1. Dolutegravir/abacavir/lamivudine versus current ART in virally suppressed patients (STRIIVING): a 48-week, randomized, non-inferiority, open-label, Phase IIIb study.
- Author
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Trottier B, Lake JE, Logue K, Brinson C, Santiago L, Brennan C, Koteff JA, Wynne B, Hopking J, Granier C, and Aboud M
- Subjects
- Adult, Aged, Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, Canada, Drug Substitution, Female, HIV Infections immunology, HIV Infections virology, HIV-1 pathogenicity, HIV-1 physiology, Humans, Male, Middle Aged, Oxazines, Piperazines, Pyridones, RNA, Viral antagonists & inhibitors, RNA, Viral metabolism, Treatment Outcome, United States, Viral Load drug effects, Anti-HIV Agents therapeutic use, Dideoxynucleosides therapeutic use, HIV Infections drug therapy, HIV-1 drug effects, Heterocyclic Compounds, 3-Ring therapeutic use, Lamivudine therapeutic use, RNA, Viral genetics
- Abstract
Background: Simplified dosing regimens are important for patients who face challenges in adhering to HIV-1 therapy. We investigated the safety and virological efficacy of switching to once-daily abacavir/dolutegravir/lamivudine (ABC/DTG/3TC)., Methods: The STRIIVING study was a randomized, open-label, Phase IIIb study in adults with HIV-1 RNA <50 copies/ml on antiretroviral therapy (ART) at enrolment (ClinicalTrials.gov identifier, NCT02105987). Subjects were randomly assigned to switch to ABC/DTG/3TC once daily for 48 weeks (early-switch group) or continue current ART for 24 weeks and then switch to ABC/DTG/3TC (late-switch group). The primary end point was the proportion of subjects with HIV-1 RNA <50 copies/ml at week 24., Results: Of 553 subjects enrolled, 275 were randomly assigned to switch immediately to ABC/DTG/3TC and 278 continued on current ART. At week 24, 85% and 88% of subjects who switched to ABC/DTG/3TC or remained on current ART, respectively, were virologically suppressed, indicating that ABC/DTG/3TC was non-inferior (difference in proportion, -3.4%; 95% CI -9.1, 2.4). At week 48, 83% and 92% were virologically suppressed in the early- and late-switch groups, respectively. Adverse events were reported more frequently with ABC/DTG/3TC (66%) than with current ART (47%) by week 24, and in the late-switch group, 60% of subjects reported adverse events post-switch. Pharmacokinetic data supported immediate switch. HIV Treatment Satisfaction Questionnaire scores improved in participants switching to ABC/DTG/3TC versus current ART., Conclusions: Data demonstrating non-inferiority of switching to ABC/DTG/3TC versus continuing current ART support ABC/DTG/3TC as an option when considering switch regimens in HIV-1-infected adults with stable viral suppression.
- Published
- 2017
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