Nevirapine pharmacokinetics and risk of rash and hepatitis among HIV-infected sub-Saharan African women
Identifieur interne : 000717 ( PascalFrancis/Curation ); précédent : 000716; suivant : 000718Nevirapine 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.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Femme.
English descriptors
- KwdEn :
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.
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<term>Female</term>
<term>Hepatitis</term>
<term>Hepatotoxicity</term>
<term>Nevirapine</term>
<term>Pharmacokinetics</term>
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<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>
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<s2>NK</s2>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Nevirapina</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Pharmacocinétique</s0>
<s5>07</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Pharmacokinetics</s0>
<s5>07</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Farmacocinética</s0>
<s5>07</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Facteur risque</s0>
<s5>08</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Risk factor</s0>
<s5>08</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Factor riesgo</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Afrique subsaharienne</s0>
<s2>NG</s2>
<s5>09</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Sub-Saharan Africa</s0>
<s2>NG</s2>
<s5>09</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Africa subsahariana</s0>
<s2>NG</s2>
<s5>09</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Femme</s0>
<s5>10</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Woman</s0>
<s5>10</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Mujer</s0>
<s5>10</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Femelle</s0>
<s5>13</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Female</s0>
<s5>13</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Hembra</s0>
<s5>13</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Toxicité</s0>
<s5>14</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Toxicity</s0>
<s5>14</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Toxicidad</s0>
<s5>14</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Hépatotoxicité</s0>
<s5>15</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Hepatotoxicity</s0>
<s5>15</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Hepatotoxicidad</s0>
<s5>15</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE"><s0>Antiviral</s0>
<s5>30</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG"><s0>Antiviral</s0>
<s5>30</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA"><s0>Antiviral</s0>
<s5>30</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE"><s0>Antirétroviral</s0>
<s5>31</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG"><s0>Antiretroviral agent</s0>
<s5>31</s5>
</fC03>
<fC03 i1="13" i2="X" l="SPA"><s0>Antiretroviral</s0>
<s5>31</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Virose</s0>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Viral disease</s0>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Virosis</s0>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Infection</s0>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Infection</s0>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Infección</s0>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Afrique</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Africa</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Africa</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Homme</s0>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Human</s0>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Hombre</s0>
</fC07>
<fC07 i1="05" i2="X" l="FRE"><s0>Composé non nucléoside</s0>
<s5>37</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>Non nucleoside compound</s0>
<s5>37</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Compuesto no nucleósido</s0>
<s5>37</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE"><s0>Inhibiteur enzyme</s0>
<s5>38</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG"><s0>Enzyme inhibitor</s0>
<s5>38</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA"><s0>Inhibidor enzima</s0>
<s5>38</s5>
</fC07>
<fC07 i1="07" i2="X" l="FRE"><s0>Inhibiteur reverse transcriptase</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>39</s5>
</fC07>
<fC07 i1="07" i2="X" l="ENG"><s0>Reverse transcriptase inhibitor</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>39</s5>
</fC07>
<fC07 i1="07" i2="X" l="SPA"><s0>Inhibitor reverse transcriptase</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>39</s5>
</fC07>
<fC07 i1="08" i2="X" l="FRE"><s0>RNA-directed DNA polymerase</s0>
<s2>FE</s2>
<s5>40</s5>
</fC07>
<fC07 i1="08" i2="X" l="ENG"><s0>RNA-directed DNA polymerase</s0>
<s2>FE</s2>
<s5>40</s5>
</fC07>
<fC07 i1="08" i2="X" l="SPA"><s0>RNA-directed DNA polymerase</s0>
<s2>FE</s2>
<s5>40</s5>
</fC07>
<fC07 i1="09" i2="X" l="FRE"><s0>Nucleotidyltransferases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="09" i2="X" l="ENG"><s0>Nucleotidyltransferases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="09" i2="X" l="SPA"><s0>Nucleotidyltransferases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="10" i2="X" l="FRE"><s0>Transferases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="10" i2="X" l="ENG"><s0>Transferases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="10" i2="X" l="SPA"><s0>Transferases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="11" i2="X" l="FRE"><s0>Enzyme</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="11" i2="X" l="ENG"><s0>Enzyme</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="11" i2="X" l="SPA"><s0>Enzima</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="12" i2="X" l="FRE"><s0>Pathologie de la peau</s0>
<s5>41</s5>
</fC07>
<fC07 i1="12" i2="X" l="ENG"><s0>Skin disease</s0>
<s5>41</s5>
</fC07>
<fC07 i1="12" i2="X" l="SPA"><s0>Piel patología</s0>
<s5>41</s5>
</fC07>
<fC07 i1="13" i2="X" l="FRE"><s0>Pathologie de l'appareil digestif</s0>
<s5>42</s5>
</fC07>
<fC07 i1="13" i2="X" l="ENG"><s0>Digestive diseases</s0>
<s5>42</s5>
</fC07>
<fC07 i1="13" i2="X" l="SPA"><s0>Aparato digestivo patología</s0>
<s5>42</s5>
</fC07>
<fC07 i1="14" i2="X" l="FRE"><s0>Pathologie du foie</s0>
<s5>43</s5>
</fC07>
<fC07 i1="14" i2="X" l="ENG"><s0>Hepatic disease</s0>
<s5>43</s5>
</fC07>
<fC07 i1="14" i2="X" l="SPA"><s0>Hígado patología</s0>
<s5>43</s5>
</fC07>
<fC07 i1="15" i2="X" l="FRE"><s0>Immunodéficit</s0>
<s5>44</s5>
</fC07>
<fC07 i1="15" i2="X" l="ENG"><s0>Immune deficiency</s0>
<s5>44</s5>
</fC07>
<fC07 i1="15" i2="X" l="SPA"><s0>Inmunodeficiencia</s0>
<s5>44</s5>
</fC07>
<fC07 i1="16" i2="X" l="FRE"><s0>Immunopathologie</s0>
<s5>46</s5>
</fC07>
<fC07 i1="16" i2="X" l="ENG"><s0>Immunopathology</s0>
<s5>46</s5>
</fC07>
<fC07 i1="16" i2="X" l="SPA"><s0>Inmunopatología</s0>
<s5>46</s5>
</fC07>
<fN21><s1>149</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>
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