Ledipasvir-sofosbuvir plus ribavirin in advanced HCV does well

Meta-analysis- SVR and its Treatment Predictors in HCV Genotype 4 Compared to Genotypes 1, 2, and 3


Sustained Virological Response and its Treatment Predictors in Hepatitis C Virus Genotype 4 Compared to Genotypes 1, 2, and 3

Brittany E Yee; Nghia H Nguyen; Bing Zhang; Derek Lin; Philip Vutien; Carrie R Wong; Glen A Lutchman; Mindie H Nguyen

  • Does treatment with pegylated interferon and ribavirin bring about sustained virological response in HCV genotype 4 as compared to genotypes 1, 2, and 3?
Discussion Only

In our primary analysis, we included five studies with a total of 20 014 patients (899 HCV-4; 12 033 HCV-1; and 7082 HCV-2/3). We observed pooled SVR rates of 53%, 44%, and 73% in patients with HCV-4, HCV-1 and HCV-2/3, respectively. While SVR rates with HCV-2/3 patients were significantly higher than HCV-4, we found no statistically significant difference between SVR rates with HCV-1 patients compared to HCV-4.

Prior guidelines from EASL in 2013[94] and AASLD in 2009[5] recommended dual therapy with PEG-IFN+RBV for HCV-4 carriers. Both societies' recommendations for response guided therapy combined recommendations for HCV-4 with HCV-1. Beginning in 2011, telaprevir and boceprevir were the first new direct-acting antivirals (DAA) licensed for use in HCV-1. Currently there are several other DAAs available, including sofosbuvir, simeprevir, sofosbuvir/ledipasvir, and paritaprevir/ritonavir/ombitasvir, which are approved for HCV-1 and HCV-4.[95–97] With shorter treatment duration and higher potency, triple therapy has significantly improved virological response rates for many HCV-infected individuals. However, this therapeutic option may remain elusive for patients in developing or under-resourced regions who lack access to DAAs. Therefore, dual therapy with PEG-IFN+RBV will likely remain the mainstay of treatment for many CHC patients in developing countries and is still a treatment option in the WHO guidelines.[98]

Although societies have grouped HCV-4 with HCV-1, there has been conflicting data as some studies showed a trend towards higher SVR rates in HCV-4 compared to HCV-1,[14,32] whereas other studies have not demonstrated any significant differences.[42,43,46] In our meta-analysis of studies directly comparing HCV-4 and HCV-1 patients, HCV-4 patients had significantly higher rates of RVR (OR 1.96, CI 1.64 to 2.35, p<0.001), but no statistically significant difference in SVR rates (53% vs 44%, OR 1.16 (CI 0.92 to 1.48, p=0.21)). Additionally, when compared to patients with HCV-2/3, patients with HCV-4 and HCV-1 both had lower rates of RVR, EVR and SVR.

Our findings are similar to results from large randomised controlled trials of PEG-IFN+RBV treatment.[8,9] However, the generalisability of these previous trials has been limited due to the paucity of HCV-4, which represented less than 41 patients or 3% of the total subjects randomised to treatment with PEG-IFN+RBV. In contrast, the current meta-analysis includes 899 HCV-4 patients from studies, which also provided comparison data for other treated genotype(s). To our knowledge, this is the first meta-analysis comparing virological response in HCV-4 to HCV-1 and HCV-2/3 patients treated with PEG-IFN+RBV. Subgroup analysis included only observational or non-randomised studies since no large RCTs with sufficient numbers of HCV-4, HCV-1 and/or HCV-2/3 patients have been performed. In the absence of any large RCTs comparing these genotypes, this meta-analysis provides the largest sample of HCV-4, HCV-1 and HCV-2/3 patients with a direct comparison of their SVR rates.

