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HCV Advocate Newsletter

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November 2011 HCV Advocate

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In This Issue:

AASLD Practice Guidelines for HCV Genotype 1—Update 2011
Alan Franciscus, Editor-in-Chief


HealthWise: Hepatitis C and Quality of Life
Lucinda K. Porter, RN


Disability & Benefits: Health Care Reform in 2012 and Major Changes in Social Security Payments
Jacques Chamber, CLU

HCV Snapshots
Lucinda K. Porter, RN


HCV Advocate Eblast
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AASLD Practice Guidelines for HCV Genotype 1—Update 2011
—Alan Franciscus, Editor-in-Chief

In October the American Association for the Study of Liver Diseases (AASLD) released “An Update on Treatment of Genotype 1 Chronic Hepatitis C Virus Infection: 2011 Practice Guideline,” which set the stage for treatment of chronic hepatitis C genotype 1.  This document now provides the principle algorithm that medical providers will refer to when using the new HCV protease inhibitor (boceprevir and telaprevir) combination therapy with pegylated interferon and ribavirin.  The recommendations include background information about boceprevir and telaprevir clinical trial data including treatment response rates, side effect profile, stopping rules, etc.

This article will only focus on the recommendations made by the AASLD.  I am listing the recommendations exactly as written in the guidelines and have made comments after most of the recommendations to further highlight important information.  The AASLD has based the recommendations on scientific data or on their collective opinion: 

Classification Description
Class 1 Conditions for which there is evidence and/or general agreement that a given diagnostic evaluation procedure or treatment is beneficial, useful, and effective
Class 2 Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a diagnostic evaluation, procedure, or treatment
Class 2a Weight of evidence/opinion is in favor of usefulness/efficacy
Class 2b Usefulness/efficacy is less well established by evidence/opinion
Class 3 Conditions for which there is evidence and/or general agreement that a diagnostic evaluation, procedure/treatment is not useful/effective and in some cases may be harmful
Level of Evidence Description
Level A Data derived from multiple randomized clinical trials or meta-analyses
Level B Data derived from a single randomized trial, or non-randomized studies
Level C Only consensus opinion of experts, case studies, or standard-of-care

Recommendations

General recommendations:

1. The optimal therapy for genotype 1, chronic HCV infection is the use of boceprevir or telaprevir in combination with peginterferon alfa and ribavirin (Class 1, Level A).
  Comments:  This recommendation establishes the triple combination of an HCV protease inhibitor and pegylated interferon plus ribavirin as the standard of care for treating persons with chronic HCV genotype 1.

2. Boceprevir and telaprevir should not be used without peginterferon alfa and weight-based ribavirin (Class 1, Level A). 
  Comment:  This reiterates that protease inhibitors should not be used as monotherapy because of the potential to develop drug resistance.  

Protease Inhibitor Therapy in Treatment-Naïve (Never Been Treated) Patients:

3.The recommended dose of boceprevir is 800 mg administered with food three times per day (every 7-9 hours) together with peginterferon alfa and weight-based ribavirin for 24-44 weeks preceded by 4 weeks of lead-in treatment with peginterferon alfa and ribavirin alone (Class 1, Level A).
  Comments:  The dose of boceprevir is 800 mg (four 200 mg pills) taken with food (light meal or snack) every 7 to 9 hours.  The reason for this requirement is that food taken with the HCV protease inhibitor enables boceprevir to be absorbed into the blood keeping it  at the level that will increase the chances of treatment success and will help to prevent the development of drug resistance.  The PI is taken in combination with pegylated interferon (weekly) and ribavirin (based on body weight with the daily dose divided in half and taken twice daily with food).  It also recommends  a 4 week lead-in treatment phase with pegylated interferon plus ribavirin (without boceprevir) followed by the triple combination of boceprevir, pegylated interferon/ribavirin for an additional 24 to 44 weeks (see below).  This is consistent with how the drug was studied in the Phase III clinical trials and as listed on the Food and Drug Administration (FDA) approved package labeling.

