Suchergebnisse

IntroductionSwitching brand name medications to generics is recommended in France in the interest of cost effectiveness but patients and physicians are sometimes not convinced that switching is appropriate. Some antiretroviral (ARV) generics (ZDV, 3TC, NVP) have been marketed in France since 2013.Materials and MethodsA multicentric cross‐sectional survey was performed in September 2013 to evaluate the perception of generics overall and ARV generics in physicians and HIV‐infected patients and factors associated to their acceptability. Adult HIV outpatients were asked to complete a self‐questionnaire on their perception of generics. Physicians completed a questionnaire on the acceptability of generics and ARV generics. Socio‐demographic data, medical history and HIV history were collected.Results116 physicians in 33 clinics (68% in University Hospital) included 556 patients (France‐native 77%, active employment 59%, covered by social Insurance 100%, homosexual/bisexual contamination 47%, median HIV duration 13 years, hepatitis coinfection 16%, on ARV therapy 95%). Overall, patients accepted and had confidence in generics in 76% and 55% of the cases, respectively. Switching ARVs for generics was accepted by 44% of the patients but only by 17% if the pill burden was going to increase. 75% of the physicians would prescribe generics, but this decreased to only 26% if the combo had to be broken. The main reasons for non‐prescription of generics were previous brand name ARV‐induced side effects (35%), refusal of generics overall (37%), lack of understanding of generics (26%), risk of non‐observance of treatment (44%), anxiety (47%) and depressive symptoms (25%). In multivariate analysis, factors associated with the acceptability of ARV generics in patients were the use of generics overall (p<0.001) and in physicians, the absence of concern regarding the drug efficacy (p<0.001) and being aware that the patient would accept generics overall (p=0.03) and ARV generics (p=0.04). No factors related to sociodemographic conditions, HIV status or comorbidities had a constrictive influence on the use of ARV generics.ConclusionAcceptability of ARV generics in this French population is mostly dictated by the patient's and physician's knowledge and use of generics overall. Switching ARV brand name to a generic would be better accepted if the pill burden remained unchanged.

AbstractIntroductionDaily pre‐exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is associated with a small but statistically significant decrease in estimated glomerular filtration rate (eGFR). We assessed the renal safety of on‐demand PrEP with TDF/FTC in HIV‐1 uninfected men.MethodsWe used data from the randomized double‐blind placebo‐controlled ANRS‐IPERGAY trial and its open‐label extension conducted between February 2012 and June 2016 among HIV‐uninfected MSM starting on‐demand PrEP. Using linear mixed model, we evaluated the mean eGFR decline from baseline over time and determined risks factors associated with eGFR decline during the study.ResultsDuring the blind phase, with a median follow‐up of 9.4 months, the mean decline slope of eGFR from baseline was −0.88 and −1.53 mL/min/1.73 m2 per year in the placebo (n = 201) and the TDF/FTC group (n = 198) respectively, with a slope difference of 0.65 mL/min/1.73 m2 per year (p = 0.27). Including both phases, 389 participants started on‐demand TDF/FTC with a median follow‐up of 19.2 months and a mean decline of eGFR from baseline of −1.14 mL/min/1.73 m2 per year (p < 0.001). The slope of eGFR reduction was not significantly different in participants with baseline eGFR ≤ 90 mL/min/1.73 m2 (p = 0.44), age >40 years (p = 0.24) or hypertension (p = 0.21). There was a dose‐response relationship between recent tenofovir exposure and lower eGFR when considering the number of pills taken in the two months prior the visit (eGFR difference of −0.88 mL/min/1.73 m2 between >15 pills/month vs. ≤15 pills/month, p < 0.01) or plasma tenofovir concentrations at the visit (eGFR difference compared to ≤2 ng/mL: >2 to ≤10ng/mL: −0.98 mL/min/1.73 m2, >10 to ≤40ng/mL: −1.28 mL/min/1.73 m2, >40 ng/mL: −1.82 mL/min/1.73 m2, p < 0.001). Three participants discontinued TDF/FTC for eGFR < 60 mL/min/1.73 m2 during the OLE phase. No case of Fanconi syndrome was reported.ConclusionsThe renal safety of on‐demand PrEP with TDF/FTC was good. The overall reduction and intermittent exposure to TDF/FTC may explain this good renal safety.

BackgroundIEtravirine (ETR) was approved in France in Sept 2008, to be used in combination with a ritonavir‐boosted protease inhibitor (bPI) and others antiretrovirals (ARV) in HIV‐infected pre‐treated patients.ObjectivesTo describe in a real life setting efficacy and tolerability of ETR‐including regimen and factors associated with virologic response.MethodIn the French DatAIDS cohort including 18,647 patients, we selected patients who initiated an ETR‐including regimen between September 2008 and July 2013. Demographic data and clinico‐biological data were collected from the standardized electronic medical record Nadis®. Analyses were done in patients starting ETR and sub‐analyses were performed in pre‐treated patients starting ETR for virologic failure (VF) or maintenance (MT) therapy, with or without bPI.Results2083 patients (ARV‐naïve n=77, VF n=1014, MT n=992) were included: median age 47 years, 73.3% male, median duration of HIV infection 15.7 years, CDC stage C 38.7%, HBV/HCV co‐infection 25.7%. In pre‐treated patients, 75.5% previously received NNRTIs (median duration on EFV and NVP of 480 and 396 days, respectively), 94.3% bPIs, 30.8% raltegravir (RAL) and 19.4% enfuvirtide. The most frequent ARVs associated with ETR were two NRTIs in 37.2% of the cases (21.9% in VF, 52.9% in MT), 1 bPI+RAL in 10.1% (13.5% in VF, 6.6% in MT), RAL in 6.2% (2% in VF, 10.5% in MT). Median duration on ETR was 3.7 and 2.2 years in the VF and MT group, respectively. In the VF group, HIV RNA was <50 c/ml in 71.7% (71.1% without bPI, 72% with bPI) of the patients at M12, 72.8% (71% without bPI, 73.3% with bPI) of the patients at M24. In the MT group, HIV RNA was<50 c/ml in 90.5% of the patients at M12 and 93.1% at M24. ETR was discontinued in 8.8% of the patients (12.8% in VF, 5.4% in MT) for adverse events in 23.9% of cases (21.5% in VF, 29.5% in MT), treatment failure in 15.2% (16.2% in VF, 7.4% in MT) or simplification in 5.4% (4.6% in VF, 7.4% in MT). In the VF group, factors associated with virologic failure in multivariate analysis were a longer duration of HIV infection (OR 2.6; 95% CI 1.7–4.0) and baseline HIV RNA >5 log10 c/ml (OR: 2.0; 95% CI 1.3–3.2) but not the association with a bPI.ConclusionThis large study shows that in ARV‐pre‐treated patients ETR is well tolerated with a high efficacy when combined with other active drugs, even when the regimen does not include a bPI.