HCV DRUGS: Triple Drug Regimens, Exclusivity Deals & Merck Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4THE FIVE: Fatigue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5PREDICTORS OF TREATMENT RESPONSE: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6SNAPSHOTS: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

IN THIS ISSUE

17February 2015 • Vol. 18, Issue 2

CONTINUED ON PAGE 2

Hepatitis C treatment and pregnanCy

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. Riba-virin had an additional issue in that it could cause miscar-riages and birth defects. This risk was so serious that the Food and Drug Administra-tion (FDA) classified it in the Pregnancy Category X, and

required ribavirin manufactur-ers to put this warning on the label:

Significant teratogenic and embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Therefore, riba-virin 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 treat-ment 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

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

2

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 treat-ment for many years since breastfeeding is not recom-mended while taking ribavi-rin. 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 Octo-ber 2014. The FDA approved Harvoni for genotype 1 pa-tients. It was labeled Preg-nancy Category B, which means, “Animal reproduction studies have failed to dem-onstrate 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 preg-nancy, she did not have to wait long. Also, the safety of breastfeeding was not de-termined, so nursing might or might not be dangerous.

Two months after Har-voni was approved, Viekira Pak was approved. Viekira Pak is used with or with-out 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 breastfeed-ing 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 repro-duction studies have shown an adverse effect on the fetus and there are no ad-equate and well-controlled studies in humans, but po-tential benefits may warrant use of the drug in pregnant women despite potential risks.” Olysio and Sovaldi would be a riskier proposi-tion, 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. How-ever, the price of HCV treat-ment 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 na-ture has a way of protecting women while they are fertile by giving them a hardier im-mune 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 be-cause 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 high-er priority to HCV-infected women of childbearing po-tential wishing to get preg-nant, it looks like they were added in as an afterthought.

CONTINUED ON PAGE 3

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3

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Women of childbearing po-tential 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 he-modialysis. However, except for the dialysis patients, the above groups are also rou-tinely denied HCV treatment.

Lack of access to HCV treatment is immoral, but par-ticularly so for fertile women. Treating women of childbear-ing age is both curative and preventive. I don’t see how insurers can live with them-selves knowing that they can prevent 4000 babies from being born HCV-positive, or justify the anxiety caused to women when HCV treatment is denied.

w O m e n a n d i n j e C t i O n 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. How-ever, that is not the case.

A recent study6 found that female IDUs were signifi-cantly 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 prac-tices included: injecting her-oin/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 treat-ments

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 in-tend to get pregnant dur-ing your treatment, which birth control methods will you use?

• If prescribed Viekira Pak, be aware that ethinyl es-

tradiol-containing medi-cations such as com-bined 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 med-ications 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 au-thor 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

CONTINUED ON PAGE 9

44

—Alan Franciscus, Editor-in-Chief

At last year’s CROI con-ference, I wrote about a

6-week study of sofosbuvir, ledipasvir, and GS-9451. This combination was tested against sofosbuvir/ledipasvir alone for 12 weeks and sofosbuvir/ledipasvir plus GS-9669 for 6 weeks. The drugs were combined into one-pill, taken once-daily. There were 20 patients in each arm.

The bottom line is that all 20 patients (100%) achieved a cure in the triple combination of sofosbuvir/ledipasvir and GS-9669 with 6 weeks of treat-ment. The most common side effects were headache, fatigue and diarrhea.

Comments: This study is a small study and there is cur-rently no information that it has yet entered into phase 3 stud-ies. But given the high cure rates and low side effects hope-fully it will be entered into clinical trials with this combination or perhaps Gilead is researching another inhibitor to include.

