Antiviral therapy for hepatitis C: Has anything changed for pregnant/lactating women?

Abstract

population, with the highest prevalence in individuals under 40. The prevalence in pregnant women varies with geographical distribution (highest in developing countries). Prevalence also increases in sub-populations of women at high risk for blood-transmitted infections. HCV infection in pregnancy represents a non-negligible problem. However, most of the past antiviral regimens cannot be routinely offered to pregnant or breastfeeding women because of their side effects. We briefly reviewed the issue of treatment of HCV infection in pregnant/breastfeeding women focusing on the effects of the new direct-acting antivirals on fertility, pregnancy and lactation in animal studies and on the potential risk for humans based on the pharmacokinetic properties of each drug. Currently, all new therapy regimens are contraindicated in this setting because of lack of sufficient safety information and adequate measures of contraception are still routinely recommended for female patients of childbearing potential. Core tip: Until recently, the only drugs available for the treatment of hepatitis C virus infection had a welldocumented teratogenic effect limiting their use in childbearing women. Recently, new generation drugs, designated the direct-acting antivirals have been approved. There are no studies available describing their effects on pregnant and lactating women. We here will try to analyze their pharmacokinetic properties and data from animal studies to try to predict their potential use pregnancy.Spera AM, Kamal Eldin T, Tosone G, Orlando R. Antiviral therapy for hepatitis C: Has anything changed for pregnant/ Anna Maria Spera, Tarek Kamal Eldin, Grazia Tosone, Raffaele Orlando Anna Maria Spera, Tarek Kamal Eldin, Grazia Tosone, Raffaele Orlando, Department of Clinical Medicine and Surgery, Section of Infectious Diseases, University of Naples Federico II, 80131 Napoli, ItalyAuthor contributions: Spera AM designed and wrote the review; Kamal Eldin T analyzed pharmacological and clinical data; Tosone G and Orlando R overview the manuscript.Conflict-of-interest statement: All authors declare any conflicting interests (including but not limited to commercial, personal, political, intellectual or religious interests). In addition, reviewers have not potential conflicting interests related to any particular paper they maybe are asked to review.

Hepatitis C Cascade of Care Among Pregnant Women on Opioid Agonist Pharmacotherapy Attending a Comprehensive Prenatal Program

“…In light of increasing opioid use among pregnant women in the U.S. (Desai et al, 2014), high probability of under ascertainment of risk, and poor access to pharmacotherapy programs (Martin et al, 2015), serious consideration should be given to universal screening. The primary argument against universal screening is the lack of effect on clinical care since current HCV treatments, direct acting antivirals (DAAs), several of which are classified by the FDA as Pregnancy Category B, are not generally used during pregnancy or breastfeeding (Spera, Eldin, Tosone, & Orlando, 2016). Likewise, consistent evidence for effective prevention of vertical transmission, which occurs in 5% to 7% of infants born to infected mothers, is also lacking (Cottrell, Chou, Wasson, Rahman, & Guise, 2013).…”

British HIV Association guidelines for the management of HIV in pregnancy and postpartum 2018

“…Furthermore, ribavirin is able to penetrate in spermatozoa with the added risk of mutagenesis. The effects of DAAs in pregnant women are largely unknown . In addition, thyroid function testing should be included as part of routine blood tests as thyroid dysfunction occurs in approximately 7% of patients on IFN therapy.…”

Ledipasvir‐Sofosbuvir for 12 Weeks in Children 3 to <6 Years Old With Chronic Hepatitis C

“…The rate of perinatal transmission of HCV infection is approximately 5%, although rates are higher in the presence of inadequately controlled human immunodeficiency virus (HIV) coinfection or high HCV‐RNA viral loads (>6 log IU/mL) . Chronic hepatitis C (CHC) likely affects at least 1% of pregnant women globally, although prevalence data at the regional level are incomplete and inconsistent . High rates exceeding 6% have been reported in certain hyperendemic regions of countries such as Egypt .…”

“…(4)(5)(6) Chronic hepatitis C (CHC) likely affects at least 1% of pregnant women globally, although prevalence data at the regional level are incomplete and inconsistent. (3,7) High rates exceeding 6% have been reported in certain hyperendemic regions of countries such as Egypt. (8) In the past decade, the incidence of acute hepatitis C has increased in young adults in the United States, including women of child-bearing potential, (9,10) corresponding with a worsening injection opioid epidemic particularly in rural areas and the Appalachian region.…”