The company noted that week 48 data met safety and efficacy endpoints in adults with HIV-1 infection currently on antiretroviral therapy. The safety and tolerability profile of DOR/ISL during the trials to date are consistent with the previously reported Phase 2 studies.
The coadministration of islatravir with dolutegravir and TDF revealed no clinically meaningful impact on islatravir, dolutegravir, and tenofovir pharmacokinetics, with no safety issues identified. These data support continued clinical investigation of islatravir as an option for the treatment and prevention of HIV-1 infection.
Islatravir a highly potent nucleoside reverse transcriptase translocation inhibitor (NRTTI) with a long intracellular half-life, is currently in development to treat and prevent HIV. The therapy works by rapidly converting to its active triphosphate (TP) form, islatravir-TP, within targeted cells. Islatravir-TP inhibits reverse transcriptase to suppress HIV replication.
Islatravir: Investigating Long-Term Treatment Options for PrEP Read More »
The pharma giant revealed top-line results this morning from its pivotal Phase III trials of a once-daily oral pill combining Merck’s FDA-approved anti-HIV treatment Pifeltro with islatravir. The participants, who are adults with HIV-1 infection who are on two different antiretroviral therapy protocols, including a bictegravir/emtricitabine/tenofovir triple, were compared at 48 weeks.
We conducted a randomized, double-blind, placebo-controlled, phase 1 trial in adults without HIV-1 infection. Participants received islatravir or placebo subdermal implants for 12 weeks and were monitored throughout this period and after implant removal.
Two phase 1 trials were conducted during initial evaluation of islatravir: rising single doses (Study 1) and rising multiple doses (Study 2) of oral islatravir in male and female participants without HIV (aged 18–60 years). Safety, tolerability, and pharmacokinetics of islatravir (plasma) and islatravir-triphosphate (peripheral blood mononuclear cells) were assessed. I
Islatravir is not expected to interact with the major pathways associated with other antiretroviral agents, including dolutegravir, doravirine, and tenofovir disoproxil fumarate [54,71,76] as well as with commonly prescribed medications, including … buprenorphine/naloxone, selective serotonin reuptake inhibitors, oral contraceptives, and… These results support the continued clinical evaluation of islatravir as an option across diverse populations
No new HIV infections were recorded during the trial. Oral ISL at both 60mg and 120mg were well tolerated by participants for the 24 weeks of the trial and reached a predetermined threshold for HIV prevention.
Merck shares results of Islatravir as PrEP trial Read More »
Islatravir (ISL) is a nucleoside reverse transcriptase translocation inhibitor in development for prevention of HIV-1. Phase 3 trials of oral ISL 60 mg once monthly (QM) are enrolling. We present unblinded safety and pharmacokinetic (PK) results through Week 24 of an ongoing phase 2a trial of monthly ISL for PrEP. Methods: This randomized, double-blind, placebo-controlled,
Islatravir (ISL, MK-8591) is a nucleoside reverse transcriptase translocation inhibitor (NRTTI) in development for the treatment and prevention of HIV-1 infection. We previously showed that ISL + doravirine (DOR) was effective in maintaining viral suppression through week 96 and was well-tolerated. Here we present a detailed safety analysis of those results. [blocked by paywall]