Study: Virological response after 6 week triple-drug regi-mens for hepatitis C: a proof-of-concept phase 2A cohort study. Authors: A Kohli et al.exClusiVity deals

Ever since AbbVie’s VIEKIRA PAK’s approval there have been intense negotiations between in-surance companies/pharmacies

Triple Drug Regimens, Exclusivity Deals & Merck Update

and AbbVie and Gilead to deter-mine who will be the exclusive distributors of the pharmaceu-tical HCV medications. These deals will help to drive down the costs of the drugs, and this will hopefully translate into more patients having access to HCV medications. The real downside is that the decision as to which medication a patient should be prescribed is now being made by someone other than a patient and medical provider. This is very bad news for patients (see “Predictors” article). The infor-mation below is from our blog as of the date that we have put together our newsletter. If you have been denied treatment in the past, you may want to check the list below (or our Blog) to find out if you would now qualify for insurance coverage. The agree-ments are on-going so keep checking back. • AbbVie: Express Scripts,

AIDS Drug Assistance Pro-grams (ADAPs)

• Gilead: Aetna, Humana, Anthem, CVS

• Both—AbbVie/Gilead: Prime Therapeutics

merCK

In January, Merck announced that it has been prioritizing por-tions of its drug development operations including hepatitis C.

In this respect, the development of a two-drug single pill (grazo-previr/elbasvir) will be acceler-ated. Merck hopes to apply for marketing approval in the first half of 2015. The combination is currently in phase 3 studies. Phase 2 studies of the two drug combination with and without ribavirin in multiple arm studies of monoinfected and HIV/HCV coinfected patient populations with and without cirrhosis re-sulted in cure rates from 90 to 100%. The most common side effects were fatigue, headache and general weakness.

gilead

Gilead has announced that it has expanded its hepatitis C generic licensing agreements to include the investigational NS5A inhibitor GS-5816, which is be-ing evaluated in Phase 3 clinical studies as part of a single tablet regimen that combines the com-pound and sofosbuvir for the treatment of all six geno types of hepatitis C. If approved by regulatory authorities, the sofos-buvir/GS-5816 regimen would become the first pan-genotypic, all-oral single tablet regimen for HCV. A pan-genotypic therapeu-tic option is particularly important for developing countries, where genotype testing is often unreli-able or not readily available.

5

1. Fatigue or feeling tired is the most common symp-tom of hepatitis C. It is also the most common extrahepatic (occurring outside of the liver) con-dition of hepatitis C. It is also one of the most common side effects of HCV therapy. It can range from mild to mod-erate to so severe that it can affect almost every area of life.

2. Causes: Fatigue can be caused by many fac-tors besides hepatitis C. Be sure to talk with your medical provider before jumping to a conclusion that the cause is hepati-tis C. Other factors that could be causing fatigue could be other extrahe-patic manifestations of hepatitis C (thyroid prob-lems, anemia, HCV treat-ment, depression, sleep problems, poor diet, lack of exercise, medications, alcohol use and so on).

3. Self-help strategies: After you have ruled out any other causes with your medical providers there are many strategies

to help improve your en-ergy levels. We have an excellent Guide to Under-standing and Managing Fatigue that can walk you through many self-help tips such as information on improving sleep, nutri-tion, exercise, meditation, complementary medi-cines and much more.

4. HCV Treatment: Severe fatigue is one of the ex-trahepatic manifestations that can qualify someone for treatment. Curing hepatitis C can also cure fatigue, though fatigue can worsen temporarily during treatment. Be sure to talk with your medical provider about the fatigue you are experiencing and other symptoms. Make sure to document al l symptoms in your medi-cal records. For some people, it is hard to com-plain or even talk about their symptoms. It is critical, however, to make sure that you document your complaints. Medical records are important for treatment and disability records.

One of the best ways to gauge your level of en-ergy or any other factor is to use a scale of 1 to 10 and keep a journal. Let’s say you have a wonderful day, full of energy, and you feel like your old self. That would be a fatigue scale of 1. Now let’s say you have a day where you are feeling sluggish but can still work. Maybe that is a fatigue day of 4. Then there are days when you can hardly get out of bed. Let’s say that is a 10 on the scale of fa-tigue. I think you get the idea. Log it into a journal every day. Take a copy with you to your medical provider and have them put it in your medical records.

