Health
Gilead to test annual HIV shot
Gilead announced Tuesday that it will soon begin a Phase 3 trial of a drug that could prevent HIV infection with a single annual shot.
If such a drug proves effective, it would be the closest thing to a vaccine that the HIV field has produced in 40 years of research. The company plans to begin testing next year, with a view to regulatory filing in late 2027.
This once-a-year drug is another formulation of lenacapavir that is already in use. made heading Earlier this year, Gilead released data showing that vaccination once every six months can prevent HIV infection.
Gilead executives revealed the 12-month formula at an analyst day dedicated to the company's HIV portfolio. They said they recently completed pharmacokinetic studies, which track how drugs behave in the body, and are now confident in their progress with the molecule. They plan to release that data next year.
The trial comes amid a series of rapid advances in the field of PrEP, as drugs to prevent HIV become known. PrEP has been available in daily pill form for 10 years. However, for a variety of reasons, this can be difficult for many people to continue to accept, and the number of HIV infections continues to skyrocket or remain largely unchanged in many regions.
In 2021, the Food and Drug Administration approved the first injectable PrEP called Apretune. It is given every two months. Gilead plans to apply for approval for the semiannual dosing regimen next year. The drug is very easy to take, requiring only two clinic visits a year, and has proven to be significantly more effective than traditional oral formulations.
However, global access to these new forms of PrEP remains uncertain. Former CDC Director Rochelle Walensky criticized ViiV, the maker of Apreitude, as follows: We're screwed We called on Gilead to quickly make lenacapavir widely available to make the drug more accessible in Africa. Gilead has a deal to make the drug available in low- and middle-income countries, but advocates say it could go further.
These drugs are not particularly vaccine. Vaccines train the immune system to recognize the virus and provide some lasting protection long after the vaccine leaves the body. PrEP drugs are made up of one or more antiviral drugs and remain effective as long as they remain in your body.
The challenge is to get them to stay for the long term. But there has been substantially more progress in this field than in the vaccine field, which has struggled to alter the immune system against one of the most insidious viruses humanity has ever encountered. after what happened recently failurethere are currently no HIV vaccines in late-stage trials, and the advent of effective, long-lasting PrEP may lead to actual clinical trials. make that Harder It is for researchers to develop it.
Gilead Vice President Jared Betan said next year's trial will test only one of several formulations of lenacapavir the company is developing as it pushes toward annual vaccinations.
Gilead is working to develop a longer-acting oral form of PrEP that can be administered once a week or even once a month in addition to annual injections. Merck had previously tested monthly oral PrEP, but stopped The trial was conducted after concerns were raised about the molecule's safety.
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