High quality of life, treatment tolerability, safety and efficacy in HIV patients switching from triple therapy to lopinavir/ritonavir monotherapy: A randomized clinical trial

Abstract

Trial design: The QoLKAMON study evaluated quality of life, efficacy and treatment safety in HIV patients receiving lopinavir/ritonavir in monotherapy (MT) versus continuing combined antiretroviral triple treatment with a boosted protease inhibitor (TT).

Methods: This was a 24-week, open-label, multicentre study in virologically-suppressed HIV-infected participants (N = 225) with a 2:1 randomization: 146 patients who switched to MT were compared with 79 patients who remained on a TT regimen. The primary endpoint was change in patient-reported outcomes in quality of life as measured by the MOS-HIV and EQ-5D questionnaires. Secondary endpoints included treatment adherence, patient satisfaction, incidence of adverse events and differences in plasma HIV-1 RNA viral load (VL) and CD4 cell counts.

Results: Baseline quality of life, measured with the MOS-HIV score, was very good (overall score of 83 ± 10.5 in the MT arm and 82.3 ± 11.3 in the TT arm) and suffered no change during the study in any of the arms (at week 24, 83.5 ± 12.2 in MT arm and 81.9 ± 12.7 in TT arm), without statistically significant differences when compared. In regards to adherence to therapy and patient satisfaction, some aspects (number of doses forgotten in the last week and satisfaction of treatment measured with the CESTA score, dimension 1) improved significantly with MT. There were also no differences in the incidence and severity of adverse events, even though 22.8% of those in the MT arm switched their treatment when they were included in the study. Moreover, there was also no significant difference between the immunological and virological evolution of MT and TT. In the MT arm, the VL was always undetectable in 83% of patients (vs 90.7% in the TT arm) and there were only 6.7% of virological failures with VL > 50 copies/mL (vs 2.3% in the TT arm), without resistance mutations and with resuppression of VL after switching back to TT.

Conclusions: In a new clinical trial, monotherapy as a treatment simplification strategy in HIV-1 infected patients with sustained viral suppression has demonstrated quality of life, safety and efficacy profiles comparable to those of conventional triple therapy regimens.

Conflict of interest statement

Competing Interests: The authors have read the journal’s policy and the authors of this manuscript have the following competing interests: Juan Pasquau has received financial grants and/or honoraria from Janssen-Cilag, Bristol-Myers-Squibb, Abbvie, Merck Sharp & Dohme, ViiV & Gilead as speaker fees and/or as Advisor fees. María Luisa Montes has served as a speaker for Janssen, BMS, ViiV and AbVie, a consultant for Janssen, BMS and Abbie. Jorge Vergas has received research grants and/or honoraria for advisories and/or conferences from Boehringer Ingelheim, GSK, ViiV, BMS, Abbott, Gilead, Janssen, Roche Farma and Merck. Jose Hernández Quero has received financial grants and/or honoraria from Janssen-Cilag, Bristol-Myers-Squibb, Abbvie, Merck Sharp & Dohme, ViiV & Gilead as speaker fees and/or as Advisor fees. Francisco Orihuela has received payment for training sessions from AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck-Sharp & Dohme, and ViiV Healthcare. Arkaitz Imaz has received financial compensation for lectures, consultancies, and educational activities, or funds for research from Abbvie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen-Cilag, Merck Sharp & Dome, and ViiV Healthcare. Fernando Lozano has acted as a consultant for AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck-Sharp & Dohme, and ViiV Healthcare and has received payment for training sessions from AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck-Sharp & Dohme, and ViiV Healthcare. Ignacio de los Santos has acted as a consultant for AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck-Sharp & Dohme, and ViiV Healthcare and has received payment for training sessions from AbbVie, Janssen, Merck-Sharp & Dohme, and ViiV Healthcare. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. CONSORT flow diagram showing disposition of patients throughout the study from baseline to week 24.

Fig 2. Final scores (mean values at week 24 with error bars showing 95% confidence intervals) of the 5 questionnaires evaluating the quality of life of both groups.