5. Support: One way to fight fatigue is to join a support group (either on-line or in-person) and talk with others who are experiencing fatigue. Try to remember to take care of yourself and to prac-tice self-care tips to keep you well and healthy.

—Alan Franciscus, Editor-in-Chief

Fatigue

6

Predictors of Treatment Response

In the past, there were many factors that predicted suc-

cessful treatment outcome. Today, that list is much longer and is somewhat dependent on the particular HCV inhibi-tor used to treat hepatitis C.

This article is about the negative predictors of treat-ment response—genotype, subtype, cirrhosis, prior treat-ment response and viral load.

genOtype: The most dramatic current

negative predictor of treat-ment response is genotype 3. The current standard of care for treating HCV genotype 3, a combination of sofosbuvir (Sovaldi) plus ribavirin for 24 weeks, has an overall cure rate of 93%. Among those in the group who had never been treated (treatment na-ïve), the cure rate was 93% for those without cirrhosis compared to 92% for those with cirrhosis. Among treat-ment experienced patients in this test group, the cure rate was 85% for those without cirrhosis compared to only 60% for those with cirrhosis. Future treatments are need-ed for people with genotype 3 that have higher cure rates with shorter treatment dura-tions, and which work in cir-

rhotic patients who have not responded to prior treat ment.

subtype: Subtype has long been

known to affect treatment outcome. In regards to gen-otype 1, subtype 1a is gen-erally harder to treat. If we look at VIEKIRA PAK to treat HCV genotype 1a without cirrhosis, adding ribavirin is indicated. There is no recom-mendation to add ribavirin to VIEKIRA PAK for treatment of genotype 1b without cir-rhosis.

CirrHOsis: People with cirrhosis have

always been harder to cure than those without it, al-though now it is not as dif-ficult as in the past. The rec-ommended treatment dura-tion for genotype 1a patients with cirrhosis is 24 weeks with VIEKIRA PAK plus riba-virin. There is a note that 12 weeks can be considered for some patients based on prior treatment history.

treatment-experienCed: Patients without cirrhosis

can be treated with HARVO-NI for 12 weeks. Treatment experienced (but not cured) patients with cirrhosis can be harder to cure, so 24 weeks

treatment with HAR VONI is recommended.

HCV rna Or Viral lOad:In the Full Prescribing

Information for HARVONI for genotype 1, there is a footnote about the recom-mended treatment duration saying that “HARVONI for 8 weeks can be considered in treatment-naïve patients without cirrhosis who have pre-treatment HCV RNA less than 6 million IU/mL.” This consideration is based on the ION-3 study of 123 patients with baseline viral loads un-der 6 million IU/mL who were treated for eight weeks. The cure rates were 97% (119 of 123 patients). This is only true with HARVONI. The viral load thresholds need to be studied in all of the newer therapies.

Even now, matching a per-son’s characteristics to the specifics of the HCV drugs can help cure most people. The future of hepatitis C treat-ment holds the promise that, when matched with all of a patient’s characteristics, new medicines or combinations of medications will be able to treat and cure everyone with HCV.

—Alan Franciscus, Editor-in-Chief

7CONTINUED ON PAGE 8

—Lucinda K. Porter, RN

Article: Next-Generation Sequencing Sheds Light on the Natural History of Hepa-titis C Infection in Patients Who Fail Treatment – Tamer Abdelrahman, et al.

Source: Hepatology Jan-uary 2015; Volume 61, Issue 1, pages 88–97

Reports show high rates of HCV reinfection among in-jecting drug users with histo-ry of HCV, along with reports of sexually transmitted HCV infection and reinfection in HIV-infected men who have sex with men. This research investigated viral quasispe-cies dynamics in patients who failed HCV treatment to determine whether treatment failure was associated with reinfection or reemergence of preexisting infection. Pre-vious studies interpreted the evidence as reinfection; this study identified the subjects as having preexisting resis-tant HCV variants.

