Infectious Disease

The month-to-month capsule exhibits promise for HIV PrEP and can enter Section Three improvement

February 03, 2021

2 min read

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Hillier S. et al. Abstract 1363. Presented at: HIV Research for Prevention; 27.-28. January and 3-4. February 2021 (virtual meeting).

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A once-monthly pill showed promise for HIV-PrEP, according to an interim analysis of the data in a Phase 2a study.

Islatravir, formerly known as MK-8591, is a novel nucleoside reverse transcriptase translocation inhibitor being developed by Merck.

Sharon L. Hillier

Speaking to reporters during the HIV Research for Prevention virtual meeting, Sharon L. Hillier, PhD, Professor of Reproductive Infectious Diseases at the University of Pittsburgh Medical School and Director of Reproductive Disease Research at UPMC Magee-Women’s Hospital in Pittsburgh, called Islatravir “extremely effective [with] an extremely long half-life. “

“Which means it is a long-acting agent that can be used for prevention or treatment,” she said.

An ongoing, randomized, double-blind, placebo-controlled, multicenter, parallel-group study is evaluating the safety, tolerability, and pharmacokinetics (PK) of oral islatravir in adults aged 18 to 65 years with a low risk of HIV.

The results presented at the meeting came from an analysis of participants who had randomly received 6 monthly oral doses of islatravir 60 mg, islatravir 120 mg, or placebo at a 2: 2: 1 ratio.

At the time of the analysis, Merck said 192 of the 250 participants had received six doses of islatravir that were found to be well tolerated and able to “meet thresholds that are believed to be sufficient to prevent HIV,” said Hillier. In particular, according to the abstract, an interim pharmacokinetic (PK) analysis of data showed that trough levels were “well above the specified PK threshold for HIV-1” after each dose, and preliminary analysis of biopsied tissues indicated “rapid, sustained and appropriate distribution ”of islatravir on tissue samples.

Phase 3 clinical trials will begin later this year to test whether islatravir can prevent HIV once a month – the first in cisgender women in the US and Africa and the second in transgender women and men who having sex with men in a global study. Said Hillier.

Since it’s a once-a-month drug, it’s “probably a little more forgiving,” Hillier said.

“That said, if the dose is taken too late or people miss a dose, it may actually still reach levels that protect,” she said.

The researchers have also reported promising data on long-acting injectable PrEP, particularly cabotegravir, which the FDA has given a breakthrough therapeutic name for HIV prevention.

Hillier said that both long-acting injectable PrEP and once-monthly oral PrEP could provide options for patients who want to prevent HIV while being discreet – something a daily oral drug doesn’t.

“I don’t think there will be a single magic bullet that is right for one person,” said Hillier.

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HIV research for prevention

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