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HIV Cure: New Vaccine Proves 100% Effective with Just Two Shots a Year

New Vaccine Proves 100% Effective against HIV | Credits: Getty Images

United States: HIV infection can now be cured with the help of two shots. As per a study, a newly developed vaccine has shown 100% effectiveness against the infection.

A new clinical trial conducted in South Africa and Uganda has demonstrated that a biannual injection of an innovative pre-exposure prophylaxis drug offers complete protection against HIV for young women, according to reports by The Conversation.

The trial evaluated whether a six-month injection of lenacapavir provides superior protection against HIV infection compared to two other PrEP drugs, both administered as daily pills.

Dr Linda-Gail Bekker, the principal investigator for the South African segment of the study, discusses with Nadine Dreyer the profound significance of this breakthrough and its future implications.

Insight into the Trial and Its Objectives

The Purpose 1 trial, encompassing 5,000 participants, was conducted at three locations in Uganda and 25 sites in South Africa to ascertain the efficacy of lenacapavir and two other medications, as per The Conversation.

Lenacapavir (Len LA) is a fusion capsid inhibitor. It disrupts the HIV capsid, a protein shell that safeguards the virus’s genetic material and enzymes necessary for replication. Administered subcutaneously, it is given once every six months.

Sponsored by Gilead Sciences, the randomized controlled trial tested multiple factors.

The primary focus was to determine if a biannual injection of lenacapavir is safe and provides better protection against HIV infection as PrEP for women aged 16 to 25 years compared to Truvada F/TDF, a daily PrEP pill that has been widely used for over a decade.

Additionally, the trial assessed whether Descovy F/TAF, a newer daily pill, was as effective as F/TDF. F/TAF has superior pharmacokinetic properties compared to F/TDF. Pharmacokinetics refers to the drug’s movement within the body. F/TAF is a smaller pill and is used among men and transgender women in high-income countries.

The trial comprised three arms. Participants were randomly assigned to one of the arms in a 2:2:1 ratio (Len LA: F/TAF oral: F/TDF oral) in a double-blind manner, meaning neither the participants nor the researchers knew which treatment participants were receiving until the trial concluded.

In eastern and southern Africa, young women bear the majority of new HIV infections. They also face challenges in adhering to a daily PrEP regimen due to various social and structural reasons.

During the randomized phase, none of the 2,134 women who received lenacapavir contracted HIV, showing 100 percent efficacy, as per The Conversation.

In contrast, 16 of the 1,068 women (1.5%) taking Truvada (F/TDF) and 39 of the 2,136 women (1.8%) on Descovy (F/TAF) contracted HIV.

The outcomes from a recent independent data safety monitoring board review prompted the recommendation to terminate the trial’s “blinded” phase and offer all participants a choice of PrEP.

This board, an independent committee of experts, reviews unblinded data at specific intervals during the trial to monitor progress and safety, ensuring the trial does not continue if there is harm or clear benefit in one arm over others.

Significance of These Trials

This landmark achievement provides substantial hope, demonstrating a highly effective prevention tool against HIV.

There were 1.3 million new HIV infections globally last year. Although fewer than 2 million infections in 2010, it is evident that the current rate will not meet the UNAIDS 2025 target (fewer than 500,000 new infections) or potentially the goal to end AIDS by 2030.

PrEP is one among several prevention tools.

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

Moreover, young men should be offered medical male circumcision for health reasons.

Despite these options, new infections persist, particularly among young individuals.

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

HIV scientists and activists hope that reducing this “prevention decision” to twice a year might diminish unpredictability and barriers, reports by The Conversation revealed.

For a young woman who struggles to visit a clinic or cannot keep pills due to stigma or violence, a biannual injection could offer a viable solution to remain HIV-free.

Future Steps

The Purpose 1 trial will continue in an “open-label” phase, where participants will be informed whether they were in the “injectable” or oral TDF or oral TAF groups and will be offered their preferred PrEP.

A sister trial, Purpose 2, is also underway, conducted in several regions, including sites in Africa, among cisgender men and transgender and nonbinary individuals who have sex with men.

Conducting trials among diverse groups is crucial, as effectiveness can vary based on the type of sexual activity.

Timeline for Drug Rollout

According to a Gilead Sciences press statement, the company plans to submit the results dossier to various country regulators, particularly in Uganda and South Africa, within the next few months.

The World Health Organization will also review the data and potentially issue recommendations. It is hoped that this new drug will be incorporated into WHO and country guidelines.

Further studies are anticipated to better understand how to integrate this drug into real-world settings.

Pricing is a critical factor to ensure accessibility and distribution in the public sector, where it is urgently needed.

Gilead Sciences has committed to offering licenses to companies that manufacture generic drugs, which is essential for reducing costs.

Ideally, governments will be able to afford this drug and offer it to everyone who needs protection against HIV.

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