The Bottom Line: Resis-tant HCV strains are more likely the reason for failure to achieve a sustained virologi-cal response (SVR) in these study subjects. This could be the result of superinfection or a limitation on the ability to test these HCV strains.

Editorial Comment: Few words cause as much fear in me as “superinfection.” What this study did not discuss is whether the lack of SVR could be connected to immune fac-tors in this study group.

Article: Association be-tween Chronic Hepatitis C Virus Infection and Low Muscle Mass in US Adults – Charitha Gowda, et al.

Source: Journal of Viral Hepatitis December 2014; Volume 21, Issue 12, pages 938–943

The purpose of this cross-sectional study was to see if chronic hepatitis C virus (HCV) infection was associ-ated with low muscle mass among adults.

Among 18,513 adults in the U.S., people with chronic HCV had a higher preva-lence of low muscle mass compared to uninfected persons (13.8% vs. 6.7%). Even HCV+ persons without significant liver fibrosis had lower muscle mass.

The Bottom Line: Chronic HCV infection is associated with low muscle mass, even in the absence of advanced liver disease.

Editorial Comment: Low muscle mass is a risk factor for osteoporosis. This study strengthens the argument that we should treat people with chronic HCV, regardless of fibrosis stage.

Article: The Epidemiology of Cirrhosis in the United States: A Population-based Study – Steven Scaglione, et al.

Source: Journal of Clinical Gastroenterology published ahead-of-print October 8, 2014

Hepatitis C is one of many conditions that can cause cirrhosis, a severe scarring of the liver. This study assessed the prevalence of cirrhosis in the US, and defined some of the characteristics of this potentially deadly condition.

The prevalence of cirrhosis is higher in the U.S. than pre-viously estimated (633,323 now versus previously esti-mated 400,000 adults). The researchers believe that the prevalence is even higher since this research relied on data from the NHANES survey, which did not col-lect data from people who were in the military, prison,

88

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hospitalized, homeless, or institutionalized.

Alcohol abuse, diabetes and hepatitis C were con-tributing factors for the ma-jority of those with cirrhosis. Non-Hispanic blacks and Mexican Americans, those living below the poverty level, and those with less than a 12th grade education had the highest prevalence of cirrho-sis. Nearly 70% of those who have cirrhosis may not know they have it.

The Bottom Line: The prev-alence of cirrhosis is signifi-cantly higher than previously thought.

Editorial Comment: The most common factors as-sociated with cirrhosis are preventable – hepatitis C, diabetes, and alcohol abuse. Hepatitis C is curable; a public health program that identifies and cures this virus may reduce the burden of cirrhosis.

Article: Cognitive Func-tion and Endogenous Cyto-kine Levels in Children with Chronic Hepatitis C – N. H. Abu Faddan, et al.

Source: Journal of Viral Hepatitis published ahead-of-print December 15, 2014

Hepatitis C is rarely stud-ied in children, and little is known about the cognitive effects of hepatitis C in young patients. This Egyptian study compared cognitive function in 35 HCV-positive children to 35 HCV-negative children. Compared to HCV-negative children, the children with HCV had reduced function in the areas of vocabulary, comprehension, memory, abstract visual reasoning test, quantitative reasoning test, and intelligence quotients.

The Bottom Line: Chil-dren with chronic HCV in its early stages showed signs of cognitive impairment, par-ticularly with memory. There appeared to be a correlation between cognitive function and immune response as measured by the production of cytokines.

Editorial Comment: This study is particularly heart breaking. Children are often the last to be studied, and the last to be treated. We tend to be afraid to treat chil-dren, understandably con-cerned that we may injure them. This study represents the tip of the iceberg, telling us how little we know about HCV in children.

