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HCV Advocate Newsletter

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February 2014 HCV Advocate

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In This Issue:

HCV Drug Development News
Alan Franciscus, Editor-in-Chief

HEALTHWISE: Acetaminophen:
Safe or Harmful?

Lucinda K. Porter, RN


HCV and Hispanics – Prevalence
Alan Franciscus, Editor-in-Chief

DISABILITY & BENEFITS: Presumptive SSI
Jacques Chambers, CLU


Snapshots
Lucinda K. Porter, RN


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HCV Drug Development News
—Alan Franciscus, Editor-in-Chief

This article will focus on recent news about HCV drugs in clinical development to treat hepatitis C.  It was a very busy month, with two studies published in the prestigious New England Journal of Medicine—AbbVie and Gilead/BMS.  Other news included the approval of Sovaldi in Europe and BMS’s European submission for approval of their HCV medication.  In addition there were preliminary results from a couple of cross-company trials.  I think, however, that the most fascinating news of the month is about a drug that may cure hepatitis C with just one infusion—at least that is what the study will eventually evaluate in people with HCV.

ABBVIE
AbbVie’s HCV interferon-free combination therapy is currently in Phase 3 studies.  The article that appeared in the New England Journal of Medicine gives the final results from their Phase 2b study. 

Study Drugs: 

  • ABT-450/r (protease inhibitor)boosted with ritonavir,

  • ABT-333 (polymerase inhibitor) or  ABT-267 (NS5A inhibitor) or both,

  • Ribavirin (one arm did not contain ribavirin)

Treatment Duration: 

  • 8, 12, or 24 weeks. 

Arms:

  • 14 treatment arms—total of 571 patients

Patients:

  • Genotype 1, treatment naïve & treatment experienced—no patients had cirrhosis

SVR12/Cure rates:

  • 88% among those who received the therapy for 8 weeks

  • 95% among those who received the therapy for 12 weeks

  • 83% to 100% among all the groups including treatment -naïve and treatment-experienced patients. 

The most frequent adverse events (side effects) were fatigue, headache, nausea, and insomnia. The cure rates were similar among people who had positive and negative predictors of treatment response (HCV subtype 1a, race, HCV RNA, non-cc IL28B). 

One percent (8 patients) discontinued treatment due to adverse events (side effects). ABT-450/r and ABT-267 were dosed once daily; ABT-333 and ribavirin  were dosed twice daily. 

Comments:
The high response rates and shorter treatment duration all point to a very effective therapy to treat hepatitis C.   Although this was a Phase 2b study, the fact that this trial had a large patient population with similar cure rates among all groups is significant.  In fact, the Phase 3 studies that have been released so far have reported similar cure rates.   

BMS & Gilead
The final results from a clinical trial of the combination of sofosbuvir and daclatasvir (with and without ribavirin) was also published in the New England Journal of Medicine

Study Drugs:

  • Daclatasvir (NS5A inhibitor)

  • Sofosbuvir (polymerase inhibitor)

  • Ribavirin (included study arms with and without ribavirin)

Treatment Duration:

  • 12 – 24 weeks (some patients received 1 week lead-in with sofosbuvir followed by 23 weeks with daclatasvir/sofosbuvir)

Arms:

  • 10 groups – 211 patients 

Patients

  • Genotype 2 = 26 patients

  • Genotype 3 = 18 patients

  • Genotype 1 (treatment naïve) = 126 patients

  • Genotype 1 (treatment experienced) = 41 patients—prior treatment experienced patients who were previously treated with HCV protease inhibitors (boceprevir or telaprevir)

SVR/Cure Rates

  • Genotype 1 treatment naïve = 98%

  • Genotype 1 treatment experienced = 98%

  • Genotype 2 treatment naïve = 92%

  • Genotype 3 treatment naïve = 89%

The usual negative predictors of treatment response (genotype 1a, and 3, non-CC Il28B genotype, race) did not affect the cure rates.  The cure rates were also similar between the groups that  did and did not receive ribavirin. Both drugs are dosed once-daily.

Comments:
This study has been the focus of a lot of noise in 2013.  While the study has a relatively small patient population the cure rates are very impressive.  Below I have listed the recently announced Phase 3 studies of daclatasvir and sofosbuvir (with and without ribavirin) that BMS is sponsoring. 