In the secondary analysis of treatment predictors, RVR rates were 39.3% in HCV-4, 24.8% in HCV-1 and 75.9% in HCV-2/3. Prior estimates of RVR in all genotypes have ranged widely: 15%–60% in HCV-4,[7,16,17,24,34,38,42–44,58,65,99] 20%–45% in HCV-1,[99–103] and 60%–95% in HCV-2/3,[99,101,102,104–107] which may be due in part to demographic or epidemiological factors as well as the distribution of advantageous IL28B phenotypes, which were not assessed by the studies included in this analysis. In direct comparison, RVR was favoured in HCV-2/3 over HCV-4, OR 4.85 (CI 3.40 to 6.94, p<0.001) and HCV-4 over HCV-1, OR 1.96 (CI 1.64 to 2.35, p<0.001), a finding previously reported in the current literature.

With both AASLD and EASL guidelines, EVR is especially important for response-guided therapy as failure to achieve EVR is used to recommend discontinuation of therapy at week 12 of therapy. In our study, overall EVR rates were 72.8% in HCV-4, 59.4% in HCV-1, and 91.4% in HCV-2/3. SVR rates in those who achieved EVR were 75.4% in HCV-4, 64% in HCV-1 and 85.2% in HCV-2/3. In contrast, SVR rates in those who did not reach EVR were 10% in HCV-4, 13.1% in HCV-1, and 22.3% in HCV-2/3. Failure to achieve EVR was a negative predictor of response to treatment for all genotypes.

As with HCV-1, lack of EVR is a good stopping rule for HCV-4 given the low SVR rate in those without EVR in the current meta-analysis and supports the societal recommendations that group HCV-4 with HCV-1. In addition, continuing therapy in HCV-4 patients who achieve EVR is also important as approximately three-quarter of HCV-4 patients treated with PEG-IFN+RBV achieved EVR and of those patients, three-quarters achieved SVR.

Although our meta-analysis is the first to quantitatively evaluate treatment predictors and outcomes in such a large population of patients with HCV-4, HCV-1, or HCV-2/3, this study was not without its limitations. Data on newer, all-oral regimens was not included. Additionally, only a small number of studies with a significant amount of heterogeneity were available for this analysis, which limited our ability to perform any additional subgroup analyses or detect publication bias. Our comprehensive literature search yielded only observational or non-randomised studies. Although randomised controlled trials are the reference standard, the studies included in this analysis may be more generalisable to routine clinic settings of heterogeneous patient populations.

In summary, in this meta-analysis of PEG-IFN+RBV treated patients, we observed a higher SVR rate in HCV-2/3 (~70%) and comparable SVR rates in HCV-4 (~50%) and HCV-1 (~45%). As in HCV-1, failure to achieve EVR may be a good stopping rule for patients with HCV-4. Considering the lower SVR rates in HCV-4 and HCV-1, HCV-4 patients infected with these genotypes may significantly benefit from the recently FDA-approved triple therapies, where available. In more resource limited regions, given the higher rate of RVR (39%) and EVR in HCV-4 patients (73%) compared to HCV-1 patients (25% and 59%, respectively) and high SVR in those with EVR (75%), a response-guided approach using PEG IFN+RBV is probably still a reasonable option for the majority of patients. As hepatitis C treatment rapidly evolves, future trials may benefit from use of more diverse patient populations to improve the representation of less common genotypes.

Read more....

BMJ Open Gastroenterology 

World Hepatitis Summit harnesses global momentum to eliminate viral hepatitis

World Hepatitis Summit harnesses global momentum to eliminate viral hepatitis

2 SEPTEMBER 2015 ¦ GLASGOW - Participants at the first-ever World Hepatitis Summit will urge countries to develop national programmes that can ultimately eliminate viral hepatitis as a problem of public health concern.

“We know how to prevent viral hepatitis, we have a safe and effective vaccine for hepatitis B, and we now have medicines that can cure people with hepatitis C and control hepatitis B infection,” said Dr Gottfried Hirnschall, Director of the WHO’s Global Hepatitis Programme. “Yet access to diagnosis and treatment is still lacking or inaccessible in many parts of the world. This summit is a wake-up call to build momentum to prevent, diagnose, treat - and eventually eliminate viral hepatitis as a public health problem.”

Around 400 million people are currently living with viral hepatitis, and the disease claims an estimated 1.45 million lives each year, making it one of the world’s leading causes of death. Hepatitis B and C together cause approximately 80% of all liver cancer deaths, yet most people living with chronic viral hepatitis are unaware of their infection.

