The PubMed/MEDLINE, Embase, and Cochrane databases were systematically searched (up to August 2013) to identify randomized controlled trials (RCTs) evaluating efficacy and/or safety of ATV/r, DRV/r, DTG, EFV, EVG/c, LPV/r, RAL, or RPV in treatment-naive HIV-1 patients. PubMed and EMBASE search terms were “HIV-1 [mesh] OR HIV infections [mesh] NOT pregnancy [mesh] AND ((dolutegravir OR GSK1349572) OR (efavirenz OR Sustiva OR Stocrin OR DMP-266) OR (raltegravir OR Isentress OR MK-0518) OR (elvitegravir OR GS-9137 OR JTK-303) OR (rilpivirine OR Edurant OR TMC 278) OR (darunavir OR Prezista OR TMC-114) OR (atazanavir OR Reyataz OR BMS-232632) OR (lopinavir OR ABT-378 OR Aluviran OR Koletra OR Kaletra) OR (Atripla OR Quad OR Stribild OR Eviplera OR Complera))”. The ClinicalTrials.gov registry, US FDA summary basis of approvals, EMA EPAR scientific discussions, and references of published systematic reviews and meta-analyses were also searched for any additional data. Abstracts of the 2013 meeting of the International AIDS Society and the Interscience Conference on Antimicrobial Agents and Chemotherapy were searched to identify recent presentations. Two phase 3 studies of DTG with data available after August 2013 were also included.
Study selection was conducted by two independent researchers who performed an initial review and selection of study titles/abstracts followed by full text review and selection. Disagreements between the reviewers were resolved by consensus. Pre-specified inclusion criteria included treatment-naive patients with HIV-1 infection; studies published in English; phase 3 or 4 RCT; patients aged ≥13 years; use of at least one of the third agents of interest; and reporting at least one of the efficacy outcomes of interest after 48 weeks of treatment. Non-randomized observational studies; single-arm studies; and studies examining different dosages of the same drug, structured treatment interruptions, maintenance treatments, or treatment switching were excluded, as were publications where outcomes specific to a treatment-naive population could not be distinguished. Studies reporting outcomes such that results could not be obtained for each treatment arm individually were also excluded. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed through all phases in the study [14] (link).
Three researchers independently abstracted data from the final selection of studies into a structured Microsoft Access database and data were reconciled for accuracy. The Effective Public Health Practice Project Quality Assessment, a quality assessment tool, was used to assess selection bias, study design, confounders, blinding, data collection methods, and withdrawals and dropouts [15] (link).
Study selection was conducted by two independent researchers who performed an initial review and selection of study titles/abstracts followed by full text review and selection. Disagreements between the reviewers were resolved by consensus. Pre-specified inclusion criteria included treatment-naive patients with HIV-1 infection; studies published in English; phase 3 or 4 RCT; patients aged ≥13 years; use of at least one of the third agents of interest; and reporting at least one of the efficacy outcomes of interest after 48 weeks of treatment. Non-randomized observational studies; single-arm studies; and studies examining different dosages of the same drug, structured treatment interruptions, maintenance treatments, or treatment switching were excluded, as were publications where outcomes specific to a treatment-naive population could not be distinguished. Studies reporting outcomes such that results could not be obtained for each treatment arm individually were also excluded. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed through all phases in the study [14] (link).
Three researchers independently abstracted data from the final selection of studies into a structured Microsoft Access database and data were reconciled for accuracy. The Effective Public Health Practice Project Quality Assessment, a quality assessment tool, was used to assess selection bias, study design, confounders, blinding, data collection methods, and withdrawals and dropouts [15] (link).
Full text: Click here