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12th Conference on Retroviruses and Opportunistic InfectionsBoston, Massachusetts - February 22-25, 2005 |
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Conf Retrovir Opportunistic Infect 2005 Feb 22-25;12:abstract no. 21
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.
| Hepatitis | Rash | Oth Asymp | ||||||
| n | Total | Asymp | Rash | Oth Asymp | Total | Only | Only | |
| 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 | 2 |
| 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 |
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| 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%) |
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| Total | 2 (0.6%) | 7 (2.0%) | 18 (5.3%) | 4 (1.2%) |
CONCLUSIONS: 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.
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Copyright © 2005 - Foundation for Retrovirology and Human Health. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed (AIDSLINE) from National Library of Medicine.
