Hep C Discussion Forum

momo3 · Newbie

RE: Pregnancy after Harvoni?

Tig · Admin

Hi Aspen,

Welcome to the forum. Congratulations on being approved for Harvoni. It should be an easy 8 weeks for you. These new protocols are so much kinder than ever before, not to mention very effective. I'm unaware of anyone here getting pregnant post Harvoni, so I wanted to point that out if you needed a quick answer. That doesn't mean there isn't! We have a lot of information and a big audience. In the meantime, here's some material from the HCV Advocate that talks about the pregnancy categories of different treatment drugs. The two components in Harvoni, Sovaldi and Ledipasvir, clear the system within a short period of time and I'm unaware of any teratogenic effect from either drug. There was no evidence of it in animal studies, with no human study evidence given.

Hope this helps. Please feel free to introduce yourself in the New Members section. I'm glad you found us. We'll be here to cheer you on!

From the HCV Advocate website:

The “Old” Days of Hepatitis C Treatment
In the olden days (before 2014), hepatitis C treatment relied on peginterferon and ribavirin. Treatment was long, and these two drugs have many side effects, making them difficult to take. Ribavirin had an additional issue in that it could cause miscarriages and birth defects. This risk was so serious that the Food and Drug Administration (FDA) classified it in the Pregnancy Category X, and required ribavirin manufacturers to put this warning on the label:

Significant teratogenic and embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Therefore, ribavirin is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking ribavirin.

This meant that women had to make a difficult choice. Should they postpone having a baby for at least 72 weeks (48 weeks for the treatment plus the 6 months after)? Or, do they skip treatment, take a chance on pregnancy, and hope the odds will be in their favor that they do not pass HCV to the baby. If you were older, treating first might mean foregoing pregnancy altogether. Having babies first meant postponing treatment for many years since breastfeeding is not recommended while taking ribavirin. Also, the medication side effects are so intense that it is often suggested that women wait until their children are at least a few years old. I was such a wreck during my first treatment that I waited until my daughter was in college before I tried it again.

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.

Two months after Harvoni was approved, Viekira Pak was approved. Viekira Pak is used with or without ribavirin. Viekira is also Pregnancy Category B, so noncirrhotic genotype 1b patients who use this drug combination without ribavirin may consider the possibility of pregnancy or breastfeeding during HCV treatment.

Sovaldi is in Pregnancy category B, but it is used with ribavirin or Olysio. Olysio is Pregnancy Category C, which states, “Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.” Olysio and Sovaldi would be a riskier proposition, but the risk is not as clearly dangerous as it is with Ribavirin.

Contraindications

If Harvoni is used in combination with ribavirin (RBV), all contraindications, warnings and precautions, in particular pregnancy avoidance, and adverse reactions to RBV also apply. Refer to RBV prescribing information.

momo3 · Newbie

Hello all,

I am fairly young but reaching the end of my fertile years. I am about to start Harvoni for 8 weeks. I am a little nervous because although the dr said there would be no problems with getting pregnant even right after treatment, I would like to hear some stories of people who have gotten pregnant after treatment and what their experiences were. thank you for sharing

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