4.  Patients without cirrhosis treated with boceprevir, peginterferon, and ribavirin, preceded by 4 weeks of lead-in of peginterferon and ribavirin, whose HCV RNA level at weeks 8 and 24 is undetectable, may be considered for a shortened duration of treatment of 28 weeks in total (4 weeks lead-in with peginterferon and ribavirin followed by 24 weeks of triple therapy) (Class 2a, Level B).
  Comments: This recommendation covers the use of the triple therapy for people without cirrhosis that includes treatment duration (28 weeks) when the viral load is undetectable at week 8 and week 24—the time points include the 4-week lead-in phase). 

5.  Treatment with all three drugs (boceprevir, peginterferon alfa, and ribavirin) should be stopped if the HCV RNA level is >100 IU/mL at treatment week 12 or detectable at treatment week 24 (Class 2a, Level B). 
  Comments:  The “Stopping Rule” (for more info see below) recommendations are to prevent the potential of drug resistance and further exposure of the patient to the protease inhibitor, pegylated interferon and ribavirin. 

6.  The recommended dose of telaprevir is 750 mg administered with food (not low-fat) three times per day (every 7-9 hours) together with peginterferon alfa and weight-based ribavirin for 12 weeks followed by an additional 12-36 weeks of peginterferon alfa and ribavirin (Class 1, Level A). 
  Comments:  The dose of telaprevir is 750 mg (two 375 mg pills) taken every 7 to 9 hours with food that is not low fat (1/2 cup of nuts, 1 cup ice cream, 2 tablespoons peanut butter, etc.).  Taking the medications with food is important to help maintain the optimum concentration level of the drug in the body to increase successful treatment outcome and to prevent the development of drug resistance.  

7.  Patients without cirrhosis treated with telaprevir, peginterferon, and ribavirin, whose HCV RNA level at weeks 4 and 12 is undetectable should be considered for a shortened duration of therapy of 24 weeks (Class 2a, Level A). 
  Comments:  The AASLD recommends that people who have an extended rapid virological response (eRVR) can be treated for a total treatment duration of 24 weeks—that is 12 weeks of telaprevir, pegylated interferon plus ribavirin followed by an additional 12 weeks of pegylated interferon and ribavirin.  Others will need to be treated for an additional 24 weeks of pegylated interferon plus ribavirin (48 week treatment duration).

8.  Patients with cirrhosis treated with either boceprevir or telaprevir in combination with peginterferon and ribavirin should receive therapy for a duration of 48 weeks (Class 2b, Level B). 

9.  Treatment with all three drugs (telaprevir, peginterferon alfa, and ribavirin) should be stopped if the HCV RNA level is >1,000 IU/mL at treatment weeks 4 or 12 and/or detectable at treatment week 24 (Class 2a, Level B).
  Comments: It is important to know that telaprevir and boceprevir have different stopping rules based on the level of viral load at certain time points during therapy (See Below). 

Protease Inhibitor Therapy in Treatment-Experienced Patients:

The next set of recommendations are for treatment of people with chronic HCV genotype 1 who have been previously treated with pegylated interferon and ribavirin, but who did not achieve a sustained virological response (HCV RNA (viral load) undetectable 24 weeks following the last dose of medicine). 

Terms used for treatment-experienced patients include:

  • Virological Relapse:  A person who becomes HCV RNA (viral load) undetectable at the end of treatment, but then becomes HCV RNA positive within 24 weeks from the end of treatment.
  • Partial-Responders:  A person who has a 2 log10 drop in HCV RNA by treatment week 12, but who does not become HCV RNA undetectable by the end of treatment.
  • Null-Responder:   A person who does not achieve a 2 log10 drop of HCV RNA by treatment week 12. 
  • Example of 2 log10 drop:
       1,000,000 to ≤ 10,000 IU/mL.

10. Re-treatment with boceprevir or telaprevir, together with peginterferon alfa and weight-based ribavirin, can be recommended for patients who had virological relapse or were partial responders after a prior course of treatment with standard interferon alfa or peginterferon alfa and/or ribavirin (Class 1, Level A).
Comments:  The AASLD recommended re-treatment of patients who relapsed or were partial responders to a previous course of interferon or pegylated interferon plus ribavirin are listed below. The recommendations for null-responders are listed separately for boceprevir and telaprevir.

