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HCV Advocate Newsletter

 

HCV Advocate — September 2014

Download printable version

 

In This Issue:

The AASLD/IDSA/IAS–USA Guidelines
Alan Franciscus, Editor-in-Chief

The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA/IAS-USA) recently issued revised guidelines. Read more...

 

HCV Drugs
Alan Franciscus, Editor-in-Chief

This month's column will feature journal articles on two Phase 3 studies of interferon-free therapies as well as a brief overview of HCV drug studies presented at the AIDS 2014 conference held in Melbourne, Australia. Read more...

 

Healthwise
Lucinda K. Porter, RN

This month Lucinda talks about hepatitis C and chronic kidney disease (CKD)encephalopathy, and the fact that HCV may be directly responsible for renal (kidney) injury. Read more...

 

Snapshots
Lucinda K. Porter, RN

Lucinda reviews studies on the changing burden of hepatitis C virus infection in the United States and research on preventing mortality in cirrhotic and genotype 1 infected individuals. Read more...

 



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The AASLD/IDSA/IAS–USA Guidelines
—Alan Franciscus, Editor-in-Chief

The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA/IAS-USA) recently issued revised guidelines:  The new section is titled, “When and in Whom to Initiate HCV Therapy,” and is part of the larger Recommendations for Testing, Managing, and Treating Hepatitis C.  The entire report can be viewed on our website

The revised guidelines contain good news and bad news portions, but I think I get why these societies took this approach given the limited resources and high prices of the current standard of care drugs for treating hepatitis C.  More on this later; but first I would like to recap the recommendations.  I have also added my comments after each section of the recommendations. 

I would also like to disclose that I am an Associate Member of AASLD, but I have no insider information that would influence my comments.   

When and in Whom to Initiate HCV Therapy
“Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure; virologic cure is expected to benefit chronically infected persons.  Limitations of workforce and societal resources may limit the feasibility of treating all patients within a short period of time.  Therefore, when such limitations exist, initiation of therapy should be prioritized first to those specific populations that will derive the most benefit or have the greatest impact on further HCV transmission.  Others should be treated as resources allow.”

First the good news:
“Treatment is assigned the highest priority for those patients with advanced fibrosis (Metavir F3), those with compensated cirrhosis (Metavir F4), liver transplant recipients, and patients with severe extrahepatic hepatitis C.”  

The tables referenced in the Recommendations list severe extrahepatic hepatitis C as certain kidney diseases (nephrotic syndrome or membranoproliferative), and Type 2 or 3 essential mixed cryoglobulinemia with end-organ manifestations (e.g., vasculitis).  (See “Patients First” in the August 2014 HCV Advocate for more information on extrahepatic manifestations.)

Comments: 
This is an appropriate and important recommendation.  People with advanced disease and severe extrahepatic disease need to be treated as soon as possible and should be treated regardless of resources or the price of the medications. 

Based on available resources, treatment should be prioritized as necessary so that patients at high risk for liver-related complications and severe extrahepatic hepatitis C complications are given high priority.”

This group includes:

  • Those people who are HBV or HIV coinfected
  • Those with another liver disease such as fatty liver disease, debilitating fatigue, diabetes, porphyria cutanea tarda (a severe skin condition) 
  • Those with F2 fibrosis

Comments: 
This is where it gets confusing to me.  The recommendations list these categories as high priority, but only where resources are available.  I think this is contradictory.  In other words, treat if you can, but wait if the resources are not available.  Most likely this will be interpreted as ‘let’s wait.’  People who are coinfected with HIV or HBV, or coinfected with fatty liver disease, diabetes and porphyria and who are suffering from debilitating fatigue should really be given priority access to treatment regardless of resources available – resources should be made available.  I just can’t imagine a medical society making recommendations to defer treatment in people with these medical conditions.  But maybe I am taking the long view and the authors are looking at the short term – until other HCV medications are approved since we know that the approval is only months away?   

“Persons Whose Risk of HCV Transmission is High and in Whom HCV Treatment May Yield Transmission Reduction Benefits*”

  • MSM (men who have sex with men) with high-risk sexual practices
  • Active injection drug users
  • Incarcerated persons
  • Persons on long-term hemodialysis

*Patients at high risk of transmitting HCV should be counseled on ways to decrease transmission and minimize the risk of reinfection.

