Safety and efficacy of treatment for chronic hepatitis C during pregnancy: A prospective observational study in Srinagar, India.

Abstract

In India, the estimated prevalence of antenatal HCV infection is 0.3%-2.8%, and the rate of mother-to-child transmission has been estimated at 5%-15%. HCV treatment during pregnancy could reduce maternal complications from HCV infection, prevent transmission to the infant, and reduce HCV infection overall in women of childbearing age. However, there are limited studies of HCV treatment with direct-acting antiviral medications during pregnancy, and therefore, direct-acting antivirals are not commonly used for treatment during pregnancy. We describe our institutional experience in this prospective observational study over 3 years at the Sher-I-Kashmir Institute of Medical Sciences, Srinagar, India. Patients with chronic hepatitis C in pregnancy were enrolled and treated with ledipasvir and sofosbuvir after the first trimester. Primary end points were sustained virologic response at 12 weeks, adverse drug reactions, and congenital malformation of the infant. The secondary end point was the transmission of HCV infection to the infant. We enrolled 26 patients in our study. The mean age was 28 years (range of 21-36y). All patients were noncirrhotic and treatment-naive. The mean HCV RNA before treatment was 9.2 ×10^5IU/ml. Among the enrolled patients, 19 (73%) were genotype 3, 5 (19%) were genotype 1, and 2 (8%) were genotype 4. All patients achieved sustained virologic response at 12 weeks. Some patients reported nausea (27%), headache (27%), and fatigue (16%). All patients had institutional delivery, and no infant was found to have congenital malformations. No child had detectable HCV RNA at 6 months of age. To our knowledge, we here report results from the largest cohort of pregnant women treated for HCV infection globally. Ledipasvir and sofosbuvir were well tolerated and highly effective for both HCV cure in the mother and elimination of mother-to-child transmission. No congenital abnormalities were detected in our cohort. Elimination of mother-to-child transmission is urgently needed, and this study has shown that treatment of HCV during pregnancy may be a pragmatic approach for the greater benefit of both mother and the newborn.