The summit, co-sponsored by WHO and the World Hepatitis Alliance, and hosted in Glasgow by the Scottish Government this week, is the first high-level global meeting to focus specifically on hepatitis, attracting delegates from more than 60 countries. The aim is to help countries enhance action to prevent viral hepatitis infection and ensure that people who are infected are diagnosed and offered treatment.

Policymakers, patient groups, physicians and other key stakeholders attending the summit aim to issue a declaration underlining their belief that the elimination of viral hepatitis is possible and urging governments to work with WHO to define and agree on global targets for prevention, diagnosis and treatment.

WHO is launching a new manual for the development and assessment of national viral hepatitis plans at the summit. Policymakers and other key stakeholders at the 3-day meeting (2-4 September) are also discussing the draft WHO Global Health Sector Strategy on Viral Hepatitis, which sets targets for 2030. The targets include a 90% reduction in new cases of chronic hepatitis B and C, a 65% reduction in hepatitis B and C deaths, and treatment of 80% of eligible people with chronic hepatitis B and C infections.

The World Summit, which is intended to become an annual event, aims to focus attention on a public health approach to viral hepatitis and to be a central forum for countries to share their experience and best practices to drive rapid advances in national responses.

“This summit is about empowering countries to take the practical steps needed at a national level. It has brought here to Scotland patients’ groups and civil society from across the world to support countries in doing this. We can eliminate viral hepatitis as a major global killer but we must all work together to make that vision a reality,” said Charles Gore, President of the World Hepatitis Alliance.

Putting in place a well-funded and comprehensive response is a challenge for many governments who have a high burden of hepatitis-related diseases. In sub-Saharan Africa and East Asia between 5-10% of the population is chronically infected with hepatitis B. High rates of chronic infections are also found in the Amazon and the southern parts of eastern and central Europe. Hepatitis C is found worldwide. Infection rates are high in Africa and Central and East Asia, and approximately two-thirds of people who inject drugs are infected with hepatitis C.

An increasing number of countries are taking action to address viral hepatitis. They include Egypt, which has substantially increased the number of people receiving treatment for hepatitis C in recent years; Georgia, which has set a goal for the national elimination of hepatitis C; and Mongolia, which has endorsed a comprehensive strategy for the control of viral hepatitis.
Media contacts

Alison Clements-Hunt
Communications Officer, WHO
Mobile: +41 793 863 943
E-mail: clementshuntal@who.int

Christian Lindmeier
Communications Officer, WHO
Mobile: +41 79 500 6552
E-mail: lindmeierch@who.int

Articles in Press - Liver Toxicity Associated with Sofosbuvir, an NS5A Inhibitor and Ribavirin Use

Journal of Hepatology
Articles in Press


Liver Toxicity Associated with Sofosbuvir, an NS5A Inhibitor and Ribavirin Use
Jessica K Dyson, John Hutchinson, Laura Harrison, Olorunda Rotimi, Dina Tiniakos, Graham R Foster, Mark A Aldersley, Stuart McPherson

Published Online: August 29, 2015

Abstract 

Hepatitis C (HCV) is a major cause of end-stage liver disease and hepatocellular carcinoma. There have been rapid advances in HCV treatment with the development of oral direct acting antivirals (DAAs). Studies have shown sustained virological response rates above 90% with combinations of DAAs, including patients with compensated cirrhosis. Thus far, significant drug toxicity has not been seen with these agents, but there is limited experience of using DAAs in decompensated HCV cirrhosis. This report describes the first experience of serious drug-induced hepatotoxicity with the new DAAs. The mechanism underlying these drug reactions is currently unknown. Few patients with decompensated cirrhosis have been treated with DAAs, so the exact pharmacokinetics in this population have not been characterised. In both cases patients were taking or had recently taken other drugs. It is possible that an unknown interaction or reaction to the drug combination caused the hepatotoxicity. Although the association with the DAAs is not proven these cases indicate that patients with advanced liver disease need close monitoring while on DAA therapy and if there is a significant unexplained deterioration in liver function the DAAs should be discontinued.