Comments: 
These are all populations that typically have very high rates of hepatitis C.  It stands to reason that by treating high risk people we can prevent the transmission of hepatitis C and decrease the prevalence.  But I’m still stuck on the "as resources allow" portion of these recommendations. 

The bad news:
“Populations Unlikely to Benefit from HCV Treatment”

“Patients with limited life expectancy for whom HCV therapy would not improve symptoms or prognosis do not require treatment.  Chronic hepatitis C is associated with a wide range of comorbid conditions.  (Butt. 2011): (Louie, 2012).  Little evidence exists to support initiation of HCV treatment in patients with limited life expectancy (less than 12 months) due to non-liver-related comorbid conditions.  For these patients, the benefits of HCV treatment are unlikely to be realized, and palliative care strategies should take precedence (Holmes, 2006); (Maddison, 2011).”

Comment: 
I included this in the article because we know that hepatitis C causes non-liver related deaths – one study estimated that hepatitis C reduced survival by more than 20 years.  Unfortunately, these recommendations will only create more apathy among medical professionals, government officials, and society in general and lead to even more people dying from hepatitis C and from hepatitis C non-liver related deaths.   

Editorial Comment
At first I was baffled and very angry with these recommendations.  We have medications that are approved by the Food and Drug Administration that have cure rates up to 90%, with tolerable side effects and shorter treatment durations.  Medical societies generally put the health of patients and society before political, monetary or any other concerns.  But after reading the recommendations over and over and especially reading the following section I think I get what was driving the recommendation:

“Limitations of workforce and societal resources may limit the feasibility of treating all patients within a short period of time.”

Background:
The two medications that are the current standard of care are sofosbuvir (Sovaldi) and simeprevir (Olysio), which cost $80,000 and $66,000 respectively and that is not counting any other medications that might be included.  The pricing of the drugs, especially sofosbuvir, has caused uproar within the press and the government, among advocates  and insurance companies and just about anyone else who has heard about the pricing.  Some insurance companies are refusing to cover it.  State Medicaids are refusing to provide coverage except to the sickest patients.  Medicare is worried it will be bankrupted by sofosbuvir.  Insurance companies are telling us it is going to cost every insured American $100 to $200 more every year on premiums.  Politicians are holding meetings demanding to know why it is priced so high.  Advocates are demonstrating.  Scare tactics – definitely, but some of these are valid concerns. 

Within a very short time, we will have two new HCV therapies approved by the FDA—combination therapies from Gilead and AbbVie.  Not long after these two drugs are approved others will follow from BMS and Merck, and there are even more drugs in the pipeline.  Typically, when new drugs are marketed the new prices are even higher than the older drugs.  Unfortunately, in this country there are no agencies that can set or limit the price of a drug – at least not yet.   

AASLD/IDSA can’t negotiate or limit drug prices, but they can issue guidelines.  In the case of the latest medications, insurance companies and government agencies have limited access to the medications because of the price, and must allocate limited resources among a great number of patients.  I think this is what AASLD/IDSA is doing with their latest guidelines.  In other words, since the price is so steep and since there are limited resources we cannot recommend treatment for everyone.  I think they are also saying that if you develop a new drug and don’t price it reasonably, considering actual societal resources, we are going to have to take a good hard look at it before we recommend it to everyone with hepatitis C.  I believe they are also sending a message to pharmaceuticals that if you want to sell your drugs to the masses you will have to invest in “societal resources,” not just dump your expensive drugs into the marketplace.The government also has to do its part to address hepatitis C – develop comprehensive resources like there are for HIV, diabetes, cancer, etc.  

This is my take on the recommendations.  I really hope that I am right and that this is not another elitist group making recommendations.  I do hope that the drug companies and the government are paying attention.  The next round of drug approvals, pricing, resources allocated to hepatitis C and the next recommendations will show the truth.  There are literally millions of lives that can be saved and billions of dollars to be made as long as appropriate resources can be devoted and drugs can be sold at prices that will be translated into treatment for everyone with hepatitis C. 

One last thing.  Even if this is the message that the medical societies are trying to convey, I think there is something terribly wrong with limiting treatment to only those who are the sickest of the sickest.  People with hepatitis C deserve more compassion and care. 


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HCV Drugs
—Alan Franciscus, Editor-in-Chief     

This month’s column will feature journal articles on two Phase 3 studies of interferon-free therapies as well as a brief overview of HCV drug studies presented at the AIDS 2014 conference held in Melbourne, Australia.

