In the olden days (before 2014), hepatitis C treatment relied on peginterferon and ribavirin. Treatment was long, and these two drugs have many side effects, making them difficult to take. Ribavirin had an additional issue in that it could cause miscarriages and birth defects. This risk was so serious that the Food and Drug Administration (FDA) classified it in the Pregnancy Category X, and required ribavirin manufacturers to put this warning on the label:
Significant teratogenic and embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Therefore, ribavirin is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking ribavirin.
Everything changed October 2014. The FDA approved Harvoni for genotype 1 patients. It was labeled Pregnancy Category B, which means, “Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.”
The solution seems so simple: treat everyone who wants to be treated. However, the price of HCV treatment is so steep that many insurance companies and state Medicaid programs are denying treatment to patients unless they have advanced liver disease. Women who are pre-menopausal tend to have the least amount of fibrosis. This is because nature has a way of protecting women while they are fertile by giving them a hardier immune system. That benefit stops about the time we turn fifty, leaving us with graying hair and a deteriorating liver. (But, don’t mess with us because we are tough!)
The sad fact is that a large percentage of young women who acquire HCV did so via injection drug use (IDU). Since women are more likely to clear HCV spontaneously than men are,5 one would think that women who inject drugs are less likely to have hepatitis C than men. However, that is not the case.
If you are prescribed HCV treatment, and you are a woman who can still get pregnant, here is what you need to discuss with your medical provider:
Are you or could you be pregnant?
Which HCV treatment is recommended for you?
Assuming you do not intend to get pregnant during your treatment, which birth control methods will you use?
If prescribed Viekira Pak, be aware that ethinyl estradiol-containing medications such as combined oral contraceptives, contraceptive patches or contraceptive vaginal rings are contraindicated. To protect yourself against unplanned pregnancy, use progestin only or non-hormonal contraception. You may restart ethinyl estradiol-containing medications two weeks after finishing Viekira Pak.
If you are a mother who has transmitted hepatitis C to her baby, please take these words to heart: Forgive yourself. Your child needs a strong mother, one who faces the truth, and is a role model for living bravely with hepatitis C.
HCSP Factsheet HCV and Women: Being a Positive Mother www.hcvadvocate.org/hepatitis/factsheets_pdf/
HCSP Factsheet HCV and Women: Pregnancy, Childbirth and Breastfeeding www.hcvadvocate.org/hepatitis/factsheets_pdf/
Ribavirin Pregnancy Registry
- Centers for Disease Control and Prevention www.cdc.gov
- Vertical Transmission of Hepatitis C Virus: Systematic Review and Meta-analysis by Benova L, et al. Clinical Infectious Disease September 15, 2014
- Reducing Risk for Mother-to-Infant Transmission of Hepatitis C Virus: A Systematic Review for the U.S. Preventive Services Task Force by Cottrell EB, et al. Annals of Internal Medicine January 15, 2013
- Recommendations for Testing, Managing, and Treating Hepatitis C – American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) www.hcvguidelines.org
- The Effects of Female Sex, Viral Genotype, and IL28B Genotype on Spontaneous Clearance of Acute Hepatitis C Virus Infection by Grebeley J, et al. Hepatology January 2014
- Higher Risk of Incident Hepatitis C Virus among Young Women who Inject Drugs Compared with Young Men in Association with Sexual Relationships: A Prospective Analysis from the UFO Study Cohort by Tracy D, et al. BMJ Open May 29, 2014