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Hepatitis C treatment appears safe and effective for pregnant women

Liz Highleyman
20 March 2019
Catherine Chappell speaking at CROI 2019. Photo by Liz Highleyman.

Treatment with sofosbuvir/ledipasvir (Harvoni) was well tolerated and cured all pregnant women with hepatitis C virus (HCV), according to a study presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2019) this month in Seattle.

While 'baby boomers' have traditionally had the highest rate of hepatitis C in the United States, HCV incidence is rising among younger people, tracking the ongoing opioid epidemic. This means more women of childbearing age are infected with HCV and at risk of transmitting the virus to their babies, but there has been little research on the use of direct-acting antivirals as treatment for this group.

Dr Catherine Chappell of Magee-Women's Hospital at the University of Pittsburgh Medical Center and colleagues conducted a phase I pilot study to evaluate the safety and efficacy of sofosbuvir/ledipasvir in pregnant women.


sustained virological response (SVR)

Undetectable hepatitis C RNA after treatment has come to an end. Usually SVR refers to RNA remaining undetectable for 24 weeks (six months) after ending treatment and is considered to be a cure. SVR4 and SVR12 refer to RNA remaining undetectable for 4 and 12 weeks respectively. 

Over the last decade, hepatitis C rates among pregnant women receiving care at Magee have doubled and in the past several years at least 2% of all women who delivered at the hospital had HCV, Chappell said. Currently there is nothing to offer these women for their own treatment or to prevent perinatal transmission. But pregnancy is a "window of opportunity" for health care that could potentially include hepatitis treatment, she added.

The trial enrolled pregnant women with genotype 1, 4, 5 or 6 chronic HCV infection; those with HIV or hepatitis B co-infection were excluded. They were enrolled at about six months into pregnancy. The US Food and Drug Administration did not allow treatment of women who were newly pregnant, according to Chappell, as drugs taken by the mother can potentially have a more harmful effect on the foetus during early gestation.

Out of 29 women screened for the study, most did not join because they had HCV genotypes 2 or 3 (10 women), continued to use illicit drugs (four women) or for other reasons. In the end, nine women were enrolled. All were white and the median age was 31 years (range 25 to 38 years). One had been perinatally infected herself and the other eight had used injection drugs, including four who were on medication-assisted treatment for addiction. All but one had HCV genotype 1a.

Participants were treated with once-daily sofosbuvir/ledipasvir (400/90mg) for 12 weeks. The study took a long time to enrol and at the start this was the only ribavirin-free regimen available, Chappell noted. The main study endpoint was sustained virological response (SVR), or continued undetectable HCV RNA three months after completing treatment, which is regarded as a cure.

All treated women experienced rapid response, Chappell reported. Eight women were cured and one is still completing SVR follow-up. All nine carried their pregnancies to term and all had undetectable HCV at the time of delivery. All but one of the infants were delivered at term and were of normal weight. None of the infants show evidence of HCV infection, including five who have been followed for a year.

Treatment with sofosbuvir/ledipasvir was safe and well tolerated. All treatment-related side-effects were mild or moderate. To date, no safety concerns have been identified in infants exposed to the drugs during gestation, Chappell said.

While it appears safe and effective, Chappell said that larger studies are needed before this treatment approach can be recommended. Noting that a substantial proportion of women were not eligible for the study because they had HCV genotypes 2 or 3, she highlighted the importance of studying pangenotypic regimens in pregnant women, such as sofosbuvir/velpatasvir (Epclusa) or glecaprevir/pibrentasvir (Maviret). She also recommended integration of HCV therapy and addiction treatment into prenatal care.


Chappell CA et al. A phase 1 study of ledipasvir/sofosbuvir in pregnant women with hepatitis C virus. Conference on Retroviruses and Opportunistic Infections, Seattle, abstract 87, 2019.

View the abstract on the conference website.

Watch the webcast of this presentation on the conference website.