Breakthrough in the fight against HIV: a drug has been developed that 100% protects against infection

Инъекционный препарат, вводимый дважды в год, на 100% эффективен в предотвращении распространения ВИЧ, согласно первым данным клинического испытания.  В случае одобрения препарат предлагает еще один вариант профилактики ВИЧ и приближает весь мир на шаг к искоренению ВИЧ.

Large Clinical Trial in South Africa and Uganda showed that twice-yearly injections of a new drug for pre-exposure prophylaxis provide young women with complete protection against HIV infection. In the course of Research tested whether a six-month injection of lenacapavir would provide better protection against HIV infection than the other two drugs, both in the form of daily pills. All three drugs are pre-exposure prophylaxis (or PrEP) drugs.

There is PrEP. Why another method of prevention?

The development of pre-exposure prophylaxis (PrEP) once a day, drugs such as Truvada and Descovy, marked tremendous progress in 
HIV medicine. When given as directed by HIV-negative individuals, PrEP reduces the risk of contracting the virus through sexual contact by about 99%.

Now the results of the phase 3 clinical trials conducted by 
Gilead Sciences, Inc., has demonstrated that their new injectable drug PrEP administered only twice a year, на 100% эффективен в предотвращении распространения ВИЧ.

“With zero infections and 100% efficacy, lenacapavir, taken twice a year, has demonstrated its potential as an important new tool for preventing HIV infection,” – said Merdad Parsi, M.D., Chief Medical Officer of Gilead Sciences. “We look forward to additional results from the ongoing TARGET clinical program and to continuing to achieve our goal – "to help end the HIV epidemic for everyone, everywhere".

The scientists said their data confirm that Lenacapavir, taken twice a year, is superior to oral medications taken daily, given the difficulty of adhering to a daily regimen. 

And this study doesn't mean that existing PrEP drugs aren't effective.

And what is the name of the new drug?

The drug is called “Lenacapavir.” It is taken twice a year. However, it should not be referred to as a medication, since Lenacapavir is a pre-exposure prophylaxis (PrEP), meaning it is effective only if you are not yet infected with HIV.

What kind of study is this?

Research Purpose 1 A study involving 5,000 people was conducted at three sites in Uganda and 25 sites in South Africa to test the efficacy of lenacapavir and two other drugs.

Lenacapavir (Len LA) is an inhibitor of capsid fusion. It affects the HIV capsid, a protein coat that protects HIV genetic material and enzymes needed for replication. It is injected directly under the skin once every six months.

In a randomized controlled trial sponsored by drug developers Gilead Sciences, several factors were tested.

The first question was whether whether a six-month injection of lenacapavir is safe and will it provide better protection against HIV infection As a PrEP drug for women between the ages of 16 and 25 than Truvada F/TDF, daily PrEP tablets that have been widely used for over a decade.

Second, the study also tested whether Descovy F/TAF, newer daily pills, as effective as F/TDF. The new F/TAF has different pharmacokinetic properties than F/TDF. Pharmacokinetics refers to the movement of a drug into, through, and out of the body. F/TAF comes in smaller tablets and is used by men and transgender women in high-income countries.

The study had three stages. The young women were randomly assigned to one of the groups in a 2:2:1 ratio (Len LA:F/TAF Oral:F/TDF orally) in a double-blind manner. This means that neither the participants nor the researchers knew what treatment the participants were receiving until the end of the clinical trial.

16 of 1,068 women (or 1.5%) taking Truvada (F/TDF) and 39 of 2,136 (1.8%) receiving Descovia (F/TAF) contracted the HIV virus.

In eastern and southern Africa, young women are the group that bears the brunt of new HIV infections. These women also believe that maintain a daily pill regimen difficult for a number of social and structural reasons.

During the randomized phase of the trial, none of the 2,134 women who received lenacapavir contracted HIV. The effectiveness was 100 percent.

The results of a recent independent review by the Data Security Monitoring Board* recommended that the blinded phase of the trial be stopped and that all participants be offered the choice of PrEP.

*This Board is an independent committee of experts that is established at the beginning of a clinical trial. They review the non-blinded data within a set time frame during the test to monitor its progress and safety. They make sure that the test does not continue if there is harm or a clear advantage of one hand over the others

What is the importance of these studies?

This is, without exaggeration, a real breakthrough in medicine! This study gives us great hope that we have there is a proven, highly effective prevention tool to protect people from HIV.

Globally, there were 1.3 million new HIV infections last year. While this is less than the 2 million infections recorded in 2010, it is clear that at this rate, we will not meet the new HIV infection target set by UNAIDS for 2025 (less than 500,000 cases worldwide), or perhaps even the goal of ending AIDS by 2030.

PrEP is not the only means of prevention

PrEP should be provided along with HIV self-testing, access to condoms, screening and treatment for sexually transmitted infections, and access to contraception for women of childbearing age. In addition, Young men should be offered medical male circumcision for health reasons.

But despite these opportunities, we have not yet reached the point where we can stop new infections, especially among young people.

For young people, the daily decision to take a pill, use a condom or take a pill during intercourse can be very difficult.

Scientists and HIV activists hope that young people may discover that having to make this "prevention solution" just twice a year can reduce unpredictability and barriers.

For a young man who has difficulty getting an appointment at a city clinic or who cannot take pills (PrEP) without facing stigma or violence, injections just twice a year are an option that could protect him from HIV.

What is happening now?

It is planned that the study Purpose 1 The study will continue, but now in the “open-label” phase. This means that the study participants will not be “blinded”: they will be told whether they were in the “injectable” TDF group, the oral TDF group, or the oral TAF group.

As the study continues, they will be asked to choose the drug they prefer.

A similar study is also being conducted in a number of regions, including parts of Africa, among cisgender men, as well as transgender and non-binary people who have sex with men.

It is necessary to conduct trials on different groups, as we have observed differences in efficacy. For example, it is important to consider what type of sex the couple has (anal or vaginal), and how this affects the effectiveness of the drug in each case.

How long does it take for the drug to be released?

We read in a press statement from Gilead Sciences that over the next few months, the company will present a dossier with all the results to regulators in a number of countries, in particular, regulators in Uganda and South Africa.

The World Health Organization will also study the data and possibly issue recommendations.

“We hope that this new drug will be included in WHO and national guidelines. We also hope that we may begin to see the drug tested in more studies so that we can better understand how to implement it in real-world settings,” – says physician-scientist Linda-Gail Becker, principal investigator of the South African part of the study.

Price is a critical factor for access and distribution in the public sector, where it is urgently needed.

Gilead Sciences said it will offer licenses to companies that make generic drugs, another important way to lower prices.

“In an ideal world, governments would be able to purchase this medication at an affordable price, and it would be made available to anyone who wants it and needs protection against HIV.”, – the researchers are convinced.