Home Search Abstracts Browse Sessions Program Committee View Session E-mail Abstract Author

 

 

Session 8 Oral Abstracts
Diagnosis and Treatment of HIV Infection in Developing Countries
Wednesday, 10 am - 12:30 pm
Presentation Time: 10:45 am
Ballroom A


21
Toxicities from Nevirapine in HIV-infected Males and Females, Including Pregnant Females with Various CD4 Cell Counts
N Phanuphak, T Apornpong, S Intarasuk, S Teeratakulpisarn, and Praphan Phanuphak*
Thai Red Cross AIDS Res Ctr, Bangkok

Background:  Nevirapine (NVP)-based highly active antiviral therapy (HAART) has been the most frequently prescribed antiretroviral regimen in less-developed countries due to its low cost and convenience. However, reported toxicities from NVP, including life-threatening liver and skin disorders, are major concerns, especially for women with high CD4 cell counts.

Methods:  The Thai Red Cross AIDS Research Centre (TRCARC) has been giving a triple drug regimen for prevention of mother-to-child transmission (PMTCT) to all pregnant women since April 2004. The PMTCT regimen is composed of zidovudine/lamivudine/nevirapine (AZT/3TC/NVP) starting from 14 weeks of gestational age in women whose CD4 cell counts were < 200 cells/mm3 and from 28 weeks in women whose CD4 cell counts were > 200 cells/mm3. TRCARC has also been one of Columbia University MTCT-Plus Initiative demonstrating sites since February 2003. All MTCT-Plus enrollees have received NVP-based triple drug regimen as their first-line defense when needed. Data on liver and skin toxicities related to NVP developed in TRCARC PMTCT and MTCT-Plus programs were collected and risk factors were analyzed.

Results:  As shown in the tables below, of 342 patients (40 in TRCARC PMTCT and 302 in MTCT-Plus programs), 9.4% developed liver and/or skin toxicities.

 

n

Total

Hepatitis

Rash

Only

Oth Asymp Only

Asymp

Rash

Oth Asymp

Total

Total Female

250

26 (10.4%)

4

2

2

8 (3.2%)

16 (6.4%)

2

Preg < = 250

81

7

1

0

1

2

5

0

Preg > 250

76

9

1

2

1

4

4

1

Non-preg

93

10

2

0

0

2

7

1

Male

92

6 (6.5%)

1

0

0

1 (1.1%)

4 (4.3%)

1

Total

342

32 (9.4%)

5

2

2

9 (2.6%)

20 (5.8%)

3

 

 

Hepatitis

Rash

gr I-II

gr III-IV

gr I-II

gr III-IV

Total Female

2 (0.8%)

6 (2.4%)

14 (5.6%)

4 (1.6%)

Preg < = 250

1

1

3

2

Preg > 250

1

3

6

0

Non-preg

0

2

5

2

Male

0 (0.0%)

1 (1.1%)

4 (4.3%)

0 (0.0%)

Total

2 (0.6%)

7 (2.0%)

18 (5.3%)

4 (1.2%)

 

Conclusion:  Although reported as a cause of life-threatening adverse events, NVP has not caused more frequent adverse events than previously reported in any group of our patients analyzed including, pregnant women with CD4 >250 cells/mm3. There were some trends of increasing gr. III-IV liver toxicities and gr. I-II skin toxicities in pregnant women with CD4 > 250 cells/mm3, but none reached a statistically significant level. With careful clinical and laboratory monitoring no fatality has been observed in this cohort. NVP-based triple regimen should still be considered as an option for PMTCT in pregnant women regardless of CD4 cell counts, especially in middle-income countries.

Keywords: nevirapine toxicity; pregnancy; CD4>250