TGIF HCV Rewind: A Week In Review With A Spotlight On Don Crocock and Greg Jefferys

TGIF HCV Rewind: A Week In Review With A Spotlight On Don Crocock and Greg Jefferys

Hello everyone, we made it through another week, only a few day's until September, where does the time go?

Did you all see the article from "People" on Pamela Anderson? After living with HCV for over sixteen years she has decided to start therapy.

Its always great when hepatitis C is in the news, especially when a celebrity is involved, Anderson's announcement may reach more people over the next week than a year of "advocacy programs" designed to raise HCV awareness and testing, here is the statement.

After Living with Hepatitis C for 16 Years, Pamela Anderson Now Says 'I Could Be Cured Within a Month'
After experimenting with various alternative medicines, Anderson recently decided to try the new anti-viral medication. The Baywatch actress says, "I could be Hep C free within the month."

Lovely Pamela is not alone, close to 130-170 million people worldwide have HCV and those numbers do not include people who have no idea they are infected. The good news is that we have a cure, the bad news is the cost. Here is an article written by Lucinda K. Porter on the sad reality....

Creating a World Free of Hepatitis C
Lucinda K. Porter, RN
Hepatitis C Treatment is Worth Fighting for
Aug 20
Hepatitis C infection is curable. Unfortunately, a hepatitis C diagnosis is not an automatic qualifier for getting the medication. Many people are engaged in what seems like an endless fight for the newest hepatitis C drugs. Insurance companies were happy to approve treatment in the past, when treatments were difficult, risky, and less successful. Now that the drugs are costly, insurance companies are denying, denying, denying.....

Despite everything you hear, sometimes there is no fight at all. This is from a reader:
I am currently taking Harvoni (after having Hep C for 40 years) and here’s how I was able to get it – FOR FREE!

To learn more about FDA approved treatments for hepatitis C, start here, to read patient friendly newsletters published by our devoted HCV community, click here.

In The Spotlight

Today the spotlight shines brightly on two familiar HCV advocates, both men may not be Hollywood celebrities, but they sure are famous in my book. Don Crocock and Greg Jefferys have waged a campaign using Twitter and Facebook offering information and support to anyone battling hepatitis C. 

Don Crocock
I have great admiration for Don, his years of zealous work to increase HCV awareness to me is simply outstanding. 

HCV survivor takes advocacy to social media to help other patients and spread awareness

Don Crocock: The Hepatitis C Dragon Slayer
BY CARLY SZABO, ASSISTANT EDITOR
Don Crocock was not ashamed of his hepatitis C diagnosis in September 2008. Shocked, yes. Shaken, yes. But not ashamed. For many, a diagnosis of hepatitis C virus (HCV) comes with a sense of embarrassment due to the disease’s stigma of being “dirty.” But for Crocock, the news came with a sense of empowerment and a deep desire to share information about the virus with others in order to prevent further spread of the disease.
Read more

Connect with Dan on Facebook or Twitter.

Greg Jefferys
Greg Jefferys, a blogger at "Hep Blogs" is featured in an August article published online at "ABC." The author writes about Mr. Jefferys incredible journey to India in search of an affordable generic version of Gilead's Sovaldi (Sofosbuvir), 

Hepatitis C sufferer imports life-saving drugs from India, takes on global pharmaceutical company
By Michael Atkin and Joel Keep
Mr Jefferys was so sick from hepatitis C last year that he was unable to get out of bed some days.

He dropped out of his university PhD studies and quit many of his hobbies, including kayaking and fishing.

He desperately needed a drug called Sovaldi, manufactured by US pharmaceutical giant Gilead, but could not afford it without selling his house.
Read more

Mr. Jefferys has documented his trip to India, and so much more here on his website.
Connect with Greg on Facebook.

Next up we have a few editorials, a new "learning activity," an inspiring patient video, plus a collection of great articles written by your favorite bloggers, followed by research and news.