  • ALLY 1:  daclatasvir and sofosbuvir with and without ribavirin for 12 weeks.  The study has 4 arms that will include genotypes 1 through 6 to test the drugs in people with cirrhosis who may need a liver transplant.

  • ALLY 2:  daclatasvir and sofosbuvir for 12 weeks to treat HCV in people who are coinfected with HIV—treatment naïve and treatment experienced.  The trial will include genotypes 1 through 6. 

  • ALLY 3:  daclatasvir and sofosbuvir for 12 weeks to treat HCV genotype 3. The study will include treatment-naïve and treatment-experienced patients. 

BMS & Vertex
The first data from a Phase 2a study of the combination of Vertex’s VX-135 (200 mg) plus daclatasvir for 12 weeks to treat HCV treatment-naïve patients were released. Eighty-three percent (83%—10 of 12 patients) achieved an SVR4. 

One patient discontinued treatment after the first dose due to a serious adverse event of vomiting/nausea, but the majority of the adverse events reported were mild.

The arm containing VX-135 (100 mg) plus daclatasvir produced SVR4 results of 73% (8 of 11 patients). 

Janssen & Idenix
The preliminary data (SVR4) from a small study of 150 mg simeprevir, 50 mg samatasvir (IDX719) and ribavirin were released.  In this part of the study, HCV genotypes 1b and 4 (treatment-naïve, non-cirrhotic patients) were treated with the triple combination for 12 weeks.  Eighty-five percent (85%—17 of 20 patients) achieved SVR4.  Both drugs are dosed once-daily.

The combination was well-tolerated.  The other arms contained the triple therapy but the dose of samatasvir was either 50, 100 or 150 mg—those results have not yet been released.  Simeprevir and samatasvir are dosed once daily. 

One-Shot Cure?
Probably the most fascinating news item that I have seen in quite a while was a recent news release about a new therapeutic technology that hopes to cure hepatitis C (and other diseases) with one shot!  The technology is based on gene-silencing. The drug is named TT-034 and it is infused once. The first in-human trial of TT-034 has been cleared by the Food and Drug Administration (FDA) for human studies. 

Here’s how it is supposed to work:  The medicine is infused into the body—it will travel through the bloodstream to the liver where it will enter any hepatitis C virus.  Once inside the virus TT-034 releases molecules that interfere with and stop the hepatitis C virus from replicating.  Not only that, but the medicine will continue to replicate in the liver so that it can prevent any further HCV from replicating.  Now, wouldn’t that be something!  

The hope is that this type of therapy could be the key to curing many diseases including hepatitis B, HIV and many other potentially life-threatening diseases.

European Medicines Agency
On January 17, 2014 Gilead announced that Sovaldi combination therapy had been approved by the European Medicines Agency (EMA) to treat HCV genotype 1 through 6.  The EMA also approved all-oral Sovaldi for HCV patients who can not take interferon and for those awaiting liver transplantation (to prevent HCV recurrence). 

BMS recently submitted their application to the EMA for daclatasvir to treat HCV genotypes 1, 2, 3, and 4 in Europe.  BMS commented that they expect the approval will enable daclatasvir to be prescribed with other HCV medications….which drug?  Hint – Sovaldi (sofosbuvir).

Research Halted
Boehringer Ingelheim (BI) announced on January 17, 2013 that it had halted the clinical development of deleobuvir-containing therapies.  The company commented that the combination of deleobuvir (with faldaprevir, ribavirin) was halted because the combination showed a higher rate of premature discontinuation of treatment which suggested that the effectiveness is not comparable to other interferon-free therapies. 

Important:  BI is currently conducting STARTVerso trials (faldaprevir, pegylated interferon plus ribavirin) that are expected to be completed soon and the trial results will be submitted to the Food and Drug Administration (FDA) for marketing approval.


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HEALTHWISE: Acetaminophen: Safe or Harmful?
—Lucinda K. Porter, RN

Is acetaminophen (Tylenol) safe or is it toxic to the liver? Both answers are true. This month’s Healthwise is devoted to acetaminophen (Paracetamol, or APAP). I also divulge the most personal disclosure I’ve ever made in the sixteen years of writing this column—APAP caused my liver to fail and nearly killed me. Despite this fact, I believe APAP is safe to take, if taken as directed.

