In people living with HIV who have achieved virologic suppression, dolutegravir plus lamivudine may be a safe and effective maintenance therapy, according to study results published in the Journal of Antimicrobial Chemotherapy.
The study included participants with HIV who achieved virologic suppression and were on first-line triple-drug regimens. Eligibility criteria included a plasma viral load ≤50 copies/mL for ≥2 years, CD4 nadir >200 cells/mm3, and non-resistant HIV prior to treatment initiation.
From week 8 to day 0 (Phase 1), participants’ current third agent was switched to dolutegravir. From day 0 to week 48 (Phase 2), participants received once-daily dolutegravir plus lamivudine, except if intolerant or if they had a plasma viral load >50 copies/mL during Phase 1.
The researchers defined virologic failure as a plasma viral load >50 copies/mL in 2 consecutive samples.
Of 110 participants enrolled in Phase 1, 104 were included in Phase 2. Participants were 86% male, 72% were men who have sex with men, and 87% were CDC stage A. Median age was 45 years, median CD4 nadir was 339 cells/mm3, median baseline CD4 was 743 cells/mm3, and median duration of viral suppression was 4.5 years.
At week 48, participants had a 97% overall success rate. Therapeutic failures occurred in 3 participants: 1 had virologic failure at week 4, 1 was lost to follow-up at week 32, and 1 had an interruption of therapeutic regimen at week 40 after a viral blip (plasma viral load 59 copies/mL). An additional 2 participants had another 3 viral blips.
The researchers did not detect M184V or integrase resistance mutations after failure or viral blips.
“Dolutegravir and lamivudine can be easily co-formulated, providing a single-pill therapeutic option,” the researchers wrote.
Joly V, Burdet C, Landman R, et al. Dolutegravir and lamivudine maintenance therapy in HIV-1 virologically suppressed patients: results of the ANRS 167 trial (LAMIDOL) [published online November 23, 2018]. J Antimicrob Chemother. doi:10.1093/jac/dky467