Gilead’s lenacapavir PrEP therapy has touted a perfect 100% efficacy result in the PURPOSE 1 trial. Image credit: Shutterstock / Sundry Photography.

Gilead received a standing ovation after announcing its full, perfect efficacy data from the Phase III PURPOSE 1 trial of pre-exposure prophylaxis (PrEP) lenacapavir at the world’s largest HIV and AIDS conference.

On top of the data, the company also committed to prioritising swift access and enabling efficient paths for regulatory approval of lenacapavir for high-incidence, resource-limited countries.

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Dr Linda-Gail Bekker, chief executive officer of the Desmond Tutu Health Foundation in South Africa, received a standing ovation from the crowd and other presenters, following her presentation of the data at the conference on 24 July.

Bekker presented the full data for the PURPOSE 1 trial (NCT04994509) which evaluated the PrEP lenacapavir versus alternative daily PrEP in 5,345 HIV-negative, adolescent girls and young women aged 16 to 26 in South Africa and Uganda.

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The full data was presented at the 25th International AIDS Society Meeting 2024 (AIDS 2024), which is taking place in Munich, Germany. The company announced the 100% efficacy statistic in interim data in June.

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The trial demonstrated zero infections in HIV prevention in women. Lenacapavir demonstrated superior prevention compared with once-daily oral Truvada and Descovy. A total of 16 incident HIV cases among 1,068 women were observed in the Truvada group while 39 incident HIV cases among 2,136 women were observed in the Descovy group.

Lenacapavir also had high rates of adherence, 91.5% at week 26 and 92.8% at one year. Daily oral adherence rates, measured through blood samples from a subset of patients, was low and declined over time. At the one-year point, 15.9% of Descovy patients recording high or medium adherence and 7% of Truvada patients reported high or medium adherence.

The trial also did not require patients to be on birth control, allowing Gilead to conduct analysis on the impact on lenacapavir in pregnant women and their children. There were 510 pregnancies among 487 participants, with 193 among women in the lenacapavir group. Gilead said this observation is ongoing and will include evaluation of the presence of lenacapavir in breast milk and infant exposure.

“Having data on pregnant and lactating women and their offspring is beyond wonderful and sets a new benchmark for these studies. The women who continue in the open-label extension phase of PURPOSE ONE will be able to access lenacapavir should they choose until this product is available in Uganda and South Africa,” Bekker said.

After meeting the primary endpoint, Gilead was able to lift the blinded phase of the PURPOSE 1 and offer open-label lenacapavir to all participants. As of July 23, more than 840 trial participants have already opted to switch to lenacapavir.

The safety profile remained good, with the most common adverse event being injection site reaction. Aside from injection site reactions, the most common AEs were headache, urinary tract infection, genitourinary chlamydia infection, and nausea.

Coined a ‘miracle drug’ by UNAIDS executive director Winnie Byanyima, Gilead answered her request to provide lenacapavir to resource-limited countries where the disease is more prevalent.

Bekker said: “Gilead is developing a robust direct voluntary licensing programme to potential generic manufacturers to expedite access to lenacapavir in high-incidence resource-limited countries. Gilead is also ensuring dedicated lenacapavir supply in the countries where the need is greatest until those genuine numeric manufacturing partners can supply high-quality, low-cost lenacapavir.”

Bekker added that the company needs results from two pivotal trials to file for regulatory approval, with results from the PURPOSE 2 trial (NCT04925752) expected in late 2024 or early 2025. PURPOSE 2 is A Phase III study assessing twice-yearly lenacapavir for PrEP among cisgender men, transgender men, transgender women, and gender non-binary patients who have sex with partners assigned male at birth.

Senior vice president of clinical development and HIV franchise head, Dr Jared Baeten said: “As the only twice-yearly choice for HIV prevention, lenacapavir for PrEP could provide a critical new option for people who need or want PrEP around the world.

“As the most comprehensive and diverse HIV prevention trial program ever conducted, the PURPOSE programme embodies both the scientific and person-centred innovations that Gilead believes are critical to helping end the HIV epidemic for everyone, everywhere.”