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Maternal and fetal safety of nevirapine-containing HAART regimens during pregnancy

Maternal and fetal safety of nevirapine-containing HAART regimens during pregnancy. Oriol Coll 1 , Montse Loncà 1 , Imma Ocaña 2 , Marta López 1 , Marjorie Diaz 2 , Mila Montero 3 , Sandra Hernández 1 , Francesc Figueras 1 , Anna Suy 2 , Ana Guelar 3.

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Maternal and fetal safety of nevirapine-containing HAART regimens during pregnancy

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  1. Maternal and fetal safety of nevirapine-containing HAART regimens during pregnancy Oriol Coll1, Montse Loncà1, Imma Ocaña2, Marta López1, Marjorie Diaz2, Mila Montero3, Sandra Hernández1, Francesc Figueras1, Anna Suy2, Ana Guelar3 • 1Hospital Clínic University of Barcelona. • 2Hospital Vall d' Hebron Autonomous University of Barcelona • 3Hospital del Mar Autonomous University of Barcelona

  2. Hitti J. J Acquir Immune Defic Syndr 2004;36:772–776 PACTG 1022. RCT (All ZDV + LMV + NFV vs NVP) 10-30 week’s gestation Toxicity* p n % Nelfinavir 1 / 21 5 Nevirapine 5 / 17 29 0.07 *Treatment-limiting hepatic or cutaneous toxicity All 5 events: CD4 > 250 cells/μL (P = 0.04). Study suspended

  3. Joy S. Obstet Gynecol 2005;106:1032–3 Retrospective study (7/2001 – 4/2005). 23 pregnancies Adverse events: 3 / 23 13% Initiation of nevirapine 3rd trimester 3 / 5 60% Earlier 0/18 0% P < .006 All > 27 weeks p., first 6 weeks of therapy and CD4+ cell count > 250 cells/µL

  4. Methods: Retrospective multicenter study (3 centers) University of Barcelona - Hospital Clínic. Autonomous University of Barcelona- Hospital Vall d' Hebron and Hospital del Mar Inclusion criteria: - All women who received HAART during pregnancy (≥ 2 weeks) - Delivered ≥ 22 weeks of gestation - Study period: July 1st 1997 and December 31st 2005. - Toxic events defined as (standard criteria) Objective To establish maternal and fetal safety of nevirapine-containing HAART regimens during pregnancy

  5. 1- Maternal toxicity: Skin rash Hepatotoxicity (NIAID toxicity guidelines) 2- Adverse perinatal outcome: Preterm delivery Small for gestational age Preeclampsia Intrauterine fetal demise - Statistical analysis - Sponsored by Boehringer Ingelheim

  6. Initiation of NVP use n % Prior to conception 79 41.4 After conception 112 58,7 Results Patients: 311 women(HAART during pregnancy) Regimens n % NVP-containing 191 61.4 Non NVP containing 120 38.6

  7. NVP containing regimens (n=191) Non-NVP containing regimens (n=120) p Age (Mean (range)) 31.3 (17-42) 31.3 (16-40) 0.97+ Caucasian ethnicity; n(%) 150/191 (78.5) 110/120 (91.7) 0.002* Primiparity; n(%) 84/191 (44) 55/120 (45.8) 0.75* Toxics in pregnancy; n(%) Smoking Other drugs 96/191 (50.3) 13/191 (6.8) 82/120 (68.3) 23/120 (19.2) 0.002* 0.001* Co-infection; n(%) HCV HbsAg 70/190 (36.8) 8/189 (4.2) 62/120 (51.7) 3/120 (2.5) 0.01* 0.42* Socio-demographic characteristics + T-test; * Chi-squared test.

