What is the appropriate therapy for a 37-year-old female with hepatitis C (HCV) and a past history of intravenous (IV) drug use, who is currently RNA negative and seeking preconception counseling?

From the Guidelines

For a 37-year-old female with hepatitis C who is currently RNA negative and seeking preconception counseling, no specific HCV treatment is needed at this time. Since she is RNA negative, this indicates she has either spontaneously cleared the infection or has been successfully treated previously 1. The patient should be reassured that if she remains HCV RNA negative, there is no risk of vertical transmission to her baby. However, I would recommend confirming her sustained virologic response with another HCV RNA test if her negative status was only recently established.

Regular screening for HCV reinfection is important given her history of IV drug use, ideally every 6-12 months if any risk factors persist 1. She should also be counseled on avoiding alcohol consumption during pregnancy and strategies to prevent reinfection, including avoiding sharing of injection equipment if she has returned to drug use. Additionally, standard preconception care should be provided, including starting prenatal vitamins with folic acid, screening for other infections like HIV and hepatitis B, and addressing any other substance use.

If she were to become reinfected and HCV RNA positive during pregnancy, treatment would typically be deferred until after delivery, as most direct-acting antivirals are not approved during pregnancy 1. However, the use of direct-acting antivirals during pregnancy is being investigated, and some studies have shown that treatment with DAAs during pregnancy may be safe and effective in preventing mother-to-child transmission of HCV. Nevertheless, the current guidelines suggest that treatment during pregnancy is a risk/benefit conversation between women and providers, and more studies are needed to establish the safety and efficacy of DAAs during pregnancy.

Some key points to consider in her management include:

• The importance of regular screening for HCV reinfection given her history of IV drug use
• The need for counseling on strategies to prevent reinfection and avoid alcohol consumption during pregnancy
• The potential for treatment with DAAs during pregnancy, although this is still being investigated and not currently recommended as standard practice
• The importance of standard preconception care, including screening for other infections and addressing any other substance use.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Patient Profile

• 37-year-old female with hepatitis C (HCV) and a past history of intravenous (IV) drug use
• Currently RNA negative and seeking preconception counseling
• Labs: hepatitis C antibody by Elisa positive, hepatitis C antibody by RIBA positive, hepatitis C RNA negative, transaminase level 2x normal, bilirubin and albumin and prothrombin time normal

Appropriate Therapy

• According to 2, HCV patients with active disease should be advised to refrain from alcohol intake, especially during antiviral therapy
• However, since the patient is currently RNA negative, antiviral therapy may not be necessary at this time
• The patient's past history of IV drug use and current RNA negative status suggest that she may be in a state of spontaneous clearance or have achieved a sustained virological response (SVR) without treatment
• Studies such as 3, 4, and 5 demonstrate the efficacy and safety of direct-acting antiviral (DAA) agents, including sofosbuvir and velpatasvir, in treating HCV infection
• However, these studies primarily focus on patients with active HCV infection, and the patient in question is currently RNA negative
• Therefore, the appropriate therapy for this patient would be to continue monitoring her HCV status and liver function, and to provide guidance on preventing HCV transmission to others, as outlined in 2

Preconception Counseling

• According to 2, pregnancy is not contraindicated in HCV-infected individuals, and breast-feeding is allowed
• The patient should be informed about the risks of HCV transmission to her infant, which is generally low, but may be higher if she has a high viral load
• The patient should also be advised to inform her healthcare providers about her HCV status before becoming pregnant, so that appropriate precautions can be taken to prevent transmission to the infant
• Studies such as 6 demonstrate the safety and efficacy of DAA agents in patients with HCV and end-stage renal disease, but the patient in question does not have this condition, and the relevance of this study to her care is limited.