Efficacy and tolerability of lamivudine plus dolutegravir compared with lamivudine plus boosted PIs in HIV-1 positive individuals with virologic suppression: a retrospective study from the clinical practice

Abstract

Background: Direct comparisons between lamivudine plus bPIs and lamivudine plus dolutegravir as maintenance strategies in virologically-suppressed HIV positive patients are lacking.

Methods: Time 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.

Results: Four-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.

Conclusions: In real practice, a switch to lamivudine+dolutegravir showed similar efficacy but longer durability than a switch to lamivudine+bPIs.

Keywords: Antiretroviral therapy; Atazanavir/ritonavir; Darunavir/ritonavir; Dolutegravir; Dual therapy; HIV; Lamivudine; Maintenance therapy.

Conflict of interest statement

Ethics approval and consent to participate

The study received approval by the “Fondazione Policlinico Gemelli” Ethics Committee (protocol number: 10978/15), and every patient signed an informed consent before data collection.

Consent for publication

Not applicable.

Competing interests

AB reports non-financial support from Bristol Myers Squibb, personal fees from Gilead Sciences, non-financial support from ViiV Healthcare, outside the submitted work. RG reports travel grants from Gilead and from Janssen-Cilag, outside the submitted work. FM reports non-financial support from Angelini, and a contract research from Novartis Vaccine and Diagnostics S.r.l., outside the submitted work. EV reports personal fees from Merck Sharp and Dohme. ADL reports grants and personal fees from Gilead, personal fees from Bristol-Myers Squibb, grants and personal fees from ViiV, personal fees from Abbvie, personal fees from Janssen, grants and personal fees from Merck Sharp and Dohme, outside the submitted work. ADL also declares to be member of the editorial board (Associate Editor) of BMC Infectious Diseases. SDG reports personal fees from Bristol-Myers Squibb, personal fees from Gilead Sciences, personal fees from Boehringer Ingelheim, personal fees from Janssen-Cilag, personal fees from GlaxoSmithKline, outside the submitted work. All other authors have nothing to disclose.

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Figures

Fig. 1

Estimated proportions surviving without TD divided by regimen type (log-rank p < 0.001)