Hi Sean.
That's a great question and a challenging scenario. You're right that current recommendations are to defer hepatitis C treatment until after pregnancy, given the lack of safety data in pregnancy. Here are the most recent DHHS HIV/HCV GLs: https://clinicalinfo.hiv.gov/en/guidelines/perinatal/hepatitis-c-virushiv-coinfection?view=full and HCV guidelines: https://www.hcvguidelines.org/unique-populations/pregnancy. Catherine Chappelle did publish a small study of led/sof after 24 weeks in pregnancy with 100% SVR12 and no safety concerns: Ledipasvir plus sofosbuvir in pregnant women with hepatitis C virus infection: a phase 1 pharmacokinetic study
However, I also fully support this recommendation from the HCV guidance: "Despite the lack of a recommendation, treatment can be considered during pregnancy on an individual basis after a patient-physician discussion about the potential risks and benefits." I would probably wait until after the first trimester to start treatment, but would definitely consider it if that's what the patient wants, understanding the lack of data.
I WOULD still recommend breastfeeding (with all the usually hepatitis C precautions about pumping and discarding during episodes of mastitis or cracked nipples, etc. and assuming that she doesn't also have HIV), and would also have a risk-benefit discussion about treating during breastfeeding vs waiting until after weaning.
This scenario is mainly tricky because postpartum retention in care is so challenging for all patients, but that's why establishing a trusting relationship now with open lines of communication and shared decision-making is so important.
Feel free to call the HCV hotline if you want to talk more with one of our specialists: https://nccc.ucsf.edu/clinician-consultation/hepatitis-c-management/
Best,
Lealah
Sciencedirect |
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Ledipasvir plus sofosbuvir in pregnant women with hepatitis C virus infection: a phase 1 pharmacokinetic study |
Hepatitis C virus (HCV) infection is increasing among pregnant women because of the opioid epidemic, yet there are no interventions to reduce perinatal HCV transmission or to treat HCV during pregnancy. Physiological changes in pregnancy alter the pharmacokinetics of some medications; thus, our aim was to compare the pharmacokinetic parameters of ledipasvir 90 mg plus sofosbuvir 400 mg during pregnancy with non-pregnant women. |
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Lealah Pollock, MD MS
UCSF, National Clinician Consultation Center, Perinatal HIV Hotline
San Francisco CA
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Original Message:
Sent: 12-22-2020 07:06
From: Sean Leonard
Subject: Hepatitis C and Pregnancy
Hi all,
I was wondering if anyone had any experience in dealing with Hepatitis C in pregnancy. Had a patient referred to me recently, She belonged to one of our mid-levels who recently left the practice. The patient's chief complaint was: "I think I may be pregnant" and sure enough she was...She has a complicated history including drug abuse and a significant amount of mental health issues as well as some typical chronic medical complaints.
I have recently started treating Hepatitis C as part of my FQHC primary care practice. (I also sat for the HIV Specialist exam last month and am waiting on the edge of my seat for results.)
So, I ordered the labwork/work up for Hep C, I optimized her meds for pregnancy. But was wondering what the recommendations were for treating Hep C with DAA's in early pregnancy? The medications themselves don't have significant feto-toxicity, but then again, there aren't any significant recommendations or literature...just a few cases. The majority of feedback that I am getting is: wait until after pregnancy for treatment and recommend no breastfeeding. That's probably the route I'll take, but will wait for labs/assessment results. If she is pretty sick from the Hep-C (elevated LFT's, elevated Fibrosure/fibrosis score) it may be worth revisiting.
Thoughts?
--Sean
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Sean Leonard
Meadville PA
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