Friday, May 8, 2015

May Newsletters: Hepatitis Awareness, Treating Genotype 1, Medications and Side Effect Management


May Newsletters, Hot Topics And Updates Around The Web

May is Hepatitis Awareness Month
The month of May is designated as Hepatitis Awareness Month in the United States, and May 19th is Hepatitis Testing Day. During May, CDC and its public health partners work to shed light on this hidden epidemic by raising awareness of viral hepatitis and encouraging priority populations to get tested.

Thunderclap
Please consider participating in our Be #HepAware Thunderclap on May 19th at 12:00 p.m. EDT/9:00 a.m. PDT. Thunderclap is a social media tool that allows supporters to sign up in advance and share a unified message simultaneously across social media platforms to create a wave or “thunderclap”. Supporters can use their Twitter, Facebook or Tumblr accounts to sign up for a one time post that will be sent on May 19th. We need 100 supporters to sign up in order for our Thunderclap to take effect. So, please join us in this effort and visit http://thndr.it/1z5X2cF to sign up and help spread the word to your members and followers.

Hot Topics

WHO adds hepatitis C drugs to essential list, urges lower prices
The World Health Organization has added new curative treatments for hepatitis C to its essential medicines list, but the U.N. agency said prices needed to fall to make them accessible to patients in poorer countries.

The VA’s Hepatitis C Problem
BY GERARD FLYNN 5/9/15 AT 11:00 AM
Ross also stresses that he recommends treating HCV as early as possible. However, a recent VA memo recommends urgently treating those with advanced liver disease but holding off for patients with mild cases of the illness. Meanwhile, the Centers for Disease Control and Prevention states clearly that “the longer people live with hepatitis C the more likely they are to develop life-threatening liver disease.”

That’s a view a view shared by Dr. Bennet Cecil III, who worked as a gastroenterologist at the Louisville VA Medical Center, in Kentucky, for 16 years before retiring last year. Cecil has for years been sparring with Ross over what he considers to be the VA’s “lack of enthusiasm” for handling the crisis. He claims that at the VA medical center where he worked, denying treatment for budgetary reasons was not official policy but he saw it happen all too often.

NHS denies lifesaving drug to 5,000 patients it gave infected blood: Sofosbuvir has been approved by regulators but victims are STILL waiting for treatment
--Thousands of victims were infected by hepatitis C through imported blood
--Breakthrough drug Sofosbuvir was approved by regulator NICE in January
--But NHS England is delaying treatment for patients until at least August

Substance Abuse Fuels Rise in HCV in Four Eastern States
Laurie Barclay, MD May 07, 2015
Medscape
Acute hepatitis C virus (HCV) infections increased 364% between 2006 and 2012 among persons 30 years of age or younger in Kentucky, Tennessee, Virginia, and West Virginia, according to a study published in the May 8 issue of the Morbidity and Mortality Weekly Report.

The increased infection rates were strongly correlated with opioid abuse and injection drug use. In addition, adults younger than 30 years accounted for 44.8% of all HCV cases in these states during the surveillance period; the median age was 25 years.

"[HCV] infection is the most common blood-borne infection in the United States, with approximately three million persons living with current infection," write Jon E. Zibbell, PhD, from the Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, and colleagues. "Percutaneous exposure to contaminated blood is the most efficient mode of transmission, and in the United States, injection drug use...is the primary risk factor for infection."

Previous state surveillance reports from 2006 to 2012 have shown a nationwide increase in reported cases of acute HCV infection, especially among states in central Appalachia and other states east of the Mississippi River. Most of these cases occur in adolescents and young adults 30 years of age or younger from nonurban areas. Nearly three quarters (73%) of these cases are associated with injection drug use as the main risk factor.

To better understand those data, Dr Zibbell and colleagues analyzed surveillance data from acute HCV case reports and drug treatment admissions in the four hardest-hit states, focusing on those younger than 30 years.

In addition to finding the overall steep rise in HCV infection in this age group, the researchers found that, nonurban residents had more than twice the increase in annual incidence compared with urban residents, although both urban and nonurban areas showed significant increases. Males and females were equally affected, and most of the cases were in non-Hispanic whites.

Moreover, between 2006 and 2012, these four states had a 21.1% increase in treatment admissions for abuse of any opioid, a 16.8% increase in treatment admissions for abuse of prescription opioids, and a 12.6% increase in treatment admissions for injection of any opioid.

