|Virological Efficacy, Durability and Safety of Darunavir/r Plus Etravirine (DRV/r-ETR) Dual Regimen in ART-experienced Patients || |
|L. Gazzola1, P. Cicconi1, D. Ripamonti2, E. De Filippo2, G. Gustinetti3, A. Di Biagio3, G. Marchetti1, T. Bini1, A. d'Arminio Monforte1|
|1University of Milan, Clinic of Infectious Diseases, Milan, Italy, 2Ospedale Riuniti Bergamo, Unit of Infectious Diseases, Bergamo, Italy, 3University of Genova, Clinic of Infectious Diseases, Genova, Italy|
|Objectives: We aimed to evaluate durability, efficacy and safety of a dual regimen including DRV/r-ETR in HIV-infected ART-experienced patients. |
Methods: We retrospectively analyzed all ART-experienced patients from three Clinics starting a regimen containing DRV/r (600/100mg bid or 800/100mg qd) plus ETR (200mg bid). Patients were stratified by HIV-RNA detectability (>40cp/mL) at DRV/r-ETR introduction (baseline) and compared for demographics and HIV parameters by Wilcoxon and Chi-squared tests. Time to any ART changes from baseline were studied by Kaplan-Meier curves. Factors associated with virological failure (VF: two consecutive HIV-RNA>40cp/mL) were evaluated by univariate analysis. Changes from baseline to 6 months of metabolic parameters were studied by paired Wilcoxon test.
Results: 68 ART-experienced patients started DRV/r-ETR (21 DRV 800mg qd); baseline characteristics of all the patients and stratified according to baseline HIV-RNA (VL) are shown in table1.
[Table 1] Patients were observed for a mean of 24.5 months (IC95% 22.5-26.5); by 12 and 24 months, 89% and 79% were still on DRV/r-ETR. Overall, 13/68 (19.1%) discontinued the study regimen. A total of 7/68 patients (10.3%) experienced VF, 5/34 (14.7%) with VL detectable and 2/34 (5.8%) with VL undetectable at baseline. The only predictors of VF at univariate analysis were longer ART exposure and number of previous ART regimens.
[Table 2] As compared to baseline, an increase in total-cholesterol and LDL at 6 months (total-cholesterol increase of 21mg/dL [IQR -10 +46], p=.004 and LDL increase of 19mg/dL [IQR -10 +38], p=.004) was observed. No differences in triglycerides, glycemia and eGFR were observed.
Conclusion: In this heavily pre-treated population DRV/r-ETR dual regimen demonstrated durability and safety, with few virological failures. Virological parameters (baseline VL and mutations) did not affect virological response. Longer ART exposure and the number of previous regimens were the only predictors of virological failure, possibly reflecting poor adherence.
MD Lidia Gazzola , University of Milan , Milan , Italy
Assigned in sessions:
17.10.2013, 12:00-14:00, Poster Session, Poster Session 1, Exhibition
18.10.2013, 12:00-14:00, Poster Session, Poster Session 2, Exhibition