A new double blind study, HPTN 083, will examine whether injectable cabotegravir is as safe and effective in HIV prevention as daily oral Truvada, the only FDA–approved pre-exposure prophylaxis regimen for HIV.
“It is essential to develop multiple effective HIV prevention modalities so the most vulnerable populations have a choice of preventive options,” Raphael J. Landovitz, MD, MSc, HPTN 083 protocol chair, associate director of Clinical AIDS Research and Education at the University of California, Los Angeles (UCLA) and associate professor of medicine at UCLA’s David Geffen School of Medicine, said in a press release. “We hope injectable cabotegravir will become one such modality.”
Raphael J. Landovitz
In this first large-scale test of a long-acting injectable drug for HIV prevention, the researchers will evaluate approximately 4,500 HIV–uninfected men who have sex with men and transgender women who have sex with men in the United States, Argentina, Brazil, Peru, South Africa, Thailand and Vietnam. They will randomly assign HIV–uninfected persons who are at risk for HIV acquisition to either injectable cabotegravir (CAB) or Truvada (tenofovir disoproxil fumarate/emtricitabine, Gilead Sciences; TDF/FTC) for up to 4 years. At the end of the study, researchers will transition participants to locally available HIV prevention services.
CAB is not the only alternative to TDF/FTC currently under investigation. Research from a phase 2 trial conducted in the U.S. between 2012-2014 revealed that PrEP regimens containing Selzentry (maraviroc, ViiV Healthcare) were safe and well-tolerated compared with TDF/FTC. In a randomized, double blind study, investigators compared four regimens, one of which was TDF/FTC. The primary outcome of each regimen was safety and tolerability, not efficacy.
Paul A. Volberding
In previous interview, Paul A. Volberding, MD, Infectious Disease News chief medical editor and director of the AIDS Research Institute at the University of California, San Francisco, said that although TDF/FTC is almost completely effective, long-term safety remains a concern, especially for those who use PrEP for prolonged periods and are otherwise healthy.
“There is a sense of urgency to develop more tools for HIV prevention,” Myron Cohen, MD, co-principal investigator for the HIV Prevention Trials Network and director of the institute for global health and infectious diseases at the University of North Carolina, Chapel Hill, said in the release. “If demonstrated to be effective, long-acting injectable cabotegravir will provide an important option independent of adherence to a daily regimen.” – by Savannah Demko
Gulick RM, et al. J Infect Dis. 2016;doi:10.1093/infdis/jiw525.
Disclosure: The HIV Prevention Trials Network is funded by the National Institutes of Health. Sponsors and collaborators of the study include the National Institute of Allergy and Infectious Diseases, ViiV Healthcare and Gilead Sciences. Volberding reports serving on a data and safety monitoring board for Merck.