Phase 2 study of the safety and tolerability of maraviroc-containing regimens to prevent HIV infection in men who have sex with men (MSM) (HPTN 069/ACTG A5305)
Gulick RM, Wilkin TJ, Chen YQ, Landovitz RJ, Amico KR, Young AM, Richardson P, Marzinke MA, Hendrix CW, Eshleman SH, McGowan I, Cottle LM, Andrade A, Marcus C, Klingman KL, Chege W, Rinehart AR, Rooney JF, Andrew P, Salata RA, Magnus M, Farley JE, Liu A, Frank I, Ho K, Santana J, Stekler JD, McCauley M, Mayer KH.
Maraviroc (MVC) is a candidate for HIV pre-exposure prophylaxis (PrEP).
Phase 2 48-week safety/tolerability study of four regimens: MVC alone, MVC+emtricitabine (FTC), MVC+tenofovir disoproxil fumarate (TDF), and TDF+FTC. Eligible participants were HIV-uninfected men and transgender women reporting condomless anal intercourse with >1 HIV-infected or unknown-serostatus man within 90 days. At each visit, assessments, laboratory testing, and counseling were done. Analyses were intention-to-treat. Registry #NCT01505114 RESULTS: Among 406 participants, 84% completed follow-up, 7% stopped early, and 9% were lost-to-follow-up; 9% discontinued their regimen early. The number discontinuing and time-to-discontinuation did not differ among study regimens (p=0.60). Grade 3-4 adverse event rates did not differ among regimens (p=0.37). In a randomly-selected subset, 77% demonstrated detectable drug concentrations at week 48. Five participants acquired HIV infection (4 MVC alone, 1 MVC+TDF; overall annualized incidence 1.4% [95% CI:0.5%, 3.3%], without differences by regimen, p=0.32); 2 had undetectable drug concentrations at every visit, 2 had low concentrations at the seroconversion visit, and 1 had variable concentrations.
MVC-containing regimens were safe and well-tolerated compared to TDF+FTC; this study was not powered for efficacy. Among those acquiring HIV infection, drug concentrations were absent, low, or variable. MVC-containing regimens may warrant further study for PrEP.
J Infect Dis. 2016 Nov 2. pii: jiw525. [Epub ahead of print]