Abstract
BackgroundDirect comparisons between lamivudine plus bPIs and lamivudine plus dolutegravir as maintenance strategies in virologically-suppressed HIV positive patients are lacking.MethodsTime to treatment discontinuation (TD) and virological failure (VF) were compared in a cohort of HIV+ patients on a virologically-effective ART starting lamivudine with either darunavir/r, atazanavir/r or dolutegravir. Changes in laboratory parameters were also evaluated.ResultsFour-hundred-ninety-four patients were analyzed (170 switching to darunavir/r, 141 to atazanavir/r, 183 to dolutegravir): median age was 49 years, with 8 years since ART start. Groups differed for age, HIV-risk factor, time since HIV-diagnosis and on ART, previous therapy and reasons for switching.Estimated proportions free from TD at week 48 and 96 were 79.8 and 48.3% of patients with darunavir/r, 87.0 and 70.9% with atazanavir/r, and 88.2 and 82.6% with dolutegravir, respectively (p < 0.001). Calendar years, HIV-risk factor, higher baseline cholesterol and an InSTI-based previous regimen predicted TD, whereas lamivudine+dolutegravir therapy and previous tenofovir use were protective. VF was the cause of TD in 6/123 cases with darunavir/r, 4/97 with atazanavir/r and 3/21 with dolutegravir. Other main reasons for TD were: toxicity (43.1% with darunavir/r, 39.2% with atazanavir/r, 52.4% with dolutegravir), further simplification (36.6% with darunavir/r, 30.9% with atazanavir/r, 14.3% with dolutegravir). Incidence of VF did not differ among study groups (p = 0.747). No factor could predict VF.Lipid profile improved in the dolutegravir group, whereas renal function improved in the bPIs groups.ConclusionsIn real practice, a switch to lamivudine+dolutegravir showed similar efficacy but longer durability than a switch to lamivudine+bPIs.
Highlights
Direct comparisons between lamivudine plus boosted protease inhibitors (bPIs) and lamivudine plus dolutegravir as maintenance strategies in virologically-suppressed HIV positive patients are lacking
Estimated probabilities of remaining free from treatment discontinuation (TD) at week 48 and 96 were, respectively, 79.8% (95% confidence interval, CI, 73.7–85.9%) and 48.3% with darunavir/r, 87.0% and 70.9% with atazanavir/r, 88.2% and 82.6% with dolutegravir
Considering that a not negligible proportion of the patients switching to lamivudine and darunavir and, above all, to lamivudine and dolutegravir were already on a dual regimen, a secondary analysis excluding these patients on a previous dual therapy was performed
Summary
Direct comparisons between lamivudine plus bPIs and lamivudine plus dolutegravir as maintenance strategies in virologically-suppressed HIV positive patients are lacking. Combination antiretroviral therapy (ART) has dramatically decreased the incidence of AIDS-defining events in the HIV-infected population [1]. International guidelines [2, 3] recommend a prompt initiation of ART independently from CD4 cell count in order to reduce morbidity and mortality associated with HIV infection. Even if non-AIDS defining events are reduced by the immediate initiation of ART [4] the beneficial effects of long-term therapy on the burden of some non-AIDS related conditions (such as cardiovascular disease) remain to be established. The indication to treat all HIV-infected patients regardless of their CD4 counts [4] raises the issue of the long-term treatment-related toxicities, such as those related to nucleoside reverse transcriptase inhibitors, NRTIs [6], and patients’ adherence [7]. The increasing prevalence of HIV infection, the improved life expectancy of the infected population, and the increased projected lifetime healthcare costs prompt the need for new treatment paradigms [8]
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