Randomized Trial of Clinical Safety of Daily Oral Tenofovir Disoproxil Fumarate Among HIV-Uninfected Men Who Have Sex With Men in the United States

• DOI: 10.1097/qai.0b013e31828ece33
• Publication Date: 2013-03-06T13:01:52Z
• Authors: Lisa A. Grohskopf; Kata L. Chillag; Roman Gvetadze; Albert Y. Liu; Melanie Thompson; Kenneth H. Mayer; Brandi M. Collins; Sonal R. Pathak; Brandon O'Hara; Marta L. Ackers; Charles E. Rose; Robert M. Grant; Lynn A. Paxton; Susan P. Buchbinder
• Keywords: Pill; Serostatus; Discontinuation

Objectives: To evaluate the clinical safety of daily tenofovir disoproxil fumarate (TDF) among HIV-negative men who have sex with men. Design: Randomized, double-blind, placebo-controlled trial. Participants were randomized 1:1:1:1 to immediate or delayed study drug (TDF, 300 mg orally per day, placebo). Methods: Four hundred healthy HIV-uninfected reporting anal another man within previous 12 months enrolled in Atlanta, Boston, and San Francisco. HIV serostatus, laboratory adverse events (AEs), adherence (pill count, Medication Event Monitoring System, self-report), sexual other sociobehavioral data assessed at 3-month intervals for 24 months. Primary outcomes safety, by incidence AEs abnormalities. Results: Study was initiated 373 (93%) participants (186 TDF 187 placebo), whom 325 (87%) completed final visit. Of 2428 reported 334 (90%) participants, 2366 (97%) mild moderate severity. Frequencies commonly did not differ significantly between placebo arms. In multivariable analyses, back pain more likely recipients (P = 0.04); these reports associated documented fractures objective findings. There no grade ≥3 creatinine elevations; grades 1 2 increases receipt. Estimated percentage doses taken 92% pill count 77% System. Seven seroconversions occurred: 4 on 3 arm yet drug. Conclusions: Daily oral well tolerated, reasonable adherence. No significant renal concerns identified.