"These increases indicate a strong correlation among opioid abuse, drug injecting, and HCV infection in these four states," the authors write.

Although prevalence of HIV in this population is presently low in these four states, the investigators warn of the potential for an increase in HIV infections, as injection drug use is a risk factor for both HIV and HCV.

"Evidence-based strategies as well as integrated-service provision are urgently needed in drug treatment programs to ensure patients are tested for HCV and persons found to be HCV-infected are linked to care and receive appropriate treatment," the report authors conclude. "These efforts will require further collaboration among federal partners and state and local health departments to better address the syndemic of opioid abuse and HCV infection."

The authors have disclosed no relevant financial relationships.

Morb Mortal Wkly Rep. 2015;64:453-458. Full text

Research

Editorial and Full Text Articles

Daclatasvir in Combination with Asunaprevir and Beclabuvir in Genotype 1 Infection with and without Cirrhosis

Editorial - Continued Progress Against Hepatitis C Infection
JAMA | May 5, 2015
Hari Conjeevaram, MD, MSc

"Several studies have demonstrated that chronic HCV infection can significantly affect both the health-related quality of life and productivity in the work place. Factors such as high utilization rate of medical resources and increased absenteeism from work can have negative economic effects on society, but these effects potentially could be reversed with eradication of HCV infection. In a study of patient-reported outcomes among patients with HCV infection and cirrhosis who were treated with sofosbuvir-containing regimens,12 achieving SVR12 with the all-oral IFN-free regimen resulted in improvement in some aspects of patient-reported outcomes. In another study,13 the presence of advanced fibrosis was independently associated with impairment of health-related quality of life and work productivity; there was significant improvement in both outcomes after achieving viral eradication with ledipasvir and sofosbuvir and this improvement was seen regardless of fibrosis stage (in both early and advanced fibrosis). Such improvement in work productivity with viral eradication is considered an important step that may contribute to substantial benefits to society."

In this issue of JAMA, Poordad and colleagues2 and Muir and colleagues3 report the results of 2 multinational studies evaluating viral eradication rates with an all-oral interferon (IFN)-free drug combination using daclatasvir (an NS5A inhibitor), asunaprevir (an NS3 protease inhibitor), and beclabuvir (a nonnucleoside NS5B inhibitor) in 415 patients infected with HCV genotype 1 who did not have cirrhosis,2 and in 202 patients who had compensated cirrhosis.3 In both studies, treatment duration was for 12 weeks and included patients who were treatment naive (312 patients without cirrhosis2 and 112 patients with cirrhosis3) and patients who failed prior treatment regimens with IFN-based combination therapies. The additional role of ribavirin was also studied among patients with cirrhosis.......
Read Full Article @ NATAP

Chronic hepatitis C virus (HCV) infection remains a substantial cause of chronic liver disease, affecting approximately 130 to 150 million individuals worldwide.1 An estimated 20% of patients with chronic HCV infection will develop cirrhosis.2 The prevalence of cirrhosis is increasing, primarily from continuing disease progression in an aging population that acquired HCV infection prior to widespread HCV testing and blood screening.3 Patients with cirrhosis have increased risk of severe sequelae, such as hepatic decompensation, hepatocellular carcinoma, and death.2 Conversely, clearance of HCV infection with effective treatment reduces the risk of disease progression and the need for liver transplantation, and can lead to cirrhosis regression and improved survival.4- 6

Treatment regimens containing peginterferon are problematic for patients with cirrhosis because of reduced response rates and more frequent and severe adverse events.7- 10 Furthermore, patients with cirrhosis more frequently have contraindications for peginterferon such as anemia, renal insufficiency, or thrombocytopenia. Consequently, interferon-free regimens comprising combinations of direct-acting antivirals are being developed to increase response rates and provide viable treatment options for patients with all stages of liver disease. The all-oral combination of daclatasvir (a potent, pangenotypic nonstructural protein 5A [NS5A] inhibitor), asunaprevir (an NS3 protease inhibitor), and beclabuvir (BMS [Bristol-Myers Squibb]-791325; a nonnucleoside NS5B thumb-1 polymerase inhibitor) was explored in a preliminary study. After 12 weeks of therapy, sustained virologic response at posttreatment week 12 (SVR12) was achieved by 92% of patients with HCV genotype 1 infection in the treatment-naive group, including 13 of the 15 enrolled patients with cirrhosis.11 The present study evaluated this regimen, administered as a twice-daily fixed-dose combination tablet with or without ribavirin, in patients who were treatment-naive and treatment-experienced with chronic HCV genotype 1 infection and compensated cirrhosis..
Current estimates indicate that 130 million to 150 million people worldwide are chronically infected with hepatitis C virus (HCV), resulting in up to 350 000 deaths per annum due primarily to cirrhosis, hepatic decompensation, and hepatocellular carcinoma.1,2 Of the 7 HCV genotypes identified, genotype 1 is the most prevalent worldwide, accounting for approximately 60% of infections.3Treatment options for HCV genotype 1 are evolving rapidly from interferon-based regimens to all-oral, direct-acting antiviral (DAA)Ðonly regimens.

