`Efavirenz plasma levels can predict treatment failure and central nervous system side effects in HIV-1-infected patients'

Marzolini, Catia; Telenti, Amalio; Décosterd, Laurent A.; Biollaz, J.; Buclin, Thierry

doi:10.1097/00002030-200106150-00023

Cited by 207 publications

(339 citation statements)

References 1 publication

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“…In the PK/PD substudy of 2NN, comprising only previously treatment-naïve patients, a C trough < 1,100 ng/ml was associated with an increased risk of virological failure, although the positive predictive value for virological failure was very low [14]. In this study, 1,100 ng/ml was the imputed median C trough of the population; thus, the EFV exposure in that study seems to be lower than in other study populations (see [7,15,16]). …”

Section: Discussionmentioning

confidence: 60%

See 1 more Smart Citation

The relation between treatment outcome and efavirenz, atazanavir or lopinavir exposure in the NORTHIV trial of treatment-naïve HIV-1 infected patients

Josephson

Andersson

Flamholc

et al. 2009

Eur J Clin Pharmacol

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Section: Discussionmentioning

confidence: 60%

“…Some investigators have found positive relations [15,17,18], whereas others have not [19,20]. This difference may be method-dependent.…”

Section: Discussionmentioning

confidence: 98%

The relation between treatment outcome and efavirenz, atazanavir or lopinavir exposure in the NORTHIV trial of treatment-naïve HIV-1 infected patients

Josephson

Andersson

Flamholc

et al. 2009

Eur J Clin Pharmacol

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“…44,45 Liver dysfunction may impair drug metabolism, which may enhance pharmacokinetic interactions between NNRTIs and PIs and increase the risk of hepatotoxicity by increasing drug concentrations. 30,34,[46][47][48][49] We were unable to investigate this hypothesis because liver histology and serum drug levels were unavailable in most patients.…”

Section: Discussionmentioning

confidence: 99%

Hepatotoxicity associated with nevirapine or efavirenz-containing antiretroviral therapy: Role of hepatitis C and B infections

et al. 2002

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Hepatologists are frequently asked to evaluate human immunodeficiency virus (HIV)-infected patients with abnormal liver enzymes and to assess the causal role of medications, such as antiretroviral drugs. Recently, the use of HIV-1 specific non-nucleoside reverse transcriptase inhibitors (NNRTIs), including nevirapine (NVP) and efavirenz (EFV), has been associated with severe hepatic injury. We prospectively studied the incidence of severe hepatotoxicity (grade 3 or 4 change in alanine or aspartate transaminase levels) among 568 patients receiving NNRTI-containing antiretroviral therapy, including 312 and 256 patients prescribed EFV and NVP, respectively. Hepatitis C virus (HCV) and hepatitis B virus (HBV) were detected in 43% and 7.7% of patients, respectively. Severe hepatotoxicity was observed in 15.6% of patients prescribed NVP and 8.0% of those prescribed EFV, but only 32% of NVP and 50% of EFV-associated episodes were detected during the first 12-weeks of therapy. The risk was significantly greater among persons with chronic viral hepatitis (69% of cases) and those prescribed concurrent protease inhibitors (PIs) (82% of cases). Nonetheless, 84% of patients with chronic HCV or HBV did not experience severe hepatotoxicity. Severe hepatotoxicity occurs throughout the course of NNRTI therapy and is more common among patients prescribed nevirapine, those coinfected with HCV or HBV, and those coadministered protease inhibitors. (HEPATOLOGY 2002;35:182-189.)

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“…Etravirine unfortunately has less favorable drug product characteristics -high pill burden and a difficult manufacturing process using a specific spray dry technology -limiting its potential in the developing world [16]. Tibotec is the developer of both of these new NNRTI compounds.…”

Section: Treatment Strategymentioning

confidence: 99%

“…Currently, the limited human pharmacokinetic data [16] that are available do not support the use of rilpivirine together with rifampicin (a core drug to treat tuberculosis) because bioavailability of rilpivirine is reduced by 80% [21]. This poses a major problem for its use in HIV/TB coinfected individuals that represent a significant proportion of the HIV population in resource-limited settings.…”

Section: Use In Specific Populationsmentioning

confidence: 99%

How developing world concerns need to be part of drug development plans: a case study of four emerging antiretrovirals

Roey

Schoen-Angerer

Ford

et al. 2008

Drug Discovery Today

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Clinical trials are usually designed to meet registration requirements in developed countries, and do not always address key concerns for use in developing countries. Four late-stage investigational new drugsrilpivirine, etravirine, raltegravir and maraviroc -show potential to improve antiretroviral therapy. However, a number of issues could limit their use in developing countries, including dose selection, treatment strategy, combination with other drugs, use in specific populations and reliance on expensive tests. Key research questions relevant for developing countries need to be answered early in the drug development process to ensure maximum benefit for the majority.

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`Efavirenz plasma levels can predict treatment failure and central nervous system side effects in HIV-1-infected patients'

Cited by 207 publications

References 1 publication

The relation between treatment outcome and efavirenz, atazanavir or lopinavir exposure in the NORTHIV trial of treatment-naïve HIV-1 infected patients

The relation between treatment outcome and efavirenz, atazanavir or lopinavir exposure in the NORTHIV trial of treatment-naïve HIV-1 infected patients

Hepatotoxicity associated with nevirapine or efavirenz-containing antiretroviral therapy: Role of hepatitis C and B infections

How developing world concerns need to be part of drug development plans: a case study of four emerging antiretrovirals

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