Twice-Yearly PrEP Shows Promise in Clinical Trials

When the FDA approved the first injectable treatment for HIV pre-exposure prophylaxis (PrEP), the agency hailed the therapy as “an important tool in the effort to end the HIV epidemic” due to its every-two-months regimen, lessening the burden of oral treatments that were taken every day. But a new injectable agent may soon be approved that reduces that treatment burden to twice a year.

Gilead Sciences, Inc. revealed on Sept. 12 that twice-yearly treatment with its lenacapavir in a second Phase III trial reduced HIV infections by 96% compared with background HIV incidence. In addition, among the 2,180 participants in the lenacapavir group in the PURPOSE 2 trial, there were two incident cases, meaning that 99.9% of the participants did not acquire HIV infection.

The treatment also demonstrated superiority over Gilead’s once-daily tablet Truvada (emtricitabine/tenofovir disoproxil fumarate), the company said.

Because the trial met both its primary and secondary endpoints, the independent Data Monitoring Committee recommended that the company stop the trial’s blinded phase and offer open-label lenacapavir to all of the participants.

A previous Phase III trial, PURPOSE 1, also was unblinded early after it met its key efficacy endpoints. Gilead said that it would use data from both trials to support global regulatory filings that it plans to begin by the end of this year, with an eye on launches in 2025.

“In the United States, the stubbornly high rate of HIV diagnoses — especially in the U.S. South, and particularly among gay and bisexual men of color and transgender people — demands novel approaches to help people prevent HIV acquisition,” said Colleen Kelley, M.D., professor of medicine at Emory University and a PURPOSE 2 principal investigator. “Because adherence to oral products can be challenging for some people, twice-yearly injectable lenacapavir for PrEP has the potential to be one of the most impactful interventions we could have to drive down new infections and bring us closer to ending the HIV epidemic in the United States.”

Lenacapavir already is available in the U.S. as Sunlenca, following the FDA’s Dec. 22, 2022, approval of it for the treatment, in combination with other antiretroviral(s), of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current ARV regimen due to resistance, intolerance or safety considerations.

Three other branded agents currently have FDA approval for PrEP. Gilead’s Truvada was the first drug to gain approval for the indication, on July 16, 2012. Several generics of the agent are now available. Another once-daily Gilead tablet, Descovy (emtricitabine/tenofovir alafenamide), was approved for PrEP on Oct. 3, 2019. Then on Dec. 20, 2021, the FDA approved ViiV Healthcare’s Apretude (cabotegravir) as the first injectable PrEP. Following an initial lead-in dosing regimen, Apretude is given every two months.

For the Managed Care Biologics and Injectables Index: Q3 2023, from Aug. 13, 2023, to Sept. 29, 2023, Zitter Insights polled 35 commercial payers covering 117.8 million lives, 28 Medicare payers covering 43.6 million lives, 50 physicians and 50 practice managers about their management and prescribing of HIV treatments, as well as the impact of the lawsuits concerning the Affordable Care Act (ACA) and access to PrEP medications.

AIS Health and Zitter Insights are both divisions of MMIT.

The ACA mandated that all non-grandfathered group and individual health plans must offer no-cost coverage of preventive services recommended by the U.S. Preventive Services Task Force (USPSTF), the Advisory Committee on Immunization Practices (ACIP) and the Health Resources and Services Administration (HRSA).

On Aug. 22, 2023, the USPSTF released a final recommendation — which was consistent with the 2019 recommendation — for clinicians to prescribe PrEP using ARV to adolescents and adults weighing at least 77 pounds who are at increased risk of acquiring HIV to decrease that risk.

However, a court decision in June on one of the ACA lawsuits, Braidwood v. Becerra, called into question the USPSTF’s ability to recommend preventive services coverage mandates to federal regulators. The ruling means that mandated coverage, for now, remains in place except for the plaintiffs in the suit.

The existing PrEP agents are indicated for adolescents and adults who are at risk of acquiring HIV infection. The USPSTF’s recommendation listed instances in which people should be considered for PrEP and receive no-cost coverage of it. Zitter Insights found that the top reasons among payers to provide this coverage are if the member has a partner who has HIV; if the member has shared needles, injected drugs or been in drug treatment within the past six months; and if the member has several sex partners (see chart).

Once the FDA approves more PrEP agents than the current options, 57% of payer respondents said that their organization would implement utilization management requirements.

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