Editorials

World Journal of Hepatology
Three decades of hepatitis B control with vaccination
It is now 50 years since the discovery of the hepatitis B virus (HBV). Effective vaccines have been available since the 80s and vaccination has proved to confer lifelong protection against hepatitis B and was highly successful in reducing the disease burden. However, the occurrence of breakthrough infections, the immunological effect of natural boosting and the effectiveness of universal hepatitis B vaccination remains a challenge. The fight against HBV is not over
Clinical Liver Disease
Hepatitis C treatment: Back to the warehouse
Like many physicians that specialize in hepatitis C virus (HCV) treatment, I have spent the last few years advising many of my patients with chronic HCV infection to defer treatment and wait for new therapies. For those without advanced fibrosis or an extraintestinal manifestation of HCV, this process of “warehousing” patients for future HCV treatment made perfect sense.
Read more

Medscape
HCV: The Best Cure Possible or the Best Possible Cure?
Is a regimen combining interferon (IFN) with a highly effective direct-acting antiviral agents (DAA) still an acceptable choice in 2015? The ultimate goal for society as a whole is to obtain what is best for each individual, but in doing so, it should aim not towards the best possible cure, but the best cure possible.
Read more

HCV Treatment: What Can I Do Now? What's Coming Next?
The development of direct-acting antivirals represents a significant improvement in HCV treatment. New combinations of drugs have led to improved response rates, even in patients with characteristics previously associated with having lower response rates: African American, high viral load, concomitant cirrhosis, infection with genotype 1a, and failed treatment with other anti-HCV drugs.

HEPATITISC.NET
Expert Answers – Should people who use injection drugs be treated?
By Editorial Team
Injection drug use is the most common means of hepatitis C transmission. It’s estimated 70-90% of current and former injection drug users are infected with hepatitis C. Many in the community debate whether injection drug users should be treated.
Read more

Healio
Recent Approval Holds Promise for Genotype 3, but Hurdles Anticipated
HCV Next, August 2015
Genotype 3 accounts for 10% to 15% of patients with hepatitis C in the United States, but has been estimated to be the second most prevalent genotype…
Read more

Learning Activity

From Medscape Education Gastroenterology

Initiating Antiviral Therapy for HCV Infection in a New Era of Care: Treatment Vignette CME
A new CME was recently launched over at "Medscape" for physicians, and other healthcare professionals examining follow up care after HCV diagnosis. Although the "CME questions or post test" may not be of interest or patient friendly, a fictitious patient video vignette in the CME is worth watching for anyone considering treatment. The scenario is that of a newly diagnosed HCV patient at a two week follow up appointment.  In this "Treatment Vignette" liver heath, lifestyle changes, HCV testing of family members, adherence to treatment and follow up blood tests is examined.

Nancy Reau, MD

CME Released: 08/24/2015 

For Your Viewing Pleasure 

Hepatitis C Patient Journey: Coping With Drug Side Effects
In part four, Jim Wilson, RPh, MBA, president of WilsonRx, discusses the difficulties he faced during treatment from interferon therapy following his liver transplant.

Wilson was infected with an acute case of Non-A/Non-B hepatitis in 1975 due to a tainted blood supply but was not diagnosed with the disease until 1999. After receiving a liver transplant in 2006, he was finally cured of HCV in 2012 after enrolling in a 12-week clinical trial of the drug Harvoni.
PUBLISHED WEDNESDAY, AUGUST 26, 2015



Source

Blogger Updates

Lucinda K. Porter, RN @ Hep blogs
Aug 24
Surprising Updates to the HCV Guidelines
The HCV Guidelines added the combination of Daklinza/Sovaldi for 12 weeks for genotype 3 patients without cirrhosis or 24 weeks with/without ribavirin for those with cirrhosis.

What I did not anticipate was that the panel would make off-label recommendations for daclatasvir. Off-label use allows physicians to prescribe approved drugs according to their clinical judgment, regardless of the indication the FDA has approved for the drug.
Read more

Greg Jefferys
Did I sound a bit angry in my last post?
That's because I was. I was angry because every day I get emails from people who are desperate to begin treatment with these new antiviral drugs and they go to their doctor and the doctor refuses to write them a prescription.
Or their specialist sneers at them and asks,
"How do you know what is in these India drugs? How do you know they are safe?"

