Biannual injections with the drug Lenacapavir offer effective protection against HIV infection, according to a phase 3 clinical study whose results were published in the New England Journal of Medicine, informs DPA.
The injection, which requires a booster dose every six months, is a more convenient alternative to daily oral “pre-exposure prophylaxis” (PrEP) treatments like Truvada.
Astrid Berner-Rodoreda from Heidelberg University Hospital in Germany believes that Lenacapavir is an important advance, noting that vaccination twice a year is much more convenient than taking a daily pill.
She also says that the injections are less stigmatized and easier to hide, especially in countries heavily affected by HIV.
The study entitled “Reason 2”, as before “Reason 1”, was completed ahead of schedule due to its promising results, allowing this medicine to be all volunteers who participated.
Its manufacturer, Gilead, plans to apply for the approval of the drug Lenacapavir as a preventive treatment against HIV in many countries, with an emphasis on its availability in low-income regions.
The drug blocks HIV at several stages of its life cycle and is already authorized in the European Union to treat existing infections.
While Lenacapavir treatment costs about $42,000 a year in the United States, its cost in poor countries remains a challenge, said Astrid Berner-Rodoreda.
The German researcher emphasized the importance of ensuring access to this medicine in regions such as sub-Saharan Africa, where the most urgent treatment needs are.
However, concerns about resistance to this drug are growing, as the active substance can remain in the body for up to a year after the vaccine is stopped, potentially promoting resistance if not it will be used correctly, said Max von Kleist of the Free University of Berlin.
In the “Purpose 2” study, nearly 3,300 seronegative people who had frequent sex participated. According to the New England Journal of Medicine, two people in the group that received Lenacapavir (about 2,200 participants) and nine people in the group that received, for comparison, Truvada (about 1,100 participants) were infected with HIV.
Lenacapavir reduced the risk of infection by 96% compared to the background event, the study authors said. Both treatments were well tolerated by the participants.
Worldwide, HIV infections are on the rise, according to a UN report published on Tuesday, with nearly 40 million people living with the virus, most of them in sub-Saharan Africa. . AGERPRES
2024-11-28 14:07:00
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**Given the early termination of the ”Reason 2″ trial due to Lenacapavir’s high efficacy, what further research is needed to ensure its safe and equitable distribution to diverse populations?**
## Groundbreaking HIV Prevention: Lenacapavir Offers Long-Acting, Convenient Protection
**New study reveals biannual injections of Lenacapavir provide highly effective HIV prevention, potentially revolutionizing pre-exposure prophylaxis (PrEP).**
Exciting news for HIV prevention emerges from a groundbreaking phase 3 clinical trial published in the prestigious *New England Journal of Medicine*. The study demonstrates that Lenacapavir, administered as a biannual injection, offers substantial protection against HIV infection,
presenting a potentially life-changing alternative to daily oral PREP treatments.
Currently, medications like Truvada are the standard for PrEP, requiring daily adherence for efficacy. However, this can be a burden for many individuals due to various factors such as remembering to take medication daily, potential side effects, and social stigma.
Lenacapavir tackles these challenges by offering a long-acting injection requiring only booster doses every six months. This simplified regimen not only enhances convenience but also significantly reduces the risk of missing doses, ultimately improving adherence and protection.
“This is a major advancement in HIV prevention,” states Astrid Berner-Rodoreda, a researcher from Heidelberg University Hospital in Germany. “Twice-yearly injections are undoubtedly more convenient than daily pill-taking, especially for those who struggle with daily medication adherence or face social stigma surrounding HIV prevention.”
She further highlights the potential benefits in regions heavily affected by HIV, where access to healthcare and medication adherence can be particularly challenging. The discreet nature of injectable PrEP could empower individuals to take control of their sexual health with less fear of judgment or discrimination.
The remarkable success of the Lenacapavir trial, aptly named “Reason 2” following a successful “Reason 1” phase, led to its early termination due to overwhelmingly positive results. This allowed all participating volunteers to receive the potentially life-saving protection of Lenacapavir.
Manufacturer Gilead enthusiastically plans to expand access to this innovative medication, paving the way for a new era of HIV prevention. As Lenacapavir moves closer to wider availability, it holds the promise of significantly reducing new HIV infections and empowering individuals towards a healthier, more secure future.
