Risk and determinants of developing severe liver toxicity during therapy with nevirapine-and efavirenz-containing regimens in HIV-infected patients

Ena, Javier; Amador, Concepción; Benito, Concepción; Fenoll, Vicenta; Pasquau, Francisco

doi:10.1258/09564620360719840

Cited by 43 publications

(34 citation statements)

References 8 publications

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“…The incidence rate of toxicity of NVP-containing regimens was consistent with that reported in other studies [2,4,7,19], and toxicity was frequently self-limiting. While a grade 3-4 elevation of alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) level was detected in 6.6% of women using a NVP-containing regimen, most of these elevations resulted in no significant clinical hepatotoxicity.…”

Section: Discussionsupporting

confidence: 87%

“…It is clear from this and other studies that ARV triple therapy represents the gold standard for accomplishing this goal [15][16][17][18]. The limited drop-out rate for patients in this large programme run in a public health setting in a limited-resource environment provides reassurance that this goal is possible even in developing countries.The incidence rate of toxicity of NVP-containing regimens was consistent with that reported in other studies [2,4,7,19], and toxicity was frequently self-limiting. While a grade 3-4 elevation of alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) level was detected in 6.6% of women using a NVP-containing regimen, most of these elevations resulted in no significant clinical hepatotoxicity.…”

supporting

confidence: 87%

“…Adverse reactions were defined according to the Aids Clinical Trial Group (ACTG) Adult Adverse Experiences Grading Scale [13]. The mean number of transaminase measurements taken was 4.1 [median 4; interquartile range (IQR): 3-5; range [2][3][4][5][6][7][8][9][10]. The number of measurements was significantly higher in the subsample of patients with liver toxicity (4.7 vs 3.2 for the whole sample; Po0.01).…”

Section: Methodsmentioning

confidence: 99%

“…A number of studies have recently raised the issue of the toxicity of nevirapine (NVP) administered during pregnancy to HIV-1-positive women [1][2][3][4][5][6][7]. The findings of these studies have not, however, been consistent.…”

Section: Introductionmentioning

confidence: 99%

“…Most of the 3-4 grade toxicities (36 out of 46) resulted in transient elevations of transaminase levels, which had decreased again by the next check-up without ARV treatment being stopped or changed. It is likely that the majority of these elevations in liver enzymes were the result of the NVP in the regimen [1][2][3][4][5][6][7]. The incidence rate of hepatic toxicities was higher in the women undergoing long-term treatment [20].…”

mentioning

confidence: 99%

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Safety of nevirapine‐containing antiretroviral triple therapy regimens to prevent vertical transmission in an African cohort of HIV‐1‐infected pregnant women

Marazzi

Germano²,

Liotta

et al. 2006

HIV Medicine

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ObjectiveTo assess the incidence and consequences of adverse reactions among African HIV-positive pregnant women treated with fixed-dose combinations of a nevirapine-containing antiretroviral (ARV) triple therapy. MethodsA retrospective analysis of the clinical files of 703 HIV-1-positive pregnant women treated with a nevirapine-containing regimen between May 2002 and July 2004 was conducted. Selection criteria for inclusion in the analysis were: (a) taking ARV for more than 14 days; (b) baseline values of transaminases below the threshold of 2.5 times the upper limit of normal (ULN). The women were on a nevirapine-containing regimen for a median of 127 days [interquartile range (IQR) 86-190 days], starting on average at the 27th week of gestation (standard deviation AE 9.5) and continuing up to a maximum of 6 months after delivery. All women were offered formula milk to feed the babies. Highly active antiretroviral therapy (HAART) was continued beyond 6 months only if the patient qualified on the first visit. The main outcome measures were incidence of hepatotoxicity, skin rashes and Stevens-Johnson syndrome. Multivariate analysis to assess the impact of several factors on the adverse reaction rate was performed. ResultsAs of 1 August 2004, 554 pregnancies reached term, 96 women were still pregnant, and 53 women dropped out of the programme before giving birth. After 2 months of therapy the percentage of patients with a viral load less than 1000 HIV-1 RNA copies/mL increased to 78.6%; average CD4 cell counts increased from 490 cells/mL before therapy to 630 after therapy. The incidence of grade 3-4 adverse reactions (hepatotoxicity, skin rashes and Stevens-Johnson syndrome) was 6.5, 2.4 and 1.1%, respectively. Five women died during pregnancy (0.88%). Only one of the deaths could be associated with ARV treatment. ConclusionNevirapine-containing regimens in pregnant woman, at all CD4 cell count levels, appear to be safe in African settings.Keywords: hepatotoxicity, HIV mother-to-child transmission, nevirapine-containing regimen, public health, resource-limited settings A major focus of the programme is the prevention of mother-to-child transmission during pregnancy, delivery and breast-feeding. Mothers are kept on highly active antiretroviral therapy (HAART) if they qualify for this treatment at the time of diagnosis. Antiretrovirals (ARVs), nutritional supplements and laboratory tests are provided free of charge.To assess the potential toxicity of, and damage caused by, NVP-containing regimens, a cohort of 703 pregnant women enrolled in DREAM were analysed retrospectively. Patients and methods PatientsThe clinical files of all 999 pregnant women enrolled in the programme between 1 May 2002 and 31 July 2004 were reviewed. The baseline characteristics of the patients are presented in Table 1.Of these patients, 28 had taken HAART for less than 14 days; 109 had not yet begun HAART because of the stage of their pregnancy; 84 refused to continue treatment after the first visit, and 53 stopped treatment before deliver...

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Section: Discussionsupporting

confidence: 87%