HCV New Drug Research
- September 02, 2015
Prior guidelines from EASL in 2013 and AASLD in 2009 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.
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.
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.
BMJ Open Gastroenterology
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.
Communications Officer, WHO
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Communications Officer, WHO
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Journal of Hepatology
Articles in Press
Jessica K Dyson, John Hutchinson, Laura Harrison, Olorunda Rotimi, Dina Tiniakos, Graham R Foster, Mark A Aldersley, Stuart McPherson
Published Online: August 29, 2015
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."
Hepatitis C Treatment is Worth Fighting for
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
I have great admiration for Don, his years of zealous work to increase HCV awareness to me is simply outstanding.
By Michael Atkin and Joel Keep
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.
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.
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
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.
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.
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.
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.
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…
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.
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
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.
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?"
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!
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.
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
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
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
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
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
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
Post-Exposure Prophylaxis for HCV Can’t Be Cost-Effective — But We Might End Up Recommending It Anyway
An email query from a colleague:
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?
In Case You Missed It
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.
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.
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.
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.
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!
Interferon-free regimens overcome the effects of portal hypertension on virological responses in Hep C
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.
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. In this review, we aim to shed light on the various and likely multifactorial mechanisms responsible for impaired responses in patients with cirrhosis.
Fatty Liver and Diabetes Increase Liver Fibrosis Risk
"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."
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.
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).
Hepatitis C in the UK 2015 report
One in Four Hepatitis C Patients Denied Initial Approval for Drug Treatment
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
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).
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
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
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.
Summary report: Hepatitis C Good Practice Roadshow, London
At the end of July the FDA approved two new drugs for hepatitis C, one for genotype 3 called Daklinza "Daclatasvir" in combination with sofosbuvir and the other is Technivie (ombitasvir, paritaprevir, ritonavir) for genotype 4. To view package insert, dosage, warnings, drug interactions and side effects, in addition research and news for both newly approved drugs, click here for Daklinza and here for Technivie. To view all approved treatments for hepatitis C, click here.
of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.
Hepatitis C News Of The Day
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Testing, Diagnosis and Treatment
Do You Have A Question About HCV?
HepCBC presents the March release of Peppermint Patti's Hepatitis C FAQs - version 10.
FDA Approved Drugs
FDA approved hepatitis C treatments
Drugs Under Development
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