-07-26T15:10:33","modified_gmt":"2024-07-26T15:10:33","slug":"twice-yearly-shot-proves-successful-at-preventing-hiv-infection-among-women-trial-data-shows","status":"publish","type":"post","link":"https:\/\/healthyretirementnews.com\/index.php\/2024\/07\/26\/twice-yearly-shot-proves-successful-at-preventing-hiv-infection-among-women-trial-data-shows\/","title":{"rendered":"Twice-yearly shot proves successful at preventing HIV infection among women, trial data shows"},"content":{"rendered":"

Two shots a year of a drug currently used to treat HIV infections were dramatically effective at preventing infections <\/strong>in a study among young women and adolescent girls in Africa. <\/p>\n

The twice-yearly injection of the drug lenacapavir can provide total protection against HIV infections, demonstrating 100% efficacy in Phase 3 trial data released by drugmaker Gilead and published Wednesday in the New England Journal of Medicine. <\/p>\n

For years, most people have taken prevention tools known as PrEP, such as a daily pill called Truvada to prevent infections of the human immunodeficiency virus or HIV. <\/p>\n

More recently, some people have received regular injections of the drug Apretude \u2013 two shots administered one month apart then every two months thereafter \u2013 to reduce their risk of HIV. <\/p>\n

The twice-a-year injections of lenacapavir could add another option at preventing HIV infections to the toolbox. <\/p>\n

Among more than 5,000 women and adolescent girls participating in the trial in Africa who were HIV negative, none of the participants who received twice-yearly lenacapavir acquired HIV infection during the course of the study, according to the results which were also presented at the International AIDS Conference in Munich. <\/p>\n

\u201cThese stellar results show that twice-yearly lenacapavir for PrEP, if approved, could offer a highly effective, tolerable and discreet choice that could potentially improve PrEP uptake and persistence, helping us to reduce HIV in cisgender women globally,\u201d Linda-Gail Bekker, director of the Desmond Tutu HIV Center at the University of Cape Town in South Africa, and former President of the International AIDS Society, said in a news release. <\/p>\n

The study, called the PURPOSE 1 trial, involved adolescent girls and young women in South Africa and Uganda who were randomly assigned to either receive lenacapavir injections every 26 weeks or daily HIV medications \u2013 either emtricitabine\u2013tenofovir alafenamide or emtricitabine\u2013tenofovir disoproxil fumarate \u2013 in pill form. It was a double-blind study, and the participants did not know which group they were in. <\/p>\n

Many of the women and girls who received lenacapavir, about 69%, experienced reactions at the injection site compared with 35% in the placebo injection group, but no safety concerns were found, according to the researchers. <\/p>\n

Among the women and girls, the researchers assessed how many HIV infections occurred over 26 weeks, and 55 infections total were observed: zero in the lenacapavir group, 39 in the daily emtricitabine\u2013tenofovir alafenamide group and 16 in the daily emtricitabine\u2013tenofovir disoproxil fumarate group. <\/p>\n

\u2018An important advance for the field\u2019<\/h2>\n

The finding of lenacapavir having 100% efficacy for HIV prevention in women \u201cis an important advance for the field, and I think that the field will welcome it as an additional prevention option,\u201d said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center. <\/p>\n

\u201cBut I do think it\u2019s important to realize that these data are only in prevention in young women. There is another study that\u2019s still ongoing, that hasn\u2019t been read out yet, in men,\u201d he said. \u201cSo, we await more data to learn about the prevention efficacy in men as well.\u201d <\/p>\n

Multiple clinical trials involving lenacapavir are ongoing. The latest Phase 3 findings are part of Gilead\u2019s PURPOSE program, which comprises five HIV prevention trials around the world. <\/p>\n

Gilead said in a news release Wednesday that it expects results later this year and <\/strong>in <\/strong>early 2025 from the program\u2019s other pivotal trial, PURPOSE 2, which is assessing twice-yearly lenacapavir for the prevention of HIV infections among men, transgender women and gender nonbinary people in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States who have sex with partners assigned male at birth. <\/p>\n

\u201cThe regulatory filing for lenacapavir for PrEP will include the results of both PURPOSE 1 and PURPOSE 2, if positive, to ensure lenacapavir for PrEP can be approved for multiple populations and communities most in need of additional HIV prevention options,\u201d according to the company, referring to potentially seeking approval of lenacapavir as an HIV prevention tool. <\/p>\n

