Abstract
Contemporary antiretroviral treatment regimens are simpler than in the past, with lower pill burden and once-daily dosing frequency common. We performed a meta-analysis of randomized controlled trials (RCTs) to investigate the impact of pill burden and once-daily vs twice-daily dosing on ART adherence and virological outcomes. A literature search of 4 electronic databases through 31 March 2013 was used. RCTs comparing once-daily vs twice-daily ART regimens that also reported on adherence and virological suppression were included. Study design, study population characteristics, intervention, outcome measures, and study quality were extracted. Study quality was rated using the Cochrane risk-of-bias tool. Nineteen studies met our inclusion criteria (N = 6312 adult patients). Higher pill burden was associated with both lower adherence rates (P = .004) and worse virological suppression (P < .0001) in both once-daily and twice-daily subgroups, although the association with adherence in the once-daily subgroup was not statistically significant. The average adherence was modestly higher in once-daily regimens than twice-daily regimens (weighted mean difference = 2.55%; 95% confidence interval [CI], 1.23 to 3.87; P = .0002). Patients on once-daily regimens did not achieve virological suppression more frequently than patients on twice-daily regimens (relative risk [RR] = 1.01; 95% CI, 0.99 to 1.03; P = .50). Both adherence and viral load suppression decreased over time, but adherence decreased less with once-daily dosing than with twice-daily dosing. Lower pill burden was associated with both better adherence and virological suppression. Adherence, but not virological suppression, was slightly better with once- vs twice-daily regimens.
Highlights
Contemporary antiretroviral treatment regimens are simpler than in the past, with lower pill burden and once-daily dosing frequency common
Based on a significant interaction previously found in the meta-analysis by Parienti et al [12], subgroup analyses were prespecified to explore the reasons for heterogeneity
These were based on patient characteristics at baseline, including the following: treatment-naive individuals initiating their first regimens of ART, treatment-experienced individuals with virological suppression, and treatment-experienced individuals with treatment failure
Summary
A literature search of 4 electronic databases through 31 March 2013 was used. RCTs comparing oncedaily vs twice-daily ART regimens that reported on adherence and virological suppression were included. Study population characteristics, intervention, outcome measures, and study quality were extracted. Study quality was rated using the Cochrane risk-of-bias tool. Inclusion Criteria We included only randomized controlled trials (RCTs) that compared once-daily vs twice-daily regimens in either ARTnaive or -experienced patients with objective measures of adherence and measures of virological outcomes. Search Strategy We systematically searched the following databases from their inception until 31 March 2013 (including those years searched by the Parienti meta-analysis): Cochrane CENTRAL, PubMed, Google scholar, and Web of Science. Our search terms included the following: “HIV,” “treatment simplification,” “coformulation,” “fixed-dose combination,” “QD,” “twice-daily,” “once-daily,” “adherence,” “HAART,” “ART,” “cART,” and “patient preference.”. The bibliographies of relevant review articles, metaanalyses, and selected articles were examined for pertinent studies
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