Daclatasvir is a potent, pan-genotypic inhibitor of the HCV NS5A protein that has demonstrated activity against HCV genotypes 1 through 6 in vitro.4 Asunaprevir is an NS3 protease inhibitor with activity against genotypes 1 and 4.5 Beclabuvir (BMS-791325) is a nonnucleoside NS5B thumb-1 polymerase inhibitor with activity against genotypes 1 and 4. All-oral therapy with daclatasvir and asunaprevir for 24 weeks achieved a sustained virologic response at posttreatment week 12 (SVR12) in 90% of treatment-naive patients infected with genotype 1b.6 In phase 2b studies, 92% of treatment-naive patients infected with genotype 1 (1a and 1b) and 100% of treatment-naive patients infected with genotype 4 achieved SVR12 with the all-oral, ribavirin-free combination of daclatasvir, asunaprevir, and beclabuvir for 12 weeks.7,8 Here we report the findings of the multinational UNITY-1 study evaluating the all-oral, fixed-dose combination of daclatasvir, asunaprevir, and beclabuvir (DCV-TRIO regimen) among both treatment-naive and treatment-experienced patients with HCV genotype 1 infection who did not have cirrhosis (see the trial protocol in Supplement 1).
Continue reading complete article, here

May Newsletters

HCV Advocate Newsletter

Preparing for Treatment: Part 2 Medical Tests, Medications and Side Effect Management, among other things for getting ready for that all important start of treatment

http://www.hcvadvocate.org/index.asp

The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education. 

HCV Advocate Newsletter

In This Issue:

HealthWise: Hepatitis C Awareness—A Little Effort Makes a Big Difference
Lucinda K. Porter, RN
May is Hepatitis Awareness Month and a good time to get involved. This article suggests ways you can help raise awareness about issues surrounding hepatitis C. 
Read more...


Overview — Preparing for Treatment: Part 2
Alan Franciscus, Editor-in-Chief
Part 2 of this article discusses Medical Tests, Medications and Side Effect Management, among other things for getting ready for that all important start of treatment.
Read more...


Alan Franciscus, Editor-in-Chief
This month, read about Merck's Breakthrough Therapy designation; phase 2 study results of AbbVie’s combo to treat genotype 4; and a new study that may finally help expand care and treatment to other medical providers.
Read more...


Alan Franciscus, Editor-in-Chief
Read about how depression rather than liver impairment reduces quality of life in patients with hepatitis C, and a study that shows that there has been a major advance in the rate of liver disease progression—most notably the increase in liver cancer. 
Read more...



Overview of the Liver, and Overview of HCV Transmission and Prevention
Alan Franciscus, Editor-in-Chief
We are continuing to update and condense our HCSP fact sheet series with two new fact sheets: Overview of the Liver, and Overview of HCV Transmission and Prevention.


HCV Advocate Mid-Month Newsletter 

April 15, 2015

In This Issue:

Alan Franciscus, Editor-in-Chief
Read about quality of life improvements in people with fibrosis following treatment with Harvoni, and about HCV and lymphoproliferative disorders, such as cryoglobulinemia and non-Hodgkin lymphoma, among others. 
The Five: Coffee
Alan Franciscus, Editor-in-Chief

There are many published studies that show that caffeinated coffee can improve the health of the liver and provide other health benefits; however, there are also some downsides to caffeine. 
Read more...