An Unintended, but Necessary Hepatitis C Advocacy
So take the interferon treatment, with a 50% possibility of a cure and a high chance of permanent organ damage but don't use Indian generics because there is a possibility they might be sub standard (or not). Go figure that out!

Rick Nash
Aug 19
Why Harvoni and Sovaldi failed me. They are amazing new drugs with high efficacy, but they may not be best for your situation..

View all blog updates at Hep Blogs , here.

Hepatitis C Research Center Blog
HCV Drug Costs: A Treatment Access Barrier
Posted on August 27, 2015
In a newly published, thought-provoking article in the journal Clinical Infectious Diseases, Stacey B. Trooskin and colleagues discuss how the high cost of newer hepatitis C therapies has become a major treatment access barrier in the US (Trooskin SB, et al. Clin Infect Dis. 2015 Aug 12 [Epub ahead of print]). Controversial insurance coverage restrictions and treatment rationing has resulted in national patient advocacy mobilization, US Congressional inquiry, and legal challenges. Authors of this article state that the establishment of a federal program, analogous to the successful AIDS Drug Assistance Programs (ADAP), would substantially reduce access barriers and facilitate focused price negotiations between pharmaceutical companies and payers.
Read more

AGA Journals BlogAug 28
Kristine Novak
Public Health Officials Call for Wider Access to HCV Drugs
Experts from the Public Health Service and President Obama’s Advisory Council on HIV/AIDS are calling on federal and state Medicaid officials to widen access to prescription drugs that could cure tens of thousands of people with hepatitis C virus (HCV) infection. They say restrictions on the drugs imposed by many
Read more

Aug 26
Is Nonceliac Gluten Sensitivity Real?
When patients with nonceliac gluten sensitivity (NCGS) unknowingly ingested small amounts of gluten for 1 week, they developed more severe abdominal pain and bloating that patients who ingested a matched placebo, researchers report in the September issue of Clinical Gastroenterology and Hepatology. The study provides evidence for a form of

Aug 19
Can we Reduce Muscle Cramps in Patients with Cirrhosis?
L-carnitine appears to be safe and effective for reducing muscle cramps in patients with cirrhosis, researchers report in the August issue of Clinical Gastroenterology and Hepatology. Many patients with cirrhosis develop frequent muscle cramps, which reduce their quality of life. L-carnitine (L-beta-hydroxy-gamma-N-trimethyl aminobutyric acid) is an amino acid that transports
Read more

Aug 12
What Causes Different Types of Fatty Liver Disease?
Hepatic steatosis and steatohepatitis are increasing in prevalence, and can progress to histologically identical, more severe liver disease. They are associated with 3 main factors: alcohol, obesity or metabolic syndrome, and exposure to toxins. Researchers review the similarities, differences, and pathogenic mechanisms of alcohol-associated steatohepatitis (ASH), nonalcoholic steatohepatitis (NASH), and toxicant-associated fatty liver

Aug 10
Does Weight Loss Resolve Fatty Liver Disease?
Two separate studies in the August issue of Gastroenterology show that weight loss, via diet or bariatric surgery, reduce features of non-alcoholic steatohepatitis (NASH). Eduardo Vilar-Gomez et al associated extent of weight loss, produced by lifestyle changes, with level of improvement in histologic features of NASH. The highest rates of NASH reduction
Read more

NEJM
Aug 20
When to Start HCV Treatment: The Intersection of Guidelines and Real-World Practice
By Kelly Eagen, MD
Treatment for hepatitis C virus (HCV) infection is changing at a pace almost too rapid for the average physician to keep up with. Until recently, HCV treatment required weekly interferon injections plus oral ribavirin for up to a year and
Read more

HIV and ID Observations
Aug 23
Post-Exposure Prophylaxis for HCV Can’t Be Cost-Effective — But We Might End Up Recommending It Anyway
An email query from a colleague:
Hi Paul,
Just got a call from one of our surgeons who got a needlestick from a suture needle, small amount of blood. Patient is HCV +. Any post-exposure prophylaxis recommended?
Thanks,
Dan
Read more

In Case You Missed It
The always informative "Mid-Month Newsletter" published by "HCV Advocate" is out.

