The American Association for the Study of Liver Diseases, Infectious Diseases Society of America, and International Antiviral Society-USA Hepatitis C Guidance Update (July 2016)

Summary: This version of guidance for those prescribing hepatitis C treatments was updated to included recent developments, such as the approval of the hepatitis C treatment Epclusa (sofosbuvir/velpatasvir).

Annals of Internal Medicine (August 2016)

• Elbasvir–Grazoprevir to Treat Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy: A Randomized Trial by Gregory J. Dore, et al.

Summary: The study evaluated Zepatier (elbasvir/grazoprevir) in treating hep C in those who inject drugs (PWID) while being treated for opioid use with opioid-agonist therapy (OAT). The study resulted in high rates of SVR12/’cure rates’ and low levels of side effects, regardless of ongoing drug use. (hivandhepatitis.com blog post with more information)

Journal of Addiction Medicine (July/August 2016)

• A Needs Assessment of the Number of Comprehensive Addiction Care Physicians Required in a Canadian Setting by J. McEachern, et al.

Summary:  Using population estimates, the assessment found 23 certifed physicians for every 1000 affected individuals. The study highlighted the need for more healthcare provider training for rural health regions. (CBC post with more information)

Journal of Hepatology (July/August 2016)

• Efficacy and safety of elbasvir/grazoprevir and sofosbuvir/pegylated interferon/ribavirin: a phase III randomized controlled trial by Jan Sperl, et al.

Summary: This head-2-head study compared the safety and efficacy of Zepatier (elbasvir/grazoprevir) and Sovaldi (sofosbuvir)  plus pegylated interferon/ribavirin (PR) in patients with hep C who were mainly treatment-naive, without liver cirrhosis, and had hep C genotype 1b. The study found that the SVR12/cure rates were 99.2% (Zepatier) and 90.5% (Sovaldi/PR). Both treatments only caused very low rates of side effects.

• Global genotype distribution of hepatitis C viral infection among people who inject drugs by Geert Robaeys, et al.

  Summary: There is a different occurrence of hep C virus types in persons who inject drugs than in the general population. Especially with hep C genotype 3 that is more common in persons who inject drugs than it is in the general population in Western countries.

• Unexpected high incidence of hepatocellular carcinoma in patients with hepatitis C in the era of DAAs: too alarming? by Qing-Lei Zeng, et al.

• Hepatocellular carcinoma and direct acting antiviral treatments: Controversy after the revolution by Jean-Charles Nault, et al.

The Lancet Gastroenterology & Hepatology (August 2016)

• Patient-reported outcomes with sofosbuvir and velpatasvir with or without ribavirin for hepatitis C virus-related decompensated cirrhosis: an exploratory analysis from the randomised, open-label ASTRAL-4 phase 3 trial by Zobair M Younossi, et al.

Summary: This is an assessment of patient outcomes looking only at patient-reported outcomes (PROs) by patients with liver cirrhosis who took Epclusa (sofosbuvir and velpatasvir) with and without ribavirin. The study found that PROs, such as emotional, mental, and social well-being as well as work productivity, dipped during the hep C treatment but improved after it.

• Efficacy and safety of 3-week response-guided triple direct-acting antiviral therapy for chronic hepatitis C infection: a phase 2, open-label, proof-of-concept study by George Lau, et al.

Summary:  In this proof-of-concept study, patients were give hep C treatments (sofosbuvir, ledipasvir, and asunaprevir; sofosbuvir, daclatasvir, and simeprevir; and sofosbuvir, daclatasvir, and asunaprevir) for only 3 weeks instead of the usual 12 or 24 weeks. The treatments were successful.

Recent Press Releases by Pharmaceutical Companies

• How a World Free from Viral Hepatitis is Possible: An Interview with Raquel Peck, CEO of the World Hepatitis Alliance
• AbbVie Receives U.S. FDA Approval of Once-Daily VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C
• CHMP Grants Positive Opinion for Shorter Treatment Duration with AbbVie’s VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) for Patients with Genotype 4 Chronic Hepatitis C with Compensated Cirrhosis (Child-Pugh A)
• European Commission Grants Marketing Authorization for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C
• Results from Merck’s Phase 3 Study Evaluating ZEPATIER™ (elbasvir and grazoprevir) in Patients with Chronic Hepatitis C Receiving Treatment for Opioid Dependence Published in Annals of Internal Medicine

The post Recently Published Hep C Studies, Articles, and Press Releases appeared first on Hepatitis C Treatment Information Project.

