SidaSubSaharaV1, Main, Exploration, bibRecord, 003A21

Nevirapine pharmacokinetics and risk of rash and hepatitis among HIV-infected sub-Saharan African women

Identifieur interne : 003A21 ( Main/Exploration ); précédent : 003A20; suivant : 003A22

Nevirapine pharmacokinetics and risk of rash and hepatitis among HIV-infected sub-Saharan African women

Auteurs : Betty J. Dong [États-Unis] ; YU ZHENG [États-Unis] ; Michael D. Hughes [États-Unis] ; Adam Frymoyer [États-Unis] ; Davide Verotta [États-Unis] ; Patricia Lizak [États-Unis] ; Frederick Sawe [Kenya] ; Judith S. Currier [États-Unis] ; Shahin Lockman [États-Unis] ; Francesca T. Aweeka [États-Unis]

Source :

AIDS : (London) [ 0269-9370 ] ; 2012.

RBID : Pascal:12-0196708

Descripteurs français

Pascal (Inist)
- Dermatite, Hépatite, SIDA, Névirapine, Pharmacocinétique, Facteur risque, Afrique subsaharienne, Femme, Femelle, Toxicité, Hépatotoxicité, Antiviral, Antirétroviral.
Wicri :
- topic : Femme.

English descriptors

KwdEn :
- AIDS, Antiretroviral agent, Antiviral, Dermatitis, Female, Hepatitis, Hepatotoxicity, Nevirapine, Pharmacokinetics, Risk factor, Sub-Saharan Africa, Toxicity, Woman.

Abstract

Objectives: To estimate nevirapine (NVP) pharmacokinetics and examine its association with rash and/or hepatotoxicity in women starting antiretroviral treatment in the AIDS Clinical Trials Group A5208/OCTANE study in Africa. Design: In HIV-infected, nonpregnant women with screening CD4 cell count less than 200cells/μI randomized to NVP (twice daily, after 14-day once-daily lead-in period) and tenofovir/emtricitabine, single NVP blood samples were collected 14 and 28 days following randomization. Rash and hepatotoxicity that occurred during therapy, or within 7 days after the last dose of NVP, were defined as toxicity. Methods: NVP pharmacokinetics were modeled by population pharmacokinetic analysis. Individual Bayesian pharmacokinetic estimates were used to calculate clearance, 24-h area under the curve, and predicted plasma concentrations. Results: Median week 4 NVP clearance was 21/h. Among the 359 women, 194 (54%) developed a rash of any grade; 82 (23%) had grade 2+ and nine (3%) had grade 3+ rash. Median clearance was 1.7l/h for participants exhibiting 3+ rash versus 2 l/h in women without 3+ rash (P= 0.₀₄₆). The odds of developing 3+ rash was 50% higher for every 20% decrease in clearance (P = 0.046). NVP discontinuation due to rash/liver toxicity was significantly more common among women with pretreatment CD4 cell count more than 250cells/μl (P=0.003). Conclusion: In this study, HIV-infected African women starting a NVP-based antiretroviral regimen had a lower NVP clearance compared to previous reports. Severe rash, but not hepatotoxicity, was associated with higher NVP exposure. Albeit observed in a small number of women, baseline CD4 cell count at least 250 celis/μl was significantly associated with NVP toxicity.

Affiliations:

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Le document en format XML

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<author><name sortKey="Aweeka, Francesca T" sort="Aweeka, Francesca T" uniqKey="Aweeka F" first="Francesca T." last="Aweeka">Francesca T. Aweeka</name>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>AIDS</term>
<term>Antiretroviral agent</term>
<term>Antiviral</term>
<term>Dermatitis</term>
<term>Female</term>
<term>Hepatitis</term>
<term>Hepatotoxicity</term>
<term>Nevirapine</term>
<term>Pharmacokinetics</term>
<term>Risk factor</term>
<term>Sub-Saharan Africa</term>
<term>Toxicity</term>
<term>Woman</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Dermatite</term>
<term>Hépatite</term>
<term>SIDA</term>
<term>Névirapine</term>
<term>Pharmacocinétique</term>
<term>Facteur risque</term>
<term>Afrique subsaharienne</term>
<term>Femme</term>
<term>Femelle</term>
<term>Toxicité</term>
<term>Hépatotoxicité</term>
<term>Antiviral</term>
<term>Antirétroviral</term>
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<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Femme</term>
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</teiHeader>
<front><div type="abstract" xml:lang="en">Objectives: To estimate nevirapine (NVP) pharmacokinetics and examine its association with rash and/or hepatotoxicity in women starting antiretroviral treatment in the AIDS Clinical Trials Group A5208/OCTANE study in Africa. Design: In HIV-infected, nonpregnant women with screening CD4 cell count less than 200cells/μI randomized to NVP (twice daily, after 14-day once-daily lead-in period) and tenofovir/emtricitabine, single NVP blood samples were collected 14 and 28 days following randomization. Rash and hepatotoxicity that occurred during therapy, or within 7 days after the last dose of NVP, were defined as toxicity. Methods: NVP pharmacokinetics were modeled by population pharmacokinetic analysis. Individual Bayesian pharmacokinetic estimates were used to calculate clearance, 24-h area under the curve, and predicted plasma concentrations. Results: Median week 4 NVP clearance was 21/h. Among the 359 women, 194 (54%) developed a rash of any grade; 82 (23%) had grade 2+ and nine (3%) had grade 3+ rash. Median clearance was 1.7l/h for participants exhibiting 3+ rash versus 2 l/h in women without 3+ rash (P= 0.<sub>046</sub>
). The odds of developing 3+ rash was 50% higher for every 20% decrease in clearance (P = 0.046). NVP discontinuation due to rash/liver toxicity was significantly more common among women with pretreatment CD4 cell count more than 250cells/μl (P=0.003). Conclusion: In this study, HIV-infected African women starting a NVP-based antiretroviral regimen had a lower NVP clearance compared to previous reports. Severe rash, but not hepatotoxicity, was associated with higher NVP exposure. Albeit observed in a small number of women, baseline CD4 cell count at least 250 celis/μl was significantly associated with NVP toxicity.</div>
</front>
</TEI>
<affiliations><list><country><li>Kenya</li>
<li>États-Unis</li>
</country>
<region><li>Californie</li>
<li>Massachusetts</li>
</region>
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<tree><country name="États-Unis"><region name="Californie"><name sortKey="Dong, Betty J" sort="Dong, Betty J" uniqKey="Dong B" first="Betty J." last="Dong">Betty J. Dong</name>
</region>
<name sortKey="Aweeka, Francesca T" sort="Aweeka, Francesca T" uniqKey="Aweeka F" first="Francesca T." last="Aweeka">Francesca T. Aweeka</name>
<name sortKey="Currier, Judith S" sort="Currier, Judith S" uniqKey="Currier J" first="Judith S." last="Currier">Judith S. Currier</name>
<name sortKey="Frymoyer, Adam" sort="Frymoyer, Adam" uniqKey="Frymoyer A" first="Adam" last="Frymoyer">Adam Frymoyer</name>
<name sortKey="Hughes, Michael D" sort="Hughes, Michael D" uniqKey="Hughes M" first="Michael D." last="Hughes">Michael D. Hughes</name>
<name sortKey="Lizak, Patricia" sort="Lizak, Patricia" uniqKey="Lizak P" first="Patricia" last="Lizak">Patricia Lizak</name>
<name sortKey="Lockman, Shahin" sort="Lockman, Shahin" uniqKey="Lockman S" first="Shahin" last="Lockman">Shahin Lockman</name>
<name sortKey="Lockman, Shahin" sort="Lockman, Shahin" uniqKey="Lockman S" first="Shahin" last="Lockman">Shahin Lockman</name>
<name sortKey="Verotta, Davide" sort="Verotta, Davide" uniqKey="Verotta D" first="Davide" last="Verotta">Davide Verotta</name>
<name sortKey="Yu Zheng" sort="Yu Zheng" uniqKey="Yu Zheng" last="Yu Zheng">YU ZHENG</name>
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<country name="Kenya"><noRegion><name sortKey="Sawe, Frederick" sort="Sawe, Frederick" uniqKey="Sawe F" first="Frederick" last="Sawe">Frederick Sawe</name>
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</tree>
</affiliations>
</record>

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	Le SIDA en Afrique subsaharienne (serveur d'exploration)
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Le SIDA en Afrique subsaharienne (serveur d'exploration)

Nevirapine pharmacokinetics and risk of rash and hepatitis among HIV-infected sub-Saharan African women

Nevirapine pharmacokinetics and risk of rash and hepatitis among HIV-infected sub-Saharan African women

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Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Le document en format XML

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Pour mettre un lien sur cette page dans le réseau Wicri