The interaction of CD4 T-cell count and nevirapine hepatotoxicity in China

A change in national treatment guidelines may be warranted

Chengda Zhang, Wei Wang, Mengyu Zhou, Yang Han, Jing Xie, Zhifeng Qiu, Fuping Guo, Yanling Li, Huanling Wang, Khalil G Ghanem, Taisheng Li

Research output: Contribution to journalArticle

Abstract

Objectives: Nevirapine (NVP), a still widely used nonnucleoside reverse transcriptase inhibitor, can cause severe hepatotoxicity. Previous studies suggest that CD4 cell counts more than 250 cells per microliter in women and more than 400 cells per microliter in men are risk factors for NVP-related hepatotoxicity. These studies have informed Chinese national treatment guidelines. We evaluate whether current Chinese guidelines for NVP use are appropriate. Methods: Longitudinal data were pooled from 2 clinical trials between 2005 and 2009 across mainland China. Five hundred sixty-six antiretroviral therapy-naive Chinese patients were given NVP-containing antiretroviral therapy for 24 weeks. Hepatotoxicity was defined as alanine aminotransferase, aspartate transaminase, or total bilirubin level greater than 1.25 times the upper limit of normal range. Severe hepatotoxicity was defined as greater than 5 times the upper limit of normal range. Results: One hundred ninety-seven (36.1%) patients developed hepatotoxicity during treatment, including 42 (7.7%) patients with severe hepatotoxicity. CD4 cell count more than 250 cells per microliter was an independent predictor for hepatotoxicity both in men [relative risk = 1.22 (95% confidence interval: 1.04 to 1.44)] and in women [relative risk = 1.72 (95% confidence interval: 1.20 to 2.46)]. Severe hepatotoxicity was also more common among all persons with CD4 .250 cells per microliter. Conclusions: Hepatotoxicity was a common adverse effect of NVP among men and women with CD4 .250 cells per microliter. Chinese treatment guidelines should be considered to reflect this risk.

Original languageEnglish (US)
Pages (from-to)540-545
Number of pages6
JournalJournal of Acquired Immune Deficiency Syndromes
Volume62
Issue number5
DOIs
StatePublished - Apr 15 2013

Fingerprint

Nevirapine
CD4 Lymphocyte Count
China
Guidelines
T-Lymphocytes
Reference Values
Confidence Intervals
Therapeutics
Reverse Transcriptase Inhibitors
Aspartate Aminotransferases
Alanine Transaminase
Bilirubin
Clinical Trials

Keywords

  • CD4 lymphocyte count
  • Drug toxicity
  • Hepatotoxicity
  • Nevirapine

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

Cite this

The interaction of CD4 T-cell count and nevirapine hepatotoxicity in China : A change in national treatment guidelines may be warranted. / Zhang, Chengda; Wang, Wei; Zhou, Mengyu; Han, Yang; Xie, Jing; Qiu, Zhifeng; Guo, Fuping; Li, Yanling; Wang, Huanling; Ghanem, Khalil G; Li, Taisheng.

In: Journal of Acquired Immune Deficiency Syndromes, Vol. 62, No. 5, 15.04.2013, p. 540-545.

Research output: Contribution to journalArticle

Zhang, Chengda ; Wang, Wei ; Zhou, Mengyu ; Han, Yang ; Xie, Jing ; Qiu, Zhifeng ; Guo, Fuping ; Li, Yanling ; Wang, Huanling ; Ghanem, Khalil G ; Li, Taisheng. / The interaction of CD4 T-cell count and nevirapine hepatotoxicity in China : A change in national treatment guidelines may be warranted. In: Journal of Acquired Immune Deficiency Syndromes. 2013 ; Vol. 62, No. 5. pp. 540-545.
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abstract = "Objectives: Nevirapine (NVP), a still widely used nonnucleoside reverse transcriptase inhibitor, can cause severe hepatotoxicity. Previous studies suggest that CD4 cell counts more than 250 cells per microliter in women and more than 400 cells per microliter in men are risk factors for NVP-related hepatotoxicity. These studies have informed Chinese national treatment guidelines. We evaluate whether current Chinese guidelines for NVP use are appropriate. Methods: Longitudinal data were pooled from 2 clinical trials between 2005 and 2009 across mainland China. Five hundred sixty-six antiretroviral therapy-naive Chinese patients were given NVP-containing antiretroviral therapy for 24 weeks. Hepatotoxicity was defined as alanine aminotransferase, aspartate transaminase, or total bilirubin level greater than 1.25 times the upper limit of normal range. Severe hepatotoxicity was defined as greater than 5 times the upper limit of normal range. Results: One hundred ninety-seven (36.1{\%}) patients developed hepatotoxicity during treatment, including 42 (7.7{\%}) patients with severe hepatotoxicity. CD4 cell count more than 250 cells per microliter was an independent predictor for hepatotoxicity both in men [relative risk = 1.22 (95{\%} confidence interval: 1.04 to 1.44)] and in women [relative risk = 1.72 (95{\%} confidence interval: 1.20 to 2.46)]. Severe hepatotoxicity was also more common among all persons with CD4 .250 cells per microliter. Conclusions: Hepatotoxicity was a common adverse effect of NVP among men and women with CD4 .250 cells per microliter. Chinese treatment guidelines should be considered to reflect this risk.",
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T1 - The interaction of CD4 T-cell count and nevirapine hepatotoxicity in China