  8. NVP containing regimens (n=191) Non-NVP containing regimens (n=120) p Diagnosis pre-pregnancy; n(%) 155/191(81.2) 108/120(90) 0.036+ Months from HIV diagnosis to delivery; (median(range)) 72(0-206) 84(1-228) 0.05# Months on HAART from diagnosis to conception; (median(range)) 11.14(0-98) 13 (0-111) 0.866# Weeks on HAART from conception to delivery; (median(range)) 33.7(0.83-40) 33.9(4-39.7) 0.909# Basal CD4 (<250 cell/mm3) ; n(%) (basal) 28(14.7) 25(20.8) 0.076+ ARVT at conception; n(%) Naive No current ARVT Non HAART regimen HAART regimen 78 (40.8) 1 (0.5) 1 (0.5) 110 (57.6) 43 (35.8) 3 (2.5) 3 (2.5) 70 (58.3) 0.378+ 0.162* 0.163* 0.897+ HIV-Related variables + Chi-squared test; # Mann-Whitney test; * Exact Fisher Test

  9. TotalNVP containingNVP containing p n=311 regimens n= 191 regimens n= 120 n (%) n (%) n (%) Hepatotoxicity 9 (2,9) 9 (4.7) 0 (0) 0.014* Skin rash 10 (3,2) 10 (5.2) 0 (0) 0.008* Toxic events 19 Patients 17 (5,5) 17 (8.9) 0 <0.001+ + Chi-squared test; * Exact Fisher Test Toxic events among patients with HAART during pregnancy

  10. TotalNVP containingNon-NVP containing p n=311 regimens n= 191 regimens n= 120 n (%) n (%) n (%) Hepatotoxicity 9 (2,9) 9 (4.7) 0 (0) 0.014* Skin rash 10 (3,2) 10 (5.2) 0 (0) 0.008* Toxic events 19 Patients 17 (5,5) 17 (8.9) 0 <0.001+ + Chi-squared test; * Exact Fisher Test Toxic events among patients with HAART during pregnancy

  11. No cases of fulminant hepatitis or maternal death occurred Acute toxic hepatitis and/or severe rash: 6 / 191 (3.1%) Toxic events among patients with HAART during pregnancy Hepatotoxic events n Grade 1-2 5 Acute toxic hepatitis 4 Rash n Mild / Moderate 6 Severe 4 ( 1: Lyell Syndrome and 2 + hepatic toxicity)

  12. Toxicity and Cd4+ cell counts • n % p • >250 cells/µL   13 / 162 8 • <250 cells/µL 4 / 28 14,3 0.65  Toxic events among patients with HAART during pregnancy • Interval betweeninitiation of NVP and toxic event (median and range): 4 weeks (1-12weeks) • Toxicity and initiation of NVP • n % • Prior to conception 1 / 79 1,3 • During pregnancy 16 / 112 14,3

  13. Initiation of Nevirapine Total n Toxicity n (%) 1-2ST trimester(0-27,6weeks) 88 14 (15.9) 3RD trimester(28-term) 24 2 (8.3) Total 112 16 (14.3) Toxic events according to trimester of initiation of NVP

  14. NVP containing regimens (n=191) Non-NVPcontaining regimens (n=120) p Premature delivery Small for gestational age Pre-eclampsia Intrauterine fetal demise 38 (19.9) 26 (13.6) 10 (5.2) 6 (3.1) 30 (25) 19 (15.8) 7 (5.8) 2 (1.7) 0.289+ 0.588+ 0.821+ 0.715* Adverse outcome 59 (30.9) 49 (40.8) 0.073+ HIV-1 vertical transmission 2/185 (1.7) 2/118 (1.1) 0.648* Adverse perinatal outcome in NVP and non-NVP containing regimens during pregnancy + Chi-squared test; * Exact Fisher Test.

  15. NVP containing regimen Yes (n=191) No (n=120) OR (95% CI) Adverse event Maternal toxicity (n=17) Adverse perinatal outcome (n=108) 17 (8.9) 59 (30.9) 0 (0) 49 (40.8) - 0.65 (0.4-1.04) Summary of adverse event in NVP and NVP containing regimens during pregnancy Adjusted for parity, ethnicity, smoking and drug consumption OR(95%CI) for adverse outcome: 0.78 (0.47-1.29)

  16. Conclusions • All toxic events occurred in women on NVP-containing regimens, but the incidence was similar than the one described in non-pregnant women • Almost all cases occurred in newly treated patients • The occurrence of toxicity was not associated to immunological status or trimester of initiation of therapy • A non-significant lower incidence of adverse perinatal outcome among these women was observed • The use of nevirapine-containing regimens during pregnancy may be justified in selected cases • ocoll@clinic.ub.es

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