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 designThe 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).MethodsThis 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.ResultsBaseline 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.ConclusionsIn 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.

Comparison of Zidovudine and Tenofovir Based Regimens With Regard to Health-Related Quality of Life and Prevalence of Symptoms in HIV Patients in a Kenyan Referral Hospital

“…Following regression analysis, this reduced the physical health of patients by -6.05 (-8.61, -3.49) units while the mental health was reduced by -1.85 (-2.72, -0.98) units. This concurs with a number of studies that have demonstrated negative effects of signs or symptoms of illness on QoL ( Dadi et al, 2017 ; Pasquau et al, 2018 ). For instance, a study on the effects on ART in the public sector in South Africa by Wouters et al highlighted the need for clinicians to be vigilant about the adverse effects of treatment since these can have severe effects on both physical and emotional QoL ( Wouters et al, 2009 ).…”

“…In addition, antiretroviral (ARV) medicines can appreciably reduce morbidity and mortality, including significant physical improvement and associated HRQoL. However, these medicines may also cause severe side-effects themselves potentially impacting on any improvement in HRQoL that could be gained through treatment, though some regimens are becoming more tolerable ( Burgoyne and Tan, 2008 ; Mannheimer et al, 2008 ; Campos et al, 2009 ; Oguntibeju, 2012 ; Velen et al, 2013 ; Dadi et al, 2017 ; Pasquau et al, 2018 ).…”

Inclusion and exclusion criteria and the problem of describing homogeneity of study populations in clinical trials

“…The problem is that the same criteria can be named inclusion (patients with a particular disease are included) or exclusion criteria (patients without this particular disease are excluded) 6 7. Criteria should be specified as inclusion or exclusion 8 9…”

An exploratory randomized controlled study on the efficacy and safety of lopinavir/ritonavir or arbidol treating adult patients hospitalized with mild/moderate COVID-19 (ELACOI)

“…Lopinavir is a human immunodeficiency virus 1 (HIV-1) protease inhibitor, usually combined with ritonavir to inhibit cytochrome P450 in order to increase the half-life of lopinavir [ 6 ] . In the past 10 years, LPV/r has been proven to have good efficacy and limited side effects for treating HIV-1 [7].…”