\u201cWe are eagerly awaiting the results of the other studies, which enrolled other populations, including men who have sex with men and are disproportionately vulnerable to HIV,\u201d Dr. Jason Zucker, assistant professor of medicine at Columbia University Irving Medical Center, who was not involved in the trial, said in an email. <\/p>\n

Barouch also was not involved in the latest Phase 3 trial, nor the newly launched US trials, but he previously studied lenacapavir as a drug to prevent simian\u2013human immunodeficiency virus infections in preclinical animal studies, which he said ultimately predicted how the drug would later behave as an HIV-prevention tool in humans. <\/p>\n

People who already take either daily PrEP pills or regular PrEP injections to prevent HIV may benefit from having lenacapavir available to them as another option, Barouch said. <\/p>\n

\u201cThis is a very good option that is very convenient because it can be given only once every six months,\u201d he said. \u201cI think for people who are at high risk, who are not yet on PrEP, it\u2019s an option because it provides a more convenient option, if that was the reason why they were not interested in PrEP beforehand.\u201d <\/p>\n

In the Phase 3 trial, researchers noted that adherence to taking a daily PrEP pill was low, and some people reported taking it only twice a week when it should have been taken daily. <\/p>\n

Lenacapavir is not approved for HIV prevention anywhere in the world, but as it continues to be studied as a pre-exposure prophylaxis drug to prevent HIV infection, questions abound around cost. <\/p>\n

\u201cWe know that the drug is efficacious in cisgender women and appears safe with all the data we have,\u201d Zucker said in the email. \u201cMy primary worry is around implementation; these drugs are often expensive after approval and those costs can serve to limit access and exacerbate disparities instead of alleviate them.\u201d <\/p>\n

Lenacapavir is already approved by the US Food and Drug Administration for the treatment of HIV infection in adults, in combination with other HIV antiretroviral medicines, and it\u2019s estimated to cost more than $40,000 in a year as a manufacturer\u2019s list price, or around $39,000 annually, as an average wholesale price. <\/p>\n

Separate research presented Tuesday at the AIDS Conference in Munich suggests that the production of a generic version of lenacapavir could cost under $100 per person. <\/p>\n

The team of researchers \u2013 from the United Kingdom, Germany and the United States \u2013 projected what the minimum pricing of lenacapavir could be, based on the drug\u2019s current ingredients, production models and cost models. The researchers demonstrated that lenacapavir could be mass-produced for up to $93 per person per year, potentially falling to about $40 per person per year. <\/p>\n

\u201cWhile Gilead awaits additional phase 3 clinical trial data and the potential regulatory filings for HIV prevention\u202fadministered twice-yearly, it is too early to state the price of lenacapavir for PrEP\u202f(prevention). Our pledge is to price our medicines to reflect the value they deliver to people, patients, healthcare systems and society,\u201d a Gilead spokeperson said in an emailed statement Tuesday. <\/p>\n

\u201cIn view of the company\u2019s ongoing commitment to communities affected by HIV, we have been developing a strategy to enable broad, sustainable access globally,\u201d the statement said in part. \u201cA key component of this strategy is to deliver lenacapavir swiftly, sustainably and in sufficient volumes, if approved, to high-incidence, resource-limited countries, which are primarily low- and lower-middle-income countries.\u201d <\/p>\n

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    \n
      <\/ul>\n<\/ul>\n<\/div>\n

      In late May, hundreds of activists wrote a letter to Gilead CEO Daniel O\u2019Day urging the company to ensure that people in low- and middle-income countries have the same access to lenacapavir as an HIV medication as do people in high-income countries. <\/p>\n

      \u201cRequiring only two injections a year, it could be a real game-changer worldwide for the people most excluded from high quality healthcare. We urge Gilead to ensure that people in the Global South living with or at risk of HIV can access this groundbreaking medicine at the same time as people in the Global North can,\u201d said the letter, released by the People\u2019s Medicines Alliance, a global coalition focused on improving access to medicines. <\/p>\n

      \u201cWe request that you license Lenacapavir now, without delay, through the Medicines Patent Pool and make the license open to all low- and middle-income countries,\u201d the letter said in part. \u201cWith Lenacapavir approved in the US and Europe for treatment, and likely to soon be available for prevention, there is no reason to delay the sharing of this technology.\u201d <\/p>\n<\/p>\n

      This post appeared first on cnn.com<\/div>\n

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