New Antiviral Drug Cocktail Safe and Effective In Treating Hep-C During Pregnancy

Among pregnant women, the antiviral drug cocktail ledipasvir/sofosbuvir resulted in 100% hepatitis C cure rate, revealed study published today in The Lancet Microbe. None of their babies contracted the virus and they developed normally and had no apparent adverse effects from the medication.

“People worry about the risk of antivirals on the baby but don’t consider the psychosocial opportunity of pregnancy,” said lead author Catherine Chappell, M.D., M.S., assistant professor of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh School of Medicine and MWRI. “Pregnancy is a time when women are regularly engaged in health care and motivated to make positive changes to support their growing families. It could be a window of opportunity for these women to get a fresh start, infection-free, both for their own health and the health of their babies.”

Eight out of the nine study participants contracted hepatitis C from intravenous drug use, and many came to the trial through the Pregnancy and Womens Recovery Center (PWRC) at UPMC Magee-Women’s Hospital, where women can get comprehensive and compassionate care for opioid use disorder.

‘New antiviral drug cocktail ledipasvir/sofosbuvir was found to be safe and effective in treating hep-c during pregnancy. ’
Although these programs can help manage and treat the chronic disease of addiction, without treatment specific to hepatitis C, the virus lingers. As a result, women may feel ongoing stigma, guilt or shame. There’s also about a 6% chance that a pregnant woman will pass hepatitis C on to her child.

Ledipasvir/sofosbuvir works by blocking the viral proteins that hepatitis C uses to replicate inside cells. Since the mechanism is specific to the virus, the side effects are minimal, Chappell said.

“The only concern we had is that sofosbuvir is excreted by the kidneys, and during pregnancy the kidneys are working on overdrive,” Chappell said. “They flush medicine out more quickly than otherwise, so we were a little worried that if participants had a significant decrease in this drug that it wouldn’t be as effective.”

Turns out, pregnant women who received the standard dose had just as much active drug in their system as reported for non-pregnant women.

Despite the promising results in these nine volunteers, Chappell warns that more study is needed before antiviral medications can be widely prescribed to pregnant women. But in service of that goal, she is joining a multicenter phase II clinical trial that will test the safety and efficacy of these drugs in dozens of hepatitis C positive pregnant women across the country.