Article: Impact of Hepatitis C Virus Infection on the Risk of Death of Alcohol-Depen-dent Patients – Daniel Fuster, et al.

Source: Journal of Vi-ral Hepatitis January 2015; Volume 22, Issue 1, pages 18–24

This longitudinal research assessed the relationship between chronic hepatitis C virus (HCV) infection and sur-vival rates. There were 675 subjects (nearly 80% male), enrolled in two detoxification units, with a median follow-up of three years.

The Bottom Line: The mortality rate was high for those with alcohol-related liver disease, regardless of HCV-status; more than 11% died (78 subjects). Risk of death was increased among younger HCV-positive par-ticipants compared to those who were HCV-negative. HCV/HIV co-infection was associated with increased risk of death.

Editorial Comment: This study speaks for itself. I can only add that if alcohol is a problem for you, please get help.

Executive DirectorEditor-in-Chief,HCSP PublicationsAlan Franciscusalanfranciscus@hcvadvocate.org

Managing Editor, WebmasterC.D. Mazoff, PhDcdmazoff@hcvadvocate.org

Contributing AuthorsLucinda K. Porter, RN

DesignLeslie HoexBlue Kangaroo Designblueroodesign@aol.com

Contact information:Hepatitis C Support ProjectPO Box 15144Sacramento, CA 95813

The HCV Advocate offersinformation about various forms ofintervention in order to serve ourcommunity. By providinginformation about any form ofmedication, treatment, therapy ordiet we are neither promoting norrecommending use, but simplyoffering information in the beliefthat the best decision is aneducated one.

Reprint permission is granted andencouraged with credit to theHepatitis C Support Project.

© 2015Hepatitis C Support Project

9

FROM PAGE 3

• HCSP Factsheet HCV and Women: Pregnancy, Child-birth and Breastfeeding www.hcvadvocate.org/hepatitis/factsheets_pdf/Wm_pregnancy.pdf

• Ribavirin Pregnancy Regis-try www.ribavirinpregnan-cyregistry.com

endnOtes1 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 Test-ing, Managing, and Treating Hep-atitis C - American Association for the Study of Liver Diseases (AASLD) and the Infectious Dis-eases Society of America (IDSA) www.hcvguidelines.org

5 The Effects of Female Sex, Viral Genotype, and IL28B Geno-type on Spontaneous Clearance of Acute Hepatitis C Virus Infec-tion by Grebeley J, et al. Hepatol-ogy January 2014

6 Higher Risk of Incident Hep-atitis C Virus among Young Wom-en who Inject Drugs Compared with Young Men in Association with Sexual Relationships: A Pro-

spective Analysis from the UFO Study Cohort by Tracy D, et al. BMJ Open May 29, 2014

CHeCK Out tHese new & updated faCt sHeets!

www.hcvadvocate.org/hepatitis/factsheets_pdf/

Treat_pregcat.pdf

www.hcvadvocate.org/hepatitis/factsheets_pdf/

GT1_Viekira.pdf

HCSP • VERSION 7 • January 2015 © 2015 Hepatitis C Support Project

1

HCSP FACT SHEETA publication of the

Hepatitis C Support Project

The information in this fact sheet is designed to help you understand and manage HCV and is not intended as medical advice. All persons with HCV should consult a medical practitioner for diagnosis and treatment of HCV.

This information is provided by the Hepatitis C Support Project a

nonprofit organization for HCV education, support and advocacy

Reprint permission is granted and encouraged

with credit to the Hepatitis C Support Project.