Updates: Herbal Supplement Crackdown—GNC Reforms
Alan Franciscus, Editor-in-Chief
In the February 2015 Mid-Monthly Advocate issue, I wrote about the New York State Attorney General’s Office crackdown on four major chains (GNC, Target, Walmart, and Walgreens). So far only GNC has complied. 
SSI and SSDI: Social Security's TWO Disability Programs
Jacques Chambers, CLU

It’s complicating enough that Social Security operates two entirely separate disability benefit plans, but having their initials only one letter apart practically guarantees confusion. Yet one letter can be very important as there is a world of difference between the two plans. 
Home of the
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May 2015 Issue
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http://www.hepmag.com
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and HepMag.com are the go-to source for educational and social support for people living with hepatitis.

Hep C Blogs
Karen Hoyt
Hepatitis C Advocate
Last Entry: Post Liver Transplant Protein and Healing (2015-05-06 06:00:12)
It is my 9th day post liver transplant and I'm so excited to share what healing foods can help us recover from surgery.

Matt Starr
Hepatitis, Liver Disease Support Coach
Last Entry: My Hepatitis C Treatment Journey - Week 4 is Here(2015-05-07 06:06:27)
For those of you following my journey with the newest hepatitis C medicines, Harvoni and ribavirin, you probably know I have three

Lucinda K. Porter, RN
Author, Hepatitis C Advocate, Health Educator
Last Entry: Be a Loud Hepatitis Awareness Advocate (2015-05-08 05:50:33)
To further raise awareness and promote testing during May, participate in the Be #HepAware Thunderclap on May 19th

Grace Campbell
A pseudonym for a person living with hepatitis C on Viekira Pak + Ribavirin
Last Entry: Hepatitis C: Oh the thinks you can think (2015-05-08 06:08:41)
"We are all stumblers, and the beauty and meaning of life are in the stumbling." - David Brooks. As you stumble along the rocky, winding path you are crossing during treatment, you often have time to do a lot of thinking. What do you think about?

May News
May 07, 2015
Harvoni Beats Hep C Among Those With Advanced Liver Disease
Harvoni and ribavirin cures hepatitis C at mostly high rates among those with decompensated cirrhosis or recurrent hep C after a liver transplant.

May 06, 2015
Could a Cancer Drug Cure Hepatitis B?
A cancer drug has shown promise as a potential cure for hepatitis B.

Daclatasvir and Sovaldi Cure High Rates of Genotype 1 of Hep C
Daclatasvir and Sovaldi, with or without ribavirin, cures high rates of people with genotype 1 of hepatitis C, according to preliminary data in a recent trial.

May 05, 2015
Joint Pain Flares Among People With HIV, Hepatitis C or Both
People with HIV and hepatitis C virus, as well as those who are coinfected with both viruses, report high levels of joint pain.

Global Hep B Could Plummet With More Vaccination and Treatment
Drastically raising the global rates of hepatitis B vaccination and treatment could deal a major blow to the disease.

Harvoni Cures High Rates of Genotypes 4 and 5 of Hepatitis C
Harvoni posted excellent results in curing genotypes 4 and 5 of hepatitis, including among those with cirrhosis, in a recent small trial.

May 04, 2015
Success for 8 Weeks of Grazoprevir/Elbasvir Plus Sovaldi
Eight weeks of Merck’s grazoprevir/elbasvir, plus Gilead Sciences’ Sovaldi cured high rates of people with genotype 1 or 3 of hepatitis C in a small trial.

Retreatment With 24 Weeks of Harvoni Often Cures Hepatitis C
People with genotype 1 of hepatitis C who have failed Harvoni have a good chance of a cure from a second round of the drug lasting 24 weeks.

Statins Appear Helpful to Hep C-Related Compensated Cirrhosis
Statins were found to be significantly beneficial to treating compensated cirrhosis among people with hepatitis C in a recent trial.

Putting Off Hep C Treatment Raised Risks With Older Treatments
Delaying hepatitis C treatment until liver damage was more advanced lowered the likelihood of a cure among interferon treatments in the pre-direct-acting antiviral era.

May 03, 2015
Viekira Pak Shows Promise for Kidney-Impaired People With Hep C
AbbVie’s Viekira Pak, with or without ribavirin, appears to work very well curing genotype 1 of hepatitis C.

Europe Is Behind the Eight Ball in Combatting Viral Hepatitis
Numerous European nations are in a poor position to combat hepatitis B and C viruses, given their inadequate systems to monitor viral hepatitis and to assess the effectiveness of interventions.

