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Session 139 Poster Abstracts
Impact of Antiretroviral Therapy during Pregnancy
Friday, 1:30 - 3:30 pm
Hall B


809    
Preliminary Findings: Incidence of Serious Adverse Events Attributed to Nevirapine among Women Enrolled in an Ongoing Trial Using HAART tor Prevent Mother-to-Child HIV Transmission
Timothy Thomas*1, P Amornkul1, J Mwidau1,2, R Masaba1, L Slutsker1, D Mwaengo1, J Vulule1, K DeCock1, and M Fowler3
1Kenya Med Res Inst/CDC, Kisumu; 2Univ of Miami, FL, USA; and 3CDC, Atlanta, GA, USA

Background:  Hypersensitivity rash/hepatotoxicity have been associated with nevirapine (NVP) use, particularly among women and patients with higher CD4 counts. There are limited data on serious adverse events related to NVP-containing HAART among HIV-infected pregnant women in Africa.

Methods:  The Kisumu Breastfeeding Study (KiBS) is an ongoing, single-arm, phase IIB trial to evaluate safety, tolerance, adherence, and efficacy of using zidovudine (ZDV), lamivudine (3TC) and NVP from 34 weeks’ gestation through the first 6 months of lactation for prevention of MTCT among HIV-infected breastfeeding women in Kisumu, Kenya. Enrollees initiate HAART and receive frequent clinical and laboratory monitoring through 24 months postpartum. At 6 months postpartum, HAART is stopped for most women and early weaning occurs; those who meet WHO treatment criteria continue HAART. Using NIAID Toxicity Tables, we report Grade 2-4 serious adverse events occurring between July 3 and August 4, which met study criteria for cessation of NVP.

Results:  By August 31, 2004, 155 women had initiated HAART, providing 2396 weeks of observation (median 13.5; range 0.14 to 55.6). At enrollment, mean age = 23.9 years (15 to 39), mean CD4=458 cells/mm3 (range 90 to 1193), 122 (79%) had CD4 > 250 cells/mm3. Thirteen serious adverse events resulting in cessation of NVP have occurred (rate 8.4%); 4 = grade 2, 8 = grade 3, 1 = grade 4. All but a have completely resolved. The median number of weeks on NVP prior to onset of the serious adverse event was 5.3 (range 2.4 to 26.1).  Table shows serious adverse events attributed to NVP by CD4 group. Percentage of serious adverse events was higher in those with low CD4 counts, but not significant (RR = 2.31, 95% CI 0.81 to 6.6). There was no difference in the percentage of grade 3-4 in each CD4 group. Two cases of Stevens’ Johnson Syndrome occurred (CD4 counts 539 and 302 cells/mm3) but no drug-related deaths.

 

Serious Adverse Events

Percentage for CD4 ≤ 250 cells/mm3

(n = 33)

Percentage for CD4 > 250 cells/mm3

(n = 122)

Total and Overall Percentage

(n=155)

Rash  

1 (3.0%)

 

3 (2.5%)

 

4 (2.6%)

 

Hepatotoxicity

3 (9.1%)

 

4 (3.3%)

 

7 (4.5%)

 

Hepatotoxicity and rash 

0 (0%)

1 (0.8%)

 

1 (0.6%)

 

Neutropenia and rash

1 (3.0%)

 

0 (0%)

1 (0.6%)

 

Total

5 (15%)

8 (7%)

13 (8.4%)

Grade 3-4

2 (6%)

7 (6%)

 

\

 

Conclusions:  Percentage of serious hepatic or cutaneous adverse events among women on NVP was similar to other trials with NVP-containing HAART. While other reports indicate increased risk for women with CD4 counts > 250 cells/mm3, this is not seen among pregnant HIV+ women in Kisumu to date. The data underscore need for close monitoring of women on NVP-HAART.

Keywords: Adverse events; Nevirapine; Prevention of Mother to Child Transmission