Gilead and Merck Partner to Develop Long-Acting Combination Therapy for HIV

Today, Gilead Sciences and MSD jointly announced that they have reached an agreement to co-develop and co-commercialize a long-acting HIV combination therapy. This regimen comprises Gilead’s capsid inhibitor lenacapavir and MSD’s innovative nucleoside reverse transcriptase translocation inhibitor (NRTTI) islatravir. Both investigational therapies are potential first-in-class agents and are currently in late-stage clinical development. Their combination holds the promise of providing a complete long-acting treatment option for people with HIV, administered either orally or by injection.

With the advancement of anti-HIV therapies, most people living with HIV can now achieve viral suppression through daily antiretroviral therapy. However, statistical data from 2019 indicate that there were still 1.7 million new HIV infections globally. Currently, the development of long-acting HIV therapies has become a key focus in HIV drug research and development. Long-acting HIV therapies may improve medication adherence among infected individuals and potentially yield better outcomes, whether used as treatment or as pre-exposure prophylaxis (PrEP).

Islatravir is an innovative nucleoside reverse transcriptase translocation inhibitor (NRTTI) developed by Merck & Co., Inc. Preclinical studies have demonstrated that it can inhibit the function of HIV reverse transcriptase through multiple mechanisms. Islatravir exhibits a long half-life in humans. Previous Phase I clinical trial data showed that, when administered as a subcutaneous sustained-release implant, a single dose of islatravir maintained drug concentrations above the level required for antiviral efficacy for 12 months.

Lenacapavir is an innovative capsid inhibitor developed by Gilead Sciences, Inc. that interferes with the assembly and disassembly of the HIV capsid protein. Lenacapavir has been granted Breakthrough Therapy Designation by the U.S. FDA, with the advantage that patients may only need to receive treatment once every six months. This investigational therapy has demonstrated significant activity in reducing viral loads in Phase 2/3 clinical trials.

Under the agreement, Merck Sharp & Dohme and Gilead Sciences will jointly develop long-acting HIV combination therapies comprising islatravir and lenacapavir, administered either orally or by injection. Clinical trials are expected to commence in the second half of this year, initially evaluating the efficacy and safety of the oral combination regimen.

Note: The original text has been abridged.

References:

[1] Gilead and Merck Announce Agreement to Jointly Develop and Commercialize Long-Acting, Investigational Treatment Combinations of Lenacapavir and Islatravir in HIV. Retrieved March 15, 2021, from https://www.merck.com/news/gilead-and-merck-announce-agreement-to-jointly-develop-and-commercialize-long-acting-investigational-treatment-combinations-of-lenacapavir-and-islatravir-in-hiv/

[2] Merck Announces HIV Collaboration with Gilead. Retrieved March 15, 2021, from https://s21.q4cdn.com/488056881/files/doc_presentations/2021/Merck-Announces-HIV-Collaboration-with-Gilead.pdf

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