“Huge relief”
Active ingredient effectively protects against HIV infection
Updated on November 27, 2024 – 3:31 p.mReading time: 4 min.
Effective means of protecting against HIV infection have been available for several years. However, they must be taken daily. This is different with lenacapavir, which can be an immense advantage.
A six-monthly vaccination with the drug lenacapavir effectively protects against infection with HIV. This is confirmed by data from the pivotal phase 3 study “Purpose 2”, which is presented in the “New England Journal of Medicine” (“NEJM”). Astrid Berner-Rodoreda from Heidelberg University Hospital praised a real breakthrough with lenacapavir.
As a depot injection, lenacapavir provides long-term protection against HIV infection; a booster is scheduled every six months – previously used HIV pre-exposure prophylaxis (PrEP) such as Truvada must be taken as a daily tablet. Getting vaccinated twice a year is much more convenient than having to remember to take a pill every day, said Berner-Rodoreda.
There is also a certain effect: Especially in some countries that are heavily affected by HIV, there is a risk of being labeled as supposedly HIV-positive by those around you who take tablets every day. An injection that is
Like the previous study “Purpose 1”, the evaluation was ended early due to the promising results in order to be able to make the drug available to all test subjects, as the manufacturer Gilead said. Lenacapavir should now be approved for HIV protection in numerous countries. Targeted work is also being done to provide care in poorer countries.
The drug should be offered prophylactically to people at high risk of HIV infection. It inhibits the life cycle of the virus at several stages of infection. In terms of efficiency, lenacapavir is comparable to Truvada, explained Max von Kleist from the Free University of Berlin. Both offer excellent, almost complete protection.
The results of the two “Purpose” studies make it seem as if there were a few more infections in the control groups given tablets – but the data is misleading, explained the head of the “Mathematics for Data Science” research group. In many cases the tablets were not taken regularly or were not taken at all at the end of the investigation period. It is not surprising that infections then occur.
Lenacapavir is already approved in the EU for the antiviral treatment of certain patients who are already infected. Gilead has not yet brought the drug onto the market in Germany. It is unclear whether it will be available as a preventive agent in this country, said Berner-Rodoreda. However, it is particularly important for poorer countries, such as women in sub-Saharan Africa.
There is a problem: Lenacapavir, used to treat an existing infection, costs around $42,000 per year in the USA – at this level it would be unaffordable for people in poorer countries. It is crucial that access is made possible for those states in which the drug is really urgently needed, emphasized Berner-Rodoreda.
Who and under what circumstances should choose lenacapavir must be carefully considered, added von Kleist. As is generally the case with such active ingredients, there is a risk of resistance developing. The problem with lenacapavir in particular is that the active ingredient can still be detected in the body for about a year after vaccinations have been stopped. “This promotes the development of resistance.” A pathogen can become resistant if the dose of an active ingredient is not sufficient to eliminate it, but puts it under selection pressure.
Stopping only with follow-up treatment?
It may be necessary to take Truvada for another year after stopping lenacapavir in order to prevent the development of resistance if an infection occurs during this period, says von Kleist. With Truvada, the corresponding risk is low: it disappears from the body within a week if it is no longer taken.
“Purpose 2” included almost 3,300 HIV-negative people who had sex more frequently. Two people in the lenacapavir group (around 2,200 test subjects) and nine in the group treated with Truvada for comparison (around 1,100 test subjects) became infected with HIV, according to the journal. Lenacapavir reduced the risk of infection by 96 percent compared to the background incidence. Both agents were generally well tolerated.
How does improper administration of lenacapavir contribute to the development of resistance in HIV treatment?
Redient can lead to the development of resistance if not administered correctly. This highlights the importance of proper medical guidance and adherence to therapy regimens.
Experts stress that while lenacapavir represents a significant advancement in HIV prevention, it should not replace existing methods but rather complement them. The goal is to expand options for individuals at high risk of HIV infection, giving them greater flexibility to choose a prevention strategy that fits their lifestyle and needs.
With lenacapavir, there is hope for improving compliance among populations that struggle with daily pill regimens. The long-acting nature of the drug may also alleviate stigma associated with HIV, as fewer individuals may be identified as being at risk when they receive injections rather than taking visible daily medications.
However, addressing the economic aspects is critical. The high cost of lenacapavir in the United States underscores the need for policies that ensure affordable access, especially in low-resource settings where HIV rates are disproportionately high. Gilead’s commitment to exploring options for accessibility in these regions is essential for translating clinical success into public health benefits.
the introduction of lenacapavir could change the landscape of HIV prevention, offering a more user-friendly alternative to traditional methods and hopefully contributing to reduced rates of infection globally. Continued research, education, and healthcare infrastructure improvements will be necessary to maximize its potential impact.