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.
You're on the right track in terms of delaying treatment and making decisions based on her actual health and the state of her pregnancy. Her pregnancy care will be complicated and most likely you will have to be very involved. Good luck.
No treatment during pregnancy.
The current guidelines do not recommend treatment in pregnancy the fetal toxicity data on most of the DAAs that I have looked do not however suggest any harm to the fetus. This is based on animal data however human data is very limited. There is data presented at CROI and ID week suggesting that SOF/LED was used at 22 weeks with overall good efficacy without any safety signal suggesting fetal harm. These are however very small studies sample size about 20. There are a few studies currently recruiting looking at this question. Based on guidelines you may want to wait for her to have the baby and treat after delivery. Experience suggest most patients are not really treated since having a baby has its own challenges and most get lost to follow-up.
CCO - Clinical Care Options has a module that looks into that.
Clinical Care Options Link for HCV Management in Women
For the current studies
ClinicalTrials.gov Identifier: NCT04382404, NCT03570112
------------------------------Leonard SowahBaltimore MD------------------------------
------------------------------Sean LeonardMeadville PA------------------------------
Cautious/conservative approach would be to wait (as per others' suggestions here), however the limited data on DAA exposure later in pregnancy seems to be reassuring thus far. Two sof/vel studies are underway in U.S. -- Dr. Sowah listed their NCT numbers below... the PK study in Pittsburgh with Catherine Chappell is still recruiting -- would that be of interest to you or your patient, if travel to study visits isn't prohibitive?
Some have pointed out that pregnancy/postpartum may be a unique opportunity to treat since many pts are generally well-engaged in care during this time...loss to follow-up and disruptions in access to care/insurance are very real for my clinic population. Thus, for very motivated patients who have been engaged in discussions about potential harms/benefits, what is known and unknown, etc. I don't think it would be wholly unreasonable to consider with close f/u and coordination... esp if there's compelling clinical reason to treat sooner rather than wait until she's no longer breastfeeding (in the event that she chooses to breastfeed). With that said, most providers probably wouldn't opt to start treatment in pregnancy given limited data and experience so far.
------------------------------Carolyn ChuSan Francisco General HospitalSan Francisco CA------------------------------
In these times with high rates of HCV and Opioid use among women in ages 19 - 30 years most providers in HCV care are seeing more and more participants pregnant with HCV. What tends to happen when you treat a lot of young women is occasionally having a someone get pregnant whilst on treatment. Invariable when you find out most patients would have done 4-6 weeks or even more of the treatment since we are checking for pregnancy prior to starting. The question that comes up is, do we continue or stop treatment at this time. Most providers that I discuss this with are doing shared decision making with this issue and deciding based on patient comfort and preferences.
However with initiating treatment, on account on the vital importance of obtaining appropriate data for or against treatment in pregnancy I still believe referral to a trial wherever available is idea.
------------------------------Carolyn ChuSan Francisco General HospitalSan Francisco CAOriginal Message:Sent: 12-22-2020 07:06From: Sean LeonardSubject: Hepatitis C and Pregnancy
Thank you all for your input. --Sean
Hi Sean, I treat HIV and HCV and have had a couple of patients in a very similar situation except both decided to terminate their pregnancies. I use the discussion in the national Hep C curriculum as a guide. Agree you need to stage her for cirrhosis which has implications for her health during pregnancy if she opts to continue. Currently because of lack of data on DAA safety in pregnancy the recommendation Is not to treat, as the risk of vertical transmission is low, also some women spontaneously clear HCV post-childbirth. I think she just needs counseling about it as you are doing. See the section on perinatal HCV transmission in the online curriculum: Core Concepts - Counseling for Prevention of HCV Transmission - Screening and Diagnosis of Hepatitis C Infection - Hepatitis C Online
Rachel Picone DNP
Thanks for linking to the UW IDEA Program's Hepatitis C Online website.
FYI to others on this thread:
By early March 2021, Hepatitis C Online will have a new lesson, Perinatal HCV Transmission, included in the 3rd Edition launch of the Treatment of Key Populations and Unique Situations (Module 6). The lesson will address current treatment and prophylactic options and link to relevant resources. The 3rd Edition launch represents the beginning of a new 3-year CE period. We are also taking this opportunity to add a second lesson, Management of Health Care Personnel Who Have Been Exposed to HCV, to this module for a total of 8 lessons. For those who don't know, this module already includes this lesson: Treatment of HCV in Persons with HIV Coinfection. Julia
Hepatitis C treatment should be deferred until she is postpartum.
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/
------------------------------Lealah Pollock, MD MSUCSF, National Clinician Consultation Center, Perinatal HIV HotlineSan Francisco CA------------------------------