New Bi-annual Prophylaxis HIV Trial is 100pc Effective Against Infection
A significant trial conducted in Uganda and South Africa has shown that administering a new PrEP(pre-exposure prophylaxis) via bi-annual injections ensures complete protection against HIV infection for young women.
The trial compared the efficacy of Lenacapavir injection administered every six months with two existing daily oral PrEP medications. Lenacapavir disrupts the HIV caspid is vital for viral replication and is subjected subcutaneously. Gilead Sciences sponsored the controlled trial with 5000 participants across three sites in Uganda and 25 sites based in South Africa.
The objectives were to assess the effectiveness and safety of lenacapavir compared to Truvada (F/TDF) and Descovy (F/TAF). The trial’s focus on women aged 16 to 25 was significant since this demographic faces the highest risk of new HIV infections in Southern and Eastern Africa. Truvada has been challenging for several young women due to various social and structural factors. The results of the trial mark a vital breakthrough in HIV prevention efforts.
The trial also evaluated the effectiveness of F\TAF to F\TDF. The former boasts superior pharmacokinetic properties compared to the latter referring to how the drug moves into, through and out of the body. It is currently used by men and transgender women in high-income countries.
The trial employed a three-arm design where young women were assigned in a 2:2:1 ratio C (Len LA: F/TAF oral: F/TDF oral) in a double-blinded manner. This ensured that the participants and researchers were unaware of the treatment the participants received until the trial ended.
In Eastern and Southern Africa, young women bear the highest burden of new HIV infections. They struggle to adhere to daily PrEP routines due to challenges including social and structural.
Lenacapavir demonstrated a 100% prevention rate since during the trial phases none of the 2,134 women who received the vaccine contracted HIV. In comparison, of those who took Truvada, 16 out of 1068 women became infected, while 39 out of 2,136 who received Descovy contracted HIV.
Based on the findings an independent review by the data safety monitoring board recommended quitting the blinded phase of the trial. This board had expert committee members appointed at the outset of the clinical trial, and reviewed unblinded data to monitor safety and progress. Their role includes ensuring that trials are discontinued if there is harm and clear benefit observed in one treatment arm over others.
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What Is The Significance Of This Breakthrough?
This breakthrough offers significant hope and provides a highly effective prevention tool against HIV. Despite a reduction in new HIV infections to 1.3 million worldwide last year from 2 million in 2010, it’s clear that at this rate we are not likely to achieve UNAID’s 2025 target of fewer than 500,000 new infections yearly or even the goal to end AIDS by 2030.
While PrEP represents a crucial preventive measure, it should be integrated with HIV self-testing, access to condoms, screening and treatment for sexually transmitted infections and the availability for women of childbearing age. It’s important to offer young men medical male circumcision for health benefits.
Despite these options, we are yet to reach a point of preventing new infections, especially with young individuals, for youth taking a daily pill, making daily decisions about taking a pill just before sex or using a condom can be deemed difficult.
HIV activists and scientists are optimistic that young people may find relief in having to make this decision only twice a year which could reduce unpredictability and barriers. For a young woman who struggles to reach a clinic in town or faces stigma or violence for taking pills, a bi-annual injection could be a solution to being HIV-free.
How long until the drug is rolled out?
According to the Gilead Sciences press statement, within the next few months, the company will submit the dossier with all the results to the Ugandan and South African regulators.
The World Health Organization will review the data and issue recommendations. We hope that this drug will be adopted into WHO and country guidelines and see it being tested in different studies to see how it can be integrated into the real world.
Price is a significant factor in ensuring access and distribution in the public sector where it’s required. Gilead Sciences reiterated that it seeks to offer licences to companies that make generic drugs which is a significant way to lower the prices. Governments will be in a position to purchase this affordably and it will be offered to those who want it and also need protection against HIV.
Lab Test Finds Persistent HIV Strains, Aiding Cure Discovery
A multinational team led by Weil Cornell Medicine investigators have developed a test that will aid in the measure of the persistence of HIV in people in Africa who are affected by viral strains- a crucial tool in the search for a cure for HIV that will benefit patients globally.
The study, published on July 2 in Nature Communications will aid in filling a major gap in the research for Human Immunodeficiency Virus (HIV). Most studies have focused on strains circulating in Western countries, particularly in men who have sex with men who are affected by subtype B. Few studies have researched the strains circulating in Africa where women are affected.
Assistant professor of microbiology and Immunology at Weill Cornell Medicine, lead author Dr, Guinevere Lee shares,“HIV cure research tends to focus on viral strains circulating in developed countries, but to achieve a cure that is globally applicable, we must study viral strains that are affecting other regions of the world,”
The findings show that HIV strains circulating in Africa establish viral reserves in human bodies. Although antiretroviral therapy (ART) reduces HIV in the human blood to undetectable levels these dormant reservoirs exist nonetheless. They consist of a huge number of defective proviral DNA genomes that can’t produce new infectious viruses, but a number of proviruses are genetically intact and can produce active viruses if ARVs is interrupted.
Dr Lee explains, “We are looking for a needle in a haystack: To achieve an HIV cure, we need to first find out whether any genome-intact proviruses remain in the body during antiretroviral treatment. Our new assay allows us to do this. Then we need to target and eliminate the intact DNA capable of producing new viruses,”
Scientists Say They Can Cut HIV out of Cells
Scientists shared that they have successfully cut out HIV from the infected cells using the Nobel Prize-winning Crispr gene-editing technology. Working like scissors, it can cut DNA so badly that bits can be removed or inactivated.
The hope is to get rid off the virus in the body entirely although more work is needed to check if it’s safe and effective. HIV medicines that exist can only stop the virus but not delete it.
Richard Angell from the Terrence Higgins Trust shared: “While year and years away, today’s research is an important step in the search for an HIV cure. The work needed to transform this technology into a cure for those already living with HIV should be expedited.
“While there’s no cure for HIV yet, it’s vital everyone knows we have incredibly effective HIV treatment. That treatment means people living with HIV can expect to live long and healthy lives. If they take their medication as prescribed, they cannot pass the virus onto their sexual partners. PrEP, a free pill that protects you from HIV, is available for HIV negative people from sexual health clinics across the UK. We have all of the tools necessary to end new HIV cases in the UK by 2030 – and mark the first time a virus was stopped without a vaccine nor cure.”
Key Points to Note
While HIV can effectively be treated with antiretroviral therapy, there’s not yet a cure that has been established. Can HIV be cured? most researchers think so but it’s not yet clear when this will happen. They are still studying several solutions including gene therapy, vaccines and immunotherapy among others.
When a cure for HIV is developed, it will require to be widely available and affordable for widespread use around the globe. There are more cases in Southern and Eastern Africa than anywhere else. Almost half of all new HIV infections are in this region.
It’s impossible to tell when a cure for HIV might be available. The United Nations and other countries globally have set a goal of ending the HIV and AIDS epidemic by 2030.This goal includes strategies for prevention and better access to existing drugs and also treatment research.
HIV attacks the immune-system cells and use their own machinery to generate copies of itself. Even with effective treatment, some go into a latent stage so they still contain the genetic material of HIV even if it’s not actively producing new virus. A number of individuals living with HIV need life-long ART. If they stop taking these drugs, the dormant virus reawakens and may cause problems again.
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