In the beginning, two injections are given one month apart, and then every two months after that. Apretude or oral cabotegravir can be used to see how well patients can take the drug for four weeks. Participants who took Apretude started the study with cabotegravir and a placebo every day for up to five weeks. Then they took Apretude 600mg injections at months one and two, then every two months after that and a placebo tablet every day. For up to five weeks, people who took Truvada took oral Truvada and a placebo every day. Then they took oral Truvada every day and a placebo intramuscular injection every month for the next two years.
The Trials and Findings
It took place in Trial 1: 4,566 men and women who are cisgender or transgender and have had sex with men were given either Apretude or Truvada. The study looked at the rate of HIV infections in people who took cabotegravir every day, then got injections of Apretude every two months, compared to people who took Truvada every day. This is what the study found: People who took Apretude had a 69% lower risk of getting HIV than people who took Truvada. Trial 2: 3,224 cisgender women took either Apretude or Truvada in that trial.
The study looked at how many people who took oral cabotegravir and injections of Apretude got HIV compared to people who took Truvada orally. Those who took Apretude were 90% less likely to get HIV than those who took Truvada in the study. People who took Apretude had more side effects than people who took Truvada in both studies. These side effects include injection site reactions, headache, pyrexia, fatigue, back pain, myalgia, and rash. Apretude has a boxed warning that says not to use the drug unless you have a negative HIV test.
The HIV variants that are resistant to drugs have been found in people who haven’t been diagnosed with the virus when they use Apretude for HIV PrEeP. People who get HIV while taking Apretude for PrEP must start taking a full HIV treatment regimen. Priority Review and Breakthrough Therapy were given to Apretude. The FDA gave Viiv the go-ahead to sell Apretude.
