Meeting NewsPerspective

Pilot study finds HCV treatment safe in pregnancy

SEATTLE — A small pilot study of hepatitis C treatment in pregnant women found that that the treatment was effective in achieving hepatitis C cure and identified no safety concerns associated with treatment, according to findings presented at CROI.

Although guidelines from the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases recommend that all women be tested for HCV at the initiation of prenatal care, treatment during pregnancy is not recommended. However, the rate of HCV infection among pregnant women is rising in the United States, increasing the risk for perinatal transmission, according to Catherine A. Chappell, MD, MSc, assistant professor of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh, and colleagues.

“Over the last decade there has been about a twofold increase in hepatitis C among pregnant women delivering at my hospital,” Chappell said in a news conference. “That’s particularly important because of the babies that are delivered from those women, about one in 20 of them will go on to have perinatal hepatitis C infection.”

Chappell and colleagues noted that there are currently no published data on the safety or efficacy of HCV direct-acting antivirals in pregnant women.

“Unlike HIV and hepatitis B, there is nothing that I can do as an obstetrician to prevent perinatal transmission of hepatitis C or to affect hepatitis C in any way during pregnancy,” Chappell said.

The objective of this first-of-its-kind open-label, phase 1 study was to identify the safety and virologic response to ledipasvir 90 mg and sofosbuvir 400 mg (LDV/SOF) therapy in pregnancy.

The researchers enrolled HIV-negative women with chronic genotype 1 HCV infection who were between 23- and 24-weeks’ gestation, and began a 12-week course of LDV/SOF. HCV viral loads were assessed during treatment, at delivery and postpartum to assess the efficacy of the treatment.

According to Chappell, nine women were included in the study and all of them were white.

Chappell and colleagues reported that all patients had a rapid response to therapy and achieved sustained virologic response 12 weeks after therapy. Additionally, all of the reported adverse events related to LDV/SOF were less than or equal to grade 2. Moreover, eight patients delivered at term with undetectable HCV viral loads measured at delivery, and the ninth patient is between delivery and SVR assessment.

“Thus far, we have a 100% cure rate among pregnant women,” Chappell said. “The treatment was well tolerated, and the side effects were all mild to moderate.”

Chappell and colleagues will follow the infants through 1 year of life. Currently, none of the infants have HCV and no safety concerns have been reported, according to Chappell.

“This was a study of only nine women, so we need to do a larger study before we can recommend wide use of directly-acting antivirals during pregnancy,” Chappell said. “Hopefully, that’s coming soon.” – by Marley Ghizzone

Reference:

Chappell CA, et al. Abstract 87. Presented at: Conference on Retroviruses and Opportunistic Infections; March 4-7, 2019; Seattle.

Disclosures: Chappell reports receiving a research grant from Gilead Sciences and Merck.

SEATTLE — A small pilot study of hepatitis C treatment in pregnant women found that that the treatment was effective in achieving hepatitis C cure and identified no safety concerns associated with treatment, according to findings presented at CROI.

Although guidelines from the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases recommend that all women be tested for HCV at the initiation of prenatal care, treatment during pregnancy is not recommended. However, the rate of HCV infection among pregnant women is rising in the United States, increasing the risk for perinatal transmission, according to Catherine A. Chappell, MD, MSc, assistant professor of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh, and colleagues.

“Over the last decade there has been about a twofold increase in hepatitis C among pregnant women delivering at my hospital,” Chappell said in a news conference. “That’s particularly important because of the babies that are delivered from those women, about one in 20 of them will go on to have perinatal hepatitis C infection.”

Chappell and colleagues noted that there are currently no published data on the safety or efficacy of HCV direct-acting antivirals in pregnant women.

“Unlike HIV and hepatitis B, there is nothing that I can do as an obstetrician to prevent perinatal transmission of hepatitis C or to affect hepatitis C in any way during pregnancy,” Chappell said.

The objective of this first-of-its-kind open-label, phase 1 study was to identify the safety and virologic response to ledipasvir 90 mg and sofosbuvir 400 mg (LDV/SOF) therapy in pregnancy.

The researchers enrolled HIV-negative women with chronic genotype 1 HCV infection who were between 23- and 24-weeks’ gestation, and began a 12-week course of LDV/SOF. HCV viral loads were assessed during treatment, at delivery and postpartum to assess the efficacy of the treatment.

According to Chappell, nine women were included in the study and all of them were white.

Chappell and colleagues reported that all patients had a rapid response to therapy and achieved sustained virologic response 12 weeks after therapy. Additionally, all of the reported adverse events related to LDV/SOF were less than or equal to grade 2. Moreover, eight patients delivered at term with undetectable HCV viral loads measured at delivery, and the ninth patient is between delivery and SVR assessment.

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“Thus far, we have a 100% cure rate among pregnant women,” Chappell said. “The treatment was well tolerated, and the side effects were all mild to moderate.”

Chappell and colleagues will follow the infants through 1 year of life. Currently, none of the infants have HCV and no safety concerns have been reported, according to Chappell.

“This was a study of only nine women, so we need to do a larger study before we can recommend wide use of directly-acting antivirals during pregnancy,” Chappell said. “Hopefully, that’s coming soon.” – by Marley Ghizzone

Reference:

Chappell CA, et al. Abstract 87. Presented at: Conference on Retroviruses and Opportunistic Infections; March 4-7, 2019; Seattle.

Disclosures: Chappell reports receiving a research grant from Gilead Sciences and Merck.

    Perspective
    Robert Turner Schooley

    Robert Turner Schooley

    This is a very important advance. [Chappell] had a lot of courage to take this to pregnant women because a lot of obstetricians are so conservative that it took us years to do the same thing with HIV. It is really great to see that the concept of eliminating HCV and reducing the risk of transmission at the same time in pregnant women has become an important research priority. As we know, with the increasing rate of transmission of HCV with our drug epidemic in the U.S., this will be more and more of a problem in pregnant women and having more solid, well-designed trials to help guide us in how to manage these women is going to be increasingly important. This was a very good first step.

    • Robert Turner Schooley, MD
    • Professor of medicine
      University of California San Diego

    Disclosures: Schooley reports serving on a scientific advisory board for Gilead Sciences, and the funding goes to his university.

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