IngentaConnect Safety of nevirapine-containing antiretroviral triple therapy reg...

Authors: Marazzi, MC¹; Germano, P²; Liotta, G³; Guidotti, G⁴; Loureiro, S⁵; da Cruz Gomes, A⁶; Valls Blazquez, MC⁵; Narciso, P⁷; Perno, CF⁸; Mancinelli, S³; Palombi, L³

Source: HIV Medicine, Volume 7, Number 5, July 2006 , pp. 338-344(7)

Publisher: Blackwell Publishing

Abstract:

Objective

To 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. Methods

A 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±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. Results

As 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/μL 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. Conclusion

Nevirapine-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

Document Type: Research article

DOI: 10.1111/j.1468-1293.2006.00386.x

Affiliations: 1: LUMSA University, Rome, Italy, 2: Community of Sant'Egidio, DREAM Programme, Rome, Italy, 3: Department of Public Health, University of Tor Vergata, Rome, Italy, 4: National Institute of Health, ISS, Rome, Italy, 5: Dream Program-Maputo, Mozambique, 6: Catholic University of Beira, Beira, Mozambique, 7: National Institute of Infectious Disease, INMI `L. Spallanzani' Rome, Italy, 8: Department of Experimental Medicine, University of Tor Vergata, Rome, Italy

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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