11. Re-treatment with telaprevir, together with peginterferon alfa and weight-based ribavirin, may be considered for prior null responders to a course of standard interferon alfa or peginterferon alfa and/or weight-based ribavirin (Class 2b, Level B.)
  Comments:  It should be noted that telaprevir is recommended for null-responders, but boceprevir is not—this is because null responders were not included in Merck’s boceprevir phase III clinical trials. 

12. Response-guided therapy of treatment-experienced patients using either a boceprevir- or telaprevir-based regimen can be considered for relapsers (Class 2a, Level B for boceprevir; Class 2b, Level C for telaprevir), may be considered for partial responders (Class 2b, Level B for boceprevir; Class 3, Level C for telaprevir), but cannot be recommended for null responders (Class 3, Level C).

The following recommendations were made to determine when a patient should stop medications to prevent the development of drug resistance and/or when treatment is believed to provide little or no benefit. 

Stopping Rules: 

13. Patients re-treated with boceprevir plus peginterferon alfa and ribavirin who continue to have detectable HCV RNA >100 IU at week 12 should be withdrawn from all therapy because of the high likelihood of developing antiviral resistance (Class 1, Level B).

14. Patients re-treated with telaprevir plus peginterferon alfa and ribavirin who continue to have detectable HCV RNA > 1,000 IU at weeks 4 or 12 should be withdrawn from all therapy because of the high likelihood of developing antiviral resistance (Class 1, Level B).

Anemia, viral breakthrough, retreatment:

The AASLD only included management recommendations about treatment-related anemia.  The management of the other side effects are included in the FDA labeling for pegylated interferon, ribavirin and protease inhibitor(s). The AASLD also included recommendations on when to discontinue treatment due to viral breakthrough and re-treatment if an SVR with current protease inhibitor therapy is not achieved.   

15. Patients who develop anemia on protease inhibitor-based therapy for chronic hepatitis C should be managed by reducing the ribavirin dose (Class 2a, Level A).

16. Patients on protease inhibitor-based therapy should undergo close monitoring of HCV RNA levels and the protease inhibitors should be discontinued if virological breakthrough (>1 log increase in serum HCV RNA above nadir) is observed (Class 1, Level A).

17. Patients who fail to have a virological response, who experience virological breakthrough, or who relapse on one protease inhibitor should not be re-treated with the other protease inhibitor (Class 2a, Level C).

IL28B

In the boceprevir and telaprevir studies it was found that people with certain variations of the IL28B (CC genotype) were more likely to achieve an SVR therefore AASLD made the following recommendation:

18. IL28B genotype is a robust pretreatment predictor of SVR to peginterferon alfa and ribavirin as well as to protease inhibitor triple therapy in patients with genotype 1 chronic hepatitis C virus infection. Testing may be considered when the patient or provider wish additional information on the probability of treatment response or on the probable treatment duration needed (Class 2a, Level B).

Endnote
It is worth noting that the guidelines established are based on “(1) a formal review and analysis of the recently published world literature on the topic (MEDLINE search up to June 2011); (2) the American College of Physicians’ Manual for Assessing Health Practices and Designing Practice Guidelines;(3) guideline policies, including the AASLD Policy on the Development and Use of Practice Guidelines and the American Gastroenterological Association’s Policy Statement on the Use of Medical Practice Guidelines; and (4) the experience of the authors in regard to hepatitis C.”


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Healthwise: Hepatitis C and Quality of Life
—Lucinda K. Porter, RN

What does quality of life mean to you? Is it your health, happiness, financial security, spiritual wellness, or social well-being? It usually means different things to different people. In healthcare, researchers use surveys to measure the quality of life related to health, abbreviated as HRQOL. When applied to hepatitis C, HRQOL is an important concern.

