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Journal of the International AIDS Society

Open Access

Safety and efficacy of lopinavir/ritonavir compared to nelfinavir-based HAART during pregnancy

  • JM Peña1,
  • MI González2,
  • JF Pascual-Pareja3,
  • J López-Aldeguer4,
  • JA Iribarren5,
  • M Leyes6,
  • P Miralles7,
  • J Sanz8,
  • A Ocampo9,
  • JL Gómez-Sirvent10 and
  • JT Ramos11
Journal of the International AIDS Society200811(Suppl 1):P221

https://doi.org/10.1186/1758-2652-11-S1-P221

Published: 10 November 2008

Purpose of the study

To compare the safety and efficacy of lopinavir/ritonavir and nelfinavir-based regimens in HIV-1 infected pregnant women.

Methods

A prospective cohort study to evaluate HIV mother-to-child transmission. The study took place at 13 Spanish hospitals. We reviewed the records of all pregnant women treated with NFV (NCR) or LOP/r-containing (LOP/r CR) regimens during pregnancy from May 2001 to December 2007. Drug selection was up to the physician. Abnormalities were graded according to the National Institute of Allergy and Infectious Disease Division of AIDS toxicity guidelines. Data of mother and their children were recorded following a standard protocol.

Summary of results

355 mothers were enrolled: mean age 31 years; Caucasian 74%; HCV co-infection 34%; 13% were on C3 according to CDC category; heterosexual transmission 64%. 40% received antiretroviral therapy for the first time during pregnancy. 121 (34%) were on LOP/r CR and 234 (66%) on NCR. Baseline characteristics, side-effects and discontinuation of LPV or NFV of both groups are shown in Table 1 (values are expressed as the median [IQR] for continuous variables and as N [%] for categorical variables). No aminotransferases abnormalities (grade 3–4) or clinical hepatitis were observed. There were no differences in both groups according to weight and gestational age of the babies at delivery. There was a case of vertical transmission (a mother treated with NFV and viral load above 500,000 copies/ml).

Table 1

 

NELFINAVIR

LOPINAVIR/RITONAVIR

p

Age (yr)

32 (28–36)

32 (26–36)

NS

C3 category

21 (10)

21 (19)

0,026

CD4 (cells/μL) at 1st visit

477 (325–652)

426 (264–600)

NS

Viral load < 50 copies/ml at 3rd trimester

142 (70)

61 (62)

NS

Hepatitis C

79 (35)

40 (33)

NS

HAART-naive patients

108 (48)

35 (29)

0.001

Gestational diabetes mellitus

15 (8)

5 (5)

NS

Vomiting

9 (4)

16 (14)

<0.001

Diarrhoea

27 (12)

15 (14)

NS

Discontinuation of LPV or NFV.

23 (10)

12 (10)

NS

Discontinuation of LPV or NFV due to virologic failure.

1 (0.4)

1 (0.8)

NS

Vertical transmission

1 (0.4)

0

NS

Conclusion

In our cohort lopinavir/ritonavir and nelfinavir-based regimens during pregnancy were safe, effective and well tolerated.

Authors’ Affiliations

(1)
La Paz
(2)
Doce de Octubre
(3)
Hospital Universitario La Paz
(4)
La Fe
(5)
Donosti
(6)
Son Dureta
(7)
Gregorio Marañón
(8)
Principe de Asturias
(9)
Xeral Cies
(10)
(11)

Copyright

© Peña et al; licensee BioMed Central Ltd. 2008

This article is published under license to BioMed Central Ltd.

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