There are some significant terms in this article that are important to know.  When treatment results are discussed it is necessary to know these terms:

  • Anemia:  A blood deficiency characterized by low red blood cells
  • F0 – F2:  Mild liver disease; F3 is advanced fibrosis/severe fibrosis; F4 is compensated cirrhosis (Treatment with the drugs in this article is not given to people with decompensated cirrhosis)
  • Genotype 1a:  Generally harder to treat than genotype 1b
  • Adverse event:  Side effect
  • Thrombocytopenia:  A blood deficiency characterized by a low platelet count
  • Treatment naïve:  Never been treated
  • Treatment experienced /Prior non-responder:  Treated before but did not achieve a viral cure – generally more difficult to treat.  Null responders are people who never went undetectable on a previous course of therapy.

BMS
In the August 2014 issue of the HCV Advocate newsletter I reported on Bristol-Myer Squibb’s (BMS’s) combination of daclatasvir (NS5A inhibitor) and asunaprevir (HCV protease inhibitor) that had been approved in Japan for the treatment of HCV genotype 1.  In this issue I will report on the Phase 3 study results of HCV genotype 1b patients that were recently published in the medical journal The Lancet

This Phase 3 study (HALLMARK-DUAL) was an interferon and ribavirin-free study conducted at 116 sites in 18 countries from May 2012 to October 2013.  All the patients were HCV genotype 1b who were either treatment naïve (never been treated), prior non-responders to a course of pegylated interferon plus ribavirin, or who were ineligible/intolerant to pegylated interferon plus ribavirin therapy. The patients in the study were given daclatasvir (60 mg daily) plus asunaprevir (100 mg twice daily) or placebo (sugar pills) twice weekly for 12 weeks.  All of the prior non-responders or ineligible/intolerant patients in the study received the study drugs.

Note: The patients who received the placebo pills were later enrolled in another BMS clinical study, after the current study, where they received the study drugs.   

The patient population included 307 treatment-naïve patients, (205 received the study drugs); all of the remaining patient groups received the study drugs.  This comprised 235 ineligible/intolerant and 205 prior non-responders (119 null responders, 84 partial responders, and 2 relapsers). 

The patient ages ranged from 20 yo to 83 yo, but the mean age was between 50 and 60.  Most were white males.  In the ineligible/intolerant group, 30% were classified as having compensated cirrhosis, 37% had anemia and 33% had compensated advanced fibrosis/cirrhosis with thrombocytopenia (low platelets). 

The cure rates were as follows:

  • Treatment-naïve patients:  90% (182 of 205 patients)
  • Ineligible/intolerant patients:  82% (192 of 235 patients)
  • Prior non-responder patients:  82% (168 of 205 patients)

Serious adverse events (side effects) were reported in 12 patients (6%) in the treatment-naïve group, 11 (5%) in the non-responder group, and 16 (7%) in the ineligible/intolerant group.  Treatment discontinuations were six (3%), two (1%) and two (1%) respectively. 

The authors concluded that the combination of daclatasvir plus asunaprevir achieved high cure rates in this study population of HCV genotype 1b including people with cirrhosis. 

Comments:
The results from the study are impressive especially among the group of people who were prior treatment non-responders who had documented cirrhosis, low platelets, and anemia.  It looks like we have much needed competition in the market to treat hepatitis C HCV genotype 1b and hopefully at a more affordable cost. 

PEG Lambda
On Aug 14, 2014, BMS announced that the development of Peginterferon Lambda will be halted so that BMS can focus on the late stage development of their portfolio of direct-acting antiviral medications to treat hepatitis C. 

It is important to know that patients who are currently enrolled in the Lambda clinical trials will have the option to complete their assigned treatment to the completion of the trial up until SVR 12.  

JANSSEN
The Phase 2 study results were recently published in The Lancet as well.  We have written so many articles on the COSMOS trial and the combination of simeprevir and sofosbuvir with and without ribavirin that I am just going to give the top line results and cure rates and refer you to our fact sheet for more detailed information. 

The study included 168 HCV genotype 1 treatment-experienced and treatment-naïve patients.  There were two treatment parts to the study.  The first part included patients who had less severe disease (F0-F2); the second part of the study included patients with more severe disease (F3-F4). 

