Two studies discussed the safety and efficacy of dolutegravir (DTG) plus lamivudine (3TC) in two-drug therapy: for people starting treatment for the first time; and for people who switch after being virally suppressed on another regimen.
The first presentation reviewed two identically designed clinical trials of 1,400 patients; the GEMINI 1 and 2 studies. These randomized, Phase III trials compared the safety and efficacy of DTG and 3TC in patients who were HIV naive with those taking the three-drug combination of DTG, tenofovir and emtricitabine. Note the May-December combination of ARVs here. For the record 3TC and DTG were introduced in 1995 and 2013, respectively. The 96-week data found that the two-drug (DTG + 3TC) regimen remained non-inferior to the three-drug regimen over the two-year period.
The second study addressing 2 drugs is TANGO, a randomized, Phase III trial studying the safety and efficacy of switching to DTG and 3TC in patients who were already virally suppressed with the three-drug combination of DTG, tenofovir and emtricitabine. TANGO included 741 participants, randomized equally between the two- and three-drug regimens. It found that, after 24 weeks of therapy, the two-drug regimen was non-inferior in terms of achieving and maintaining viral suppression. While the study will continue through 148 weeks, this initial analysis suggests that switching to the two-drug regimen could indeed be an option for those on three drugs.
Reference:
1. Cahn P et al. Durable efficacy of dolutegravir (DTG) plus lamivudine (3TC) in antiretroviral treatment-naïve adults with HIV-1 infection - 96-week results from the GEMINI studies. 10th International AIDS Society Conference on HIV Science, Mexico City, abstract WEAB0404LB, 2019. http://programme.ias2019.org/Abstract/Abstract/4767
2. Van Wyk J et al. Switching to DTG+3TC fixed dose combination (FDC) is non-inferior to continuing a TAF-based regimen (TBR) in maintaining virologic suppression through 24 weeks (TANGO study). 10th International AIDS Society Conference on HIV Science, Mexico City, abstract WEAB0403LB, 2019. http://programme.ias2019.org/Abstract/Abstract/4903
7/24/2019 6:29 PM
Two-drug Regimens May Be Better Than Three… Depending on the Drugs
Source: Reporting from Mexico City for PRN News: Bill Valenti, MD