My near-death experience occurred in 1988. Prior to that, I battled mental illness for more than 20 years, resulting in many hospitalizations and suicide attempts. During one of my psychiatric stays, I learned from another mentally ill patient that APAP was the number one drug used for suicides in the United Kingdom. I filed this for future reference, in case life became unbearable. On a January day, I checked into a motel, wrote a suicide note, and washed down nearly 40,000 milligrams (mgs) of APAP with a bottle of liquor. This was ten times the recommended maximum daily dose. The maid found me the next day.

My liver failed first, followed by other organs. With liver enzymes exceeding 18,000, the doctors told me to put my affairs in order. They could not believe I was alive let alone conscious, and estimated that I would be dead within a day. With my liver unable to make clotting factors, I was given blood products so I wouldn’t bleed to death. The blood kept me alive and gave me hepatitis C.

I am interrupting the story for a moment. In the second paragraph, I said that I learned from someone else about how lethal APAP could be. This is the main reason I don’t tell people the details of my suicide attempt. If you are depressed, get help. If you feel hopeless about life, find any way you can to stay alive. My life turned completely around since then, and for twenty-six years, most of the time I live in peace, gratitude, and joy.

 

acetaminophen

 

You know the end of the story, because obviously I would not be writing this if I had died. The reason why I am mentioning this painful account is so you understand that I take APAP warnings very seriously. Now on to the facts, or the closest approximation to facts that we have.

APAP is the leading cause of acute liver failure in the U.S. Like my case, many of these are from suicide attempts. More people die from APAP overdose than from overdose by any other over-the-counter (OTC) drug. This is a tricky “fact” because many more people die from other over-the-counter drugs, particularly non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen (Advil, Motrin, etc), and naproxen (Aleve). Regular use of NSAIDs at normal doses can cause stomach bleeding, kidney problems, and other problems, so when people die from these, the cause of death isn’t directly attributed to NSAID use. Additionally, these complications occur at normal doses, so these deaths are adverse events, and not overdoses.

Data about NSAID deaths are scant. The most recent study is from 1999, reporting 16,500 annual deaths in the U.S. One of the researchers mentioned in an article published by Pro Publica, wrote that the estimates are outdated and “probably one-fourth of that.” Let’s assume that the conservative estimate is 4000 annual deaths. Note though, that the Centers for Disease Control and Prevention (CDC) reported only 15 overdose deaths for the entire class of pain relievers, both prescription and OTC, including ibuprofen in 2010.

In the same year, the CDC recorded 321 APAP deaths, of which more than half were due to accidental overdose. The data also reported 78,000 emergency room visits and 33,000 annual hospitalizations. Compared to 4000 or more NSAID deaths, APAP looks safer, especially considering that 50 million a people use it every week.

So, what is the problem with APAP? This relatively safe drug at recommended doses can be toxic at doses slightly over the recommended ones. Toxicity can occur at just twice the dose of APAP (8000 mgs), where it would take twenty-times a dose of ibuprofen for toxicity to occur. A person with a fever or pain would have to be really out of it to take that much ibuprofen, whereas popping twice the dose of APAP may make sense to someone who doesn’t know the risk.

Although the data vary about the number of APAP deaths, most experts agree that APAP is safe if taken as directed. There were a handful of cases of people who had liver injuries below the maximum dose, and there appears to be no explanation for this.

So how do you take acetaminophen safely?

  • Talk to your doctor or nurse about the right dose for you.

  • The maximum daily dose for a healthy adult who weighs at least 150 pounds is 4,000 mgs, divided over 24 hours. Liver enzyme elevations have been seen at that dose, albeit rarely. It’s best to take the lowest dose you can, and 3,000 mg per day has a clean safety record for adults. Many liver experts recommend 3000 mgs for their patients who don’t have advanced liver disease.

  • Follow dosing instructions precisely. Never take more than 1,000 mgs in a single dose. The January 2014 Harvard Medical School newsletter has an easy-to-read chart listing specific doses.

  • Be sure that your total APAP dose includes all sources of this drug. APAP is added to over 600 other medications, including pain meds, sleep meds, cold meds, cough meds, sinus meds, etc. Check here to see if your medication has APAP in it.