The combined overall cure rate from both parts of the study was 92% (154 out of 167 patients).  Treatment with ribavirin and extending treatment to 24 weeks did not improve cure rates.  Additionally, treatment across all treatment arms including the usual negative predictors of treatment response (compensated cirrhosis, IL28b non-CC genotype, age, subtype, race, gender, etc.) did not affect cure rates. 

Comments:  
This study was a game changer in regards to an interferon-free therapy that could cure almost everyone with hepatitis C – with few side effects, short treatment duration and very high cure rates.  This was regardless of negative predictors of treatment response. 

AIDS 2014
In July 2014 the 20th International AIDS Conference was held in Melbourne, Australia.  The conference also included information on the treatment of hepatitis C in people taking methadone and buprenorphine and treatment of hepatitis C in people who are also infected with HIV.  We now have cure rates that are comparable to those in mono-infected individuals, but we need more drug combinations without interferon and/or ribavirin, and we need cheaper drugs (as is the need for those who are mono-infected).  Treatment of HCV in people with HIV is complicated because of the potential for drug-drug interactions with HIV medications.

ABBVIE
AbbVie’s 3D combination—ABT-450/r, ombitasvir, dasabuvir, ribavirin*—results from two studies were presented at the AIDS 2014 conference. 

The first study was to evaluate the safety and effectiveness of the 3D combination to treat people with HCV genotype 1 who were on stable opioid replacement therapy. 

The Phase 2 study enrolled 38 people.  Most were white males with a median age of 48 yo, about 2/3 were HCV genotype 1a, 95% were treatment naïve and 79% had mild liver disease.  The patients were evenly divided as to methadone and buprenorphine use (50%/50%) with and without naloxone.  AbbVie’s 3D combination did not affect the drug concentration levels of methadone or buprenorphine.  

The cure rate was 97%.  The 3D drug therapy was generally safe and well-tolerated.  One patient discontinued treatment, but it was unrelated to the study drugs.

The most common side effects were nausea (50%), fatigue (47%), headache (32%), insomnia (18%) and rash (16%). 

Comments:
This is a very important study since people on methadone and buprenorphine have very high rates of hepatitis C and are in need of therapies to treat hepatitis C that do not include interferon.  The high cure rates and low side effects mean that we can now treat a large population of people who are in need of these treatments.  It was also noted in the presentation that the participants in the study had a very high rate of adherence to the study medications. 

Another study of AbbVie’s 3D combination presented at AIDS 2014 was on treating HCV genotype 1 patients who were also infected with HIV.  This study was a two part study – two treatment arms – 12 weeks and 24 weeks.  Most of the 63 HCV genotype 1 patients were white males, ~51 yo, HCV genotype 1a ~90%, treatment naïve ~67%.  The average CD4 cell count was above 600/mm3.

Drug-drug interaction studies found that there were no meaningful interactions between the study drugs and the drugs the patients were taking to control HIV—tenofovir/emtricitabine (brand name Truvada), atazanavir (Reyataz) or raltegravir (Isentress).  Ritonavir (used to boost ABT-450) was also found to boost atazanavir. 

The first part – 12 week arm – of the study has been completed and the cure rates are reported here – 94% (29 of 31 patients) were cured.  Of the two patients who were not cured, one patient relapsed at week 2, and one patient had viral breakthrough at week 10. 

The medications were generally safe and well-tolerated.  No patients discontinued treatment due to side effects.  The most common side effects in the 12-week treatment arms were fatigue (58%), insomnia (16%), nausea (16%) and headache (19%). 

The 24-week arm results are pending completion of treatment.

Comments:  
The high response rates, low side effects and shorter treatment duration in this study of 12-weeks of AbbVie 3D therapy make this a very attractive therapy for people with hepatitis C including those who are also infected with HIV. 

*One pill – once-a-day (ABT-450 [HCV protease inhibitor], boosted with ritonavir, plus ombitasvir).  Dasabuvir taken twice a day and ribavirin taken twice a day based on body weight.

GILEAD
An interferon-free trial of sofosbuvir (Sovaldi) plus ribavirin for the treatment of HCV genotypes 1, 2, 3 and 4 in people who are also infected with HIV was presented at AIDS 2014. 

The study included treatment-naïve and treatment-experienced patients.  All of the patients were treated for 24 weeks except the HCV genotype 2 patients who were treated for 12 weeks. 