For many, quality of life is a significant factor when making decisions about hepatitis C treatment. Patients want to know if they are going to get back a better quality of life in exchange for a temporarily reduced one caused by the side effects of the HCV medications. In short, should they stick with what they have, or go through a rough spell in order to improve on their health? In this article, I highlight research on HRQOL and various aspects of living with chronic hepatitis C virus (HCV) infection. These aspects include quality of life with HCV, during HCV treatment, and after treatment.

Quality of Life with HCV

If you look at the research, it is clear that HRQOL is generally lower for those living with HCV. In a recent study published by Yamini and colleagues,1 patients with HCV reported reduced quality of life. HCV negatively affected patients physically, mentally, emotionally, and socially. Yamini wrote, “The deleterious effects of HCV extend beyond liver disease, as exhibited by the high prevalence of depression and fatigue in the study population.” 2 (See HCV Snapshots for more about this study.)

Reduced quality of life is a global problem. An Italian study conducted by Umberto Cillo and colleagues, compared patients with alcoholic liver disease to patients with alcoholic liver disease and HCV.3  The findings were that having HCV negatively affects quality of life.

Multiple studies from all over the world confirm these findings. Graham R. Foster, Professor of Hepatology at London School of Medicine wrote, “Chronic infection with HCV has a profound effect on health-related quality of life.”4 HCV patients report problems with fatigue, depression, and sexual function. A chief complaint is neurocognitive problems, such as impaired concentration and attention problems. Sleep disturbances are another complaint among those with HCV, which also lowered HRQOL.

If quality of life is affected by having HCV, then it would stand to reason that patients with more liver damage (fibrosis and cirrhosis) would report a lower HRQOL. At a meeting of the American Association for the Study of Liver Diseases, Gerlinde Teuber and colleagues presented a poster that tested this hypothesis.5 They found that as liver fibrosis increased, quality of life declined. They also reported that viral load and genotype were not associated with HRQOL.

Some studies compared HRQOL among the various liver diseases and other causes of viral hepatitis. In a Greek study, Katerina Karaivazoglou and colleagues found no HRQOL differences between those with hepatitis B virus compared to those with HCV.6 Their findings showed fatigue and impaired psychological function, particularly depression, as the key factors that affected quality of life.

Although biological effects of HCV are well-documented, other factors may also have an impact on HRQOL. HCV is stigmatized and many patients report feelings of guilt, shame, and rejection. These feelings affect self-esteem and relationships, which heavily influence quality of life. In fact, knowledge of an HCV diagnosis lowers HRQOL. A few studies examined this, with varying results. The findings are best summarized as: those with HCV have a lower HRQOL, but those who know they have HCV have a lower HRQOL than those who are unaware of their positive HCV status.

Quality of Life during HCV treatment

In the years I have worked in this field, either as a nurse or as an HCV advocate, I never once heard a patient report a better quality of life during treatment. I’ve collected a few anecdotes of positive side effects. A nurse at another hospital told me of two male patients who begged to stay on ribavirin because it improved their sex life. One female patient of mine with exceptionally thick hair said that her hair never looked better because of treatment-related hair loss. However, these and the few other tales I collected do not amount to an improved quality of life during HCV treatment.

With its high side effect profile, it seems unlikely that patients are going to feel better while they are actually taking HCV medications—they take them hoping to get rid of the virus and to feel better after the effects of the medication have worn off. Studies confirm what any patient will tell you—HRQOL declines during HCV treatment.

However, the intensity of side effects is subjective, which may affect how we perceive quality of life. Knowledge of laboratory results may influence how we feel. A few studies showed that patients reported improvements of quality of life after learning they had a good response to the medications. However, the perception of quality of life isn’t all in the head. Research conducted by Strauss and Teixeira showed that before results were revealed to them, patients who were HCV negative after treatment reported a better HRQOL than those who were HCV-positive.7

Adherence to treatment does not seem to influence HRQOL, a fact supported by multiple studies. Most recently, Patrick Marcellin and colleagues observed that quality of life did not seem to fluctuate with the level of adherence to treatment regimen.8 The real changes in quality of life occurred after treatment.

