The Ribavirin Pregnancy Registry: An Interim Analysis of Potential Teratogenicity at the Mid-Point of Enrollment

Sinclair, Susan M.; Jones, Judith K.; Miller, Richard K.; Greene, Michael F.; Kwo, Paul Y.; Maddrey, Willis C.

doi:10.1007/s40264-017-0566-6

Cited by 64 publications

(48 citation statements)

References 29 publications

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“…Until recently, ribavirin was a cornerstone of HCV therapy. As this drug is known to be teratogenic and embryotoxic in all animal species studied, its use—and consequently all classical forms of HCV therapy—during pregnancy has been contra‐indicated . However, new, potentially much safer combinations of DAAs drugs are now available that are ribavirin free.…”

Section: Introductionmentioning

confidence: 99%

Review article: direct‐acting antivirals for the treatment of HCV during pregnancy and lactation ‐ implications for maternal dosing, foetal exposure, and safety for mother and child

Freriksen

Seyen²,

Judd

et al. 2019

Aliment Pharmacol Ther

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Summary Background With the global efforts to eradicate hepatitis C virus (HCV), treatment during pregnancy is becoming a priority for research as this, and maternal cure should reduce vertical transmission. However, as information on the efficacy and safety of direct‐acting antivirals (DAAs) in pregnancy is generally lacking, treatment of HCV infection during pregnancy is not currently recommended. Aim To provide an overview of current knowledge regarding maternal exposure, placental handling and safety of DAAs during pregnancy and lactation Methods A literature search was performed focusing on the effect of pregnancy on maternal exposure to DAAs, the placental handling of DAAs, the safety of DAAs for mother and child during pregnancy and the safety of DAAs during lactation. Results Exposure to all DAAs studied is likely to be altered during pregnancy, mostly related to pregnancy‐induced effects on drug absorption and metabolism. Although animal studies show that most DAAs are reported to cross the placenta and transfer into breast milk, most DAA combinations show a favourable safety profile. Because of the rapid viral decline after treatment initiation, and to avoid the critical period of organogenesis, treatment may be started at the end of the second trimester or early third trimester. Conclusions Treatment of HCV infection during pregnancy is realistic, as DAAs are highly effective and treatment duration is relatively short. There is an urgent need to study DAAs during pregnancy and lactation to contribute to the goal of HCV elimination.

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Section: Introductionmentioning

confidence: 99%

Review article: direct‐acting antivirals for the treatment of HCV during pregnancy and lactation ‐ implications for maternal dosing, foetal exposure, and safety for mother and child

Freriksen

Seyen²,

Judd

et al. 2019

Aliment Pharmacol Ther

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“…In addition, HEV can be vertically transmitted from infected mothers to their infants, with significant perinatal morbidity and mortality [20][21][22]. Ribavirin and IFN-α are contraindicated in pregnancy because of the risk of teratogenicity [23][24][25]. Therefore, only supportive care is provided for pregnant women with HEV infection.…”

Section: Introductionmentioning

confidence: 99%

Hepatitis E virus infection during pregnancy

Xia

2020

Virol J

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Background: Hepatitis E virus (HEV) generally causes self-limiting viral hepatitis. However, in pregnant women, HEV infection can be severe and has been associated with up to 30% mortality in the third trimester. Additionally, HEV infection in pregnancy is also associated with high rates of preterm labor and vertical transmission. Main body: HEV is now recognized as a global health problem in both developing and industrialized countries. HEV can be transmitted via the fecal-oral route, zoonotic route, and blood transfusion route. An altered immune status, hormonal levels, and viral factors may be related to the severity of the disease. Currently, no established treatment is available for HEV in pregnant women. A Chinese vaccine has been demonstrated to be protective against HEV in the general population and seems to be safe in pregnancy; however, its safety and efficacy in a large population of pregnant women remain to be determined. Conclusion: This review summarizes the current knowledge about HEV infection during pregnancy and focuses on the epidemiology, clinical manifestations, mechanisms underlying severe liver injury, and management and prevention of HEV infection during pregnancy. Considering that HEV infection during pregnancy may result in poor outcomes, screening for and monitoring HEV infection early in pregnancy should be taken into account. In addition, a better understanding of the pathogenesis will help to develop potential treatment strategies targeting HEV infection in pregnancy.

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“…Women who become pregnant while on therapy with or without ribavirin should discuss the risks versus benefits of continuing treatment with their physicians. Ribavirin is contraindicated in pregnancy due to its known teratogenicity [11]. In case of an additional morbidity like kidney transplantation with immunosuppression, the pregnancy can be more complicated and the risk of vertical transmission can be higher.…”

Section: Introductionmentioning

confidence: 99%

Untitled

2020

Int J Transplant Res Med

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Ovarian function with regular menstrual cycles is usually restored in women of reproductive age after solid organ transplantation. The number of pregnancies reported in these patients increases gradually. Pregnancy is always considered high risk, and if not properly planned, may lead to serious complications. The best for the patient is to conceive in a period of good general health and good stable graft function, after appropriate preparation. However, hepatitis C virus (HCV) infection will be an additional risk factor in these cases. The present study was designed to review the possible risks and outcome of pregnancies in kidney transplant recipients with HCV.

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The Ribavirin Pregnancy Registry: An Interim Analysis of Potential Teratogenicity at the Mid-Point of Enrollment

Abstract: ClinicalTrials.gov identifier: NCT00114712.

Cited by 64 publications

References 29 publications

Review article: direct‐acting antivirals for the treatment of HCV during pregnancy and lactation ‐ implications for maternal dosing, foetal exposure, and safety for mother and child

Review article: direct‐acting antivirals for the treatment of HCV during pregnancy and lactation ‐ implications for maternal dosing, foetal exposure, and safety for mother and child

Hepatitis E virus infection during pregnancy

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