Fact Check: Twice-yearly lenacapvir shot shows no HIV infections in trial participants.

Fact Check: "Twice-yearly lenacapvir shot shows no HIV infections in trial participants."

What We Know

The claim that "twice-yearly lenacapvir shot shows no HIV infections in trial participants" is based on findings from clinical trials evaluating lenacapavir as a pre-exposure prophylaxis (PrEP) for HIV. In the PURPOSE 1 and PURPOSE 2 trials, lenacapavir was tested among various populations, including cisgender men and women. The results indicated that among 2,134 participants receiving lenacapavir, there were zero HIV infections reported during the trial period, which supports the claim that the treatment was effective in preventing HIV infection (Gilead, Pharmacy Times).

However, it is important to note that in a broader analysis involving 3,265 participants, which included both the lenacapavir and a control group receiving daily oral emtricitabine-tenofovir disoproxil fumarate (F/TDF), two infections occurred in the lenacapavir group, resulting in an incidence rate of 0.10 per 100 person-years (PubMed, NEJM). This indicates that while the incidence was significantly lower than the background rate of HIV infections in the population studied, it was not entirely zero.

Analysis

The evidence from the clinical trials demonstrates that lenacapavir is highly effective as a preventive measure against HIV. The PURPOSE 1 trial reported no infections among participants, which is a strong indicator of the drug's efficacy in that specific cohort (Gilead). However, the broader analysis that included a larger sample size revealed that while the incidence of HIV infections was significantly lower in the lenacapavir group compared to the control group (0.10 vs. 0.93 per 100 person-years), it was not completely absent (PubMed, NEJM).

The source reliability is generally strong, as the studies were published in reputable medical journals and conducted by Gilead Sciences, a major player in HIV research and treatment. However, it is essential to consider potential biases, as Gilead has a vested interest in promoting its products. The FDA's approval of lenacapavir was based on these trials, which adds a layer of credibility to the findings (NBC News, Stat News).

Conclusion

The claim that "twice-yearly lenacapvir shot shows no HIV infections in trial participants" is Partially True. While it accurately reflects the results from the PURPOSE 1 trial, which reported zero infections, it overlooks the findings from the larger analysis that included infections in the lenacapavir group. Therefore, while lenacapavir shows remarkable efficacy in reducing HIV infections, it does not completely eliminate the risk, as evidenced by the two reported cases in the broader study.

Sources

1. Twice-Yearly Lenacapavir for HIV Prevention in Men and ...
2. Yeztugo Lenacapavir Is Now the First and Only FDA Approved ...
3. Twice-Yearly Lenacapavir for HIV Prevention in Men and ...
4. FDA Approves Twice-Yearly Lenacapavir for HIV ...
5. FDA Approves Twice-a-Year Injection for HIV Prevention
6. FDA approves powerful HIV prevention drug
7. HIV protection with just two shots a year: FDA approves Gilead ...
8. Lenacapavir Approval Could Change Course of Treating, ...