Quality of Life after HCV treatment

Here is the good news: Marcellin and many others have researched this topic so extensively that there seems little room to believe anything else—quality of life increases when patients respond to treatment. In short, patients feel better when HCV is gone. The evidence is robust and plentiful. There is so much research telling us that curing HCV is associated with improved quality of life, that to doubt it is like believing that the world is flat.

When I thought about undergoing HCV treatment again (this will the third time), it was from the perspective of stopping disease progression. I can see and feel this disease taking its toll on my body. I want to stop HCV in its tracks. Another compelling reason is that research tells us that a sustained virologic response (SVR) to treatment reduces mortality from all causes, not just liver-related ones.9 Increasing my mortality rate is an excellent reason to undergo treatment for a third time.

However, now there is more incentive. The evidence points to the fact that I may not just arrest the disease, but in time, I could actually feel much better. The difference is subtle but important. Stopping HCV is a good thing, but it is much more powerful to think that treatment offers more than just stopping things before they get worse. The notion that I could feel better is powerful motivation.

From time to time, I ask people who had a sustained response to treatment if they can tell the difference. The response is always the same. They glow when they tell me, “You have no idea how good it feels.”  It is all I need to know to make my decision.

Further Reading

Endnotes

  1. Yamini D, et al. - Tobacco and Other Factors Have a Negative Impact on Quality Of Life in Hepatitis C Patients; Journal of Viral Hepatitis October 2011; Vol.18, Issue 10
  2. ibid.
  3. Cillo U, et al.- Hepatitis C Virus Adversely Affects Quality of Life; Blood Purification  2011Vol. 32, No. 2
  4. Foster G R - Quality Of Life Considerations for Patients with Chronic Hepatitis C; Journal of Viral Hepatitis September 2009 Vol 16 Issue 9
  5. Teuber G, et al. - Effects of Chronic HCV Infection on Health-Related Quality Of Life and Fatigue: The Role of Liver Fibrosis Progression; American Association for the Study of Liver Diseases 2007 meeting Abstract 1330
  6. Karaivazoglou K et al.- Fatigue and Depressive Symptoms Associated with Chronic Viral Hepatitis Patients’ Health-related Quality of Life; Annals of Hepatology Oct-Dec 2010 Vol 9, No 4
  7. Strauss E, Teixeira, MCD - Quality of Life and Hepatitis C; Liver International September 2006 Vol 26 No 7
  8. Marcellin P, et al. - Adherence to Treatment and Quality Of Life during Hepatitis C Therapy: A Prospective, Real-Life, Observational Study; Liver International April 2011 Vol 31 Issue 4
  9. El-Kamary S, Jhaveri R, Shardell M - All-Cause, Liver-Related, and Non–Liver-Related Mortality among HCV-Infected Individuals in the General US Population;  Clinical Infectious Disease July 2011 Vo 53 Issue 2



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Disability & Benefits: Health Care Reform in 2012 and Major Changes in Social Security Payments
—Jacques Chambers, CLU

This month’s column covers two topics. The first is a review of portions of the new health care reform act taking effect in 2012; this is followed by an announcement about Social Security plus other federal government agencies changing their method of payments to beneficiaries.

Health Care Reform was passed by Congress in 2010 with the Affordable Care Act (ACA). Provisions of that law started becoming effective shortly thereafter, but many provisions were postponed into 2012, 2013, 2014, and all the way into 2020.

Over the past year and a half, the ACA has already brought changes to health insurance that benefits the market and people with insurance. However, according to a recent Kaiser Family Foundation poll, only about half of the non-elderly without health coverage are familiar with the main reforms of the ACA.  While 47% of the population does not believe the ACA will affect them personally, yet a large percentage (44%) still view the ACA unfavorably. In actuality, changes have been made and are continuing to be made that affect virtually everyone with and without health insurance currently.

Health insurance companies are now prohibited from imposing a maximum benefit on their payments. Health plans must cover certain preventive care services at 100% without a deductible or co-pays. 2.3 million young adults have become insured under their parents’ coverage since the age limit for children was changed to age 26 for persons not covered by their own employer.

“Regardless of the results of the elections, it will be very difficult for Congress to repeal the entire law.”

