The online version of this article (doi:10.1186/s12879-017-2371-3) contains supplementary material, which is available to authorized users.
Whether the non-inferior efficacy and safety results of switching virologically suppressed HIV-1-infected patients from nevirapine immediate-release (NVP-IR) to NVP extended-release (NVP-XR) demonstrated in the TRANxITION study conducted in Europe and North America are also applicable to virologically suppressed HIV-infected Taiwanese patients remains unknown. We evaluated the comparative safety and efficacy of continuing NVP-IR versus switching to NVP-XR in virologically suppressed HIV-infected Taiwanese adults receiving combined antiretroviral therapy (cART) regimens.
We conducted a retrospective cohort study at Kaohsiung Veterans General Hospital from April 1, 2013, to March 31, 2015. Eighty-four virologically suppressed HIV-infected adults receiving NVP-IR cART were split into two groups: those continuing with NVP-IR (n = 49) and those being switched to NVP-XR (n = 35). Demographic characteristics, clinical variables, and laboratory findings were compared. Therapeutic drug monitoring of steady-state plasma NVP concentrations and genotype analysis of CYP2B6 516 were also performed in 22 participants. The primary endpoint was continued virological suppression at the end of the study. Secondary endpoints were time to loss of virological response and adverse events.
During a mean follow-up of 18.4 months, the NVP-XR group demonstrated similar success at maintaining virological response compared with the NVP-IR group (82.9% vs. 85.7%; P = 0.72). Cox regression analysis indicated that there were no significant differences between NVP regimens for time to loss of virological response (hazard ratio: 0.940; P = 0.754). Furthermore, there were no significant differences in adverse events between these two groups. In the 22 participants, there was a non-significantly lower level of steady-state plasma NVP concentrations in the NVP-XR group than in NVP-IR recipients (5145.0 ng/mL vs. 6775.0 ng/mL; P = 0.267). The prevalence of CYP2B6 516 GT was 86.6%, and there was no significant difference in the distribution of CYP2B6 516 between these two groups.
We found that switching from NVP-IR to NVP-XR appeared to have similar safety and efficacy compared with continuing NVP-IR among virologically suppressed, HIV-infected Taiwanese patients. Our finding of higher Ctrough levels in both groups compared with other studies conducted in Caucasian populations and the high prevalence of CYP2B6 516 GT requires further investigation in a larger Taiwanese cohort.
Additional file 1: Multivariate analysis of treatment failure in 84 virologically suppressed HIV-infected patients. In Cox regression, the hazard ratios for TLOVR between NVP regimen (NVP-XR vs. NVP-IR) was 0.940 (95% CI, 0.254–3.484; P = 0.926). (DOCX 14 kb)12879_2017_2371_MOESM1_ESM.docx
Additional file 2: Comparison of demographic characteristics, steady-state plasma concentration of NVP, and genotype analysis of CYP2B6 516 in 48 HIV-infected patients enrolled in KVGH from January 1, 2014 to December 31, 2014, by patients enrolled or not enrolled in the retrospective part of the current study. The 22 patients enrolled in the retrospective analysis of the current study were older (37 vs. 27.5, P < 0.001) and heavier (74.5 kg vs. 64.8 kg, P = 0.021) than the 26 patients not enrolled in the retrospective analysis of the current study. There were no significant differences between these two groups in sex, height, the steady-state plasma NVP concentration, and genotype analysis of CYP2B6 516. (DOCX 15 kb)12879_2017_2371_MOESM2_ESM.docx
Additional file 3: Demographic characteristics, steady-state plasma concentration of NVP, and genotype analysis of CYP2B6 516 of 22 virologically suppressed, HIV-infected patients enrolled in this study, by NVP regimens. There were no significant differences between NVP-XR and NPV-IR in age, sex, height, weight, steady-state plasma NVP concentrations, and genotype analysis of CYP2B6 516. (DOCX 15 kb)12879_2017_2371_MOESM3_ESM.docx
Additional file 4: PCR-restriction fragment length polymorphism analysis of CYP2B6 516. Three cases (A, B, C) participating in genotype analysis of CYP2B6 516 in the current study are shown. Lane M represents a size marker. After digestion with BsrI restriction enzyme, wild-type GG (case B) is visible as one band of 152 base pair. Heterozygous GT (case C) is visible as two bands (152 base pair and 204 base pair); homozygous mutant TT (case A) is visible as one band of 204 base pair. (PPTX 122 kb)12879_2017_2371_MOESM4_ESM.pptx
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- Efficacy and safety of switching from nevirapine immediate-release twice daily to nevirapine extended-release once daily in virologically suppressed HIV-infected patients: a retrospective cohort study in Taiwan
Calvin M Kunin
Susan Shin-Jung Lee
- BioMed Central
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