  • Reduce your dose to 2000 mg a day if you are a liver transplant patient or if you drink alcohol. No alcohol is advised for those with hepatitis C or other liver diseases. The University of Pennsylvania provides information about safe APAP use for liver transplant patients.

  • Start small. A single dose ranges from 325 mg, 500 mg, 650 mg or 1000 mg; some people have good results at the lower doses.

  • The risk of liver failure from APAP used for infants and children is greater than for adults, so never let little ones exceed the APAP dose recommended by pediatricians.

  • Liver-injury isn’t the only risk associated with APAP. Serious skin reactions, such as Stevens-Johnson Syndrome and toxic epidermal necrolysis may occur at regular doses. These potentially life-threatening skin reactions are rare, and may occur with many other drugs, including telaprevir (Incivek).

  • The reason I survived all that acetaminophen, was that I was given n-acetylcysteine, the antidote for APAP overdose. The problem with accidental overdose is that APAP is not initially suspected as a cause, so n-acetylcysteine is not administered in a timely fashion. If you are taking APAP and suspect overdose, seek urgent medical help so appropriate intervention may be taken quickly.

  • There is much more to be said about APAP than I can fit into this article, including a disturbing story about a more than 37-year attempt to get the FDA to set stronger APAP warnings. For riveting journalism, read Pro Publica’sUse Only as Directed” by Jeff Gerth and T. Christian Miller. You can also listen to or read the transcript of another fantastic piece with the same title: “Use Only as Directed” on This American Life.

It was many years before I took acetaminophen again. I take it now when I have a headache or a fever, because I believe it is a safer choice. I take one 500 mg pill no more than once every six hours and never exceed 2000 mgs. Alternatively, I could take two 325 mgs pills, but I seem to get relief from what I take. I nearly lost my liver to this potent drug, and I will not let that happen again.

As this article was heading to press, the FDA announced the strictest acetaminophen guidelines to date, advising doctors not to prescribe combo pills with more than 325 milligrams of acetaminophen. The FDA is planning to withdraw approval for such medications. New regulations on non-prescription versions are coming soon.

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

Resources:



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HCV and Hispanics—Prevalence
—Alan Franciscus, Editor-in-Chief

The National Health and Nutrition Examination Survey (NHANES) estimates that 1.3% of the U.S. Hispanic population is infected with hepatitis C (HCV).  This is somewhat misleading because the U.S. Hispanic population (like any population) is a diverse group with many backgrounds.  A new study conducted by Albert Einstein College of Medicine of Yeshiva University was released that, thankfully, is providing a more detailed picture about HCV prevalence in Hispanics based on the background of origin.  The study gathered information from the NHANES survey and Hispanic Community Health Study/Study of Latinos (HCHS/SOL).

It was noted that prior studies focused on Mexican-American Hispanics.  This study provided a demographic breakdown of U.S. Hispanic backgrounds:

  • Men:

    • Puerto Rican - 11.6%

    • Mexican - 1.9%

    • Dominican - 1.5%

    • Central American - 1%

    • South America - 0.4%

    • Cuban - 0.8%

Unfortunately, the news article did not list the complete breakdown of HCV among Hispanic women, except to note that HCV was less common in Hispanic women than men, and that the highest prevalence of HCV in women was found in Puerto Rican women (3.9%). 

The prevalence of HCV not only differed by Hispanic American background but also by the city where the survey was conducted.  The Bronx had a prevalence of 4.5% compared to San Diego (1.7%), Chicago (1.2%), and Miami (0.8%).  

Source:  http://www.einstein.yu.edu/news
/releases/965/prevalence-of- hepatitis-c-
infection-found-to- vary-widely-among-hispanics/



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Disability & Benefits—Presumptive SSI
—Jacques Chambers, CLU

When someone first leaves work on disability, there is a serious financial issue in addition to the stress and paperwork involved.

Social Security Disability is currently taking four to six months to process a claim before any payments are made; furthermore, even after approval, SSDI never pays the first five calendar months of a disability.

Only five states mandate that employees carry any type of temporary disability benefit that would pay while the Social Security applications are being processed; they are California, Hawaii, New Jersey, New York, and Rhode Island. Unless you live in one of those five states or unless your employer offers some type of short term disability benefits, there will be no income for the first five or six months of disability.

