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Purpose of the studyTRANxITION compared the efficacy and safety of switching virologically suppressed patients from NVP IR (200 mg BID) to NVP XR (400 mg QD) and demonstrated the non‐inferior efficacy of NVP XR in virologically suppressed patients. Here, post‐48‐week safety and efficacy results of patients initially randomized to NVP IR and allowed to switch to NVP XR after 48 weeks, were compared to patients on NVP XR throughout the study.MethodsTRANxITION was an open‐label, parallel‐group, non‐inferiority clinical trial where adult HIV‐1 patients receiving NVP IR plus a fixed‐dose NRTI combination of lamivudine (3TC)/abacavir (ABC), tenofovir (TDF)/emtricitabine (FTC) or 3TC/zidovudine (ZDV), with undetectable viral loads (VL) were initially randomized (2:1) to NVP XR or NVP IR. After week 48, patients initially randomized to NVP IR were allowed to switch to NVP XR. Primary endpoint was continued virologic suppression (VL<50 copies/mL) at week 24. Secondary endpoints included long‐term follow‐up at 48 and 144 weeks.Summary of resultsAt week 48, proportions of patients with virologic response (LLOQ = 50 copies/mL TaqMan, FAS) were 88.5% (131/148) NVP IR BID arm, and 88.8% (262/295) NVP XR QD, with an observed difference of 0.3% (95% CI −6.1, 6.7). Division of Acquired Immunodeficiency Syndrome (DAIDS) grade 3 and 4 events were similar for the NVP XR and NVP IR groups at week 48, 6.4% (19/295) vs. 6.1% (9/148) respectively, although serious AEs were slightly higher in the NVP XR group (10.2%, 30/295, vs. 8.1%, 12/148 for the NVP‐IR group). After week 48, all but 13 patients in the NVP IR arm switched to NVP XR. At week 144, proportions of patients with virologic response were 115/121 (95.0%, patients switching from IR to XR after week 48 [IRpost48XR]), and 238/250 (95.2%, patients on XR throughout [XRpost48]). DAIDS grade 3 and 4 events were similar for both post‐week‐48 XR groups at week 144, with (10/130, 7.7%, [IRpost48XR] vs. (31/276, 11.2% [XRpost48]), while serious AEs were higher in the XRpost48 patients (54/276, 19.6% vs. 17/130, 13.1% for the IRpost48XR group).ConclusionsNVP XR QD resulted in continued virologic suppression at weeks 48 and 144. While fewer patients remained in the study post‐week 48, both XR groups had high virologic response rates. Rates of serious AEs were modestly higher than seen at week 24 in both post‐week‐48 XR arms up to week 144, most likely due to the open‐label design of the study.

BackgroundHere we report 96‐ and 144‐week follow‐up data from VERxVE, which demonstrated that NVP XR (400 mg QD) was non‐inferior to NVP IR (200 mg BID), each on a backbone of emtricitabine/tenofovir at 48 weeks.MethodsVERxVE was a double‐blind, double‐dummy, non‐inferiority study in adults with screening viral‐load (VL) >1000 copies/mL and CD4+ cell count <400 cells/mm3 (males) and <250 cells/mm3 (females). Randomization was stratified by baseline VL (copies/mL), ≤100,000 or >100,000. Primary endpoint was confirmed virologic response (<50 copies/mL) at Week 48. Cochran's statistic incorporating baseline‐VL strata tested non‐inferiority of XR efficacy to IR. Secondary endpoints included 144‐week sustained virologic response and safety.Results1011 patients were randomized and treated; 736 (NVP XR: 378, NVP IR: 358) completed 144 weeks. Virologic response was 63.6% for NVP XR and 58.5% for NVP IR (adjusted difference of 4.8% [95% CI: −1.1%, 10.8%] favoring NVP XR). No significant differences were seen in changes in CD4+ T cell counts from baseline, virologic failures, and total discontinuation rates between treatment arms regardless of demographic or baseline characteristics.













48 Weeks
96 Weeks
144 Weeks



NVP IR 200 mg BID
NVP XR 400 mg QD
NVP IR 200 mg BID
NVP XR 400 mg QD
NVP IR 200 mg BID
NVP XR 400 mg QD




% Virologic response
75.9
81.0
66.6
69.3
58.5
63.6


Change from baseline in CD4+ Count (cells/mm3)
207
213
257
275
286
317


Virologic failures (%)
5.9
3.2
10.7
11.1
15.8
15.1


Discontinuation rate (%)
19.2
16.6
26.1
23.6
29.2
25.1


Discontinuations due to AEs
8.3
6.3
9.5
8.3
10.7
8.5




ConclusionsNVP XR continued to demonstrate non‐inferior virologic efficacy to NVP IR in prior treatment‐naïve HIV infected patients out to week 144. NVP XR continued to be well‐tolerated with a safety profile similar to NVP IR.

PurposeVery scarce information has been published to date with the combination of ABC/3TC/NVP but it is currently being used in clinical practice in Spain and Portugal. Our aim was to present the clinical experience with this regimen in a cohort of adult HIV‐infected antiretroviral (ARV)‐naïve patients.MethodsRetrospective, multicentre, cohort study. Consecutive adult HIV‐infected ARV‐naïve HLA‐B*5701‐negative patients, who started ABC/3TC/NVP between 2005‐2013, with at least one follow‐up visit, were included. Demographic, clinical and laboratory variables were assessed at baseline, month 1, and every three–four months thereafter. The primary end point was HIV‐1 viral load (VL)<40 c/mL at 48 weeks. Data were analyzed by intent‐to‐treat (ITT) (switch=failure, and missing=failure) and on treatment (OT) analyses.Results78 patients were included. Median follow up was 26 (0.1‐84) months. 86% were male, median age 41 (23‐69) years, 9% had AIDS, 8% were HCV+, baseline CD4 was 275 (10‐724) cells/µL and median VL 4.58 (3.02‐6.92) log. After 48 weeks, VL was<40 c/mL in 89.8% (OT), 79.7% (M=F) and 65.4% (S=F) and at 96 weeks in 88.5%, 78.9% and 61.6%, respectively. CD4 increased +246 (p<0.001) and +292 (p<0.001) cells/uL after 48 and 96 weeks, respectively. One or more drugs of the regimen were discontinued in 33 (42.3%) patients. In 15 (19.2%) patients (13 NVP, 2 ABC/3TC) therapy was stopped due to toxicity after a median of one month (in only two cases after six months of follow up): 80% of them had rash/liver toxicity. Six (7.7%) patients discontinued ART due to virologic failure, five (6.4%) because of other reasons and seven (9%) were lost to follow‐up. ALT but not AST significantly increased (+0.07 ukat/L at 96 weeks, p=0.033). A significant increase of 25%, 26% and 42% in total cholesterol, LDLc and HDLc, respectively, and a significant decrease in TC/HDL ratio (6%, p=0.008) was observed after 96 weeks.ConclusionsDespite a considerable proportion of patients had to stop therapy due to toxicity (most associated with NVP), those initially tolerating this regimen presented a high virologic and immunologic response after 96 weeks, as well as a favourable lipid profile. ABC/3TC/NVP may be a suitable alternative first regimen, mainly in countries with economic constraints.