Mid-Month Newsletter


August 15, 2015
In This Issue:


Alan Franciscus, Editor-in-Chief
In this month’s column of HCV Drugs I discuss the exciting news about the Food and Drug Administration (FDA) approval of AbbVie’s and BMS’s HCV medications, the study results from AbbVie’s once-a-day combination to treat genotype 1b, and the acceptance by the FDA of Merck’s new drug application for grazoprevir and elbasvir and the decision date.
Read more...


Balance Billing by Out-of-Network Providers
Jacques Chambers, CLU
Jacques Chambers monthly column is a MUST READ for anyone who wants to avoid a big surprise on their medical bill. Read this informative article to learn how to avoid costly mistakes that could put you in DEBT.
Read more...


Alan Franciscus, Editor-in-Chief
The Five column this month tackles some of the most common HCV myths: HCV being a death sentence, which genotype is the worse one, if there are symptoms or not, the myth of a HCV vaccine, and more.
Read more...


Alan Franciscus, Editor-in-Chief
The Mid-Month Edition of Snapshots will cover three abstracts—children and HCV treatment, the problem of HCV related cirrhosis medical coding and the numbers, and the association of HCV and cardiac problems.
Read more...

What's New:
Alan Franciscus, Editor-in-Chief
A sneak peak of our new website and the date it will be launched – HINT—September 1, 2105 – check it out!
Read more...

Research

Interferon-free regimens overcome the effects of portal hypertension on virological responses in Hep C
Aug 28
September's publication of the Alimentary Pharmacology & Therapeutics investigated the effects of portal pressure on virological responses in hepatitis C patients treated with interferon-free regimens.
Read more

Resistance-Associated Gene Variants Found In Hep C Patients Who Received First-Generation DAAs
First-generation triple therapies for hepatitis C virus (HCV) infection are being phased out in favor of next-generation interferon-free direct-acting antiviral agents (DAAs).
Read more..

Mechanisms of Non-response to Hepatitis C Therapy
Liver International, August 28, 2015
Since the introduction of interferon-based therapy for hepatitis C virus (HCV) infection, predictors of response have been carefully evaluated to determine which patients are more likely to respond and why. While many of these factors were identified and explained, the presence of cirrhosis remains one of the well established yet least understood conditions that complicate HCV therapy.[1] In this review, we aim to shed light on the various and likely multifactorial mechanisms responsible for impaired responses in patients with cirrhosis.
Read more

Fatty Liver and Diabetes Increase Liver Fibrosis Risk
The combination of diabetes and nonalcoholic fatty liver disease increase the risk for liver fibrosis more than fivefold, according to a large prospective cohort study published online July 14 in Hepatology.

"These findings underline the significant role of these — potentially modifiable — risk factors in liver fibrosis and stress the importance of early targeting insulin resistance and/or [diabetes mellitus]," write Edith M. Koehler, MD, from the Erasmus MC University Hospital Department of Gastroenterology and Hepatology in Rotterdam, the Netherlands, and associates. "[They also] suggest that [nonalcoholic fatty liver disease] may be an important determinant of clinically relevant fibrosis in a population that has a very low prevalence of viral hepatitis."
Read more

Interferon-free regimens for the treatment of hepatitis C virus in liver transplant candidates or recipients
Treatment against hepatitis C virus has dramatically improved with the novel direct-acting antivirals (DAAs). The currently available DAAs are sofosbuvir, simeprevir, daclatasvir, ledipasvir/sofosbuvir, paritaprevir/ombitasvir and dasabuvir. IFN-free combinations of these novel DAAs with or without ribavirin give excellent sustained virological response in patients with decompensated cirrhosis awaiting liver transplantation and those with recurrence of hepatitis C post liver transplantation. More data regarding the safety and efficacy of these new DAAs are needed, but ongoing clinical trials and real life data will clarify better these issues.
Read more

