|Title||Dolutegravir/abacavir/lamivudine versus current ART in virally suppressed patients (STRIIVING): a 48-week, randomized, non-inferiority, open-label, Phase IIIb study.|
|Publication Type||Journal Article|
|Year of Publication||2017|
|Authors||Trottier B, Lake JE, Logue K, Brinson C, Santiago L, Brennan C, Koteff JA, Wynne B, Hopking J, Granier C, Aboud M|
|Date Published||2017 Apr 12|
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.
|Alternate Journal||Antivir. Ther. (Lond.)|