FDA suspends Merck's HIV drug islatravir oral and implantable investigational new drug application

CompilationFan Dongdong

A few days ago, Merck announced that the US FDA has suspended the investigational new drug application (IND) for oral and implantable islatravir (MK-8591)

The company previously applied for islatravir for HIV-1 pre-exposure prevention (PrEP), eslavir injection for HIV-1 treatment and prevention, and combination with dolaverin (DOR/ISL) for HIV-1 Treat once a day

As part of the PrEP trial, participants currently receiving islatravir (including oral and implant preparations), as well as subjects used for treatment and prophylaxis of islatravir, will no longer receive treatment with the study drug, and researchers will be responsible for monitoring the The recovery of CD4+ T cell and total lymphocyte counts in patients with this category

Trial studies that have been completely clinically shelved include the following:

MK-8591-016 is a phase 2a PrEP trial that evaluates the safety and pharmacokinetics of oral islatravir once a month in participants with a low risk of HIV-1 infection;

MK-8591-022 (IMPOWER22) is a phase 3 PrEP trial that evaluates the efficacy of oral islatravir once a month in cisgender women at high risk of HIV-1 infection;

MK-8591-024 (IMPOWER24) is a phase 3 PrEP trial that evaluates the efficacy of oral islatravir once a month on cisgender men and transgender women who have sex with men and are at high risk of HIV-1 infection;

MK-8591-034 is a phase 1 study evaluating islatravir injection;

MK-8591-035 is a phase 2 PrEP trial that evaluates monthly oral islatravir in transgender and different gender individuals.

MK-8591-043 is a phase 2a PrEP trial that evaluates the efficacy of islatravir injection once a year in individuals at low risk of HIV-1 infection.

The following studies have been put on hold in some clinical trials:

MK-8591-011 is a phase 2 dose range study of oral DOR/ISL and lamivudine (3TC) for untreated HIV-1 infected adult participants.

MK-8591A-017 is a once-a-day, open-label Phase 3 oral study to evaluate the efficacy of virologically suppressed HIV-1 adult patients’ conversion from antiretroviral therapy (ART) to DOR/ISL.

MK-8591A-018 is a phase 3 oral study evaluating the conversion of virologically suppressed HIV-1 adult patients from bitegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) For the efficacy of DOR/ISL, patients have completed registration;

MK-8591A-019 is a phase 3 study that evaluates the efficacy of oral islatravir and DOR/ISL once a day in participants who have received a large number of treatments (HTE) infected with HIV-1;

MK-8591A-020 is a phase 3 study evaluating oral islatravir and DOR/ISL once a day in untreated HIV-1 infected participants;

MK-8591A-028 is a phase 2 open-label study that evaluates the treatment of oral DOR/ISL once a day on HIV-1 children who have received ART virological inhibition for ≥3 months or have not received treatment;

MK-8591A-033 is a phase 3 open-label follow-up study of HIV-1 adult and child participants treated with oral DOR/ISL once a day in an early clinical study

In addition, another HIV research trial of islatravir by Merck also encountered setbacks

The decision was made after the two companies jointly announced on November 23 that they would suspend further recruitment and screening research, which began in October 2021

Reference source: Merck Announces Clinical Holds on Studies Evaluating Islatravir for the Treatment and Prevention of HIV-1 Infection