CONTACT INFORMATION

Hepatitis C Support ProjectPO Box 15144

Sacramento, CA 95813alanfranciscus@hcvadvocate.org

EXECUTIVE DIRECTOR, EDITOR-IN-CHIEF,

HCSP PUBLICATIONSAlan Franciscus

DESIGNLeslie Hoex,

Blue Kangaroo Design

PRODUCTIONC.D. Mazoff, PhD

HCSP FACT SHEETa series of fact sheets written by experts in the field of liver disease

www.hcvadvocate.org

•HCV TREATMENT: GENERAL INFORMATION•

ForewordWhich drugs are safe to take for a woman while she is pregnant? If a woman becomes pregnant while on therapy is there a risk to the fetus? If a woman is pregnant, which drugs increase the risk of birth defects? To help guide medical providers and patients, the Food and Drug Administration (FDA) has established certain categories that for the most part define what is safe and what is not safe. But there are gray areas within most of the categories. This is why it is so important to seek medical advice—medical providers base decisions on a variety of factors, such as does the risk outweigh the benefit, personal experience using a certain drug and the latest medical research.

The pregnancy categories are only applied to medications that have been approved by the FDA. Over-the-counter medications (OTC), herbs and most supplements are not assigned a pregnancy classification unless they have been previously scrutinized by the FDA. In these instances medical providers will use their previous experience or information from scientific sources to advise what is safe or unsafe to take.

In a perfect world every drug would have solid scientific data on humans to advise about the potential risk of medications, but this isn’t always the case. There are many reasons why studying a drug in humans isn’t feasible or why pharmaceutical companies don’t pursue these trials, such as the obvious risk of exposing pregnant women and their unborn babies to certain drugs, the cost of studying the issues and the potential lawsuits the pharmaceutical companies may be subject to. As a result much of the information about medications and pregnancy is based on test tube or animal studies and anecdotal information about drugs that have a long history of use.

Pregnancy Drug CategoriesWritten by: Alan Franciscus, Editor-in-Chief

HCSP • VERSION 1 • January 2015 © 2015 Hepatitis C Support Project

1

HCSP FACT SHEETA publication of the

Hepatitis C Support Project

The information in this fact sheet is designed to help you understand and manage HCV and is not intended as medical advice. All persons with HCV should consult a medical practitioner for diagnosis and treatment of HCV.

This information is provided by the Hepatitis C Support Project a

nonprofit organization for HCV education, support and advocacy

Reprint permission is granted and encouraged

with credit to the Hepatitis C Support Project.

EXECUTIVE DIRECTOR, EDITOR-IN-CHIEF,

HCSP PUBLICATIONSAlan Franciscus

DESIGNLeslie Hoex,

Blue Kangaroo Design

PRODUCTIONC.D. Mazoff, PhD

a series of fact sheets written by experts in the field of liver diseasewww.hcvadvocate.org

•HCV TREATMENT: FDA-APPROVED MEDICATIONS•

ForewordIn December 2014, The Food and Drug Administration (FDA) approved the combination of VIEKIRA PAK with and without ribavirin to treat hepatitis C genotype 1a and 1b including people with HIV and hepatitis C coinfection and people with compensated cirrhosis. The information is taken from the Highlights of Prescribing Information issued by the FDA.

HCSP FACT SHEETGenotype 1: VIEKIRA PAK Therapy

Written by: Alan Franciscus, Editor-in-Chief

CONTACT INFORMATION

Hepatitis C Support ProjectPO Box 15144

Sacramento, CA 95813alanfranciscus@hcvadvocate.org

Medications: • Ombitasvir• Paritaprevir/ritonavir• Dasabuvir

Note: Brand Name: VIEKIRA PAK• With and without ribavirin

VIEKIRA PAK comes in a packet of pills that is taken twice daily. If ribavirin is prescribed (see below) it is also taken twice daily.

Food Requirements: • VIEKIRA PAK and ribavirin are taken with food.

Side Effects: • The most common side effects were fatigue, nausea, pruritus (itching),

skin reactions, insomnia, and general weakness.

Treatment discontinuations: • The treatment discontinue rates in the phase 3 clinical trials was less

than 1%.

www.hcvadvocate.orgHCSPP.O. Box 15144Sacramento, CA95813

Get Tested. Get Treated. Get Cured.