752 
Toxicities from Nevirapine-based ART Regimens in Pregnant Women with CD4 Count between 250 and 350 Cells/mm3
N Phanuphak1, T Apornpong1, S Limpongsanurak2, W Luesomboon3, A Tangsathapornpong4, N Singhakovinta5, C Viravasiri6, P Toro7, E Abrams7, and Praphan Phanuphak*7
1Thai Red Cross AIDS Res Ctr, Bangkok; 2King Chulalongkorn Memorial Hosp, Bangkok, Thailand; 3Queen Sawangwattana Memorial Hosp, Chonburi, Thailand; 4Thammasat Univ Hosp, Bangkok, Thailand; 5Queen Sirikit Hosp, Chonburi, Thailand; 6Police Gen Hosp, Bangkok, Thailand; and 7Columbia Univ Mailman Sch of Publ Hlth, New York, NY, US
Background: ART is
currently recommended for women with CD4 count ≤350 cells/mm3
who have clinical stage III, and the trend is to consider ART for those in
clinical stage I or II. Higher risk of nevirapine (NVP)
toxicities in women with CD4 >250 cells/mm3 has been reported.
However, risk in women who have CD4 count of 250 to 350
cells/mm3 especially in developing countries is
unclear. We studied toxicities from NVP in pregnant Thai women with a wide
range of CD4 count who received NVP-based ART for their own health or for prevention
of mother-to-child transmission (PMTCT).
Methods: A
prospective cohort study of pregnant women was performed at the Thai Red Cross
AIDS Research Centre. Zidovudine (AZT) + lamivudine (3TC) + NVP was provided from 14 weeks of gestation
if CD4 count <200 cells/mm3 and from 28 weeks if CD4 count
>200 cells/mm3. The ratio of amino transferase to alanine aminotransferase was checked at baseline, at week 2, 4, 6, and 8, and then
every 4 weeks until delivery. NVP was stopped if toxicities ≥grade II
occurred. Data from the start of ART until delivery were retrieved from all
pregnant women enrolled during April 2004 and August 2006.
Results: Among 494
pregnant women enrolled, 98 (19.8%) had a CD4 count between 251 and 349
cells/mm3 (median 424). Mean time on ART was longer in women with
CD4 count ≤250 cells/mm3 (12 vs 8
weeks, p <0.001). Grade I-IV hepatotoxicity
was found in 14.8% and grade I to IV rash in 12.3%.
Conclusions: Grade I to II hepatotoxicity, asymptomatic hepatotoxicity,
and grade III to IV rash were found more frequent in pregnant women with CD4
count >350 cells/mm3, as expected, but we did not find any higher
rate of toxicities among women with CD4 count between 250 to 350 cells/mm3.
Our findings, although with limited number of women, support the safety of NVP
use among women in this CD4 count range.
|
Hepatitis
|
|
CD4 count
(cells/mm3)
|
n
|
Hepatitis,
all
n
(%, per 100 person-years)
|
Mean onset (week)
|
*p-value,
OR (95%CI)
|
grI-II
|
*p-value, OR (95%CI)
|
asymptomatic
|
*p-value, OR (95%CI)
|
|
≤250
|
140
|
15 (10.7 to 0.8)
|
4.6
|
Ref
|
15
|
Ref
|
15
|
Ref
|
|
251-349
|
98
|
12 (12.2 to 1.6)
|
4.0
|
0.506,
1.3 (0.6 to 3.1)
|
11
|
0.662,
1.2 (0.5 to 2.9)
|
10
|
0.875,
1.1 (0.4 to 2.6)
|
|
>350
|
256
|
46 (17.9 to 2.2)
|
3.5**
|
0.009**,
2.4 (1.2 to 4.5)
|
38
|
0.043**,
1.98 (1.0 to 3.8)
|
41
|
0.023**,
2.1 (1.1 to 4.1)
|
|
Rash
|
|
CD4 count
(cells/mm3)
|
n
|
Rash, all
n
(%, per 100 person-years)
|
Mean onset (week)
|
*p-value,
OR (95%CI)
|
grI-II
|
*p-value, OR (95%CI)
|
grIII-IV
|
*p-value, OR (95%CI)
|
|
≤250
|
140
|
16 (11.4%, 0.9)
|
2.5
|
Ref
|
13
|
Ref
|
0
|
Ref
|
|
251-349
|
98
|
6 (6.1%, 0.8)
|
2.3
|
0.305,
0.6 (0.2 to 1.6)
|
5
|
0.391,
0.6 (0.2 to 1.8)
|
0
|
0.579,
0.5 (0.1 to 5.1)
|
|
>350
|
256
|
39 (15.2%, 1.8)
|
2.6
|
0.157,
1.5 (0.8 to 2.8)
|
22
|
0.836,
1.1 (0.5 to 2.2)
|
4
|
0.049**,
3.5 (1.0 to 12.0)
|
*per 100 person-years. **p<0.05
|
