most agonizing are those of mothers who have passed hepatitis C virus
(HCV) to their children. Although the risk is relatively low that an
HCV-positive woman will pass the virus to her baby (6 percent1),
it is tortuously high to those who carry the burden. This risk is
substantially greater if the mother is co-infected with HIV
(approximately 11 percent2 and perhaps much higher).
especially with the recent approvals of new HCV medications.
Tragically, this preventable infection isn’t being prevented. Women of
childbearing age are having problems getting the new hepatitis C drugs.
If you want to know what the problem is, keep reading.
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:
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.
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.”
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.
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
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.
Now That We Can Easily Cure Hepatitis C, What’s the Problem?
The solution seems so
simple: treat everyone who wants to be treated. However, the price of
HCV treatment is so steep that many insurance companies and state
Medicaid programs are denying treatment to patients unless they have
advanced liver disease. Women who are pre-menopausal tend to have the
least amount of fibrosis. This is because nature has a way of
protecting women while they are fertile by giving them a hardier immune
system. That benefit stops about the time we turn fifty, leaving us
with graying hair and a deteriorating liver. (But, don’t mess with us
because we are tough!)
So, if you are a young woman, it is unlikely that you fit the criteria4
for priority treatment. Although AASLD and IDSA assigned a higher
priority to HCV-infected women of childbearing potential wishing to get
pregnant, it looks like they were added in as an afterthought. Women
of childbearing potential are at the bottom of AASLD/IDSA’s list,
preceded by men who have high-risk sexual practices with other men,
active injection drug users, incarcerated persons, and those on
long-term hemodialysis. However, except for the dialysis patients,
the above groups are also routinely denied HCV treatment.
is immoral, but particularly so for fertile women. Treating women of
childbearing age is both curative and preventive. I don’t see how
insurers can live with themselves knowing that they can prevent 4000
babies from being born HCV-positive, or justify the anxiety caused to
women when HCV treatment is denied.
Women and Injection Drug Use
The sad fact is that a large percentage of young
women who acquire HCV did so via injection drug use (IDU). Since women
are more likely to clear HCV spontaneously than men are,5 one would think that women who inject drugs are less likely to have hepatitis C than men. However, that is not the case.
found that female IDUs were significantly more likely to become
infected with HCV than men were, most likely because of high-risk
injecting behaviors. Women were significantly less likely to inject
alone. Other risky injection practices included: injecting
heroin/opioids, borrowing used syringes, reuse of a cooker previously
used by another injector, injecting every day, pooling money with
others to buy drugs, and having a steady IDU sex partner.
What Women Need to Know about Current HCV Treatments
If you are prescribed HCV treatment, and you are a
woman who can still get pregnant, here is what you need to discuss with
your medical provider:
Are you or could you be pregnant?
Which HCV treatment is recommended for you?
Assuming you do not intend to get pregnant during your treatment, which birth control methods will you use?
If prescribed Viekira Pak,
be aware that ethinyl estradiol-containing medications such as combined
oral contraceptives, contraceptive patches or contraceptive vaginal
rings are contraindicated. To protect yourself against unplanned
pregnancy, use progestin only or non-hormonal contraception. You may
restart ethinyl estradiol-containing medications two weeks after
finishing Viekira Pak.
If you are a mother who has transmitted hepatitis C to her baby, please take these words to heart: Forgive
yourself. Your child needs a strong mother, one who faces the truth,
and is a role model for living bravely with hepatitis C.
HCSP Factsheet HCV and Women: Being a Positive Mother www.hcvadvocate.org/hepatitis/factsheets_pdf/
HCSP Factsheet HCV and Women: Pregnancy, Childbirth and Breastfeeding www.hcvadvocate.org/hepatitis/factsheets_pdf/
Ribavirin Pregnancy Registry
- Centers for Disease Control and Prevention www.cdc.gov
- Vertical Transmission of Hepatitis C Virus: Systematic Review and Meta-analysis by Benova L, et al. Clinical Infectious Disease September 15, 2014
- Reducing Risk for Mother-to-Infant Transmission
of Hepatitis C Virus: A Systematic Review for the U.S. Preventive
Services Task Force by Cottrell EB, et al. Annals of Internal Medicine January 15, 2013
- Recommendations for Testing, Managing, and
Treating Hepatitis C – American Association for the Study of Liver
Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) www.hcvguidelines.org
- The Effects of Female Sex, Viral Genotype, and
IL28B Genotype on Spontaneous Clearance of Acute Hepatitis C Virus
Infection by Grebeley J, et al. Hepatology January 2014
- Higher Risk of Incident Hepatitis C Virus among
Young Women who Inject Drugs Compared with Young Men in Association
with Sexual Relationships: A Prospective Analysis from the UFO Study
Cohort by Tracy D, et al. BMJ Open May 29, 2014