T2 - A change in national treatment guidelines may be warranted

AU - Zhang, Chengda

AU - Wang, Wei

AU - Zhou, Mengyu

AU - Han, Yang

AU - Xie, Jing

AU - Qiu, Zhifeng

AU - Guo, Fuping

AU - Li, Yanling

AU - Wang, Huanling

AU - Ghanem, Khalil G

AU - Li, Taisheng

PY - 2013/4/15

Y1 - 2013/4/15

N2 - Objectives: Nevirapine (NVP), a still widely used nonnucleoside reverse transcriptase inhibitor, can cause severe hepatotoxicity. Previous studies suggest that CD4 cell counts more than 250 cells per microliter in women and more than 400 cells per microliter in men are risk factors for NVP-related hepatotoxicity. These studies have informed Chinese national treatment guidelines. We evaluate whether current Chinese guidelines for NVP use are appropriate. Methods: Longitudinal data were pooled from 2 clinical trials between 2005 and 2009 across mainland China. Five hundred sixty-six antiretroviral therapy-naive Chinese patients were given NVP-containing antiretroviral therapy for 24 weeks. Hepatotoxicity was defined as alanine aminotransferase, aspartate transaminase, or total bilirubin level greater than 1.25 times the upper limit of normal range. Severe hepatotoxicity was defined as greater than 5 times the upper limit of normal range. Results: One hundred ninety-seven (36.1%) patients developed hepatotoxicity during treatment, including 42 (7.7%) patients with severe hepatotoxicity. CD4 cell count more than 250 cells per microliter was an independent predictor for hepatotoxicity both in men [relative risk = 1.22 (95% confidence interval: 1.04 to 1.44)] and in women [relative risk = 1.72 (95% confidence interval: 1.20 to 2.46)]. Severe hepatotoxicity was also more common among all persons with CD4 .250 cells per microliter. Conclusions: Hepatotoxicity was a common adverse effect of NVP among men and women with CD4 .250 cells per microliter. Chinese treatment guidelines should be considered to reflect this risk.

AB - Objectives: Nevirapine (NVP), a still widely used nonnucleoside reverse transcriptase inhibitor, can cause severe hepatotoxicity. Previous studies suggest that CD4 cell counts more than 250 cells per microliter in women and more than 400 cells per microliter in men are risk factors for NVP-related hepatotoxicity. These studies have informed Chinese national treatment guidelines. We evaluate whether current Chinese guidelines for NVP use are appropriate. Methods: Longitudinal data were pooled from 2 clinical trials between 2005 and 2009 across mainland China. Five hundred sixty-six antiretroviral therapy-naive Chinese patients were given NVP-containing antiretroviral therapy for 24 weeks. Hepatotoxicity was defined as alanine aminotransferase, aspartate transaminase, or total bilirubin level greater than 1.25 times the upper limit of normal range. Severe hepatotoxicity was defined as greater than 5 times the upper limit of normal range. Results: One hundred ninety-seven (36.1%) patients developed hepatotoxicity during treatment, including 42 (7.7%) patients with severe hepatotoxicity. CD4 cell count more than 250 cells per microliter was an independent predictor for hepatotoxicity both in men [relative risk = 1.22 (95% confidence interval: 1.04 to 1.44)] and in women [relative risk = 1.72 (95% confidence interval: 1.20 to 2.46)]. Severe hepatotoxicity was also more common among all persons with CD4 .250 cells per microliter. Conclusions: Hepatotoxicity was a common adverse effect of NVP among men and women with CD4 .250 cells per microliter. Chinese treatment guidelines should be considered to reflect this risk.

KW - CD4 lymphocyte count

KW - Drug toxicity

KW - Hepatotoxicity

KW - Nevirapine

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