Social Security has programs that can help some people in this situation; however, these programs are not always available to persons with HCV or HBV.  It is best that you be aware of these programs if only to avoid confusion should you hear rumors about them.

Supplemental Security Income (SSI) program is a needs-based disability program. In addition to low income, claimants cannot have more than $2,000 in liquid assets, bank accounts, mutual funds, etc.

SSI has two program designed to help people in such a financial bind. These were very helpful programs, but unfortunately, by the time that Social Security finished making the rules and requirements for the programs, they had become programs that very few claimants could access.

However, while the programs are not easily accessible, they are the source of a lot of rumor and misinformation, so it is important for people with HCV to be aware of them, even if they are not commonly able to utilize them. Plus it may benefit persons with a dual diagnosis with HIV.
The two programs are:

  • Presumptive SSI, which allows Social Security to “presume disability” due to the severe nature of your medical condition, will start paying SSI benefits immediately and allow up to six months of benefits while you complete the paperwork, they review your claim and make a final decision; and,

  • Emergency Advance Payment which will advance all or a part of the next month’s SSI payment due to an immediate, urgent need.

Presumptive Disability Program
Goal: The purpose of Presumptive SSI is to start monthly payments for seriously ill claimants while the initial paperwork and determination for disability are made.  To accomplish this with a minimum of initial paperwork, Social Security will start paying monthly SSI benefits and will continue doing so for up to six months, so the claimant can have income while completing the paperwork and waiting for Social Security to review it.

Eligibility: Social Security regulations limit “Presumptive Disability” payments to specific impairment categories. To receive these payments, you must meet all the regular income and resource requirements for SSI eligibility and also provide initial documentation, usually a physician’s statement and recent bank statements, which show that you fit within one of the categories of people who are eligible for this benefit.

You may be eligible to receive SSI benefits “right away determination” if you have one or more of the following medical conditions:

  • Amputation of a leg at the hip;

  • Allegation of total deafness; that is, no sound perception in either ear;

  • Allegation of total blindness; that is, no light perception in either eye;

  • Allegation of bed confinement and immobility without a wheelchair, walker, or crutches, due to a longstanding condition excluding recent accident and recent surgery;

  • Allegation of stroke (cerebral vascular accident) more than three months in the past and continued marked difficulty in walking or using a hand or arm;

  • Allegation of cerebral palsy, muscular dystrophy, or muscular atrophy and marked difficulty in walking (for example the use of braces), speaking, or coordination of the hands or arms;

  • Allegation of Down syndrome;

  • Allegation of severe mental deficiency made by another individual filing on behalf of a claimant who is at least 7 years of age;

  • A child has not reached his or her first birthday and the birth certificate or other medical evidence shows a weight below 1,200 grams (2 pounds, 10 ounces) at birth:

  • A child has not attained his or her first birthday and available medical evidence shows a gestational age (GA) at birth with these corresponding birth-weights:

    • GA: 37-40 weeks; weight at birth: less than 2000 grams (4 pounds, 6 ounces);

    • GA: 36 weeks; weight at birth; 1875 grams (4 pounds, 2 ounces) or less;

    • GA: 35 weeks; weight at birth: 1700 grams (3 pounds, 12 ounces) or less;

    • GA: 34 weeks; weight at birth: 1500 grams (3 pounds, 5 ounces) or less; or

    • GA: 33 weeks; weight at birth: at least 1200 grams, but no more than 1325 grams (2 pounds, 15 ounces);

  • Symptomatic human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS); Form SSA-4814 or SSA-4815 is needed;

  • A physician confirms by telephone or in a signed statement that an individual has a terminal illness with a life expectancy of six months or less; or a physician or knowledgeable hospice official (for example, hospice coordinator, staff nurse, social worker or medical records custodian) confirms that an individual is receiving hospice services because of a terminal illness;

  • Allegation of a spinal cord injury producing an inability to ambulate without the use of a walker or bilateral hand–held assistive devices for more than two weeks with confirmation of such status from an appropriate medical professional;

  • Allegation of end stage renal disease (ESRD) requiring chronic dialysis, and the file contains a completed CMS–2728-U3 End Stage Renal Disease Medical Evidence Report–Medicare Entitlement and/or Patient Registration;

  • Allegation of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease.