Prevalence of Insomnia and Sleep Patterns among Liver Cirrhosis Patients
Few studies are available regarding the prevalence of sleep disturbance in cirrhotic patients without overt hepatic encephalopathy. This study aimed to assess the prevalence of insomnia in stable liver cirrhosis patients who are attending the outpatient clinics at King Abdulaziz Medical City, Riyadh (KAMC-KFNGH).
Read more

Hepatitis C in the UK 2015 report
Download PDF

Hot Topic

One in Four Hepatitis C Patients Denied Initial Approval for Drug Treatment 
New Haven, Conn. -- Nearly one in four patients with chronic hepatitis C (HCV) are denied initial approval for a drug therapy that treats the most common strain of the infection, according to a Yale School of Medicine study. The finding, published Aug. 27 in PLOS ONE, identifies a new barrier to caring for patients with this severe condition.

Here is the PLOS ONE study; Drug Authorization for Sofosbuvir/Ledipasvir (Harvoni) for Chronic HCV Infection in a Real-World Cohort: A New Barrier in the HCV Care Cascade

A Look At This Week's Headlines

Hepatitis C: Meet the Meds
By Roger Pebody
From TheBody.com
August 28, 2015
Hepatitis C treatment used to have a terrible reputation. Until very recently, it consisted of weekly injections with pegylated interferon and daily tablets of ribavirin.

Not everyone did badly, but a significant number of people had debilitating side effects from the injections, including fever, tiredness and depression. Treatment usually lasted six months to one year. Worse, it didn't get rid of hepatitis C in everyone.

The new generation of hepatitis C treatments are different. You only need to take pills, and often just for 12 weeks (three months).

Oysters harbor, transmit human norovirus: Avoid raw ones
American Society for Microbiology
Washington DC - August 28, 2015 - Oysters not only transmit human norovirus; they also serve as a major reservoir for these pathogens, according to research published August 28 in Applied and Environmental Microbiology, a journal of the American Society for Microbiology. "More than 80 percent of human norovirus genotypes were detected in oyster samples or oyster-related outbreaks," said corresponding author Yongjie Wang, PhD.

FDA warns of severe joint pain risk with DPP-4 diabetes drugs
- A class of diabetes drugs that include Merck & Co Inc's Januvia have been linked with severe joint pain, the U.S. Food and Drug Administration said on Friday.

Harvoni Sees Near-Perfect Cure Rate for Hep C Genotype 4
Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) cured almost all people with genotype 4 of hepatitis C in a small trial.

Health ministry approves new hepatitis C drug under insurance scheme
A health ministry panel has added a new highly effective, but expensive, hepatitis C virus drug to the national health insurance scheme, giving high hopes for patients who have had to endure painful interferon injections. 

Wider Reach Is Sought for Costly New Hepatitis C Treatments
WASHINGTON — Federal and state Medicaid officials should widen access to prescription drugs that could cure tens of thousands of people with hepatitis C, including medications that can cost up to $1,000 a pill, health care experts have told the White House.

Hepatitis C - Liver Damage Significantly Underestimated and Underreported
The number of hepatitis C patients suffering from advanced liver damage may be grossly underestimated and underdiagnosed, according to a study led by researchers at Henry Ford Health System and the U.S. Centers for Disease Control and Prevention.

Of Interest

August 2015
Summary report: Hepatitis C Good Practice Roadshow, London
This report provides a summary of the good practice hepatitis C roadshow held by HCV Action and Public Health England on 26th June 2015. The roadshow was aimed at sharing good practice around hepatitis C and instigating local action to address the virus. The report includes summaries of the talks and workshops held on the day, as well as suggested next steps to be taken in order to tackle hepatitis C more effectively in the capital. 

August 2015
Developed by the Hepatitis C Coaltiion on the basis of interviews with patient and clinical experts, as well as drawing upon the expertise within the Hepatitis C Coalition’s membership, this fact-sheet provides an overview of the linkages between hepatitis C and alcohol-related liver disease. As well as detailing the interactions between the two conditions, it also details the health impact, as well as the latest relevant policy developments.

View Complete List Of August Reports @ HCV Action.

Enjoy the upcoming weekend.
Tina