All the patients in the study were on HIV medications – tenofovir DF/emtricitabine (brand name Truvada), plus efavirenz (Sustiva), atazanavir (Reyataz), darunavir (Prezista), raltegravir (Isentress).

There were 6 arms in the study – the study results are listed in the table below.

However, if you break down the cure rates by those who did and did not have cirrhosis and by subtype (1a vs. 1b) you have a different picture:

Genotype 1: 

Treatment naïve:

  • 88% cure rates without cirrhosis compared to 65% with cirrhosis
    • 1a – 87% cure rates without cirrhosis compared to 62% with cirrhosis
    • 1b – 100% cure rates without cirrhosis compared to 75% with cirrhosis

Genotype 3:

  • Treatment naïve – 91% without cirrhosis compared to 100% with cirrhosis
  • Treatment experienced – 92% without cirrhosis compared to 78% with cirrhosis

Note:  I omitted genotype 2 and 4 patient data since the number of these patients in the study was relatively low. 

Comments: 
The cure rates are high, but if you factor in subtype and cirrhosis the cure rates are lower than expected.  However, Gilead is conducting clinical studies on the combination of sofosbuvir and ledipasvir for the treatment of HIV/HCV coinfection that will hopefully improve the cure rates for HCV in people with HIV regardless of degree of liver damage or HCV genotype subclass.

Arm

Genotype

Prior
Treatment

No. of
Patients

Cure Rate

1

1

Naïve

112

84%

2

2

Naïve

19

90%

3

3

Naïve

57

91%

4

4

Naïve

31

84%

5

2

Experienced

6

83%

6

3

Experienced

49

86%



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HealthWise: Hepatitis C and Kidney Disease
—Lucinda K. Porter, RN

A chronic hepatitis C (HCV) diagnosis often spurs us to educate ourselves about the liver. We learn about liver care, what to eat, and what to avoid. However, few of us think about our kidneys, but we should. A recent study by Jia-Jung Lee and colleagues found that HCV patients with CKD (chronic kidney disease) have a higher risk of developing End-Stage Renal Disease (kidney failure) compared to those without HCV (52.6% vs. 38.4%). (“Hepatitis C Virus Infection Increases Risk of Developing End-Stage Renal Disease Using Competing Risk Analysis,” PLoS One June 27, 2014)

Earlier studies reported similar results. A large six-year study lead by Yi-Chun Chen concluded that HCV infection is associated with increased risk for chronic kidney disease (CKD). CKD is a gradual loss of kidney function, and this risk occurs in the absence of cirrhosis, suggesting that HCV may be directly responsible for renal (kidney) injury. The researchers recommended that HCV patients be informed of their risk for kidney disease and be closely monitored for CKD.

So, let’s talk about our kidneys. The kidneys are two organs located on each side of the spine in the middle of the back, below the ribs.  They are shaped like kidney beans and are about the size of your fists. The kidneys are essential. You can’t live without them, although you can live with only one kidney. Like the liver, you can live with substantial kidney damage.

Each kidney contains roughly a million units called nephrons. Each nephron contains a microscopic filter called a glomerulus. The glomerulus is made up of tiny blood vessels, and is attached to a tubule. Our blood passes through the kidneys several times a day. When blood enters the glomerulus, it is filtered, and the remaining fluid is passed along to the tubule. This filtered fluid is processed according to the body’s needs. The final product is urine, which is stored in the bladder and then excreted when we urinate.

The kidneys do much more than make urine. Here are some of the functions of the kidneys:

  • Filter the blood – The kidneys remove wastes and drugs from the body; maintain the body’s proper fluid balance; regulate electrolytes; and keep the acid/base concentration in the blood constant.
  • Regulate blood pressure.
  • Stimulate red blood cell manufacture.
  • Maintain calcium levels in the body.

Kidney Disease
More than 26 million Americans have kidney disease, which is roughly one in nine adults. Millions more are at increased risk for getting it. Kidney disease that is detected and treated early may prevent more serious kidney disease and other complications.

Kidney disease usually affects both kidneys. If the kidneys’ ability to filter the blood is impaired, then waste and excess fluid can build up in the body. Like liver disease, kidney disease may be silent or have vague symptoms in its early stages.

