학술논문

Brief Report: Vaginal Viral Shedding With Undetectable Plasma HIV Viral Load in Pregnant Women Receiving 2 Different Antiretroviral Regimens: A Randomized Clinical Trial
Document Type
article
Source
JAIDS Journal of Acquired Immune Deficiency Syndromes. 88(4)
Subject
Reproductive Medicine
Biomedical and Clinical Sciences
Perinatal Period - Conditions Originating in Perinatal Period
Clinical Research
Prevention
Infectious Diseases
Clinical Trials and Supportive Activities
HIV/AIDS
Pediatric
6.1 Pharmaceuticals
Evaluation of treatments and therapeutic interventions
Reproductive health and childbirth
Infection
Good Health and Well Being
Adult
Alkynes
Anti-HIV Agents
Antiretroviral Therapy
Highly Active
Benzoxazines
Cyclopropanes
Drug Resistance
Viral
Female
HIV Infections
Humans
Infant
Infectious Disease Transmission
Vertical
Lamivudine
Pregnancy
Pregnancy Complications
Infectious
Pregnant Women
Raltegravir Potassium
Vigna
Viral Load
Virus Shedding
Zidovudine
viral load
vaginal viral shedding
infectious disease transmission
vertical
absorption
physiological
Clinical Sciences
Public Health and Health Services
Virology
Clinical sciences
Epidemiology
Public health
Language
Abstract
BackgroundPregnant women using antiretrovirals (ARVs) may have persistent vaginal viral shedding, which could be associated with sexual and perinatal HIV transmission. However, there are scant data on vaginal viral load (VVL) in pregnant women with undetectable plasma viral load (PVL).MethodsThis study was a post hoc analysis of an open-label randomized trial to evaluate the virologic response of 2 ART regimens. The participants were ART-naive women living with HIV initiating ART regimens between 20 and 36 weeks of pregnancy recruited at 19 clinical sites in 6 countries. Participants were randomized to receive 400 mg of raltegravir 2 times a day or 600 mg of efavirenz 4 times a day in addition to 150 mg of lamivudine and 300 mg of zidovudine 2 times a day. VVL and PVL tests were performed at every study visit. The primary outcome measures were HIV-1 PVL and VVL at maternal study week 4 and rates of perinatal HIV transmission.ResultsA total of 408 were enrolled, of whom 323 had VVL samples 4 weeks after enrollment and were included in this analysis. Among women with undetectable/nonquantifiable PVL during ART, the overall rate of quantifiable VVL at week 4 was 2.54% (7/275). Of the 275 with nonquantifiable PVL, 99.1% (115/116) and 96.2% (153/159) had nonquantifiable VVL in the efavirenz and raltegravir arms, respectively. None of the 7 women with quantifiable VVL at the week 4 study visit transmitted HIV to their infants.ConclusionsDetectable VVL in pregnant women with undetectable/nonquantifiable PVL while receiving ART was rare and not associated with perinatal HIV transmission.