As you can see from the above listings, it would be unusual for a person with HCV to qualify for Presumptive Disability under SSI even if they meet the resource and income requirements, although someone with a dual diagnosis of HCV and HIV might.

Payments: Presumptive SSI payments:

  • Are for the same amount for which you would be eligible for under regular SSI rules;

  • May be made for up to 6 months pending the formal determination of disability or blindness;

  • Begin with the month in which the presumptive disability/blindness finding is made by the local Social Security office or State disability determination agency based on specific criteria; and,

  • End after 6 months if a formal determination has not been made.

Final determination: If the formal determination is eventually made that you are not disabled or blind:

  • You will not receive any further SSI benefits;

  • You can keep the money you’ve received – unless the formal rejection is due to a nonmedical factor of eligibility, such as if you were not truthful about the amount of your income or resources.

Emergency Advance Payments
If you have been approved for SSI eligibility, whether through the normal process or through Presumptive Disability, you may request an Emergency Advance Payment. An Emergency Advance Payment is to assist you when financial emergencies strike, such as when you are moving and need extra money for the move or are about to be evicted from your apartment.

The Social Security office will issue you a check for the emergency. However, the amount of the check will be deducted from the next month’s payment. At Social Security’s option, if taking the amount of the check out of your next month’s check will create a substantial burden, SSA may elect to withhold 1/6 of the Emergency Advance Payment from the next six SSI checks.

NOTE: Not all Social Security field offices have check-writing capabilities. You need to find a District office. If you apply for an Emergency Advance Payment at a District office, you should be able to walk out with a check. Branch offices usually can get a check issued but it may take two to three days for you to get it.

You should also be aware that issuing such checks is considered burdensome by some offices. There are offices that will deny the ability to issue immediate checks, hopefully not many, but there are some.

These programs have sufficient restrictions that they are relatively difficult to access, but you should know of these programs and their availability if you should ever have need of and qualify for them.

Compassionate Allowance
Social Security Disability (SSDI) and SSI will speed through the claims process for certain diagnoses. These are generally conditions that are terminal or life-threatening. A list of the medical conditions available for Compassionate Allowance can be found at www.ssa.gov. HCV and HBV are not included in those conditions, but knowing about them helps you separate the rumor mill from facts that can help you.

Hepatitis is one of those infections where the symptoms can vary substantially from none to life-threatening. It is not one that follows a predictable and debilitating progression. Because of that, the diagnosis alone does not indicate whether or not a person can work, so the time-consuming task of reviewing each individual’s symptoms and their severity must usually be completed before a decision can be made.


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Snapshots
—Lucinda K. Porter, RN

Article: The Changing Epidemiology of Hepatitis C Virus Infection in the United States: National Health and Nutrition Examination Survey 2001 through 2010 – Ivo Ditah, et al.
  Source: Journal of Hepatology Accepted manuscript November 2013

The National Health and Nutrition Examination survey (NHANES) collects hepatitis C virus (HCV) data in the U.S. civilian population. The goal of this study was to assess the current burden of HCV. More than 52,000 participated; 38,000 were tested for HCV.

The results showed a decline in HCV-antibody prevalence from 1.9% in 2001 to 1.3% in 2005, remaining stable through 2010. About 67% of these were positive for HCV RNA, which was extrapolated to 2.3 million people with chronic HCV infection; 70% of HCV infections occur in those born between 1945 and 1965.

The risk of acquiring HCV infection in the US is at its lowest since the 1990s. HCV-antibody prevalence among those under age 30 is approximately 17,000 new infections annually. This survey  confirms other recent studies showing that risk of HCV transmission among non-HIV infected heterosexual partners is almost nonexistent, regardless of the number of lifetime sexual partners. Sexual transmission of HCV is a significant risk among HIV-infected men who have sex with men.

The Bottom Line: The biggest risk factors for HCV are being between ages 45 and 65, born in the USA, having less than high school education, lifetime drug use, abnormal alanine aminotransferase (ALT) levels, and having antibodies to herpes simplex virus type 2.