There are six warning signs of kidney disease:

  • High blood pressure.
  • Blood and/or protein in the urine.
  • Abnormal creatinine and blood urea nitrogen (BUN) blood test. Increased BUN and creatinine results indicate that waste is building up in the blood because of reduced kidney function.
  • A glomerular filtration rate (GFR) less than 60. GFR is a blood test that measures kidney function.
  • More frequent urination, particularly at night; difficult or painful urination.
  • Puffiness around the eyes, swelling of hands and feet.

Kidney Diseases Associated with Hepatitis C
The incidence of chronic kidney disease in the U.S. is rising. Diet and sedentary lifestyle contribute to this risk, and so does having hepatitis C. In addition to CKD, other kidney diseases associated with HCV include:

  • Cryoglobulinemia – A disorder caused by abnormal proteins (cryoglobulins) that clump together in the blood. These proteins can accumulate in the small and medium sized blood vessels, particularly in the kidneys. Blood flow is restricted, which damages the kidneys.
  • Membranoproliferative glomerulonephritis (MPGN) – A disease in which the body’s immune system attacks healthy kidney cells, injuring the glomeruli (the kidneys’ filters).
  • Membranous nephropathy – A disease that also affects the glomeruli. The glomeruli become inflamed and thickened, which reduces kidney function.
  • Polyarteritis nodosa – An autoimmune disease that affects the arteries. Kidney failure may result. 

The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) recently updated their Recommendations for Testing, Managing, and Treating Hepatitis C, and assigned the highest treatment priority to HCV patients with HCV-related kidney diseases. 

Cirrhosis and Kidney Failure
Liver failure may lead to kidney failure, causing a complication known as hepatorenal syndrome. This occurs when someone with severe cirrhosis has a loss of kidney function. Less urine is removed from the body, and there is a build-up of nitrogen-containing waste products in the blood. Up to 10% of those with liver failure will experience hepatorenal syndrome.

Kidney Failure as a Risk Factor for Hepatitis C
While hepatitis C may lead to kidney failure, kidney disease patients on hemodialysis have a small risk for contracting HCV. In Healthcare-Associated Hepatitis B and C Outbreaks Reported to the Centers for Disease Control and Prevention (CDC) in 2008-2013, 7 outbreaks occurred in hemodialysis settings, resulting in 68 cases of HCV.

To reduce the risk of hemodialysis-related HCV exposure, consider peritoneal dialysis. With peritoneal dialysis, you self-administer treatments at home, at work, or while traveling. Peritoneal dialysis isn’t an option for everyone, because you need to manage the process or have a reliable caregiver who can. However, there are many advantages to peritoneal dialysis besides limiting your exposure to HCV. The benefits include more independence, a less restrictive diet, and reduction in medications compared to hemodialysis.

Kidney (and Heart and Liver) Health
What is good for the kidneys is good for the heart, liver, and the rest of the body. You can probably guess what the recommendations are for taking care of your kidneys, because they are the same ones that show up when we talk about overall health.

  • Control your weight.
  • Exercise regularly.
  • Quit smoking.
  • Keep your blood pressure in the target range.
  • If you have diabetes, control your blood glucose level.
  • Keep cholesterol levels in normal ranges.
  • Take medicine as directed. Don’t overuse over-the-counter painkillers or NSAIDs, such as ibuprofen or naprosyn.
  • Follow a healthy, balanced diet. Choose foods that are healthy for your heart: fresh fruits, fresh or frozen vegetables, whole grains, and low-fat proteins.
  • Reduce salt. Aim for less than 2,300 milligrams of sodium each day; 1500 milligrams or recommended amounts if you already have kidney disease.
  • Limit alcohol consumption, and avoid it altogether if you have liver disease.
  • Stay hydrated.
  • Avoid cola drinks. Drinking two or more cola drinks (either diet or regular) daily may increase kidney disease risk. Non-colas do not seem to increase the risk. If you already have kidney disease, skip colas altogether.
  • Get regular medical check-ups.
  • Know your family medical history – tell your medical provider if kidney disease runs in your family.

Nearly three million Americans have chronic hepatitis C, compared to 26 million who have kidney disease. If you already have HCV, minimize your risk of kidney disease by taking your health into your hands.

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 http://www.lucindaporterrn.com/


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Snapshots
—Lucinda K. Porter, RN

We are trying something a bit different in this month’s HCV Snapshots. Instead of four brief snapshots, there are two slightly longer ones. Feel free to give us feedback on your preferences.

