Regulatory Merck gets approval from FDA for testing of HIV...

Merck gets approval from FDA for testing of HIV drug


After a dozen of the company’s trials were abandoned due to safety concerns, the Food and Drug Administration has now given Merck & Co. permission to continue studying its experimental HIV drug islatravir at a lower dose.

As per the agreement, Merck will start three new Phase 3 clinical trials of islatravir in combination with its licensed HIV drug Pifeltro, two of which will be conducted on adults with HIV-1 infection who have not received treatment in the past and the third on adults who have been on other antiviral medications which suppress the virus.

The participants will be given a choice to shift to a different study with a lower dosage of Islatravir if they are currently engaged in once-daily treatment studies with DOR 100 mg/ISL 0.75 mg and the dosage of the medication islatravir will be lower as compared to earlier research. 100 mg of Doravirine plus a lower dose of Islatravir will be administered orally once a day.

Merck’s growing experimental drug is islatravir, which the company has positioned as “the cornerstone of future Merck HIV treatment and prevention routines.” It is intended to work effectively in two-drug routines for HIV treatment, including those made for less frequent administration. The company has been working on developing it as an implant, injectable, and possibly oral formulation.

In addition, a Phase 2 study of islatravir and Gilead Sciences’ HIV therapy lenacapavir will be restarted with the use of a lower dose of Merck’s medication. In late October of last year, Merck was compelled to stop administering doses in a study of the medication after experts discovered that some patients had decreased levels of specific white blood cells. A week later, enrollment in a trial examining the combination of islatravir and lenacapavir was suspended by Merck and Gilead. Lenacapavir and islatravir are not licensed for usage together and are currently under investigation. The effectiveness of the combination of both drugs has not yet been observed. 

Eliav Barr, chief medical officer at Merck Research Laboratories, released a statement “Through extensive research work, discussions, and evaluations with FDA, we are confident to launch our new Phase 3 clinical study to evaluate islatravir for the treatment of HIV-1 infection. The business has always aimed at creating new medications for enhanced HIV protection”.

After extensive consideration and research, Merck will stop working on the once-monthly oral Islatravir for PrEP (pre-exposure prophylaxis). The daily monitoring of participants in the ongoing phase-III PrEP once-monthly investigations will continue and simultaneously the company will shortly begin a Phase 1 trial of a different substance that functions similarly to islatravir. All this progress and future development are in line with the goal of the company, and hence the success of these trials will guide the future course of the company. 

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