High-Dose Nevirapine: Safety, Pharmacokinetics, And Antiviral Effect In Patients With Human Immunodeficiency Virus Infection

Havlir, Diane V.; Cheeseman, Sarah H.; McLaughlin, Margaret; Murphy, Robert; Erice, Alejo; Spector, Stephen A.; Greenough, Thomas C.; Sullivan, John L.; Hall, David B.; Myers, Maureen; Lamson, Michael; Richman, Douglas D.

doi:10.1093/infdis/171.3.537

Cited by 277 publications

(137 citation statements)

References 20 publications

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“…In our study, as with most other authors [10]- [13], anti-infectious sulfonamides were the most frequently involved drugs. They were followed by the antiretrovirals and quinine.…”

Section: Discussionsupporting

confidence: 88%

“…Antiretroviral (nevirapine) occupied the second place in our study. Nevirapine is known as a major provider of drug eruptions, and several studies have documented the high incidence of drug reactions induced by nevirapine and their severity [13]- [17]. In opposite, in the series of Pitche et al in Togo [11] and Mame Thierno et al in Senegal [5], antiretroviral drugs have not been found, which can be due to the fact that in Togo, despite the high prevalence of HIV infection no HIV-infected patients in this country was on antiretroviral treatment (for economic reasons, the majority of HIV-infected patients did not yet have access to antiretroviral drugs in Africa) [11].…”

Section: Discussionmentioning

confidence: 99%

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Severe Drug Eruption in Guinea Conakry

Cissé¹,

Tounkara²,

Diané³

et al. 2014

JCDSA

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Severe drug reactions are defined as mucocutaneous complications secondary to systemic administration of drugs likely to be life threatening. Our work was designed to determine the evolutio- 33%). The lethality rate was 9.09% (2/22) in the Stevens-Johnson syndrome and 53.85% (7/13) in the Toxic Epidermal Necrolysis. HIV infection was found in 17.95% (7/26) of our patients and 71.42% (5/7) of the deceased. The drug accountability was established in 79.48%; the most commonly implicated drugs in the Toxic Epidermal Necrolysis were sulfonamides followed by ARVs (nevirapine) and anti TB (isoniazid); in the SJS sulfonamides followed by salts of quinine and anti TB, the only case of DRESS was due to quinine. No drug was found in 20.52% (8 cases). HIV infection remains a poor prognostic factor. Our study shows the scarcity of Drug Rash with Eosinophilia and Systemic Symptoms and Acute generalized exanthematous pustulosis in our service.

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“…In our study, as with most other authors [10]- [13], anti-infectious sulfonamides were the most frequently involved drugs. They were followed by the antiretrovirals and quinine.…”

Section: Discussionsupporting

confidence: 88%

Section: Discussionmentioning

confidence: 99%

Severe Drug Eruption in Guinea Conakry

Cissé¹,

Tounkara²,

Diané³

et al. 2014

JCDSA

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“…[12][13][14][15][16][17] C max = peak concentration; C min = trough concentration; T max = Time to attain C max ; AUC = area under the plasma concentration versus time curve; t ½ = half-life; BMI = body mass index. fact that Indian patients weigh less than Europeans and Americans and that nevirapine clearance is dependent on body weight.…”

