AEGiS-15IAC: Evaluation of nevirapine toxicity in a cohort of HIV-1 infected pregnant women.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

Evaluation of nevirapine toxicity in a cohort of HIV-1 infected pregnant women.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. ThOrB1354)

Joao EC, Calvet GA, Menezes JA, Salgado LT, D'Ippolito MM, Silva SS, Cruz ML, Braga RC, Matos H
Hospital dos Servidores do Estado, Rio de Janeiro, Brazil

BACKGROUND: Toxicity of nevirapine (NVP) has been reported in women with an overall risk higher than in men, but the rate has not been established in pregnant women. The most common toxicity of NVP is rash, usually in the first 4 weeks. Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis may occur. NVP may also cause asymptomatic hepatitis or severe clinical hepatitis. Objectives: To evaluate NVP toxicity as part of combination therapy in a cohort of HIV-1 infected pregnant women and the prevalence of skin and liver toxicity.

METHODS: Data were abstracted from charts of a cohort of 559 HIV-1 pregnant women from January 1996 to July 2003: clinical history and physical exam were used to evaluate skin toxicity and CBC and ALT/AST at baseline and 1 month for liver toxicity, CD4 counts and viral load were determined at baseline and every 3 months. HBV and HCV co-infections, drug and alcohol abuse were recorded as were obstetrical complications and other adverse events. US DAIDS criteria were used to grade NVP skin and liver toxicity. Data were analyzed by SPSS 9.0 program.

RESULTS: 188 pregnant women took NVP as part of therapy. In 145 the duration of therapy was at least 10 days. Toxic effects were seen in 8 (5,51%): skin rash in 6 (75%) - 4 grade 1, one grade 2, one grade 4-(SJS) and abnormalities of AST/ALT in 2 (25%)- one grade 2 but was co-infected by HCV. NVP was discontinued in 50%. Two women were black, and six non-black. Mean time of NVP exposure was 19.5 days(Std: 11 to 28 days). Median CD4 count near delivery was 368 cells/mm³. Alcohol abuse, HBV co-infection were not reported. The median gestational age at onset was 38 weeks. One case of grade 1 rash had a premature labor with fetal demise.

CONCLUSIONS: NVP toxicity rate was 5.51% leading to drug discontinuation in 50%. Most cases (75%) presented as skin rash including one grade 4. In this cohort the use of NVP during pregnancy was safe.

Keywords: AEGIS, Nevirapine, HIV-1, CD4 Lymphocyte Count, Viral Load, HIV-1 Reverse Transcriptase, Drug Toxicity, Disease Progression, Pregnant Women, Humans, Female, Male, Pregnancy, methods

040711
ThOrB1354