Abstract
BackgroundNevirapine extended-release (NVP-XR) taken once daily remains an effective antiretroviral agent for patients infected with HIV-1 strains that do not harbor resistance mutations. Presence of tablet remnants of NVP XR in stools was reported in 1.19% and 3.05% of subjects in two clinical trials. However, the prevalence may have been underestimated because the information was retrospectively collected in the studies.MethodsBetween April and December 2014, we prospectively inquired about the frequency of noticing tablet remnants of NVP XR in stools in HIV-1-infected patients who switched to antiretroviral regimens containing NVP XR plus 2 nucleos(t)ide reverse-transcriptase inhibitors. Patients were invited to participate in therapeutic drug monitoring of plasma concentrations of NVP 12 or 24 hours after taking the previous dose (C12 and C24, respectively) of NVP XR using high-performance liquid chromatography. The information on clinical characteristics, including plasma HIV RNA load and CD4 lymphocyte count, at baseline and during follow-up was recorded.ResultsDuring the 9-month study period, 272 patients switched to NVP XR-based regimens and 60 (22.1%) noticed tablet remnants of NVP XR in stools, in whom 54.2% reported noticing the tablet remnants at least once weekly. Compared with patients who did not notice tablet remnants, those who noticed tablet remnants had a higher mean CD4 lymphocyte count (629 vs 495 cells/mm3, P = 0.0002) and a similar mean plasma HIV RNA load (1.57 vs 1.61 log10 copies/mL, P = 0.76) on switch. At about 12 and 24 weeks after switch, patients who noticed tablet remnants continued to have a similar mean plasma HIV RNA load (1.39 vs 1.43 log10 copies/mL, P = 0.43; and 1.30 vs 1.37 log10 copies/mL, P = 0.26, respectively), but had a lower median NVP C12 (3640 vs 4730 ng/mL, P = 0.06), and a similar median NVP C24 (3220 vs 3330 ng/ml, P = 0.95) when compared with those who did not notice tablet remnants.ConclusionsThe presence of tablet remnants of NVP XR in stools is not uncommon in HIV-1-infected Taiwanese patients receiving NVP XR-based antiretroviral regimens, which does not have an adverse impact on the virological and immunological outcomes.
Highlights
Nevirapine (NVP), a potent non-nucleoside reverse-transcriptase inhibitor, has been an important component of antiretroviral therapy for HIV-1 infection with high efficacy and lower rates of metabolic complications over the past two decades, the adverse effects such as hepatotoxicity and hypersensitivity have precluded it from the preferred antiretroviral regimens [1,2,3]
Between April and December 2014, we prospectively inquired about the frequency of noticing tablet remnants of NVP nevirapine extended-release (XR) in stools in HIV-1-infected patients who switched to antiretroviral regimens containing NVP extended-release (NVP XR) plus 2 nucleos(t)ide reverse-transcriptase inhibitors
During the 9-month study period, 272 patients switched to NVP XR-based regimens and 60 (22.1%) noticed tablet remnants of NVP XR in stools, in whom 54.2% reported noticing the tablet remnants at least once weekly
Summary
Nevirapine (NVP), a potent non-nucleoside reverse-transcriptase inhibitor (nNRTI), has been an important component of antiretroviral therapy for HIV-1 infection with high efficacy and lower rates of metabolic complications over the past two decades, the adverse effects such as hepatotoxicity and hypersensitivity have precluded it from the preferred antiretroviral regimens [1,2,3]. Presence of tablet remnants of NVP XR in stools has been reported to occur in 1.19% and 3.05% of the subjects in the two trials, respectively, by retrospective investigation [8]. Such a prevalence may have been underestimated due to the fact that the information was obtained by self-reporting. Another post-marketing population-based cohort study with NVP XR tablets reported that 31 out of 536 (6%) patients had “whole” tablet in their stools, which was not associated with adverse outcomes [9]. The prevalence may have been underestimated because the information was retrospectively collected in the studies
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