Maternal toxicity with continuous nevirapine in pregnancy: results from PACTG 1022.
OBJECTIVE
To compare the safety of nelfinavir and nevirapine-based antiretroviral treatment in HIV-1-infected pregnant women.


METHODS
In Pediatric AIDS Clinical Trials Group Protocol 1022, 38 antiretroviral-naive pregnant women at 10-30 weeks' gestation were randomized to nelfinavir or nevirapine with zidovudine plus lamivudine. The study was suspended because of greater than expected toxicity and changes in nevirapine prescribing information. The incidence of treatment-limiting hepatic or cutaneous toxicity was compared between groups for all subjects and for the subset with CD4 cell counts greater than 250 cells/microL at study entry.


RESULTS
Toxicity was seen in 1 (5%) of 21 subjects randomized to nelfinavir and 5 (29%) of 17 subjects randomized to nevirapine (P = 0.07). Within the nevirapine group, 1 subject developed fulminant hepatic failure and died, and another developed Stevens-Johnson syndrome. The one adverse event associated with nelfinavir occurred in a subject with a CD4 cell count less than 250 cells/microL. All 5 events among subjects with a CD4 cell count greater than 250 cells/microL were associated with nevirapine (P = 0.04).


CONCLUSIONS
Continuous nevirapine may be associated with increased toxicity among HIV-1-infected pregnant women with CD4 cell counts greater than 250 cells/microL, as has been observed in non-pregnant women.
Hitti
Jane
J
University of Washington, Seattle, 98195, USA. jhitti@u.washington.edu
Frenkel
Lisa M
LM
Stek
Alice M
AM
Nachman
Sharon A
SA
Baker
David
D
Gonzalez-Garcia
Adolfo
A
Provisor
Arthur
A
Thorpe
Edwin M
EM
Paul
Mary E
ME
Foca
Marc
M
Gandia
Jorge
J
Huang
Sharon
S
Wei
Lee-Jen
LJ
Stevens
Laura M
LM
Watts
D Heather
DH
McNamara
James
J
D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects*; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D007231:Infant, Newborn; D017114:Liver Failure, Acute / Q000139:chemically induced; D019888:Nelfinavir / Q000008:administration & dosage / Q000009:adverse effects; D019829:Nevirapine / Q000008:administration & dosage / Q000009:adverse effects*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy* / Q000276:immunology; D012449:Safety; D013262:Stevens-Johnson Syndrome / Q000139:chemically induced
D019380:Anti-HIV Agents; D019829:Nevirapine; D019888:Nelfinavir