Merck unveils Phase 2b results of investigational HIV-1 therapy

By Mateen Dalal

	New findings come from evaluation of Doravirine combined with Islatravir versus DELSTRIGO.
	 
	The company plans to start Phase 3 trials soon.


Merck & Co., (Merck), a leading biopharmaceutical company known as MSD across the globe except Canada and U.S.A., has reportedly declared results from a Phase 2b medical trial evaluating the safety, efficacy and tolerability of Islatravir [MK-8591], the company’s Investigational HIV-1 therapy.

Reports cite, clinical study evaluated once-daily, three oral doses of Islatravir, for 24 weeks initially, in combination with the company’s doravirine plus lamivudine (3TC, 300 mg) and for an additional 24 weeks in combination with just doravirine, as compared to DELSTRIGO in HIV-1 infected adults.

In all dose levels, the doravirine and Islatravir combination maintained antiviral activity when measured by the number of participants gaining HIV-1 RNA levels <50 copies/mL, same as DELSTRIGO in 48th week of study.

These clinical trial findings were presented at the 10th International AIDS Society Conference on HIV Science (IAS 2019) held in Mexico City, Mexico and was also presented in official IAS press program 2019.

A combination of PIFELTRO (doravirine, 100 mg) with other ARV agents is indicated for treating HIV-1 infection among adults with no previous ARV treatment history. Meanwhile, DELSTRIGO (tenofovir disoproxil fumarate 300 mg/ doravirine 100 mg/ 3TC 300 mg) is indicated to be a whole regimen to treat HIV-1 infection in adult patients with no previous ARV treatment history.

The Prof of Infectious Disease, Paris Diderot University, Head of Infectious Disease Department, Saint-Louis Hospital, Paris, and the study’s lead investigator Dr. Jean Michel Molina stated that these results facilitate proof for antiviral properties of doravirine in combination with Islatravir as a probable once-daily double regimen for people with HIV-1. Dr. Molina further added that there is a continuing necessity for additional effective therapeutic regimens to treat the people with HIV-1, and Islatravir study warrants further study.

The collected data would further be used in the Phase 3 trials where Islatravir would be combined with doravirine across a diverse demographic to meet the changing needs of people suffering from HIV-1.

Source Credit: https://www.mrknewsroom.com/news-release/research-and-development-news/merck-announces-presentation-phase-2b-results-investigati