Courier joins forces to develop long-acting HIV combination therapy, Gilead and Merck start Phase 2 trials

▎Editor of WuXi AppTec Content Team On October 26, 2021, Gilead Sciences and Merck & Co.
(MSD) announced that they will start a phase 2 clinical trial to obtain virological suppression after receiving antiretroviral therapy.
In HIV-infected patients, evaluate the effectiveness of the combination of islatravir/lenacapavir orally administered once a week
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Gilead Sciences’ capsid inhibitor lenacapavir and Merck’s innovative nucleoside reverse transcriptase translocation inhibitor (NRTTI) islatravir are both potential “first-in-class” drugs and are both in the late stage of clinical development
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Lenacapavir can interfere with the assembly and disassembly of the HIV virus capsid protein and play a role in multiple stages of the HIV-1 life cycle
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Lenacapavir was granted a breakthrough therapy designation by the U.
S.
FDA in May 2019, and is used in combination with other antiretroviral drugs to treat patients with multiple drug resistance and severely treated HIV-1 infection
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A previous Phase 2/3 trial showed that lenacapavir allows patients to expect to receive only one injection every 6 months to maintain its effectiveness
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▲Introduction to Lenacapavir therapy (picture source: Gilead Sciences official website) Preclinical studies have shown that islatravir can inhibit the function of HIV reverse transcriptase through a variety of mechanisms.
Its mechanism of action is different from the currently approved anti-HIV therapies and traditional nucleosides.
Class reverse transcriptase inhibitors (NRTIs)
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At present, Merck has carried out a number of clinical trials to test its effect as a single-agent PrEP therapy and in combination with other antiviral therapies to treat HIV infection
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▲The molecular structure of Islatravir (picture source: Edgar181, Public domain, via Wikimedia Commons) This clinical trial is based on the cooperation reached between the two companies in March 2021
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Islatravir and lenacapavir both have a long half-life and show activity at low doses.
Their combination is expected to provide a complete oral or injection long-acting treatment plan for HIV patients
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The primary endpoint of this open-label, active-control, multi-center Phase 2 trial is that at week 24 of treatment, compared with commonly used drugs B/F/TAF, adult HIV patients with HIV-1 RNA viral load ≥50 copies/ml The proportion of subjects
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Dr.
Jared Baeten, Vice President of HIV Clinical Development of Gilead Sciences, said: "Our goal is to provide long-term treatment options to help address the needs of different HIV-infected people
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The
launch of this clinical trial is an important step towards this goal.
One step
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"Reference: [1] Gilead and Merck Initiate Phase 2 Study Evaluating an Oral Weekly Combination Regimen of Investigational Lenacapavir and Investigational Islatravir for HIV-1 Treatment in Virologically Suppressed Adults.
Retrieved October 26, 2021, from https://www .
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