Outcomes in Infants Exposed to Lopinavir/Ritonavir in Utero

February 2014

4th International Workshop on HIV and Women

A systematic review of outcomes of infants born to women receiving lopinavir/ritonavir (LPV/r) in pregnancy -- performed by investigators from the originator company -- suggests that in utero exposure may not increase the risk of preterm birth.

M Martinez presented data from an assessment of the vertical transmission rate and risk of adverse infant outcomes among women treated with LPV/r based regimens in pregnancy at the 4th HIV & Women Workshop, 2014.

The investigators searched PubMed/EMBASE databases and HIV conferences for studies published to the end of January 2013 or March 2013 respectively. They looked for randomised trials or prospective/retrospective cohort studies of outcomes of infants exposed to LPV/r in utero as a primary or secondary endpoint.

The investigators also searched the AbbVie Global Safety Database for the infant outcome of prematurity to the end of December 2011.

They included 27 publications (n=12) and abstract presentations (n=15) describing 17 studies in the review. These studies reported on 4331 women receiving LPV/r in pregnancy, of these 2263 received LPV/r 800/200 mg/day, 101 received >800/200 mg/day, and for 1967 the dose was undocumented. Table 1 shows the results.

Table 1: Infant Outcomes From a Systematic Review of LPV/r in Pregnancy
Outcome Studies Reporting Outcome (n) Rate Reported (%)
Vertical transmission 10 0 - 2.8
Preterm birth 13 8.7 - 25.0
Very preterm birth 6 0.4 - 5.0
Low birth weight 6 0.4 - 5.0
Very low birth weight 4 0.3 - 3.0
Still birth 5 1.0 - 4.8
Infant mortality 4 0 - 5.8

Post-marketing safety data from the company database showed a preterm rate of 0.66/10,000 patient treatment years for LPV/r.

One study showed similar preterm, low birth weight and vertical transmission rates for women receiving 800/200 mg and >800/200 mg LPV/r.

Three studies reporting birth defects showed a prevalence of 2% to 8.5%, which compared to the Antiretroviral Pregnancy Registry (APR) rate of 2.4%.

In one study the incidence of mortality among preterm infants was similar with LPV/r based treatment to that for women treated with triple NRTIs.

The authors concluded: "Preterm birth rates in the included studies reflected the rate for the geographical area in which the study was conducted; these data and post-marketing safety data suggest that in utero exposure to LPV/r may not increase risk of preterm birth. Infants born to women who received LPV/r 800/200 mg/day and those born to women who received >800/200 mg/day had similar rates of preterm birth, low birth weight, and MTCT."


Although analyses (particularly conclusions) performed by the originator company need to be approached with a little caution, these can be useful and results from this one supports the current APR data for LPV/r.


Martinez M et al. Systematic review of clinical outcomes of infants born to women receiving lopinavir/ritonavir-based antiretroviral therapy (ART) during pregnancy. 4th International Workshop on HIV & Women, Washington DC. 13-14 January 2014. Oral Abstract_21.

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This article was provided by HIV i-Base. It is a part of the publication HIV Treatment Bulletin. Visit HIV i-Base's website to find out more about their activities, publications and services.

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