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Dolutegravir/abacavir/lamivudine versus current ART in virally suppressed patients (STRIIVING): a 48-week, randomized, non-inferiority, open-label, Phase IIIb study.

TitleDolutegravir/abacavir/lamivudine versus current ART in virally suppressed patients (STRIIVING): a 48-week, randomized, non-inferiority, open-label, Phase IIIb study.
Publication TypeJournal Article
Year of Publication2017
AuthorsTrottier B, Lake JE, Logue K, Brinson C, Santiago L, Brennan C, Koteff JA, Wynne B, Hopking J, Granier C, Aboud M
JournalAntivir Ther
Date Published2017 Apr 12
ISSN2040-2058
Abstract

BACKGROUND: Simplified dosing regimens are important for patients who face challenges in adhering to HIV-1 therapy. We investigated the safety and virologic 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 endpoint 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% confidence interval, -9.1 to 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 vs current ART.

CONCLUSIONS: Data demonstrating non-inferiority of switching to ABC/DTG/3TC vs continuing current ART support ABC/DTG/3TC as an option when considering switch regimens in HIV-1-infected adults with stable viral suppression.

DOI10.3851/IMP3166
Alternate JournalAntivir. Ther. (Lond.)
PubMed ID28401876