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Promising Results from Phase III Trials of Islatravir/Renacapavir Combination

On June 8, Gilead Sciences and Merck & Co., Inc. announced encouraging top-line results from two Phase III trials evaluating their innovative HIV treatment regimen of Islatravir and Renacapavir, which is administered once a week in a single oral tablet. This novel combination drug, if approved, could become the first long-acting oral treatment for HIV to be taken weekly.

The Phase III trials, known as ISLEND-1 and ISLEND-2, focused on HIV-positive individuals who had achieved viral suppression. In these trials, researchers assessed the efficacy and safety of switching to the combination therapy (Islatravir 2 mg and Renacapavir 300 mg) from either the existing treatment, Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in ISLEND-1, or standard daily antiretroviral therapy in ISLEND-2.

The results indicated that the combination was statistically non-inferior to the current standard of care. Both trials reached their primary endpoint of efficacy at Week 48, showing a similar safety profile to the control groups with no new safety concerns identified.

Dr. Jared Baeten, Senior Vice President of Clinical Development and Head of Infectious Diseases at Gilead, emphasized the potential impact of this long-acting oral medication: “Long-acting oral drugs represent a new trend in HIV treatment innovation that could significantly change the way treatment is administered. A groundbreaking HIV treatment that reduces dosing frequency could provide meaningful changes for people living with HIV, improving their flexibility and expanding their choices.”

The ISLEND-1 trial utilized a double-blind design to compare the weekly Islatravir/Renacapavir regimen against B/F/TAF, while ISLEND-2 was an open-label trial comparing it against standard antiretroviral therapy. The trials showed that the proportion of participants experiencing viral failure (with HIV-1 levels above 50 copies/mL) was comparable across the groups, suggesting robust efficacy and safety.

Renacapavir acts by targeting multiple stages of the HIV lifecycle, offering a unique approach to therapy. The collaboration between Gilead and Merck represents a shared commitment to ongoing research and development in the fight against HIV. Dr. Eliav Barr, Senior Vice President and Chief Medical Officer of Merck, noted that “This result is a strong testament to our shared goal and commitment to continuously research for the benefit of people living with HIV.”

If approved by regulatory authorities, this combination therapy could provide patients with an unprecedented option in oral HIV treatment, significantly contributing to their quality of life and adherence to treatment plans. The dual-action mechanism of Islatravir and Renacapavir may deliver enhanced viral suppression while simplifying the treatment regimen.

As of now, neither Islatravir nor Renacapavir has been approved in any country, highlighting the anticipation surrounding these trials. The urgency is amplified given the ongoing need for innovative therapies, as there is currently no cure for HIV or AIDS.

Key Details of the ISLEND Trials

• - ISLEND-1 (NCT06630286) evaluated the safety and efficacy of switching stable HIV-positive patients from Bictegravir to the Islatravir/Renacapavir regimen. Over the course of 48 weeks, it measured viral suppression outcomes and changes in CD4 count among participants.
• - ISLEND-2 (NCT06630299) similarly compared the weekly regimen to patients continuing standard therapy. Both trials aimed to establish that Islatravir/Renacapavir is as effective as, if not more so than, the existing standard therapies.

Conclusion

The promising results from these clinical trials reflect a significant advancement in HIV management, paving the way for a new era of treatment methodologies. As Gilead and Merck continue their pursuit of innovative solutions, the potential for a once-weekly oral treatment could reshape patient experiences, enhancing their adherence and ultimately improving outcomes in the fight against HIV.