Twice-Yearly Injection Cuts HIV Risk by 96%, But Will Cost Cut Access?

THURSDAY, Sept. 12, 2024 (HealthDay News) — It could be a real breakthrough for people at risk for HIV infection: A shot given every six months that reduces their risk by a whopping 96%.

That”s according to new trial results released Thursday by Gilead Sciences, which is repurposing its HIV treatment, the antiviral lenacapavir, as a twice-yearly preventive shot.

There”s a catch, however: Given as either a pill or injection and currently branded as Sunlenca, lenacapavir as treatment for HIV infection is pricey, costing $3,450 per month or over $41,000 per year, NBC News reported.

Its price tag as a twice-yearly preventive injection — pre-exposure prophylaxis, or PrEP — has not yet been released by Gilead.

That has patient advocates worried.

“While lenacapavir is a valuable addition to our toolkit, for it to reach its full potential, it must be made accessible to those who stand to benefit the most from its effectiveness,” Dr. Boghuma Titanji, an infectious disease specialist at Emory University, told NBC News.

The new trial involved a group of more than 3,200 individuals over the age of 15, mostly men who have sex with men. Participants were living in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States.

Beginning in 2021, all were randomly selected to take either the twice-yearly lenacapavir injection for PrEP or a once-daily Truvada pill, a longstanding form of PrEP.

No placebo group was included since leaving patients with no protection against HIV would be unethical.

The result: “99.9% of participants did not acquire HIV infection in the lenacapavir group, with 2 incident cases among 2,180 participants,” Gilead said in a news release.

That beat Truvada”s performance: There were nine cases of HIV infection among 1,087 people in the group taking the daily pill.

Relative to Truvada, twice-yearly lenacapavir reduced the odds for HIV infection by 96%, the researchers reported.

No safety concerns for those taking the drug were reported.

The performance of the Gilead drug was so impressive that the trial was halted early so that everyone could avail themselves of the treatment, the company said.

The new findings follow those of another clinical trial of twice-yearly lenacapavir, with similarly impressive results. That trial was conducted among at-risk women living in sub-Saharan Africa and was also ended early, after the Gilead regimen showed 100% effectiveness in preventing infection.

Gilead”s CEO Daniel O”Day has high hopes for injected lenacapavir”s potential, and the company plans to submit the drug for U.S. Food and Drug Administration approval by the end of 2024.

“With such remarkable outcomes across two phase 3 studies, lenacapavir has demonstrated the potential to transform the prevention of HIV and help to end the epidemic,” he said in the company news release.