Presence of Tablet Remnants of Nevirapine Extended-Release in Stools and Its Impact on Virological Outcome in HIV-1-Infected Patients

Nevirapine 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.

Between 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.

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. 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 log₁₀copies/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 log₁₀copies/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.

The 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.

Below:   A photograph taken by one of the patients showing a washed tablet remnant of nevirapine extended-release collected from stools

Full article at: http://goo.gl/eJCo9L

By:

Yi-Chieh Lee

Department of Internal Medicine, Lotung Poh-Ai Hospital, Lo-Hsu Foundation, Inc., I-Lan, Taiwan

Shu-Wen Lin, Ching-Hua Kuo

Department of Pharmacy, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan

Shu-Wen Lin

Graduate Institute of Clinical Pharmacy, National Taiwan University College of Medicine, Taipei, Taiwan

Mao-Yuan Chen, Wang-Huei Sheng, Szu-Min Hsieh, Hsin-Yun Sun, Mon-Ro Wu, Wen-Chun Liu, Chien-Ching Hung, Shan-Chwen Chang

Department of internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan

Sui-Yuan Chang

Department of Laboratory Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan

Sui-Yuan Chang

Department of Clinical Laboratory Sciences and Medical Biotechnology, National Taiwan University College of Medicine, Taipei, Taiwan

Ching-Hua Kuo

School of Pharmacy, National Taiwan University, Taipei, Taiwan

Wang-Huei Sheng, Hsi-Yen Chang, Pei-Ying Wu, Shang-Ping Yang, Jun-Yu Zhang, Yi-Ching Su, Yi-Zhen Luo

Center of Infection Control, National Taiwan University Hospital, Taipei, Taiwan

Chien-Ching Hung

Department of Medical Research, China Medical University Hospital, Taichung, Taiwan

Chien-Ching Hung

China Medical University, Taichung, Taiwan

   

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