More changes are scheduled to start in 2012:

  • To help pay for the additional costs of the ACA, members of the pharmaceutical industry will be paying an additional 2 billion dollars in taxes.
  • Insurance companies raising premiums by more than ten percent (10%) must publicly justify their rate hikes. More and more states are legislating the right to reject unjustified premium increases.
  • Insurers must also spend at least 80% of your premiums on actual medical care, not marketing, administrative expenses, or executive bonuses. Carriers that violate this rule will be required to give their insured members rebates of the excess premiums.
  • Employers with more than 250 employees must report the cost of coverage for each employee in their year-end W-2, although the premiums paid by an employer for coverage for the employee, spouse, and children (not domestic partners) remain income tax free. This requirement will extend to all employers regardless of size in 2014.
  • Employers will be required to provide new four page summaries of health care benefits reformatted for clarity.
  • All insurance literature must be written in a “clear and understandable language” and must clearly explain what is covered and how the plan works.
  • Employees must be notified in writing at least 60 days before any changes in benefits are effective.

The new Pre-Existing Conditions Insurance Plans (PCIP) allows persons who have been unable to purchase health insurance on the open market due to their health history and/or medical condition and have been uninsured for at least six months to purchase coverage under a state-administered plan. Those PCIP programs have now been established in all states.

For persons on Medicare, you will see some changes as well. As discussed in last month’s column, the Annual Election Period (Open Enrollment) is changed to October 15 through December 7 with the changes effective January 1, 2012. Also, beginning in 2011, the gradual elimination of the “Donut Hole” began with brand name medications costing 50% of the normal price. In 2012, in addition to continuing the 50% discount, the federal government will subsidize 14% of the cost of generic medications. The full cost of the medications will still count towards the plan’s out-of-pocket maximum benefit, when the Catastrophic portion of Part D Prescription benefit will kick in. 

Medicare Advantage Plans (privately insured plans offered in lieu of traditional fee-for-service Medicare) will have their government subsidy reduced to more closely resemble the amount spent on persons with traditional Medicare.

Readers may wonder about the future of the ACA with all the vocal calls and promises to repeal “Obamacare” as they have labeled the ACA. No one can accurately predict exactly what will happen. Of course, a lot depends on the results of the presidential and congressional elections in November, 2012.

It should be kept in mind, however, that many provisions of ACA are already in effect. Regardless of the results of the elections, it will be very difficult for Congress to repeal the entire law. They would have trouble throwing the 2.3 million young adults off their parent’s policy. Also, it will be difficult to allow insurance companies to reinstitute maximum benefit caps or add deductibles and co-pays back on to preventive services.

In addition, there are some signs that the implementation of the ACA is already starting to have an effect on the rising health care and health insurance rates. Mercer, a well-known independent benefits consulting firm released a survey of employers showing that their health insurance cost increases will average 5.4% for 2012. This is the survey’s smallest increase since 1997. Goldman Sachs has also reported “widespread anecdotal observations that suggest health reform may be a factor contributing to slower growth in per capita health spending.” If this slowing of health care cost increases continues, it will make the law ever more difficult to erase when the new Congress begins work in early 2013.

Changes to Social Security Payments

The U.S. Department of Treasury is doing away with sending paper checks including the monthly benefits Social Security sends out. This will apply to all beneficiaries receiving payments from Social Security whether it is for Retirement, Disability, survivors, dependents, or Supplemental Security Income (SSI). Beneficiaries may change to electronic payments at any time, but all must switch by March 1, 2013. The change is not only a savings for the federal government, but it protects beneficiaries from lost or stolen checks, and provides beneficiaries quicker access to their funds.

When switching to electronic payment, a person will be able to choose from three choices:

  • Direct deposit into an existing checking or savings account.
  • If you do not have bank accounts, the U.S. Department of the Treasury has designed the Electronic Transfer Account (ETA) for Federal payment recipients. The ETA is a low-cost account you can open at a participating federally insured bank, savings and loan, or credit union.
  • A beneficiary will also be able to obtain a prepaid Debit Card. The benefit will be downloaded onto the card each month and the card can be used to obtain cash, pay bills, or purchase items.

