Health-related quality-of-life in people living with HIV after switching to dual therapy with ritonavir-boosted darunavir + dolutegravir: a DUALIS sub-study

ABSTRACT

The DUALIS study demonstrated efficacy and safety of switching to dolutegravir plus ritonavir-boosted darunavir (DRV/r) (2DR) as compared to standard-of-care-therapy with two nucleoside reverse transcriptase inhibitors + DRV/r (3DR) in pretreated people living with HIV (PLWH), 48 weeks after switching. This DUALIS sub-study investigates health-related-quality-of-life (HrQoL) in this study-population. The Hospital Anxiety and Depression Scale (HADS) and the Medical Outcome Survey-HIV (MOS-HIV) were used assessing anxiety and depression symptoms, respectively HrQoL. Data were collected at baseline, 4, 24, and 48 weeks after randomization. Outcome scores were dichotomized and used as criteria in longitudinal models identifying differential developments. Odds ratios (ORs) with 95% confidence intervals (CIs) were computed as main measures of effects. ORs<1 indicate better results for HADS, and worse for MOS-HIV scores in the 2DR compared to 3DR group. In total, 263 subjects were randomized and treated (2DR n=131, 3DR n=132; median age 48 years). Significant different progressions could only be found for HADS-Depression scores (OR=.87, 95% CI: .78, .98, p=.02). While HADS-Depression scores decreased in the 2DR group, they increased in 3DR group. This sub-study showed no disadvantages regarding HrQoL in PLWH after switching to DTG+DRV/r. Considering lifelong requirements for antiretroviral medication, close attention to HrQL is required.

KEYWORDS:

• Darunavir
• dolutegravir
• depression
• anxiety
• quality-of-life
• switch
• HIV

Acknowledgment

We thank the involved participants, sites, and staff as well as the clinical research organizations Munich Study Center (Helen Bidner for study coordination) and MUC Research (Annamaria Balogh for data management and statistical analyses), Munich, Germany. Parts of this study were presented at the International AIDS Society Conference in Mexico 2019 and the European AIDS Society Conference in Basel 2019. We thank the members of the Data Safety Monitoring Board (Georg Behrens, Armin Koch, and Christian Hoffmann), as well as the study coordinators Marcus Kosch and Helen Bidner (both Technical University Munich) for their overall assistance.

Disclosure statement

Christoph Bösecke received honoraria for lectures and/or consultancies from AbbVie, Gilead, Janssen, MSD and ViiV, funding from Deutsche Leberstiftung, DZIF, Hector Stiftung and NEAT ID. Jochen Schneider reports personal fees from Gilead Sciences and from AbbVie outside the submitted work. Simon Weidlich reports travel grants and speaker honoraria from Gilead Sciences as well as personal fees from Takeda, Jansen-Cilag and AbbVie. Hans Heiken reports honoraria for lectures and advisory boards received from AbbVie, Gilead, Janssen, MSD and ViiV Healthcare. These honoraria were not related to the conduct of the study. Hans-Jürgen Stellbrink has received honoraria for scientific advice and presentations from GILEAD Sciences, Janssen-Cilag, MSD, and Theratechnologies. He reports no other conflicts of interest. Stefan Scholten received honoraria for consultancy from Abbvie, Gilead, GSK, Janssen, MSD, ViiV, a sponsorship for congress participation from Abbvie, Gilead, Janssen, MSD, ViiV and honoraria for talks and presentations from Abbvie, Gilead, Janssen, MSD, ViiV. Björn Erik-Ole Jensen reports personal fees from Gilead, personal fees from ViiV, and personal fees from Janssen-Cilag outside the submitted work. Eva Wolf reports fees for consulting or lectures at educational events from AbbVie, Gilead Sciences, GlaxoSmithKline, Janssen-Cilag, MSD Sharp & Dohme, Roche, and ViiV Healthcare. Christoph D. Spinner reports grants and personal fees from Jansen-Cilag, grants and personal fees from ViiV Healthcare, during the conduct of the study; grants and personal fees from Gilead Sciences, personal fees from AbbVie, personal fees from MSD, outside the submitted work. All other authors have nothing disclosed.

Additional information

Funding

This work was supported by Technical University Munich (TUM) with grants from Janssen-Cilag and ViiV Healthcare.