Women With Chronic Hepatitis C Virus Infection

Recommendations for Clinical Practice

Mary Jane Burton, MD; James B. Brock, MD; Stephen A. Geraci, MD

Disclosures

South Med J. 2013;106(7):422-426. 

In This Article

Antiviral Therapy in Women

Choosing when to initiate HCV therapy in women can be challenging, particularly with regard to maternal age and family planning. There is evidence that advanced age decreases the likelihood of an SVR in women more so than in men.[29,30] Given the risk of vertical transmission, it may be preferable to complete treatment in women of reproductive age before they conceive. Because use of ribavirin is contraindicated in pregnancy, women of childbearing age who are considering therapy for HCV require careful counseling regarding the potential danger to a child conceived during the treatment period.

Although ribavirin has not been studied formally in human gestation, several animal studies have demonstrated significant embryocidal and teratogenic effects; as a result, ribavirin is contraindicated during pregnancy (pregnancy category X).[58] The serum half-life of ribavirin is 12 days; the drug also is pooled in erythrocyte populations, which can result in prolonged postadministration exposure.[59] Two forms of effective contraception are required during and 6 months following therapy with ribavirin in women capable of conception.[58] Women who are capable of conception should be aware that if their male partners are receiving ribavirin, then the use of two forms of contraception during and 6 months after treatment is recommended. In addition, women of childbearing age should take a pregnancy test before treatment initiation and submit to monthly pregnancy tests during the treatment period.[58] Because ribavirin has not been studied in human pregnancy, women inadvertently exposed to ribavirin 6 months before or during pregnancy should consider enrollment in the Ribavirin Pregnancy Registry (www.ribavirinpregnancyregistry.com).

The effects of interferon on the fetus are uncertain (pregnancy category C). Interferon-[alpha] does not appear to cross the placental barrier or demonstrate teratogenic effects.[60] Case studies of pregnant women with leukemia have not demonstrated fetal malformation associated with interferon use, but intrauterine growth retardation has been observed in this setting.[61]

Boceprevir and telaprevir have been assigned to pregnancy category B by the Food and Drug Administration; however, these medications are administered exclusively with ribavirin and pegylated interferon-[alpha], precluding any use during pregnancy. Both drugs are potent CYP3A4 substrates and inhibitors, resulting in many potentially dangerous interactions with other drugs, including oral contraceptives. Telaprevir and boceprevir may cause systemic hormonal contraceptives to be unreliable during concurrent administration.[62,63] Drosperinone concentrations double in the presence of boceprevir, contraindicating coadministration because of concern for potentiating hyperkalemia.[63] Barrier methods and intrauterine devices are the preferred methods of contraception in women receiving boceprevir or telaprevir in combination with pegylated interferon-[alpha] and ribavirin.[55,56] Given the wide range of drug–drug interactions involving these agents, close review of package inserts or consultation with a clinical pharmacist is recommended in patients receiving concomitant medications during therapy.[64]

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