Section: Discussionmentioning

confidence: 99%

Steady-State Pharmacokinetics of Nevirapine in HIV-1 Infected Adults in India

Ramachandran

Hemanthkumar

Rajasekaran

et al. 2007

Journal of the International Association of Physicians in AIDS

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Background and Objectives:A variety of demographic factors, sex, and degree of immunosuppression can influence antiretroviral drug concentrations. The authors studied the influence of immune status, sex, and body mass index (BMI) on the steady-state pharmacokinetics of nevirapine delivered as a fixed-dose combination in HIV-1-infected patients in India. Methods: Twenty-six HIV-1-infected adult patients undergoing treatment with nevirapine-based highly active antiretroviral therapy regimens participated in the study. Pharmacokinetic variables were compared between patients divided based on CD4 cell counts, sex, and BMI. Results: Patients with higher BMI had lower peak and trough concentration and exposure of nevirapine than those with lower BMI; none of the differences in the pharmacokinetic variables of nevirapine between the various patient groups was statistically significant. Conclusions: Patients' immune status, sex, or BMI had no impact on the pharmacokinetics of nevirapine. Plasma nevirapine concentrations were maintained within the therapeutic range of the drug in the majority of the patients.Keywords: pharmacokinetics; nevirapine; India; immune status; sex; BMI Access to antiretroviral drugs for HIV-1-infected patients in developing countries is a global public health priority. The World Health Organization currently recommends first-line therapy with 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 non-NRTI (NNRTI)⎯a combination with good efficacy, tolerability, simplicity, and low cost. 1 Generic fixed-dose combinations (FDCs) of such regimens are widely regarded as crucial for scaling up AIDS treatment in developing countries. Two triple-drug combinations consisting of nevirapine and lamivudine with either stavudine or zidovudine as the third agent are available as FDCs in the developing world. A vast majority of HIV-infected patients in India receive nevirapine-based highly active antiretroviral therapy (HAART), the common co-drugs being lamivudine and stavudine. 2 A few studies have reported the effectiveness and safety of generic FDCs for treatment of HIV-1-infected adults. [2][3][4][5] It has been suggested that a variety of demographic factors such as age, body size, and weight can influence antiretroviral drug concentrations. 6 Sex-based differences in the pharmacokinetics of nevirapine have also been observed. 7 Keating et al reported that malabsorption correlates significantly with the degree of immunosuppression. 8 We undertook a study to obtain information on the pharmacokinetics of nevirapine in HIV-infected patients on treatment with FDCs in India, as well as the influence of immunological status, sex, and body mass index (BMI) on the pharmacokinetics of these drugs, as very limited information is available on this aspect. Methods PatientsThe study participants were composed of HIV-infected patients of ethnic Indian origin who were participating in a controlled clinical trial and were being followed

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“…Since the occurrence of HAART, there is an additional risk of cutaneous toxicity associated with some of these drugs [5][6][7], mainly nevirapine. Indeed, several studies have documented the high incidence of drug-induced dermatitis induced by nevirapine [6][7][8][9].…”

Section: Introductionmentioning

confidence: 99%

“…Indeed, several studies have documented the high incidence of drug-induced dermatitis induced by nevirapine [6][7][8][9].…”

Section: Introductionmentioning

confidence: 99%

Lyell Syndrome with Fatal Outcome in Two Pregnant Women Receiving Antiretroviral Therapy in Guinea Conakry

Cissé¹,

Soumah²,

Tounkara³

et al. 2013

JCDSA

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An old woman, 28 years old, weighing 74 kg was referred for skin detachment associated with bubbles and mucosal erosions. This clinical picture had occurred 15 days after the institution of a triple combination: AZT (300 mg) + 3TC (150 mg) and nevirapine (200 mg), during a pregnancy of 20-week gestation. The woman was in her third gestation. The second case is aged 26, weighing 65 kg. This clinical picture had occurred 20 days after the administration of a triple therapy combination: AZT (300 mg) + 3TC (150 mg) and nevirapine (200 mg), during a pregnancy of 32-week gestation. It was the fourth gestation. The birth of a stillborn had occurred the day before his admission into our service. The diagnosis of Toxic Epidermal Necrolysis with nevirapine was selected on the basis of the clinical and anamnestic arguments. The biological tests showed the following results: transaminases (ALT and AST) were within normal limits, blood glucose, and urea > 10 mmol/l. The evolution was marked by the patient death to Day 9 (D9) and at D2 of hospitalization. Discussion: NET and the SJS have been reported in pregnant women as potentially dangerous complications that are often associated with suspected drugs. Among these drugs, antiretroviral drugs, prescribed to pregnant women to prevent mother to child transmission of HIV are often reported. Our case is an illustration of the problem of HIV management in pregnant women. It also focuses on the association between pregnancy and Toxic Epidermal Necrolysis. Nevirapine is an effective drug in the regimens proposed in the management of HIV patients in limited resources countries. But the high frequency of toxidermia with this drug should lead to its replacement by other antiretrovirals least providers of toxidermia as anti proteases in the context of PMTCT programs.

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High-Dose Nevirapine: Safety, Pharmacokinetics, And Antiviral Effect In Patients With Human Immunodeficiency Virus Infection

Cited by 277 publications

References 20 publications

Severe Drug Eruption in Guinea Conakry

Severe Drug Eruption in Guinea Conakry

Steady-State Pharmacokinetics of Nevirapine in HIV-1 Infected Adults in India

Lyell Syndrome with Fatal Outcome in Two Pregnant Women Receiving Antiretroviral Therapy in Guinea Conakry

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