Future Pregnancy after Harvoni

[Kat83]

I am currently waiting to hear back after a first denial from my insurer, and just stuck in the amber.  As such, I am turning over all sorts of scenarios in my head with what treatment actually means.  I have no children yet.  My husband and I would like to have children - and sooner than later.

I keep reading about the importance of birth control during treatment and 6 months after, which makes sense.  Gilead warns of severe birth defects and/or death, but there are no details as to what the birth defects actually are (physical/cognitive).

With this being a relatively new drug, how many studies have been done on babies born on the other side of those 6 months?  Physical defects would be easy to ascertain and diagnose, but what about cognitive function?  It seems that would take a few years to let the child grow older to determine whether or not the child had developed "normally."  It just doesn't seem like enough time has passed to certify its safety. 

Perhaps I'm paranoid because I recall an international legal case wherein a pharmaceutical company actually marketed morning sickness pills (thalidomide) to pregnant women.  The pills ultimately resulted in severe mental and physical deformities or death of those babies.  That said - the injury occurred while the woman was pregnant and concurrently taking the medication.  I imagine Harvoni would be out of the system entirely within the 6 month window. 

So, I guess my question is, could Harvoni damage an unfertilized egg/ova?  Does anyone know anywhere I could go to do some research or has anyone on the forum had a child after treatment?

I was born with Hep C myself, but read that it's quite rare with as few as 1 in 20 mothers passing it on.  If injury to an unfertilized egg is a possibility, could it be safer to forgo treatment and have a baby while still Hep C positive and then seek treatment later?


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United Healthcare - one denial and on an appeal now
Genotype 1a
F0
VL <6million

[Lynn K]

HealthWise: Hepatitis C Treatment and Pregnancy —Lucinda K. Porter, RN

http://hcvadvocate.blogspot.com/search/label/pregnancy%20and%20treatment

The “New” Days of Hepatitis C Treatment
Everything changed October 2014. The FDA approved Harvoni for genotype 1 patients. It was labeled Pregnancy Category B, which means, “Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.”

In short, Harvoni could be used during pregnancy, but only if the potential benefit justified the potential risk to the fetus. There was the added benefit of shorter treatment of 8 to 12 weeks, so if a woman delayed pregnancy, she did not have to wait long. Also, the safety of breastfeeding was not determined, so nursing might or might not be dangerous. 

[Kat83]

Lynn, thank you for your reply.  I guess my concern is less with pregnancy while on Harvoni, as that can be easily avoided, but pregnancy after finishing a treatment with Harvoni. 

I guess that if it's category B and *could* be used during pregnancy that it barely - if at all - affects the female reproductive system.  I'd imagine that if if wouldn't affect an active pregnancy that it's probably won't affect the ova...

It's also classified as a drug with a low cytotoxicity, which I think means that it's less likely to cause damage.  I do have an appointment with the doctor so I can ask all of these questions, but since it's so new I wasn't sure how much he would know.

[Lynn K]

I have run across a couple of other things looks like the doctors aren't that worried about it post tx. My uneducated guess is once the half life of the meds have expired which I think for Harvoni is 72 hours to be out of your blood stream in should not be any concern but doctors one would hope know more than us they did go to college for 8 years and more to be specialists.

[Kat83]

I think that the better the doctor is - the more likely he or she is to say, "I'm not sure now, but I will find out for you."  At least I'd hope!

That's interesting about the half life.  I wonder why there is a strongly suggested 6 month waiting period before a pregnancy after one completes the treatment.  Liability possibly...

I'll be sure to post again after I speak with him.

[Lynn K]

I had not seen the six month probably better to err on the side of caution. So much better for those wanting to have children soon than the old treatments interferon riba tx for 48 weeks then wait for an additional six months to a year post tx for either the man or woman being treated for hep c

[Corona]

I am interested in the same question.  I asked my doctor how soon after finishing Harvoni I could try to get pregnant and he seemed quite unconcerned about it.  He said Harvoni clears from your system very  quickly and I could "wait three months just to be safe".  (For what it's worth, my doctor is a leader in hepatitis treatment.). Anyway,  I would love to hear any updates or further information the original poster was able to glean from her doctor.  thanks!

[Kt923]

I don't see why harvoni would have any effect on a baby after the 6 months.....I mean it's put of your body No? I too want to have another baby and I finished harvoni in February. Going to wait til after my 6 month blood work to start trying. I honestly don't think it can harm your baby. I mean your not taking it while pregs so.....I dunno I'm going to ask my doctor as well