What is the recommended treatment for hepatitis C (HCV) in pregnant women?

Treatment of Hepatitis C in Pregnancy

Pregnant women with hepatitis C should NOT receive direct-acting antiviral (DAA) therapy during pregnancy except within a clinical trial setting, and should instead be treated either before conception or after delivery and cessation of breastfeeding. 1, 2

Current Treatment Recommendations

During Pregnancy

• DAA regimens should only be initiated within a clinical trial setting during pregnancy (SMFM GRADE 1C recommendation). 1
• No DAA therapy has been approved for use during pregnancy due to lack of adequate human safety data. 1
• While the AASLD/IDSA states that treatment can be considered on an individual basis after patient-physician discussion about risks and benefits, this represents a shift from previous strict avoidance but still emphasizes the experimental nature of such treatment. 3

Optimal Timing for Treatment

• Ideally, women should be treated prior to pregnancy to achieve cure before conception. 3
• If diagnosed during pregnancy, defer treatment until after delivery and cessation of breastfeeding. 2
• Women of reproductive age with HCV should be counseled to undergo antiviral treatment before pregnancy or postpartum. 2

Rationale for Deferring Treatment

Safety Concerns

• Human safety data in pregnancy remain insufficient despite reassuring animal studies. 3, 1
• Safety during breastfeeding has not been established. 3
• Most DAAs cross the placenta and transfer into breast milk based on animal studies. 4
• Ribavirin (part of older regimens) has teratogenic and embryocidal effects and is absolutely contraindicated during pregnancy. 5

Limited Clinical Evidence

• Only one small pilot trial has been conducted: 9 patients treated with sofosbuvir/ledipasvir during second and third trimesters showed good tolerability, but this is insufficient for widespread recommendation. 3
• Larger scale studies are needed to establish safety and efficacy. 3

Pregnancy Management Without Treatment

Screening and Monitoring

• Universal screening is recommended: Test all pregnant patients for anti-HCV antibodies at every pregnancy, regardless of risk factors (ACOG, CDC, USPSTF). 1
• When anti-HCV antibodies are positive, obtain quantitative HCV RNA, genotype, liver function tests, albumin, platelet count, prothrombin time, and screen for co-infections (HIV, syphilis, gonorrhea, chlamydia, hepatitis B). 1
• Serial laboratory surveillance of liver function or viral load is NOT recommended during pregnancy as it does not change management. 1, 2
• ALT levels naturally decrease during second and third trimesters. 1
• Third trimester fetal growth assessment may be performed. 1, 2

Delivery Management

• Cesarean delivery is NOT indicated solely for HCV infection as it does not reduce vertical transmission risk (approximately 5%). 1, 2
• Avoid internal fetal monitors, early artificial rupture of membranes, and episiotomy unless medically necessary. 1, 2

Breastfeeding Guidance

• HCV status should not alter standard breastfeeding counseling and recommendations. 1, 2
• Temporarily abstain from breastfeeding only if nipples are cracked or bleeding until healing occurs. 1, 6
• The benefits of breastfeeding outweigh the minimal risk of HCV transmission when proper precautions are taken. 2

Vertical Transmission Risk

• Mother-to-child transmission risk is approximately 5% in HCV-monoinfected women. 1, 2
• If prenatal diagnostic testing (amniocentesis) is requested, counsel that data on vertical transmission risk are reassuring but limited. 1, 2

Key Clinical Pitfalls to Avoid

1. Do not initiate DAA therapy outside of clinical trials during pregnancy, despite promising early data showing tolerability. 1
2. Do not perform cesarean delivery for HCV indication alone—this is not evidence-based and does not reduce transmission. 1, 2
3. Do not discourage breastfeeding unless nipples are actively bleeding or cracked. 1, 2, 6
4. Do not perform serial viral load monitoring during pregnancy—it provides no clinical benefit and does not change management. 1, 2

Future Considerations

While treatment during pregnancy remains investigational, ongoing studies are evaluating postpartum treatment with sofosbuvir/velpatasvir after cessation of breastfeeding, and pharmacokinetic trials are investigating use during pregnancy. 3 Initial data suggest DAAs have high efficacy and low risk of adverse events, but establishing safety during third trimester and breastfeeding will be necessary before widespread adoption. 3, 7