Hep Forums
Welcome to the Hep Forums, a round-the-clock discussion area for people who have Hepatitis B, C or a co-infection, their friends and family and others with questions about hepatitis and liver health. Check in frequently to read what others have to say, post your comments, and hopefully learn more about how you can reach your own health goals. 
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The primary goal of the Caring Ambassadors Program is to help individuals with challenging health conditions to become ambassadors for their own health. We are here to help you—that is now and always will be our singular focus.

Monthly Pubmed Review of the most relevant research on HCV
PDF Download: April 2015 Literature Review

Index
CLINICAL TRIALS, COHORT STUDIES, PILOT STUDIES
BASIC AND APPLIED SCIENCE, PRE-CLINICAL STUDIES
HIV/HCV COINFECTION
COMPLEMENTARY AND ALTERNATIVE MEDICINE
EPIDEMIOLOGY, DIAGNOSTICS, AND MISCELLANEOUS WORKS
LIVER CANCER

Weekly News
Weekly news updates are currently posted on the Internet site and sent out via e-blast to provide up-to-date information on what has been covered in the news regarding hepatitis C in the previous week. Topics include all stories related to hepatitis C as well as personal stories and events.

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"Accessing and Managing Hepatitis C Treatment: Benefits of Working with a Specialty Pharmacy"

If you’re undertaking treatment for hepatitis C, your medication(s) will likely be dispensed through a specialty pharmacy. Learn about the difference between retail and specialty pharmacies and how specialty pharmacies can help you manage your Hep C treatment through insurance coordination, financial assistance, personalized education, nursing support and medication compliance programs.
Join us for a new webinar! "Accessing and Managing Hepatitis C Treatment: Benefits of Working with a Specialty Pharmacy" will take place on Thurs. 5/28, 12-1pm ET.
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HepCBC Hepatitis C Education and Prevention Society

HepCBC’s MONTHLY NEWSLETTER
The hepc.bull, has been “Canada’s hepatitis C journal” since the late 1990′s and has been published nonstop since 2001. The monthly newsletter contains the latest research results, government policy changes, activities and campaigns you can get involved in, articles by patients and caregivers, and a list of support groups plus other useful links.

DOWNLOAD
May, 2015 hepc.bull HERE.

Health Critic MP Murray Rankin - gets tested publicly - for hepatitis C

· A credible attempt to eliminate - hepatitis C - from the Republic of Georgia

· Patient Group Input requested - for new drug combo HOLKIRA PAK™- from AbbVie

· Hepatitis C - Link to Cancer explored

· 2015 is Year 5 of HepCBC Liver Warrior Participation in Victoria Marathon

· Australian advisory committee recommends "no undo clinical restrictions" on new treatment

· May is Aboriginal Hepatitis C Awareness Month!

· Hep C Outreach to Immigrants: Ideas Shared at conference |

· Integrated Health Clinics

· VOLUNTEERS Needed for VANCOUVER new office

· GET CHECKED ONLINE: Confidential Testing Project now "Live" in Vancouver

· Honour Roll of people cured of hepatitis C - hope your name is on it soon!

· Treatment Coverage through 1996 - 1990 Class Action Settlement

· Hepatitis C Conferences throughout the world!

· Medication Assistance, Compensation

· Support Groups/Clinics: in Canada WHERE & WHEN

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NYC Hep C Task Force
The New York City Hepatitis C Task Force is a city-wide network of service providers and advocates concerned with hepatitis C and related issues. The groups come together to learn, share information and resources, network, and identify hepatitis C related needs in the community. Committees form to work on projects in order to meet needs identified by the community.

Press Conference | Hep Free NYC – Steps of City Hall, May 14 @ 10AM
May 4, 2015
May is Hepatitis Awareness Month! National Hispanic Hepatitis Awareness Day | National Hepatitis Testing Day Join us for a citywide Hep Free NYC Awareness Event Steps of City Hall – Thursday, May 14th, 10-11AM To learn more or get involved, contact the Hep Free NYC Awareness Day Planning Group Join us on the Steps of City … 

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GI & Hepatology News is the official newspaper of the AGA Institute and provides the gastroenterologist with timely and relevant news and commentary about clinical developments and about the impact of health-care policy. The newspaper is led by an internationally renowned board of editors.

Read breaking news stories now: visit the GI & Hepatology News website.

May Newsletter 
Download - May 2015 PDF
Or read -  May 2015 Interactive Version

In This Issue
Cirrhosis mortality has dropped, except with sepsis

Innovation to help patients with chronic liver disease

New hepatitis treatments cost effective for some
and more...