Editorial Comment: The statement that stands out for me in this paper is, “This prevalence is almost certainly an underestimate as NHANES does not include some high risk populations, including the incarcerated, hemodialysis patients and the homeless.” Since NHANES collects data from the non-institutionalized, civilian U.S. population, the numbers have long been called into question. Other experts feel the numbers are significantly higher, a possibility this paper acknowledges.

Article:  Minimal Impact of Sofosbuvir and Ribavirin on Health Related Quality of Life in Chronic Hepatitis C – Zobair Younassi, et al.
  Source: Journal of Hepatology December 2013

Interferon-based treatment has long been associated with reduced quality of life in hepatitis C patients. The goal of this study was to assess health-related quality of life in patients using interferon-free hepatitis C treatments. Comparisons were made in the following:

  • patients taking sofosbuvir and ribavirin versus placebo
  • patients taking sofosbuvir and ribavirin with and without pegylated interferon

Health-related quality of life decreased in all treatment arms. Scores were similar between sofosbuvir and ribavirin versus placebo. However, patients taking pegylated interferon had significantly reduced quality of life. Longer durations of treatment with sofosbuvir and ribavirin did not further reduce quality of life. Patients taking sofosbuvir and ribavirin who had a sustained virologic response at 12 weeks (SVR-12) had improved health-related quality of life.

The Bottom Line: Patients taking sofosbuvir and ribavirin reported mild reductions in health-related quality of life, but appeared to be improved after achieving an SVR-12.

Editorial Comment: Hepatitis C patients have waited a long time for interferon-free treatment. With the approval of Sovaldi (sofosbuvir), the wait is over for patients with genotypes 2, 3, and other sub groups. Patients are wondering if they should start treatment now or wait for ribavirin-free choices. This study may help them make that choice.  

Article: Minimum Costs for Producing Hepatitis C Direct Acting Antivirals, for Use in Large-Scale Treatment Access Programs in Developing Countries – Andrew Hill, et al.
  Source: Clinical Infectious Diseases Advance Access published January 6, 2014

In this study, Andrew Hill and colleagues predict manufacturing costs for 12-week courses of various hepatitis C drugs. Here are the findings in U.S. dollars:

  • $68 - $136 for sofosbuvir (Sovaldi)
  • $130 - $270 for simeprevir (Olysio)
  • $21- $63 for ribavirin
  • $10 - $30 for daclatasvir (not FDA-approved yet)
  • $100 - $210 for faldaprevir (not FDA-approved yet)

The Bottom Line: These numbers make it possible to treat hepatitis C globally in the next fifteen years.

Editorial Comment: The cost of research and development drives up the cost of drugs, but so does profit. This analysis seems so optimistic when compared to the Wholesale Acquisition Costs of sofosbuvir (Sovaldi) at $84,000 and simeprevir (Olysio) at $66,360. Although I hope that profit does not interfere with the very real chance that hepatitis C could be eradicated, I alternate between being skeptical and cautiously optimistic.

Article: Health Care Reform and Hepatitis C: A Convergence of Risk and Opportunity – Kathryn Fitch, et al.
  Source: Milliman Report commissioned by Janssen Therapeutics December 2014

The Affordable Care Act (ACA) is changing healthcare, and this report explores the impact of hepatitis C virus (HCV) on public health and policy. The Milliman Report authors use the term “the great convergence” to describe factors that are coming together:

  • CDC recommendations endorsed by the USPSTF to screen the U.S. Baby Boomers, those born 1946 to 1964. This screening is a covered service that must be provided at no cost to those who have medical insurance.
  • The “baby boomer” population is entering into Medicare.
  • These factors mean that more people will become aware of their HCV status.
  • Because of ACA, the number of those with health insurance is expanding, thus more people will have access to HCV treatment.
  • New HCV treatments are in development, opening up more opportunities for patients.

The Bottom Line: In deference to the following statement, “Because extracts of this report taken in isolation may be incomplete or misleading, we ask that this report be distributed only in its entirety,”  a link to the entire report is provided rather than a bottom line: http://us.milliman.com/insight/2013/Healthcare-reform-and-Hepatitis-C-A-convergence-of-risk-and-opportunity/

Editorial Comment: My 2009 copy of the Milliman Report, Consequences of Hepatitis C Virus (HCV) is dog-eared from use. This current report is not as compelling, but contains good graphics and information.


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