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Single Antiretroviral Switches for Pregnant Women Compared to Non-pregnant Women and Men Who Initiated HAART in the MTCT-Plus Initiative
Patricia Toro*, M Katyal, D Nash, and R Carter
Columbia Univ, New York, NY, US
Background: More women will have the opportunity to
initiate HAART during pregnancy as prevention of mother-to-child transmission (PMTCT)
programs in resource-limited countries improve access to HAART. We evaluated
whether women starting HAART during pregnancy had higher rates of side effects
or toxicity leading to a single drug substitution then non-pregnant adults
(women and men).
Methods: Routine service delivery data from HAART-naïve
adults age ≥15 who initiated HAART between February 2003 and January 2007
at MTCT-Plus Initiative sites were analyzed. All adults had a potential for ≥6
months of follow-up. Regimens at each clinic visit was evaluated and ART
switches were defined as a change in a single drug that was >7 days
duration. We compared the rates of single drug substitutions for all causes
(including side effects) among pregnant and non-pregnant women and men.
Results: A total of 2098 adults initiated HAART,
including 575 (27%) pregnant, 1013 (48%) non-pregnant females, and 510 (24%)
males. During 3923 person-years of follow-up, 288 (14%) individuals (99
pregnant) experienced a single drug substitution as their first ART switch. Initial
regimens were primarily nevirapine (NVP)/lamivudine (3TC)/zidovudine (ZDV) (n
= 1500; 72%) and NVP/3TC/didanosine (d4T) (n = 409; 19%). Median follow-up
time was 695 days (IQR 407 to 945). Median gestational age at HAART initiation
was 7 months. In Kaplan-Meier analysis time to single drug substitution for reasons
of side effects or toxicity did not differ among pregnant women, non-pregnant
women, and men (log-rank p = 0.128).
Single-drug substitutions
|
Type
|
n (%)
|
Reason for switch
|
n = All groups (%)
|
n = Pregnant only (%)
|
Median time to substitution
—all (weeks)
|
|
ZDV to d4T
|
140 (49)
|
SE/Toxicity
|
114 (81)
|
44 (39)
|
16
|
|
Other
|
23 (16)
|
|
105
|
|
Unknown
|
3 (3)
|
21
|
|
NVP to EFV
|
89 (31)
|
SE/Toxicity
|
32 (36)
|
4 (13)
|
5
|
|
Other
|
42 (47)
|
|
24
|
|
Unknown
|
15 (17)
|
52
|
|
d4T to ZDV
|
22 (8)
|
SE/Toxicity
|
20 (91)
|
3 (15)
|
43
|
|
Other
|
1 (4.5)
|
|
75
|
|
Unknown
|
1 (4.5)
|
87
|
|
EFV to NVP
|
12 (4)
|
SE/Toxicity
|
2 (17)
|
0
|
107
|
|
Other
|
9 (75)
|
|
12
|
|
Unknown
|
1 (8)
|
40
|
|
d4T to TDF
|
5 (2)
|
SE/Toxicity
|
5 (100)
|
3 (60)
|
120
|
|
Other
|
0
|
|
NA
|
|
Other
|
20 (6)
|
|
|
Total
|
288 (100)
|
Single-drug substitutions in pregnant vs non-pregnant
adults
|
|
Rate of ART switch
All causes/
100 patient-years
|
Rate of ART switch
Toxicities/
100 patient-years
|
|
Pregnant
|
12.1
|
7.4
|
|
Non-pregnant women
|
8.6
|
5.8
|
|
Men
|
7.1
|
4.6
|
Conclusions: Pregnant women had a similar rate of single
drug substitution for reasons of toxicity compared with non-pregnant adults. Pregnancy
resource-limited countries should not delay HAART initiation because of
concerns about medication toxicities or side effects.
| 