What is the Biggest Obstacle to Ending the Global HIV Epidemic?
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HIV Vaccine Requiring Just Two Injections a Year: What is the Biggest Obstacle to Ending the Global HIV Epidemic?
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HIV Vaccine Requiring Just Two Injections a Year: What is the Biggest Obstacle to Ending the Global HIV Epidemic?
One of the most exciting developments in HIV prevention is the introduction of a vaccine that only requires two injections a year to protect against HIV infection. Clinical trial results released in June and September of this year have shown that this medication is over 99.9% effective at preventing HIV infection, both in transgender individuals and men who have sex with men. Could this be the solution to ending the global HIV epidemic? What remains the greatest challenge?
The United Nations reports that in 2023, nearly 40 million people were living with HIV, and over 9 million were not receiving any treatment, meaning someone dies from AIDS-related illnesses every minute.
Despite the slowdown in HIV research and reduced funding, the most promising news is that Gilead Sciences has developed a preventive HIV medication, lenacapavir, that is gaining significant attention and hope.
Lenacapavir: A Preventive HIV Drug Administered Twice a Year
The first-round data from the PURPOSE clinical trials, released in June 2024, revealed that lenacapavir, when administered to 2,134 young women from Uganda and South Africa, resulted in 100% effectiveness, with zero cases of HIV infection.
In comparison, among women using the conventional HIV preventive drugs Truvada and Descovy, 16 and 39 cases of HIV infection were reported, respectively.
On September 12, 2024, Gilead announced additional results from the PURPOSE 2 trial, further confirming lenacapavir’s effectiveness. This trial involved over 3,200 participants from Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the U.S., most of whom were men who have sex with men. Since 2021, only two participants receiving lenacapavir every six months contracted HIV, representing a 99.9% prevention rate. In comparison, 9 participants taking Truvada daily contracted HIV, with an 89% efficacy rate. This means that lenacapavir, administered twice a year, reduces the risk of HIV infection by up to 96% compared to Truvada.
Other HIV prevention medications, such as Truvada, Descovy, and Apretude (which requires injections every two months), have been highly effective, reducing the risk of HIV infection from sexual activity by about 99% and from injection drug use by at least 74%. However, long-term adherence remains a challenge. Studies in Africa have shown that only about 30% of participants consistently took Truvada or Descovy, with adherence rates declining over time.
Due to lenacapavir’s impressive efficacy and long-lasting effects, both Phase 3 clinical trials were halted early to allow participants to access the treatment.
Can Lenacapavir End the Global HIV Epidemic?
Lenacapavir has demonstrated exceptional protection against HIV in both transgender individuals and men who have sex with men. It is the only drug globally that requires just two injections per year to prevent HIV infection.
With such promising results from two Phase 3 trials, lenacapavir has the potential to revolutionize HIV prevention and help bring the world closer to ending the epidemic, “bringing us nearer to a generation without AIDS.”
Currently marketed under the brand name Sunlenca, lenacapavir has been approved in the U.S., Canada, Europe, and other regions for the treatment of HIV. It is used in combination with other antiretroviral drugs to treat adult patients with multidrug-resistant HIV. Unlike other antiviral drugs, lenacapavir can inhibit HIV replication at multiple stages without cross-resistance.
However, the biggest barrier to lenacapavir’s widespread use is its cost. In the U.S., two injections of lenacapavir cost $42,250. Gilead plans to submit the drug for FDA approval by the end of 2024 for use in HIV prevention. The company has also committed to making lenacapavir available at more affordable prices in low-income, high-HIV-incidence countries.
Conclusion
Lenacapavir is the only HIV prevention drug that requires just two injections per year, with an effectiveness rate of 99.9% to 100%. However, its high cost remains the biggest obstacle to ending the global HIV epidemic.
HIV Vaccine Requiring Just Two Injections a Year: What is the Biggest Obstacle to Ending the Global HIV Epidemic?
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