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Obstetrics, Gynecology and Reproductive Sciences
University of Pittsburgh
Catherine Chappell, MD, MSc, has disclosed that she has received consulting fees from Gilead Sciences and funds for research support from Gilead Sciences and Merck.
The revolution of hepatitis C virus (HCV) treatment with the advent of direct-acting antivirals has made HCV eradication possible. These oral regimens—including 1-pill, once daily options—are extremely well tolerated with cure rates > 90%. Unfortunately, the opioid epidemic continues to fan the flames of the HCV epidemic with an ever-increasing rise among young persons, including women of reproductive age. Young people, especially those who inject drugs, are less likely to engage in the health care system or to seek routine care. Therefore, we cannot expect to utilize routine health care systems to fully address the ongoing HCV epidemic, nor can we anticipate that initiatives focused on testing alone will make a substantial change overall in the prevalence of HCV. The young women with HCV that I see in my practice are dealing with many challenges, including substance use disorders, poverty, mental illness, intimate partner violence, and homelessness. For them, obtaining HCV treatment is not the highest priority. Therefore, unique windows of opportunity for HCV testing and immediate treatment must be integrated into the care that young women with HCV may be already receiving. For example, HCV testing and treatment might be integrated into opioid use disorder treatment clinics or into rehabilitation or incarceration facilities. The goal should be to get treatment to persons who need it in an efficient way that does not require much effort for the patient.
For women of reproductive age, plans for HCV treatment may be complicated or interrupted by episodes of pregnancy and breastfeeding. However, we might consider this period to be an exceptional opportunity to identify HCV infection and engage young women in HCV care. Pregnancy is a time when women are uniquely motivated to engage in activities to improve their own health and ensure the health of their unborn child. An important rationale for treating HCV during pregnancy is the potential for prevention of maternal-to-infant HCV transmission. Perinatal HCV transmission occurs in ~ 5% of pregnancies in women with HCV infection, and no known interventions have been shown to reliably reduce the risk of transmission. Treating HCV and the associated reduction in HCV viral load may be the intervention that ultimately works.
We recently published the first study of HCV treatment with ledipasvir/sofosbuvir during pregnancy. This small study of 9 women with genotype 1 HCV who initiated HCV treatment at 23-24 weeks of gestation provided reassuring data on the safety and efficacy of a 12-week course of ledipasvir/sofosbuvir. No clinically significant pharmacokinetic changes were identified, and all of the women were cured of HCV. In addition, there were no significant safety issues reported for the mothers or their infants, all of whom were followed to 1 year of age. These data are the first indication that HCV treatment during pregnancy may be a safe, effective strategy for young women with HCV.
Although the data with ledipasvir/sofosbuvir are reassuring, we need more data from a larger study using a pangenotypic regimen to confirm the safety and efficacy of HCV treatment during pregnancy before HCV treatment for pregnant women can be recommended. In the meantime, identifying HCV infection before pregnancy in women of childbearing age provides an opportunity for curing the infection prior to potential future pregnancies, and identifying HCV during pregnancy allows opportunities for linkage to HCV care so that treatment can be provided postpartum. Creating a “1-stop shop” for HCV testing and treatment alongside care for the unique needs of young women is critical to the mission of HCV eradication. We are on the path, but we have a considerable way to go.
Are you seeing an increasing number of young women with HCV in your practice? How do you counsel your patients on HCV treatment during pregnancy? Answer the polling question and join the discussion by posting a comment.