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Updates Around The Web


My Take on New Guidance for Treating Genotype 1 HCV–Infected Patients With Decompensated Cirrhosis
Norah Terrault, MD, MPH - 5/5/2015 

With the availability of highly effective, highly tolerable all-oral treatment options for essentially all patients infected with HCV, management of these individuals has become much more straightforward and approachable in many ways. Indeed, many have suggested that primary care physicians can now oversee the treatment of HCV-infected individuals with mild disease who are otherwise healthy. However, we must remember that a subset of patients—namely those with decompensated cirrhosis—still require very specialized care and a thoughtful management approach. In late 2014, the AASLD/IDSA guidance was updated to integrate newly available therapies into diagnosis, staging, and treatment approaches for patients with HCV infection, including those with decompensated cirrhosis. When I review this guidance and consider how it applies to my practice, several themes evolve.

Management of Treatment-Naive Patients
For the patient with genotype 1 HCV infection who has decompensated liver disease, the options are limited to ledipasvir (LDV)/sofosbuvir (SOF) with or without ribavirin (RBV), in contrast to compensated cirrhosis where we have 3 all-oral combinations available to us. Thus, in our clinic, the first steps are to evaluate treatment history and determine whether the patient is a suitable candidate for RBV. Often patients with decompensated disease have a history of anemia or may have renal dysfunction, both of which may make tolerability of RBV more difficult and patients with eGFR < 30 mL/min should not be treated with this regimen according to the label. In addition, patients with cardiopulmonary disease or a history of retinopathy need to be carefully evaluated. For patients with these comorbidities, RBV is likely to be poorly tolerated and potentially dangerous to the patient’s wellbeing, and thus best avoided.

For treatment-naive individuals who are expected to tolerate RBV, the guidelines recommend LDV/SOF plus RBV (600 mg initial dose, increasing as tolerated) for 12 weeks. Alternatively, the guidance recommends that treatment-naive patients unable to tolerate RBV receive LDV/SOF without RBV for 24 weeks. The results from both of these options are excellent in terms of the anticipated SVR rates, which are in the 85% to 90% range.

At my facility, we are quite comfortable using RBV and managing the associated side effects, including anemia, using established algorithms where patients are monitored carefully and dose adjusted as appropriate. Consideration of the initial RBV dose is important, taking into account the patient’s baseline hemoglobin level and renal function. For decompensated patients, starting at a RBV dose of 600 mg or less may be warranted with stepwise increase in dose to tolerability. We still need to occasionally administer erythropoiesis-stimulating agents for anemia management but the need for transfusions is extremely rare. So, given our experience and comfort level with RBV use, my preference in my genotype 1 HCV patients with decompensated cirrhosis who are treatment naive is to give 12 weeks of therapy whenever possible.

Options for Treatment-Experienced Patients
For patients with genotype 1 HCV infection and previous treatment failure, the options are further limited. The AASLD/IDSA guidance recommends LDV/SOF plus RBV (600 mg initial dose, increasing as tolerated) in these patients, but for an extended period of 24 weeks. Thus, RBV tolerability becomes even more critical for this group of patients. In contrast to the guidelines, we treat treatment-experienced patients similar to treatment-naive patients, using 12 weeks of LDV/SOF plus RBV except that if their platelet count is < 75 x 109/L, we use 24 weeks of LDV/SOF plus RBV. For patients who are not RBV candidates, I will still administer 24 weeks of LDV/SOF without RBV because I have nothing else to offer them and deferring treatment is not a good strategy, given the future risk of additional liver complications.

The Most Challenging Patients
Unfortunately, there are patients with decompensated cirrhosis who are not candidates for treatment with current therapies. Patients with renal insufficiency (eGFR < 30 mL/min) cannot be safely treated with LDV/SOF due to the renal metabolism of SOF.

All patients with decompensated cirrhosis should be simultaneously considered for liver transplantation. For those who are not eligible for HCV therapy, transplantation may be the only means of achieving improved liver function and prevent progression of decompensation with HCV treatment in the posttransplant period. However, there are certain patients with decompensated liver disease who are not transplant candidates, and we are motivated to treat those patients with the goal of stabilizing their liver disease and reversing their complications of liver failure. We have no data showing a mortality benefit from treating this population; however, encouraging preliminary data are emerging that patients do have improvement in their MELD and CPT scores following treatment, suggesting that reversal of liver complications is possible. Overall, for patients with decompensated cirrhosis, the combination of LDV/SOF plus RBV can be applied broadly, except for those with renal dysfunction and those patients in whom we are uncomfortable administering RBV.

