By Nina Cosdon
Cabotegravir has a deadline of January 24, 2022, and would become the first approved long-acting HIV PrEP therapy.
ViiV Healthcare announced today that the Food and Drug Administration (FDA) granted priority review for a New Drug Application (NDA) for cabotegravir, for an HIV prevention indication.
The FDA set a projected approval date of January 24, 2022, and if approved, cabotegravir will be the first long-acting therapy for HIV prevention.
Cabotegravir is an injectable form of pre-exposure prophylaxis (PrEP) intended for people at risk of sexually acquired HIV infection. Its priority review status follows its previous designation by the FDA as a breakthrough therapy.
The NDA was granted following a review of two double-blind, phase 2b/3 studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of long-acting cabotegravir. Participants in HPTN 083 included 4,566 men who have sex with men and transgender women who have sex with men, and participants in HPTN 084 included 3,223 cisgender women at increased risk of HIV infection. HPTN 083 opened for enrollment in November 2016, and HPTN 084 opened for enrollment in November 2017.
The trials included an oral introduction to ensure that all test subjects could tolerate cabotegravir well before starting intramuscular injections every eight weeks.
The most common side effects experienced by at least 1% of test subjects were injection site reaction, diarrhea, headache, sleep disturbances, fatigue, dizziness, nausea, and abdominal pain. In addition, some participants in HPTN 083 experienced pyrexia and flatulence, and some participants in HPTN 084 experienced vomiting, myalgia, and rash.
Both trials were stopped early by Data Safety Monitoring Boards after initial results showed that long-acting cabotegravir is superior to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in preventing HIV transmission.
Kimberly Smith, MD, MPH, director of Research and Development at ViiV Healthcare, emphasized the importance of the FDA's priority review of long-acting cabotegravir, which she touted as evidence of the injection's effectiveness over previous PrEP drugs.
Smith added: “In the United States, less than 25% of people who could benefit from PrEP are currently taking it, which points to the need for additional HIV prevention options. We believe that new options, such as the investigational long-acting cabotegravir for PrEP, will help play an important role in our collective efforts to end the HIV epidemic.”