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Simplification to co-formulated rilpivirine/emtricitabine/tenofovir in virologically suppressed patients: Data from a multicenter cohort

Carmela Pinnetti, Simona Di Giambenedetto, Franco Maggiolo, Patrizia Lorenzini, Massimiliano Fabbiani, Chiara Tommasi, Alessandra Latini, Adriana Ammassari, Laura Loiacono, Gaetana Sterrantino, Rita Bellagamba, Evangelo Boumis, Andrea Antinori, Mauro Zaccarelli

Abstract


Background: To assess efficacy and safety of treatment simplification to co-formulated Rilpivirine/Emtricitabine/Tenofovir (RPV/FTC/TDF) in virologically suppressed patients.

Materials and Methods: Endpoints of the analysis were: (a) treatment discontinuation of RPV/FTC/TDF for any reasons and (b) occurrence of virological failure (VF) defined as confirmed HIV-RNA >50 cp/mL).

Results: Overall, 508 patients from five Italian reference centres were included: male gender 71.9%; median age 47 years (IQR 40–52); IVDU as HIV risk 17.7%; HCV-AB positive 23.4%; CDC-C stage 17.5%; median CD4 cells/µL at switch 655 (IQR: 487–843); median number of previous regimens three (IQR 2–7). In a median follow-up of 196 days (IQR: 84–287), 31 patients discontinued RPV/FTC/TDF (virological failure n=5, hypersensitivity reaction n=2, GI-toxicity n=6, liver toxicity n=1, CNS-toxicity n=4, kidney toxicity n=5, patient's decision/lost in follow-up n=10). Moreover, VF occurred in eight patients (five discontinued regimen, while three remained on RPV/FTC/TDF). At survival analysis, the probabilities of treatment discontinuation or VF were 5.5% and 1.2% at 6 months, 13.2% and 2.8% at 12 months, respectively (Figure 1). At adjusted Cox model, factors associated with discontinuation were: <200 CD4 cells/µL at switch (HR 5.3, 95% CI 1.1–25.9, p=0.038), number of pre-switch regimens (for each extra regimen: HR 1.05, 95% CI 1.01–1.10, p=0.024), male gender (HR 0.4, 95% CI 0.2–0.9, p=0.032). Only the number of pre-switch regimens was associated with VF (HR 1.13, 95% CI 1.06–1.21, p=0.001). Type of pre-switch regimen was not associated with discontinuation or failure, but no VF was observed if switching from co-formulated Efavirenz/FTC/TDF or from Raltegravir containing regimens. Switching to RPV/FTC/TDF led to significant improvement in fasting lipids levels: the decrease in cholesterol, LDL and triglycerides was observed switching from any regimen, but was more marked from boosted PI. In contrast, a moderate increase in transaminase (switching from all regimens except NNRTI-containing) and creatinine (except from TDF-containing regimens) were observed.

Conclusions: Our data suggest that switching to RPV/FTC/TDF in virologically suppressed patients could be a good strategy with low risk of virological failure or treatment discontinuation; the switch is also associated with significant improvement in lipid profile.

(Published: 2 November 2014)

Citation: Abstracts of the HIV Drug Therapy Glasgow Congress 2014

Pinnetti C et al. Journal of the International AIDS Society 2014, 17(Suppl 3):19812

http://www.jiasociety.org/index.php/jias/article/view/19812 | http://dx.doi.org/10.7448/IAS.17.4.19812




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