Use of Raltegravir in HIV-Infected Pregnant Women: A Case Series and Review of the Literature

Milena M Mclaughlin

doi:10.4172/2155-6113.1000386

Abstract

Objective: To evaluate the safety and tolerability of RAL therapy and the rapidity with which RAL decreases viral load in HIV-infected pregnant women. Methods: Women were considered for inclusion in the study if they were HIV-seropositive, ≥18 years of age, and received RAL during pregnancy. Men, non-pregnant women, or those that did not meet the inclusion criteria were not considered. HIV viral load, CD4 count (absolute), pregnancy demographics, antiretroviral regimens, adverse events, liver function enzymes, and APGAR scores were collected. Results: Eight HIV-infected RAL-naive pregnant women presented between 6 to 39.4 weeks gestational age with a median RNA viral load of 41,083 copies/mL at the initiation of RAL. From the initiation of RAL until delivery, the median decline in RNA viral load was 1.60 log. At delivery, two patients reached <48 copies/mL and two had <500 copies/mL. The median RNA viral load at delivery was 911 copies/mL. No adverse events in the mother or neonate due to RAL therapy were noted during this study. Conclusions: These results support the safe and efficacious addition of RAL to HAART regimen to decrease RNA viral load late in pregnancy if a patient is not yet virologically suppressed. Further prospective study is needed.

Highlights

The rate of perinatal transmission of the human immunodeficiency virus (HIV) in the United States has decreased to 2% with the implementation of Pediatric AIDS Clinical Trial Group Protocol 076 (PACT076) treatment guidelines encouraging measures such as routine HIV counseling and testing and antiretroviral (ARV) prophylaxis [1,2]
Current Department of Health and Human Services (DHHS) guidelines recommend starting a combination of Highly Active Antiretroviral Therapy (HAART) early in pregnancy to decrease the risk of perinatal transmission
RAL was added to decrease RNA viral load over a median of 6 days before delivery; in one case, RAL was used in lieu of ritonavirboosted lopinavir due to presumed toxicity from the protease inhibitors 133 days prior to delivery

Summary

Introduction

The rate of perinatal transmission of the human immunodeficiency virus (HIV) in the United States has decreased to 2% with the implementation of Pediatric AIDS Clinical Trial Group Protocol 076 (PACT076) treatment guidelines encouraging measures such as routine HIV counseling and testing and antiretroviral (ARV) prophylaxis [1,2]. Raltegravir (RAL) is the first integrase strand transfer inhibitor approved by the FDA in 2007 and is classified as FDA Pregnancy Category C [3] It is considered one of the preferred initial therapies for the treatment of HIV in adults and adolescents by the DHHS guidelines [3]. RAL demonstrates a rapid reduction of viral load [4,5,6,7] due to its antiretroviral mechanism targeting a later stage in the celllife cycle [8]. For this reason, RAL has been used to reduce transmission risk during emergency surgical procedures [9]

Methods

Results

Conclusion