Drug trials show twice-yearly injections are 100% effective against infection

Large clinical trials in South Africa and Uganda have shown that twice-yearly injections of a new pre-exposure prophylaxis drug completely protect young women from HIV infection.

The trial tested whether a six-month course of injections of lenacapavir offered better protection against HIV infection than two other drugs, both of which are taken daily. All three drugs were used as pre-exposure prophylaxis (or Pre-EP) Drugs.

Physician-scientist Linda Gayle BeckerThe South African research team's lead investigator spoke to Nadine Dreyer about why this groundbreaking discovery is so important and what we can expect next.

Tell me about this test and its purpose.

of Objective 1 A trial involving 5,000 participants was conducted at three sites in Uganda and 25 sites in South Africa to test the effectiveness of lenacapavir and two other drugs.

Lenala Building (LenLA) teeth Fusion Capsid InhibitorsThe drug acts on the HIV capsid, the protein shell that protects HIV's genetic material and the enzymes it needs to replicate. It is given subcutaneously once every six months.

Company-sponsored randomized controlled trials Gilead SciencesI tested a few things.

The first is an injection every six months. Rena Capa Building PrEP for women aged 16 to 25 years is safe and provides better protection against HIV infection. Truvada F/TDFIt's a PrEP pill taken daily that has been widely used for over a decade.

Second, in this study, Descoby I know/I knowThe newer daily tablet, F/TAF, was as effective as F/TDF. The newer F/TAF was better. Pharmacokinetics Add properties to F/TDF. Pharmacokinetics refers to how a drug moves into, through, and out of the body. F/TAF is a small pill that is used by men and transgender women in high-income countries.

The study was divided into three arms, and young women were randomly assigned to one of the arms in a 2:2:1 ratio (Len LA: oral F/TAF: oral F/TDF). Double-blind This means that neither the participants nor the researchers knew what treatment the participants were receiving until the trial ended.

In East and Southern Africa, young women Bearing the brunt of new HIV infectionsThey also found that daily PrEP therapy challenging For several social and structural reasons, it is not sustainable.

During the randomized phase of the study, 2,134 women People who were given lenacapavir contracted HIV. It was 100 percent effective.

By comparison, 1,068 women (or 1.5%) took Truvada (F/TDF), and 39% 2,136 1.8% of patients treated with Descovy (F/TAF) became infected with the HIV virus.

Recent Independent Data Safety Monitoring Board The review resulted in a recommendation that the “blinding” phase of the trial should be stopped and all participants offered the option of PrEP.

This committee is an independent panel of experts appointed at the start of a clinical trial to review the unblinded data at scheduled times throughout the trial to monitor progress and safety, and will not continue the trial if one arm shows more harm or clear advantage than the other.

What is the significance of these tests?

This breakthrough offers great hope that we now have a proven and highly effective prevention measure to protect people from HIV.

there were 1.3 million new HIV infections Over the past year, worldwide 2 million infected Looking at the situation in 2010, it is clear that we are not going to meet our HIV targets if we continue on our current path. New infection targets The UNAIDS goal of eradicating AIDS by 2025 (500,000 people worldwide) has been achieved. 2030.

PrEP is not the only prevention measure.

PrEP should be offered alongside HIV self-testing, access to condoms, testing and treatment for sexually transmitted infections, and access to contraception for women of childbearing age.

In addition, young men Medical Male Circumcision For health reasons.

But despite these options, we are not yet close to stopping new infections, especially among young people.

For young people, the daily decision to take the pill, use a condom, or take the pill during sex is a big one. Very rewarding.

HIV scientists and activists hope that young people will realize that making this “prevention decision” just twice a year could reduce unpredictability and barriers.

For young women who struggle to get an appointment at a local clinic or cannot keep up with their medication without facing stigma and violence, the twice-yearly injection could be an option to stay HIV-free.

What just happened?

The plan is to continue the objective 1 trial but is now in the “open label” phase, which means study participants will be “unblinded,” meaning they will be told whether they were in the “injected” or oral TDF group, or the oral TAF group.

As the trial progresses, you will be given the option of which PrEP you prefer.

Sister studies are also underway: Objective 2 In many regions, including some in Africa, studies have been conducted among cisgender men and transgender and non-binary people who have sex with men.

It is important to conduct studies across different groups, as differences in efficacy may be observed. Anus or vagina are important and may affect validity.

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

Gilead Sciences Press Statement The company plans to submit full results to regulators in multiple countries, notably Uganda and South Africa, in the coming months.

The World Health Organization will also review the data and may issue recommendations.

We hope that this new drug will be adopted into WHO and national guidelines.

We are also hopeful that more studies will begin to test the drug to better understand how it might translate into real-world situations.

Price is a key factor in ensuring access and distribution in the public sector where it is desperately needed.

Gilead Sciences has announced that it will offer licenses to companies that manufacture generic versions of the drug. Prices fall.

In an ideal world, governments would be able to buy this at an affordable price and it would be made available to everyone who wants it and needs protection from HIV.