Article: The Changing Burden of Hepatitis C Virus Infection in the United States: Model-Based Predictions – Mina Kabiri, et al.
  Source: Annals of Internal Medicine August 2014

This research, funded by the National Institutes of Health, sought to project the effect of screening recommendations and the use of new direct-acting antiviral agents (DAAs) on chronic hepatitis C virus (HCV) infection in the U.S. Projections were based on:

  • The number of chronic HCV cases in 2013 was 2.3 million. Note: Researchers estimated that the current number of chronic cases in the United States is actually lower than the commonly reported estimate of 3.2 million. Prevalence decreased mainly because of deaths and successful treatment results. However, this study’s researchers state that the HCV prevalence data (NHANES) underestimates the number of HCV infections in the United States by excluding the institutionalized population.

  • One-time birth cohort screening beginning in 2013 projected to identify 487,000 HCV cases in the next 10 years. Note: This model projected that fewer patients are eligible for birth-cohort screening than previously estimated because they accounted for the possibility that patients in the birth cohort progressed beyond cirrhosis or became aware of their disease before the implementation of screening in 2013. Editorial Note: Birth-cohort screening has not officially begun in most healthcare settings, and has been sluggish at best.

  • In 2011, the estimated economic burden associated with chronic HCV infection in the United States was $6.5 billion.

  • This model did not account for co-infections and other risk factors, such as alcohol consumption, that affect disease progression, so the projected burden from HCV may be higher. The model did not estimate future disease transmission.

Findings: One-time birth cohort screening beginning in 2013 projected to identify 487,000 HCV cases in the next 10 years. In contrast, one-time universal screening could identify 933,700 cases.  Recently approved HCV antiviral therapies and one-time birth-cohort screening could prevent approximately 124,200 cases of decompensated cirrhosis, 78,800 cases of hepatocellular carcinoma (liver cancer), 126,500 liver-related deaths, and 9900 liver transplantations by 2050.

The current screening recommendations are helpful in decreasing the future burden, but instituting more aggressive screening and treatment would yield better results.

The Bottom Line: New HCV antiviral therapies and more aggressive HCV screening could make HCV infection a rare disease in the next 22 years.

Editorial Comment: It is wonderful to imagine that HCV will be a rare disease in 22 years. What stood out most for me in this research is the difference between one-time birth cohort screening identifying 487,000 HCV cases vs one-time universal screening identifying 933,700 cases.  I hope the Centers for Disease Control and Prevention and the United States Prevention Services Task Force take note.

Article: The Number Needed to Treat to Prevent Mortality and Cirrhosis-Related Complications among Patients with Cirrhosis and HCV Genotype 1 Infection – Adriaan J. van der Meer, et al.
  Source: Journal of Viral Hepatitis August 2014; Volume 21, Issue 8, pages 568–577

Acknowledging the value of curing HCV patients by achieving sustained virologic response (SVR), this research pointed out that SVR is not the ultimate goal. The goal is to prevent liver failure, hepatocellular carcinoma (HCC or liver cancer), and to prolong life expectancy. What if we measured treatment results by its ability to prevent, or rather postpone, these clinical outcomes instead of by SVR?

Using the term number of patients that needs to be treated (NNT), NNT evaluates the ability to prevent an event in one patient. This study evaluated how new antiviral therapies influenced the NNT to prevent all-cause mortality or disease progression among patients with chronic HCV genotype 1 infection and cirrhosis.

This study followed 248 HCV genotype 1, cirrhotic patients from Canada and Europe for more than eight years. Fifty-nine (24%) patients attained SVR. SVR was associated with reduced all-cause mortality and clinical disease progression. There was a significant difference in the 10-year mortality rates between the patients without SVR (30.8%) and patients with SVR (8.9%)

A total of 64 patients died during the follow-up, of which only three patients had attained SVR.

The Bottom Line: HCV antiviral therapy prevents and/or postpones liver failure and hepatocellular carcinoma and prolongs life expectancy.

Editorial Comment: The current controversy affecting patients with HCV is deciding who and when to treat. The cost of sofosbuvir (Sovaldi) is creating economic and moral dilemmas. Patients are being denied treatment, particularly if they live in certain states. This research, along with the other one discussed this month, make compelling arguments for offering treatment to everyone with HCV. Be sure to read the lead article by Alan Franciscus for more about this.


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