Note that switching to any of the electronic payment methods will NOT change the day of the month when your benefits are paid.

For more information on the switch to electronic payment or to enroll on line, go to www.GoDirect.org or call the Electronic Payment Solutions Center at 800-333-1795.


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HCV Snapshots
—Lucinda K. Porter, RN

Article: Tobacco and Other Factors Have a Negative Impact on Quality Of Life in Hepatitis C Patients – D Yamini, B Basseri, GM Chee, A Arakelyan, P Enayati, TT Tran, F Poordad
Source: Journal of Viral Hepatitis October 2011; Volume 18, Issue 10, Pages 714-720

Researchers retrospectively reviewed clinical data from 1998-2007 of 800 patients with chronic hepatitis C (HCV) infection; patient data was collected prospectively. Liver biopsies showed 37% with stage 0 fibrosis; 28% had advanced fibrosis; 18% with cirrhosis. 

“Patients reported themselves to be unwell with a reduced quality of life.” Depression was reported by 29% of the study population; fatigue was nearly 45%. Loss of interest in sexual intercourse was reported by 7.7%. Sleep difficulties was almost 4%. Patients who were treated and had viral eradication reported improved sleep. Awareness of HCV diagnosis did not affect quality of life.

The most significant findings were about smokers. Current smokers had double the odds for advanced fibrosis. Ex-smokers did not have this increased risk. Smokers had a higher incidence of depression, fatigue, sleep difficulties, and disinterest in sex. Former drinkers with moderate to heavy alcohol use also had twice the odds for advanced fibrosis.

The Bottom Line: HCV affects quality of life, especially for smokers.

Editorial Comment: The more we do for our health, the better off we are. However, quitting tobacco use is easier said than done. If you want to quit, get help for this. (Fact sheets about this are provided at www.hcvadvocate.org)

Article: Liver Transplant Recipient Survival Benefit with Living Donation in The Model For Endstage Liver Disease Allocation Era – CL Berg, RM. Merion, TH Shearon, KM Olthoff, RS Brown Jr, et al.
Source: Hepatology October 2011; Volume 54, Issue 4, Pages 1313-1321

In this research conducted between February 2002 and August 2009, 868 adult liver transplant candidates from multiple centers were followed. The study compared the mortality rates of Living Donor Liver Transplant (LDLT) recipients with Deceased Donor Liver Transplant (DDLT) recipients.  Of the 868 participants, 83 died without transplant, and 73 were alive without transplant at the last study time point; 712 underwent transplantation (406 LDLT; 306 DDLT)

The Bottom Line: Overall, the results found a 56% lower mortality rate for LDLT recipients. Patients without hepatocellular carcinoma (HCC) who underwent LDLT had higher survival rates than DDLT. There was no apparent difference between LDLT and DDLT for patients with HCC and low Model for Endstage Liver Disease (MELD) scores.

Editorial Comment: The need for livers far exceeds the number of available organs. There are more than 16,000 people on the list in the U.S. Roughly, 3100 received organs in the first half of 2011, and approximately 124 of these were from living donors. The surgery for the living donor is very extensive and involves significant risks.  However, living donors represent the difference between life and death for many patients with end-stage liver disease.

Article: Hepatitis G Virus (HGV): Where We Stand and What to Do? – Q. Mughis Uddin Ahmed
Source: International Journal of Immunological Studies 2011; Volume 1, Number 3, Pages 255 - 263

In this article, Ahmed reviews sixteen years of scientific literature to learn more about the hepatitis G virus (HGV). First identified in 1995, HGV was relabeled as GB virus C (GBV-C), and is the term chosen for this Shapshot. In 1997 the US Food and Drug Administration (FDA) declared it as non-harmful, but Ahmed challenges this assessment. 

Ahmed reveals that GBV-C has a high global prevalence with no screening of the blood supply for this virus. He reports a link between GBV-C and hepatitis, cirrhosis of the liver and perhaps hepatocellular carcinoma. GBV-C may also be associated with various blood disorders and malignancies.