Treatment Timing and Other Considerations
When managing patients with decompensated cirrhosis, it is important to be mindful of the fact that treatment does not immediately alter the natural history of their disease or its complications. Thus, ongoing management of current liver complications and surveillance for new complications is essential. For example, it is important to provide prophylaxis for variceal bleeding or spontaneous bacterial peritonitis as indicated and perform surveillance for liver cancer at 6-monthly intervals. These patients are preferably treated in a facility that is affiliated with a liver transplant program that has expertise in managing these complications. For patients on the waiting list for transplantation, the timing of HCV treatment needs to take into consideration of anticipated time of transplantation and treatment decisions should be done in concert with the transplant physicians.

The big question is whether we can reverse liver decompensation to the point where the patient no longer requires transplantation. Will all patients who achieve SVR derive improvements in the MELD score, and by how much will the score improve? We don’t have the answers to these important questions and the lack of data complicates decisions regarding treatment of patients on the waiting list. Since the MELD score determines the priority for liver transplantation, a patient with decompensated cirrhosis who achieves SVR and a reduction in MELD score (but not necessarily improvement in his or her symptoms of liver decompensation) may become ineligible for transplantation and more likely to experience progression of liver disease. Defining the group of waitlisted patients who benefit most from HCV treatment is an important future goal. However, certainly for patients who are not transplant candidates, HCV treatment is an important intervention and these patients should definitely be treated in hopes of achieving improvements in symptoms and lengthening survival.

We are in an exciting time where we now have effective options for treating HCV in our most ill patients, but we still have much more to learn about how best to manage these individuals in terms of treatment timing. Ideally, with highly effective and tolerable therapies, patients can be effectively treated earlier in the course of HCV, and our experiences with decompensated cirrhosis will become increasingly more rare.

Your Thoughts?
What is the impact of all-oral therapies and the AASLD/IDSA guidance when managing patients with decompensated cirrhosis? I invite readers to post their thoughts in the comments section below.

Patients with cirrhosis, genotype 3 HCV infection, and HIV coinfection 
Evolving HCV Management in Harder-to-Treat Populations
In this module, Nancy Reau, MD, discusses recent clinical data on the management of HCV infection in harder-to-treat patient populations, including patients with cirrhosis, genotype 3 HCV infection, and HIV coinfection. Please join us for the corresponding dinner meeting series, where Dr. Reau and other faculty will apply the data shown here to the management of these key patient populations.
Faculty: Nancy Reau MD
Released: 5/5/2015

Downloadable Slideset
In this downloadable slideset, Nancy Reau, MD, highlights key clinical data on the management of patients with cirrhosis or reduced renal function, genotype 3 HCV infection, or HIV coinfection.




EASL Conference Coverage 

CCO’s Independent Conference Coverage of EASL 2015 includes Capsule Summaries, expert faculty analysis of key studies, and downloadable slides.

Begin, here.....

New At Clinical Liver Disease

The latest issue of Clinical Liver Disease is available on Wiley Online Library

Liver Transplantation
Guest Edited by Paul Martin, MD
Care of the patient with cirrhosis (pages 100–104)
Anitha Yadav and Hugo E. Vargas
Article first published online: 7 MAY 2015 | DOI: 10.1002/cld.462

Update on MELD and organ allocation (pages 105–107)
Eric F. Martin and Christopher O'Brien
Article first published online: 7 MAY 2015 | DOI: 10.1002/cld.464

and more.....

Healthy You 

How Fructose Messes up Your Liver
In the video above, Dr. Robert H. Lustig and Dr. Elissa S. Epel explain how excess sugar can mess up liver metabolism and ultimately lead to diabetes.






ACP Internist provides news and information for internists about the practice of medicine and reports on the policies, products and activities of ACP

Current Issue - May Issue

Preventive aspirin inflames opinions
By Charlotte Huff
Aspirin's long-standing role in cardiovascular health does not resolve its precise benefit in terms of cardiovascular prevention, specifically in patients who haven't had a myocardial infarction or stroke.
MORE



Download a PDF version of the May Issue of NIH News in Health

Have a wonderful Mother's Day!

Always Tina 

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