Most recent research on post-Harvoni pregnancy?

[katrinat]

Looking for the most recent research on pregnancy outcomes/ baby health when pregnancy occurs AFTER Harvoni treatment.(not during Harvoni treatment)  Birth defects? Miscarriage? Complications? Normal?  How long after treatment did pregnancy begin? What experience have forum members had?

[Lynn K]

Here is a thread on this subject from 2015

https://forums.hepmag.com/index.php?topic=2398.0

[Lynn K]

Ok one of the links in the old post doesn't work

Here is a fresh link

https://www.hepmag.com/article/hepatitis-c-pregnant-26893

And this from the Harvoni prescribing information sheet about risk of birth defects fotctaking Harvoni while pregnant

 http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf

8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
If HARVONI is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. Refer to the ribavirin prescribing information for more information on use in pregnancy.
No adequate human data are available to establish whether or not HARVONI poses a risk to pregnancy outcomes. In animal reproduction studies, no evidence of adverse developmental outcomes was observed with the components of HARVONI (ledipasvir or sofosbuvir) at exposures greater than those in humans at the recommended human dose (RHD) [see Data]. During organogenesis in the rat and rabbit, systemic exposures (AUC) to ledipasvir were approximately 4 (rats) and 2 (rabbits) times the exposure in humans at the RHD, while exposures to the predominant circulating metabolite of sofosbuvir (GS-331007) were ≥3 (rats) and 7 (rabbits) times the exposure in humans at the RHD. In rat pre/postnatal development studies, maternal systemic exposures (AUC) to ledipasvir and GS-331007 were approximately 5 and 7 times, respectively, the exposure in humans at the RHD.
The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

[Lynn K]

Of course the best person to ask is your doctor or pharmacist who is providing your meds.

Also you could contact Giliead for the Harvoni support path

http://www.gilead.com/responsibility/us-patient-access/support%20path%20for%20sovaldi%20and%20harvoni

The SUPPORT PATH® patient assistance program assists eligible hepatitis C patients in the United States access SOVALDI® (sofosbuvir), EPCLUSA® (sofosbuvir/velpatasvir) or HARVONI® (ledipasvir/sofosbuvir). The program offerings include:

A call center staffed with associates trained to help patients and their providers with insurance-related information.
Access education and support, such as a 24/7 nursing support service line.
Co-pay Coupon Programs, which provide co-pay assistance for eligible patients with private insurance who need assistance paying for their out-of-pocket medication costs. Most eligible patients will pay no more than $5 per co-pay (restrictions apply). Not valid for patients enrolled in government healthcare prescription drug programs, such as Medicare Part D and Medicaid. Patients in the coverage gap known as the "donut hole" also are not eligible..
The Support Path Patient Assistance Program will provide SOVALDI®, HARVONI®, or EPCLUSA® at no charge for eligible and qualified uninsured patients.
To learn more about Support Path, please call 1-855-769-7284, Monday through Friday between 9:00 a.m. and 8:00 p.m. (Eastern Time).