What's New at the HCV Advocate: February 1, 2015

Updated Fact Sheets

• Pregnancy Drug Categories
  
  
• Genotype 1: VIEKIRA PAK Therapy
  
  

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

Of all the stories I hear, the 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). 

This adds up to 4000³ new hepatitis C cases in the U.S. every year. These 4000 hepatitis C infections are preventable, 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:

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.

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.

Lack of access to 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.

A recent study⁶ 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. 

Final Words
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.

Lucinda K. Porter, RN, is a long-time contributor to the HCV Advocate and author of Free from Hepatitis C and Hepatitis C One Step at a Time. Her blog is www.LucindaPorterRN.com

Additional Resources

• HCSP Factsheet HCV and Women: Being a Positive Mother www.hcvadvocate.org/hepatitis/factsheets_pdf/
  Wm_Mother.pdf  
• HCSP Factsheet HCV and Women: Pregnancy, Childbirth and Breastfeeding www.hcvadvocate.org/hepatitis/factsheets_pdf/
  Wm_pregnancy.pdf  
• Ribavirin Pregnancy Registry
  www.ribavirinpregnancyregistry.com  

Endnotes

1. Centers for Disease Control and Prevention www.cdc.gov
2. Vertical Transmission of Hepatitis C Virus: Systematic Review and Meta-analysis by Benova L, et al. Clinical Infectious Disease September 15, 2014
3. 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
4. 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
5. 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
6. 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

http://hcvadvocate.org/news/newsLetter/2015/advocate0215.html#1

Risk-based testing in primary care missed most patients with HCV

Risk-based testing for hepatitis C virus in the primary care setting may have missed more than 80% of patients with hepatitis C virus antibodies, according to researchers from the CDC.

“This may be due in part to the difficulty in capturing complete patient risk history (eg, injection drug use) in [electronic medical records (EMR)] to support the implementation of comprehensive risk-based HCV testing algorithms,” the researchers wrote in Clinical Infectious Diseases. “HCV-infected persons who are not aware of their status cannot receive further clinical evaluation, antiviral treatment, and are unlikely to benefit from preventive services or secondary prevention recommendations (eg, reduction in alcohol use and other lifestyle changes) aimed at limiting disease progression and reducing liver-related morbidity and mortality.”

The researchers evaluated EMR data from patients enrolled in the Birth Cohort Evaluation to Advance Screening and Testing for HCV (BEST-C) study to estimate how many patients with HCV remained unidentified after risk-based testing in the primary care setting. They also quantified the prevalence of HCV antibody positivity among primary care patients and determined predictors of HCV infection.

Read more....

My life with hepatitis C

María José Gandasegui is hopeful a new generation of drugs will cure her of the virus 

 María José Gandasegui was 12 when she began to suffer from prolonged bouts of extreme fatigue. Her family had no idea what was wrong with her, and people around her began labeling her lazy. She tried to make up for it by spending extra hours studying at school.

She ended up with two university degrees, a PhD on 18th-century law, a job as a court clerk, and three children, all of which she managed despite long periods of exhaustion. Finally, at the age of 48, she learned that she had hepatitis C, a virus that had been continually eating away at her liver.

Now 66, the last few years have been particularly hard for Gandasegui: cirrhosis, an encephalopathy caused by liver degeneration that severely affected her ability to concentrate, and a liver transplant followed by serious complications that put her in hospital for five months, nearly killing her.

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BMS Foundation Awards US$3.5 Million In Hepatitis Grants

AsianScientist (Feb. 2, 2015) - The Bristol Myers Squibb Foundation has in the past month awarded nine new multi-year grants for more than US$3.5 million to strengthen efforts against hepatitis B virus (HBV) and hepatitis C virus (HCV) in India and China, which constitute the most vulnerable populations worldwide.

The grants were made through the Foundation’s Delivering Hope initiative, an independent philanthropic wing of BMS to prevent hepatitis in Asia. These align with the World Health Organization’s (WHO) call for action against the global hepatitis threat with comprehensive strategies for awareness, prevention and treatment. Last year, Delivering Hope established three Centers of Excellence, one in China and two in India, that are focusing on just these goals.

 An urgent public health issue, hepatitis is an inflammation of the liver, most commonly caused by a viral infection. The WHO estimates that hepatitis B and C affect over 500 million people worldwide. Viral hepatitis is often referred to as a ‘silent epidemic’ because most people do not realize that they are infected and, over decades, progress to severe liver diseases. This underscores the urgent need for universal access to immunization, screening, diagnosis and antiviral therapy.

Read more from Asian Scientist Magazine at: http://www.asianscientist.com/2015/02/pharma/bms-foundation-awards-us3-5-million-hepatitis-grants/

Pakistan: Gang busted for spurious drugs sale

The Federal Investigation Agency (FIA) has arrested four accused involved in selling and manufacturing spurious drugs [Fake drugs] including injections for Hepatitis C patients.

Addressing a press conference on Saturday, FIA Punjab Director Dr Usman Anwar said FIA received information that a person, Arshad, was involved in the printing of labels, stickers etc of spurious drugs. He said a team ridded a place in Dina and arrested accused Jameel Anjum who had been getting the printed material from Muhammad Arshad of Jhelum.

The FIA director also claimed that a large quantity of printing material pertaining to spurious drugs was recovered from the spot including Injection Peg-INF, Capsule Xolox Capsule Ribasole (all used for Hepatitis C), Injection Fentin (for epilepsy), tablet Aminess (Multivitamin), machinery and stickers used for manufacturing of injection Peg-INF.

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Egypt: Egypt has highest infection level of hepatitis C: study

According to a new study by researchers from Weill Cornell Medical College in Qatar (WCMC-Q) and London School of Hygiene and Tropical Medicine in the UK, Egypt has the highest infection level of the disease in the world. About 15% of the population carry HCV, with at least 100,000 new cases every year, but the proportion of these new infections that occur through different transmission routes is not well understood. This study is the first, for any country, to estimate the number of new cases of HCV as a consequence of mother-to-child (vertical) transmission.

The authors estimated that in 2008, between 3,000 and 5,000 new cases of the infection were caused by this transmission route, which can occur during pregnancy, childbirth and the postpartum period from an infected mother to her child.

In addition, the findings show that mother-to-child transmission is an important transmission route among children under five years of age, contributing between a third and a half of new cases in that age group in Egypt.

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