THU-137-DAA therapy in women of child bearing age: Accidental conception during therapy and pregnancy outcome

El-Sayed, Manal Hamdy; Elakel, Wafaa; Elsharkawy, Aisha; Eletreby, Rasha; Elsaees, Kadry; Elshazly, Yehia; El-Serafy, Magdi; Doss, Wahid

doi:10.1016/s0618-8278(19)30412-8

Cited by 12 publications

(17 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The only data available on sofosbuvir/daclatasvir in human pregnancy include one study on accidental sofosbuvir/daclatasvir exposure around the time of conception (n = 7). No adverse birth outcomes were reported but one infant tested HCV positive at 18 months with low viral load, which is not unexpected as all women discontinued therapy early, before week 9 of gestation …”

Section: Safety Of Direct‐acting Antivirals During Pregnancymentioning

confidence: 80%

“…An important example that needs to be taken into consideration is the widespread use of sofosbuvir/daclatasvir in Egypt, which is one of the countries with the highest HCV prevalence worldwide . Women becoming pregnant using daclatasvir are advised to stop their treatment because of the lack of knowledge regarding safety and efficacy, despite not knowing whether cessation of treatment during pregnancy, likely resulting in HCV disease relapse, may be less advantageous than continuing treatment. Given the paucity of data and the potential exposure to daclatasvir during conception or early pregnancy, research is needed on daclatasvir efficacy in human pregnancy and global pregnancy registry databases are warranted to assess its safety.…”

Section: Discussionmentioning

confidence: 99%

“…Pregnancy‐associated anatomical and physiological changes may influence drug pharmacokinetics (PK), in some cases leading to the need for dose adjustments . To date, only one abstract is available on sofosbuvir/daclatasvir in pregnancy and two abstracts on sofosbuvir/ledipasvir . Although all women included in these three studies had a rapid HCV RNA response to therapy, no results from PK analysis are reported (yet).…”

Section: Effect Of Pregnancy On Maternal Exposure To Direct‐acting Anmentioning

confidence: 99%

“…Despite recent interest and major advancements in available treatment options, data on DAAs in this population are limited to three abstracts on either intentional or accidental exposure during pregnancy in a small number of women . There are a number of important aspects to consider prior to implementation of DAA therapy during pregnancy, which we review here.…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

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

View full text Add to dashboard Cite

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.

show abstract

Section: Safety Of Direct‐acting Antivirals During Pregnancymentioning

confidence: 80%

Section: Discussionmentioning

confidence: 99%

Section: Effect Of Pregnancy On Maternal Exposure To Direct‐acting Anmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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

View full text Add to dashboard Cite

show abstract

“…This is based on observations of women with accidental pregnancy while receiving this DAA therapy. (62) Finally, is useful to compare guidelines for management of HBV and HCV in pregnancy. In HCV infection, it is advised to defer otherwise indicated treatment due to pregnancy, whereas in HBV infection, it is advised to initiate treatment in women who have no indication for therapy other than the prevention of vertical transmission-despite the risk of clinical decompensation following pregnancy.…”

Section: Future Directions and Needs For Researchmentioning

confidence: 99%

HCV in Women and Pregnancy

et al. 2019

View full text Add to dashboard Cite

Viral Hepatitis in Pregnancy: An Update on Screening, Diagnosis, and Management

Sanghi

Lindenmeyer

2021

Clinical Liver Disease

View full text Add to dashboard Cite

Viral hepatitis in pregnancy is common; accordingly, there is a need for evolved best practices in the approach to treatment of this special population. 1 Historically, the major limitation to standardization of evaluation and management of pregnant patients with viral hepatitis had been the availability of high-quality evidence and consensus expert opinion. In this article, we review the updated evidence for the screening, diagnosis, and management of acute and chronic viral hepatitis in pregnancy.Viral hepatitis in pregnancy increases the risk for pregnancy-related complications, as well as the risks associated with acute and chronic liver disease for both the mother and the infant as a result of mother-to-child transmission (MTCT) (Table 1). 1 A comprehensive and multidisciplinary approach to the management of viral hepatitis in pregnancy is necessary to reduce morbidity, mortality, and need for liver transplantation. This methodology involves early identification by screening, use of prevention techniques, encouragement of safe breastfeeding, treatment of infection, and immunoprophylaxis (Tables 1 and 2). HePaTiTis a virUsHepatitis A virus (HAV) typically has minimal impact on pregnancy. Testing in acute illness includes serum anti-HAV

show abstract

THU-137-DAA therapy in women of child bearing age: Accidental conception during therapy and pregnancy outcome

Cited by 12 publications

References 0 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

HCV in Women and Pregnancy

Viral Hepatitis in Pregnancy: An Update on Screening, Diagnosis, and Management

Contact Info

Product

Resources

About