Simplification to dual therapy containing lamivudine and raltegravir or dolutegravir in HIV-infected patients on virologically suppressive antiretroviral therapy

Abstract

Background Antiretroviral dual regimens including lamivudine and one boosted PI or dolutegravir are warranted in order to optimize combination ART (cART), prevent long-term toxicity and reduce the cost of treatments. Objectives We hypothesized that a maintenance dual regimen of lamivudine plus raltegravir would be effective and as well tolerated as the dual maintenance combination of lamivudine plus dolutegravir. Methods We performed an observational, retrospective study of HIV-infected patients on suppressive ART who switched to a dual regimen containing lamivudine 300 mg once daily plus raltegravir 1200 mg once daily or dolutegravir 50 mg once daily. Results In total, 109 patients (79 men; mean age 46.4 years; mean CD4+ T lymphocyte count 605 cells/mm3) were enrolled. Overall, 50 subjects switched to lamivudine plus raltegravir (Group A) and 59 to lamivudine plus dolutegravir (Group B). After 12 months, 45 patients (90%) in Group A and 52 (88.1%) in Group B had HIV RNA <20 copies/mL. No patients had severe adverse effects in either group, and the percentages of patients with mild adverse effects were comparable, except for a higher incidence of headache and sleeping disturbances in Group B than in Group A (30.5% versus 14%, P < 0.001). A comparable and non-significant weight increase was reported in both groups (+1.91 kg in Group A and +2.28 kg in Group B). Conclusions In our study, dual therapies containing lamivudine plus raltegravir or dolutegravir in virologically suppressed patients showed high and comparable efficacy, as well as good tolerability.

HIV Treatment with the Two-Drug Regimen Dolutegravir Plus Lamivudine in Real-world Clinical Practice: A Systematic Literature Review

“…In the other two studies, one population was 29% White, 45% Black, and 27% Hispanic [ 42 ] and the other population was 52% White, 35% Black, and 13% Asian [ 43 ]. Median ages ranged from 34.0 to 60.5 years among the 17 studies that reported median age [ 29 – 37 , 39 , 41 , 42 , 44 , 45 , 47 , 48 ]. Among studies clearly reporting treatment history, 4474 individuals switched from another regimen, and 73 were treatment naive (effectiveness was reported in 3489 and 69 PWH, respectively).…”

“…Those who switched from another regimen had extensive ART experience ranging from 1.3 to 17.9 years in studies that reported prior ART duration [ 29 , 30 , 32 – 36 , 38 , 41 , 42 , 44 , 46 – 49 ]. This analysis includes 1251 individuals who switched to dolutegravir plus lamivudine with no prior virologic failure and no known resistance where reported across eight studies [ 29 , 34 , 43 , 47 , 50 – 53 ]. Previous virologic failure was reported for 603 PWH in 9 studies [ 29 , 30 , 34 , 35 , 41 , 43 , 45 , 46 , 48 ].…”

“…This analysis included 5017 PWH who were reported to be using dolutegravir plus lamivudine. In 20 studies that reported data for sex, the majority of PWH treated with dolutegravir plus lamivudine were male (range, 60-97%) [29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48]. In five of seven studies with reported racial demographics, C 90% of PWH were identified as White [30,32,33,42,43,46,47].…”

“…In 20 studies that reported data for sex, the majority of PWH treated with dolutegravir plus lamivudine were male (range, 60-97%) [29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48]. In five of seven studies with reported racial demographics, C 90% of PWH were identified as White [30,32,33,42,43,46,47]. In the other two studies, one population was 29% White, 45% Black, and 27% Hispanic [42] and the other population was 52% White, 35% Black, and 13% Asian [43].…”

A Phase IV Study on Safety, Tolerability and Efficacy of Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate in Treatment Naïve Adult Indian Patients Living with HIV-1

“…Very few events of sleep disturbance and no events of weight gain were seen, though such reports have been widely observed previously. 12,[30][31][32][33][34] No clinically significant abnormalities in vital signs, laboratory assessments and physical examination from baseline were reported during the study period. This is consistent with a DTG study conducted previously in the Indian population.…”