Large-scale research in Africa opens an important breakthrough in HIV prevention

Scanning electron micrograph of HIV-1 budding (green) from cultured lymphocytes. Photo: C. Goldsmith, CDC / public domain.

Women make up the above half Young women between the ages of people living with HIV around the world 10 and 24 It has twice the HIV prevalence of young men of the same age group. In East and Southern Africa, young women are infected with HIV on average 5-7 years earlier than men.

Researchers are working hard to find the effect HIV prevention Measures.

Most notable are the pre-exposure prophylaxis (PrEP) pills known as: Torubada.. This is a combination of two antiretroviral drugs, tenofovir and emtricitabine. This is effective in preventing HIV infection. However, taking daily pills is not practical for many.

HIV Prevention Trial Network Scientist Recently found The PrEP regimen of long-acting Cabotegravir (CAB LA) injections once every eight weeks was superior to the daily tablets used for HIV prophylaxis. Ina Skosana asked Sinead Delany-Moretlwe, a research professor at the University of the Witwatersrand in South Africa and head of research at the Wit Reproductive Health & HIV Institute, for more information.

Please tell us about your research.

This study HPTN 084 It is the first to compare the effectiveness of two HIV prevention or pre-exposure prophylaxis regimens.

The first regimen consisted of injections of the long-acting antiretroviral drug Cabotegravir, which was given every 8 weeks. The second regimen was a daily oral dose of Truvada. Truvada has been shown to be very effective in preventing HIV when taken as prescribed in different populations and situations.

We have enrolled more than 3,200 sexually active HIV-free cisgender women on 20 sites in seven countries. The survey was conducted between November 2017 and November 2020 in Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda and Zimbabwe.

In our study, participants were randomized to one of two arms. One arm received the active Cabotegravir and Tolbada placebo. The other arm received active torbada and placebo for Cabotegravir. Cabotegravir was orally administered daily via intramuscular injection at 5- and 8-week intervals after the initial 4-week interval loading.

What did you find?

Preliminary findings show that 1% of all participants were infected with HIV during the study period. This suggests that both cabotegravir and Truvada are very effective in preventing HIV in this population.

The 34 incident infections detected in the participants assigned to Truvada represent 1.79% of the incidents. And the four infections detected in the participants assigned to cabotegravir correspond to an incidence of 0.21%. This identifies a new preventive option for women that requires consistent daily use and offers significant advantages over existing oral PrEPs associated with significant adherence challenges.

The number of HIV infections in the Tolbada group was about 9 times higher than that in the Cabotegravir group. This finding suggests that cabotegravir is far more effective than torubada in preventing HIV transmission in women. And we have reached the criteria for early discontinuation of the exam. Based on these findings, an independent data and safety monitoring committee recommended that the blinded portion of the study be stopped early and that the results be made available to the scientific and broader community.

In an early sibling study of cisgender men and transgender women, HPTN 083 Similar results were shown. A preparatory regimen containing long-acting cabotegravir, which can be injected once every eight weeks, was superior to the population’s daily oral torbada.

What is the next step?

The findings are important and timely, as more methods are urgently needed to prevent HIV among women at high risk of HIV. These include taking daily or almost daily pills, using condoms, or relying on sex refrains. The development of alternative methods to prevent HIV and a more compliant schedule than currently available will increase HIV prevention options and women’s acceptance and reduce new HIV infections.

We have contacted the Research Ethics Commission, which oversees this study, and national drug regulators, and field investigators and study participants will be notified of the results as soon as possible. Participants can learn about the medicines they were receiving. Protocol amendments will be submitted for regulatory review so that participants can continue to take the assigned medication or switch to Cabotegravir if necessary.

Truvada participants will be provided with cabotegravir as soon as the drug is available. All participants are invited to continue their research. And if they choose not to stay in the study, they will be referred for the best HIV prevention services available locally. We look forward to presenting these results in peer review settings at future meetings as we complete the primary analysis.

Sinead Delany-Moretlwe is an associate professor and research director at the University of the Witwaters Land, Wit Reproductive Health and HIV Institute I.

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