Benefits of Lenacapavir
Lenacapavir is an innovative HIV-1 capsid inhibitor developed by Gilead Sciences, which has demonstrated significant potential in the prevention and treatment of HIV. Here are the key benefits of lenacapavir:
1. Long-Acting Dosing
Benefit: Lenacapavir is administered twice yearly, providing a long-acting option for HIV prevention and treatment.
- Improved Adherence: The extended dosing schedule reduces the frequency of administration, which can significantly improve adherence compared to daily medications.
- Convenience: Fewer doses mean less frequent healthcare visits and less burden on patients, making it a convenient option for many.
2. Efficacy in HIV Prevention
Benefit: In clinical trials, lenacapavir has demonstrated 100% efficacy in preventing HIV infections among cisgender women.
- Zero Infections: In the Phase 3 PURPOSE 1 trial, there were no incident cases of HIV infection among women receiving lenacapavir, highlighting its effectiveness.
- Superior Performance: Lenacapavir showed superiority over daily oral Truvada® and background HIV incidence (bHIV) in the same trial.
3. Potential to Reduce HIV Transmission
Benefit: As a potent preventive measure, lenacapavir can play a crucial role in reducing the transmission of HIV.
- Community Impact: By effectively preventing new infections, lenacapavir could help lower HIV incidence rates in high-risk populations and communities.
- Public Health Benefit: Widespread use of lenacapavir could contribute to the broader goal of ending the HIV epidemic.
4. Tolerability and Safety
Benefit: Lenacapavir has been generally well-tolerated in clinical trials, with no significant or new safety concerns identified.
- Minimal Side Effects: The drug has shown a favorable safety profile, making it a viable option for long-term use.
- Patient Confidence: Good tolerability can increase patient confidence and willingness to adhere to the treatment regimen.
5. Addresses Adherence Challenges
Benefit: The twice-yearly dosing schedule of lenacapavir helps overcome common adherence challenges associated with daily oral PrEP (pre-exposure prophylaxis).
- Stigma Reduction: Less frequent dosing may reduce the stigma and discrimination some people face when taking or storing daily oral PrEP pills.
- Improved Persistence: The extended dosing interval can help maintain consistent protection against HIV, improving overall persistence with the prevention regimen.
6. Versatility in HIV Treatment
Benefit: Lenacapavir is being studied for use in both HIV prevention and treatment, showcasing its versatility.
- Combination Therapy: In addition to its use as PrEP, lenacapavir is being investigated as part of combination therapy for HIV treatment, providing a new option for people living with HIV.
- Broad Applicability: Its potential use across different stages of HIV management makes it a valuable addition to the arsenal of HIV therapies.
7. Inclusion in Diverse Populations
Benefit: The ongoing clinical trials for lenacapavir include diverse populations, ensuring its effectiveness across various demographics.
- Inclusive Research: Trials like PURPOSE 2 are assessing lenacapavir among cisgender men who have sex with men, transgender men, transgender women, and gender non-binary individuals, ensuring broad applicability.
- Health Equity: By focusing on diverse populations, lenacapavir aims to address health disparities and promote health equity in HIV prevention and treatment.
Independent Data Monitoring Committee Recommended That Gilead Stop the Blinded Phase of the PURPOSE 1 Trial at Interim Analysis and Offer Open-Label Lenacapavir to All Participants
Foster City, Calif. – June 20, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) has announced the interim analysis results from its pivotal Phase 3 PURPOSE 1 trial, indicating that the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100% efficacy for HIV prevention in cisgender women.
The PURPOSE 1 trial met its key efficacy endpoints, proving the superiority of twice-yearly lenacapavir over once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and the background HIV incidence (bHIV). Based on these results, the independent Data Monitoring Committee (DMC) recommended stopping the blinded phase of the trial and offering open-label lenacapavir to all participants.
