Introduction The efficacy of Stribild®, an integrase strand transfer inhibitor (INSTI) -based STR, has been evaluated in randomised clinical trials. However, restricted selection criteria, monitoring frequency and selection bias hamper data extrapolation in routine practice. Here we analysed the virologic outcomes, safety and tolerability profile of Stribild® in clinical practice.
Methods Retrospective monocentric analysis on HIV-1-infected patients, who started with or were switched to Stribild®. The percentage of patients remaining free of therapeutic failure was estimated using the time-to-loss-of-virologic-response (TLOVR) algorithm, by intent-to-treat analysis.
Results We analysed the data of 197 patients (56 ART-naïve and 141 treatment-experienced patients). At the end of follow-up (median 33 months), 87.3% of treatment-naïve and 80.3% of treatment-experienced patients remained free of therapeutic failure. A total of 17 patients stopped treatment with Stribild®, 5.4% (3/56) of them were treatment-naïve and 9.9% (14/141) were treatment-experienced patients. The Stribild® therapy was discontinued in 2 because of VF, loss to follow-up in 4, and drug-drug interactions in 2 patients. Adverse events were in 7 (3.6%) patients the reason to switch from therapy with Stribild® and further 2 (1.0%)patients decided personally to switch. In two patients novel resistances in integrase-gene (N155H and S119R) emerged. In one further patient with VF two novel mutations in the RT-gene were observed when compared to historical genotypic test result (V106I/M and M184V).
Conclusion In treatment-naïve patients effectiveness of Stribild® was consistent with data obtained in clinical trials. The safety and tolerability profile as well as resistance development confirmed clinical efficacy of Stribild® in a daily practice setting.
Disclosure of interest statement Heiko Jessen received honoraria related to speakers’ activities and consulting from ViiV Healthcare, AbbVie Germany, Bristol-Myers Squibb and Gilead Sciences, grants from MSD Sharp and Dohme and ViiV Healthcare and an additional grant from Gilead Sciences for this study.