Trial reportAIDS (London, England)2012
Nevirapine pharmacokinetics and risk of rash and hepatitis among HIV-infected sub-Saharan African women.
Trial report in AIDS (London, England), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
21 citing papers in PubMed, 37 citations in OpenAlex.
- A decade of HIV care in rural Tanzania: Trends in clinical outcomes and impact of clinic optimisation in an open, prospective cohort.PloS one · 2017Trial
- The pharmacokinetics of nevirapine when given with isoniazid in South African HIV-infected individuals.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2013Trial
- Differences in antiretroviral safety and efficacy by sex in a multinational randomized clinical trial.HIV clinical trialsTrial
- The role of corticosterone in nevirapine-induced idiosyncratic drug-induced liver injury.Toxicological sciences : an official journal of the Society of Toxicology · 2024Article
- Inclusion of pregnant women in antiretroviral drug research: what is needed to move forwards?Journal of the International AIDS Society · 2019Article
- Optimizing Pediatric Dosing Recommendations and Treatment Management of Antiretroviral Drugs Using Therapeutic Drug Monitoring Data in Children Living With HIV.Therapeutic drug monitoring · 2019Review
- Determinants of virological outcome and adverse events in African children treated with paediatric nevirapine fixed-dose-combination tablets.AIDS (London, England) · 2017Article
- Effects of CYP2B6 and CYP1A2 Genetic Variation on Nevirapine Plasma Concentration and Pharmacodynamics as Measured by CD4 Cell Count in Zimbabwean HIV-Infected Patients.Omics : a journal of integrative biology · 2015Article
- Perspectives on pharmacogenomics of antiretroviral medications and HIV-associated comorbidities.Current opinion in HIV and AIDS · 2015Review
- Cytochrome P450 2B6 genetic variants are associated with plasma nevirapine levels and clinical response in HIV-1 infected Kenyan women: a prospective cohort study.AIDS research and therapy · 2015Article
- Case Report: Stevens-Johnson syndrome following a single double dosing of nevirapine-containing regimen once in an HIV-infected woman on long-term antiretroviral therapy.F1000Research · 2015Article
- CYP2B6 c.983T>C polymorphism is associated with nevirapine hypersensitivity in Malawian and Ugandan HIV populations.The Journal of antimicrobial chemotherapy · 2014Article
- Pharmacogenomics of antimicrobial agents.Pharmacogenomics · 2014Review
- Incidence and determinants of nevirapine and efavirenz-related skin rashes in West Africans: nevirapine's epitaph?PloS one · 2014Article
- Association between CYP2B6 polymorphisms and Nevirapine-induced SJS/TEN: a pharmacogenetics study.European journal of clinical pharmacology · 2013Article
- Changing incidence of nevirapine-induced cutaneous drug reactions: After revised guideline Nov 2011.Indian journal of sexually transmitted diseases and AIDS · 2013Article
- Nevirapine inhibits the anti-HIV activity of CD8+ cells.Journal of acquired immune deficiency syndromes (1999) · 2013Article
- DRESS Syndrome due to Nevirapine Treated with Methylprednisolone.Case reports in medicine · 2013Article
- Multiple genetic variants predict steady-state nevirapine clearance in HIV-infected Cambodians.Pharmacogenetics and genomics · 2012Article
- Clinical perspectives on human genetic screening to prevent nevirapine toxicity.Personalized medicine · 2012Article
Corrections and comments
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Authors and funding
11 authors at 4 institutions in 2 countries.
Funding
Abstract
objectivesTo 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.
designIn HIV-infected, nonpregnant women with screening CD4 cell count less than 200 cells/μl 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.
methodsNVP 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.
resultsMedian week 4 NVP clearance was 2 l/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 1.7 l/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 250 cells/μl (P = 0.003).
conclusionIn 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 cells/μl was significantly associated with NVP toxicity.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.