The Bottom Line: The researcher for this article recommends screening blood donors for HGV as well as further research on this virus.

Editorial Comment: Many of us remember being told that HCV was nothing to worry about. Fortunately, it was only four years between HCV discovery and developing reliable screening methods so we can deliver a clean blood supply in the U.S. Now seems like a good time to apply this method to GBV-C. On a positive note, presumably there is a high prevalence of GBV-C among those with other viruses that are already being screened, thus inadvertently eliminating GBV-C from the blood supply.

As we consider this, it is worth noting that research has shown that GBV-C may have a positive effect in at least two situations—in the presence of HIV and long-term post-liver transplantation (after 3 years).

Regardless, GBV-C seems to be inadequately researched. A search on Google Scholar for articles on HGV since 2010 yielded 918 results; 145 results for GBV-C. Compared to 17,800 results for HCV, it looks like there may be room to learn much more about GBV-C, unless it really turns out to be nothing to worry about.

Article: The Epidemiology and Natural History of Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis in Adults – G Vernon, A Baranova, ZM Younossi
Source: Alimentary Pharmacology & Therapeutics August 2011 Volume 34, Issue 3, Pages 274-285

Across the globe, Non-alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) are common causes of chronic liver disease. Both are the result of fatty liver cells (steatosis). This study looks at literature about NAFLD from the past 30 years. NASH (not NAFLD) progresses to cirrhosis and hepatocellular carcinoma. However, NAFLD may progress to NASH. Obesity is highly associated with NAFLD.

The results showed that NAFLD is the most common reason for elevated liver enzymes in the U.S. affecting about one-third of the population. The prevalence of NASH is 2 to 5%. Latinos have the highest prevalence of NAFLD, followed by non-Hispanic Whites, with the lowest rate reported in African Americans. The prevalence of NAFLD in American Indian and Alaska-Native populations ranges from 0.4% to 2%.

The Bottom Line: With the obesity epidemic on the rise, the prevalence and impact of NAFLD is threatening to increase the prevalence of NASH, pushing NASH ahead as potentially the most common cause of advanced liver disease. Because of the presence of fatty liver cells, 20% of donor livers are ineligible for transplantation.

Editorial Comment: NASH is on track to do as much or more damage to the livers in America as alcohol is doing. Obesity is not just harming our hearts, it is killing our livers. This report is disturbing, EXCEPT that it is preventable.

Article: Telaprevir Alone or with Peginterferon and Ribavirin Reduces HCV RNA in Patients with Chronic Genotype 2 but Not Genotype 3 Infections – GR Foster, C Hézode, JP Bronowicki, G Carosi, O Weiland, et al.
Source: Gastroenterology September 2011; Volume 141, Issue 3, Pages 881-889

This study looked at 23 subjects with genotype 2 - hepatitis C virus (HCV) and 26 with genotype 3. They were randomly assigned to one of three study arms: 1) peginterferon, ribavirin and telaprevir, 2) peginterferon, ribavirin and placebo, 3) telaprevir only. The balance of disease characteristics and demographics was evenly distributed among subjects. 

HCV viral load (HCV RNA) dropped for all genotype 2 subjects, even for those receiving telaprevir monotherapy. The group assigned to peginterferon, ribavirin and telaprevir had the highest sustained virologic response (SVR) at 100%; 89% for those receiving peginterferon and ribavirin; 56% for on telaprevir alone. Genotype 3 subjects did not fare as well—with 67% for the peginterferon, ribavirin and telaprevir group; 44% for those receiving peginterferon and ribavirin; 50% for on telaprevir alone. 

The Bottom Line: The title of this article says it all: “Telaprevir alone or with peginterferon and ribavirin reduces HCV RNA in patients with chronic genotype 2 but not genotype 3 infections”.

Editorial Comment: This is a very small study, so it is important not to put too much weight on it until more research is done. Although it is interesting to see the different response rates between genotypes 2 and 3, what is noteworthy is how well genotype 2 performed. This research may be the springboard to more research to learn if genotype 2 can have shorter treatment lengths when using peginterferon, ribavirin and telaprevir.

 

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