“With zero infections and 100% efficacy, twice-yearly lenacapavir has demonstrated its potential as an important new tool to help prevent HIV infections,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We look forward to additional results from the ongoing PURPOSE clinical program and continuing toward our goal of helping to end the HIV epidemic for everyone, everywhere.”
Topline PURPOSE 1 Data
The Phase 3 PURPOSE 1 trial is a double-blind, randomized study evaluating the safety and efficacy of twice-yearly, subcutaneous lenacapavir for pre-exposure prophylaxis (PrEP) and once-daily oral Descovy® (emtricitabine 200mg and tenofovir alafenamide 25mg; F/TAF) in more than 5,300 cisgender women and adolescent girls aged 16-25 across 25 sites in South Africa and three sites in Uganda. Participants were randomized in a 2:2:1 ratio to lenacapavir, Descovy, and Truvada, respectively.
There were zero incident cases of HIV infection among the 2,134 women in the lenacapavir group (0.00 per 100 person-years), compared to 16 incident cases among 1,068 women in the Truvada group (1.69 per 100 person-years). These results demonstrated the superiority of twice-yearly lenacapavir over bHIV (2.41 per 100 person-years) and over once-daily Truvada, with p<0.0001 for both endpoints. Lenacapavir was generally well-tolerated with no significant or new safety concerns identified.
Broader Context and Future Directions
HIV incidence in the Descovy group was numerically similar to that in the Truvada group, with 39 incident cases among 2,136 women (2.02 per 100 person-years), and was not statistically superior to bHIV. Challenges with adherence to daily oral pills for PrEP were noted, and adherence analyses for Descovy and Truvada from PURPOSE 1 are ongoing. Both Descovy and Truvada were generally well-tolerated with no new safety concerns identified.
“Twice-yearly lenacapavir for PrEP, if approved, could provide a critical new choice for HIV prevention that fits into the lives of many people who could benefit from PrEP around the world—especially cisgender women,” said Linda-Gail Bekker, MBChB, DTM&H, DCH, FCP(SA), PhD, Director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, and past President of the International AIDS Society.
Additional Trials and Future Approvals
Additional PURPOSE trials assessing twice-yearly lenacapavir for PrEP are ongoing. Results from PURPOSE 2, which focuses on cisgender men who have sex with men, transgender men, transgender women, and gender non-binary individuals in various countries, are expected in late 2024 or early 2025. The regulatory filing for lenacapavir for PrEP will include results from both PURPOSE 1 and PURPOSE 2 to ensure approval for multiple populations in need of additional HIV prevention options.
Gilead remains committed to enabling access to lenacapavir for PrEP, especially in high-incidence, resource-limited countries. The company will brief community partners and provide a public statement regarding its planned access approach for these countries.
For more information about the PURPOSE program, visit www.purposestudies.com.
U.S. Indication and Important Safety Information for Descovy for PrEP®
DESCOVY for PrEP is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. The U.S. FDA has not evaluated the effectiveness of DESCOVY for PrEP in this population.
BOXED WARNING
RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION AND POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
DESCOVY FOR PrEP must be prescribed only to individuals confirmed to be HIV negative immediately prior to initiation and at least every 3 months during use. Severe acute exacerbations of hepatitis B have been reported in individuals infected with hepatitis B virus (HBV) who discontinued products containing FTC and/or TDF and may occur with discontinuation of DESCOVY.
About Gilead HIV
Gilead Sciences, Inc. is a biopharmaceutical company committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. Gilead operates in over 35 countries with a mission to create a healthier world for all people.
For more than 35 years, Gilead has led the field in HIV research, developing 12 HIV medications, including the first single-tablet regimen and the first long-acting injectable HIV treatment. Gilead aims to end the HIV epidemic through scientific innovation, education, and expanding access to care.
Forward-Looking Statements
This press release includes forward-looking statements subject to risks, uncertainties, and other factors, including Gilead’s ability to complete clinical trials and obtain regulatory approvals. These risks are detailed in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the U.S. Securities and Exchange Commission. Gilead assumes no obligation to update any forward-looking statements.