Sofosbuvir‐based therapy for late pregnant women and infants with severe chronic hepatitis C: A case series study

Abstract

Data on sofosbuvir-based therapy for pregnant women and infants with severe chronic hepatitis C (CHC) are lacking. Two late pregnant women and one female infant with severe CHC were enrolled for treatment. Pregnant Women 1 and 2 and Infant 3 were 30, 33, and 1.2 years old, respectively; the gestational ages of pregnant Women 1 and 2 were 31 and 26 weeks, respectively. Notably, pregnant Women 1 and 2 and Infant 3 had hepatitis C virus (HCV) RNA levels of 139 000, 198 000, and 8 450 000 IU/ml; alanine aminotransferase levels of 420, 781, and 220 U/L; and received sofosbuvir/ ledipasvir, sofosbuvir/velpatasvir, and sofosbuvir/ledipasvir for 12 weeks, respectively.All three patients were safely cured with favorable tolerance, and two newborns were both breastfeeding and were consistently negative for the anti-HCV antibody during the 1-year follow-up after birth. Additionally, two newborns and Infant 3 had normal growth parameters during the follow-up year one. In conclusion, this case series study found that sofosbuvir-based therapy for pregnant women and infants with severe CHC is safe and effective. The data may fill the gap and provide evidence of the use of sofosbuvir-based therapy as a reference when similar severe CHC situations are encountered during clinical practice.

HCV Antiviral Drugs Have the Potential to Adversely Perturb the Fetal-Maternal Communication Axis through Inhibition of CYP3A7 DHEA-S Oxidation

“…Despite the fact that none of the aforementioned drugs are deemed safe for use during pregnancy and no clinical trials have been performed in this patient population group, we did find reports of their use during pregnancy. Velpatasvir, ledipasvir, paritaprevir, and sofosbuvir all have been previously used during pregnancy (AbdAllah et al 2021;Zeng et al 2022;Curtis and Chappell 2023;Kislovskiy et al 2021;Chappell et al 2020).…”

Defer no more: advances in the treatment and prevention of chronic hepatitis C virus infection in children

“…& ]. Successful DAA treatment has been described in several paediatric liver transplant candidates [55,56] and at least two adolescent kidney transplant recipients [57]. To our knowledge, there has not yet been published experience with intentional transplant of solid organs from HCV-viraemic donors to paediatric recipients.…”

“…Several additional case reports and small case series report intentional DAA treatment starting at the second or third trimester of pregnancy with 100% SVR12 in mothers completing therapy and no cases of vertical transmission [56,102,103]. Abdallah et al [104 & ] reported first trimester DAA exposure in 100 women who became pregnant while on DAA, with no obvious maternal or foetal safety signal observed.…”

“…In some challenging clinical situations, DAA administration before age 3 years may be indicated, as described in two children under age 1 year who required liver transplant for non-HCV related indications [55,64 ▪ ]. Successful treatment of a 1-year-old otherwise healthy child with transaminitis and nausea/vomiting attributed to HCV infection has been described [56]. Of note, hepatic inflammation with mild-moderate transaminitis occurs commonly in the first several years [9], is usually asymptomatic and is not by itself an indication for early treatment.…”

Hepatitis C infection seroprevalence in pregnant women worldwide: a systematic review and meta-analysis

“…The advent of direct-acting antiviral agents (DAAs) with over 95% effectiveness in treating patients with chronic HCV infection 19 prompted the World Health Organization (WHO) to formulate the “Global Health Sector Strategy on viral hepatitis” with a goal of eliminating HCV infection by 2030. 20 , 21 While the use of DAAs for HCV in pregnancy lacks extensive clinical trial evidence, 22 , 23 , 24 , 25 , 26 recent recommendations from the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) suggest that DAA treatment may be considered on a case-by-case basis, taking into account potential risks and benefits. 27 Moreover, despite recommendations advocating for universal and risk-based HCV screening among adults aged 18 to 79, 27 , 28 with a particular emphasis on pregnant women, the screening for HCV in women of childbearing ages and pregnant women remains uncommon.…”