Lenacavir vaccine is effective in preventing HIV infection

Lenacavir, a drug vaccine given once every six months, is effective in preventing HIV infection. Data from the pivotal Phase 3 study “Aim 2” published in the New England Journal of Medicine (“NEJM”) confirm this.

Astrid Berner-Rodoreda of Heidelberg University Hospital praised Napawe as a real breakthrough. As a long-acting injection, lenacavir provides long-term protection against HIV infection; booster shots are scheduled every six months – previously used HIV pre-exposure prophylaxis (PrEP) such as Truvada had to be taken in tablet form every day. Bernard-Rodoreda said getting vaccinated twice a year is much more convenient than having to remember to take medication every day.

Tablets make people around you suspicious

There are also consequences: especially in countries heavily affected by HIV, people who take the pill every day risk being labeled HIV-positive. Injections given only twice a year are easier to keep secret. So there's no doubt that Lenacavir represents “huge relief” for many people.

As with the previous “Aim 1” study, as the results were promising, the evaluation was ended early to be able to make the drug available to all test subjects, as the manufacturer Gilead said. Lenapavir should now be approved for HIV protection in many countries. Targeted work has also been undertaken to provide care services in poorer countries.

A laboratory in South Africa is conducting research on lenapasvir.Image: trapezoid

quite effective protection

This drug should be given prophylactically to people at high risk for HIV infection. It inhibits the viral life cycle at several stages of infection. Max von Kleist of Freie Universität Berlin explains that in terms of efficiency, lenacapavir is comparable to Truvada. Both offer excellent, nearly complete protection.

The head of the “Mathematics for Data Science” research group explained that the results of the two “purpose” studies made it appear that the control group taking the pills had more infections, but the data was misleading. In many cases, the pills were not taken regularly, not even at the end of the survey period. It is not surprising that infection ensues.

Lenacavir is approved in the EU for antiviral treatment in certain infected patients. But Bernard-Rodoreda said this is especially important for women in poorer countries, such as sub-Saharan Africa.

Can those who need it most afford it?

There's a problem: Lenacapavir, used to treat existing infections, costs about $42,000 a year in the United States — a level that's out of reach for people in poorer countries. Berner-Rodoreda emphasized that it is critical to make the drug available to states that truly need it.

Preparations for vaccination with Lenacavir are underway.Image: trapezoid

Von Kleist added that who and under what circumstances should choose to come to Nakawi must be carefully considered. As is usually the case with active ingredients of this type, there is a risk of developing resistance. The problem with lenacavir in particular is that the active ingredient can still be detected in the body for about a year after stopping vaccination. “This promotes the development of resistance.” If the dose of the active ingredient is not sufficient to eliminate the pathogen, but it is placed under selective pressure, the pathogen may develop resistance.

Only stopped with follow-up treatment?

If an infection occurs during this period, Truvada may need to be taken for a year after stopping lenacapavir to prevent resistance from developing, von Kleist said. With Truvada, the corresponding risks are low: If you don't take it anymore, it disappears from your body within a week.

Aim 2 included nearly 3,300 HIV-negative people who had more frequent sexual intercourse. Two people in the lenacapavir group (about 2,200 test subjects) and nine people in the Truvada treatment group (about 1,100 test subjects) became infected with HIV, the journal reported. Lenacapvir reduced the risk of infection by 96% compared with background incidence. Both drugs are generally well tolerated.

In July alone, encouraging results from the phase III study “Aim 1” were announced at the World AIDS Congress in Munich and published in the NEJM. About 5,300 HIV-negative girls and young women in South Africa and Uganda participated. No infections occurred among the 2,100 participants who received twice-yearly injections of lenacavir. Among the roughly 3,200 participants in the control group who took other drugs for prevention, there were 55 people with HIV.

A cure is still not possible

The HIV virus weakens the immune system and makes the body susceptible to various diseases. This clinical manifestation is called AIDS. If detected and treated early, the life expectancy of an infected person is almost the same as a normal person. However, in most cases, the infection cannot be completely eliminated, which is why lifelong use of viral suppressive drugs is required.

HIV infections are increasing in 28 countries, according to a United Nations report presented on Tuesday. According to UNAIDS, 39.9 million people worldwide are infected with the virus, mostly in sub-Saharan Africa. In 2023, 630,000 people will die from AIDS and 1.3 million people will be newly infected with HIV. (DAB/Sudan Development Authority/Department of Political Affairs)

Lenacavir, a drug vaccine given once every six months, is effective in preventing HIV infection. Data from the pivotal Phase 3 study “Aim 2” published in the New England Journal of Medicine (“NEJM”) confirm this.