The FDA is scheduled make a decision on injectable cabotegravir by Jan. 24, 2022.
A therapy under review at the FDA would, if approved, be the first long-acting injectable pre-exposure prophylaxis (PrEP) for the prevention of HIV infection. The FDA has accepted and granted priority review for ViiV Healthcare’s new drug application for cabotegravir.
A cabotegravir-rilpivirine combination, sold under the brand name Cabenuva, was approved by the FDA earlier this year as an HIV treatment. Now the question is whether the agency will approve cabotegravir to prevent HIV infection.
ViiV, which is owned by GlaxoSmithKline and Pfizer, has submitted data from two separate phase 2b/3 studies that evaluated the safety and efficacy of cabotegravir for PrEP in men who have sex with men, transgender women, and cisgender women. Both studies were stopped early by independent monitoring boards after cabotegravir was shown to be superior to daily oral Truvada (emtricitabine/tenofovir disoproxil fumarate) in preventing HIV.
In the HPTN 083 study, cabotegravir was administered every eight weeks. The study enrolled 4,566 men who have sex with men and transgender women who have sex with men in Argentina, Brazil, Peru, United States, South Africa, Thailand and Vietnam.
In the HPTN 084 study, 3,223 women were enrolled who are at increased risk of HIV acquisition in Botswana, Kenya, Malawi, South Africa, Eswatini, Uganda and Zimbabwe.
Cabotegravir and Truvada tablets were both well tolerated, with most adverse events being mild or moderate in severity.
An estimated 38 million people are living with HIV around the world, and there were 1.7 million new cases of HIV at the end of 2019. In the United States, HIV diagnoses are decreasing. From 2015 to 2019, diagnoses declined 9%, according to the CDC.
“In the United States, fewer than 25% of those who could benefit from PrEP are currently taking it, which points to the need for additional HIV prevention options. We believe new options like investigational cabotegravir long-acting for PrEP will help play a significant role in our collective efforts to end the HIV epidemic,” Kimberly Smith, M.D., head of research & development at ViiV Healthcare, said in a statement.
The FDA granted breakthrough designation to cabotegravir in November 2020.
ViiV Healthcare officials said the company will initiate submissions of cabotegravir to other regulatory authorities by the end of 2021.
ViiV Healthcare, a company focused on developing therapies for HIV, also released data at IDWeek Sept. 29, 2021 to Oct. 3, 2021, about Dovato, a therapy that combines the integrase strand transfer inhibitor dolutegravir with the nucleoside reverse transcriptase inhibitor lamivudine.
Data from the TANGO study showed Dovato maintained viral suppression over the course of the study. At three years, no participants taking Dovato met virologic failure, versus three participants in the control group who were taking tenofovir alafenamide fumarate regimen.
The FDA approved Dovato in 2019.