Wednesday August 24, 2016 to MIDNIGHT ON Wednesday September 21, 2016 is tentatively when input will be sought.

Submitting Input to BC PharmaCare about Hepatitis C Treatments and Epclusa

The BC PharmaCare approval process seeks input from patients and caregivers or loved ones of those who have or have had hepatitis C. If you are a BC resident and answer YES to any of the following questions, you can complete a questionnaire and send BC PharmaCare your input into whether or not they should cover Epclusa:

1. Do you have hep C?
2. Are you a caregiver to someone who has hep C?
3. Does your patient group represent patients who have hep C AND have you registered with PharmaCare to give input? (Learn more about registering your organization).

Please note that PharmaCare’s questionnaire for Epclusa input wont tentatively be available for another two weeks. The Hepatitis C Treatment Information Project will send the questionnaire’s link out when BC PharmaCare makes it available.

Epclusa

Epclusa is the first pan-genotypic hepatitis C treatment to be approved for use in Canada against all six hep C virus types. A pan-genotypic treatment is a treatment able to cure all six of the hep C virus types with high success rates against all six.

More Information about Epclusa

• Epclusa: An Information Sheet for an Approved Treatment
• Epclusa: Approved treatment for all hep C types
• Hepatitis C treatment Epclusa approved in Canada—key information by CATIE
• Gilead Canada‘s press release about receiving a Notice of Compliance (NOC) from Health Canada for Epclusa
• Epclusa’s Canadian product monograph by Gilead

For more information, please contact Your Voice or the Hepatitis C Treatment Information Project.

The post Is Epclusa soon-to-be considered for BC PharmaCare coverage? appeared first on Hepatitis C Treatment Information Project.

The Canadian Drug Expert Committee Final Recommendation is important within the Canadian drug approval process as it’s sent to the provinces and territories to help them decide on how they want to cover the treatment through their PharmaCare plans.

The CDEC Final Recommendation for Sunvepra (asunaprevir) when combined with Daklinza (daclatasvir)

The CDEC advocates that Sunvepra, in combination with Daklinza (daclatasvir), be listed by drug plans as a treatment for adults with chronic hepatitis C genotype 1b and with Daklinza, pegylated interferon, and ribavirin, for patients with hep C genotype 1 or 4, if the following criteria/conditions are met:

Recommended Clinical Criteria

• None listed. This is the first CDEC report for a hep C treatment to not recommend that the treatment only be covered for patients who have a liver fibrosis stage of F2 or higher–this is a great omission.
  

Recommended Conditions

• Drug plans should save money when comparing this treatment’s cost to the cheapest hep C treatment alternative.

• Treatment should be started by hepatologists or physicians experienced with treating chronic hepatitis C.

Reasons for the Above Sunvepra Recommendations

1. A review of clinical trial results suggests that Sunvepra’s treatment response rates are comparable to success/cure rates of other interferon-free hep C treatments. However, it was noted that there are no trial results with direct comparisons to other treatments already covered by public drug programs. This has also been noted in CDEC recommendations for other hep C treatments.

2. “There is uncertainty regarding the cost-effectiveness of ASV [Sunvepra] combination regimens…” when they are compared with other hepatitis C treatments.(CDEC)

Noted Discussion Points

• Efficacy of these Sunvepra-based treatment combinations for patients with decompensated liver disease, hepatitis B, or HIV coinfection, malignancy, or recent drug use, remains uncertain. However, the current data indicates that Daklinza + Sunvepra is effective and safe for all of these patients.
• The CDEC believes that there will be “limited use” of pegylated interferon with ribavirin-based treatments when there are interferon-free treatments available.
• Further research into patients infected with hepatitis C with L31 or Y93 HCV NS5A-resistant variant at baseline is needed. (CDEC)

The Canadian Drug Expert Committee’s Final Recommendation for Sunvepra can be found here.

Sunvepra (asunaprevir)

Sunvepra (asunaprevir) is prescribed with other hepatitis C treatments/direct-acting antivirals (DAAs). It is a treatment for patients with chronic hepatitis C genotype 1 or 4.

Sunvepra, in combination with Daklinza, peginterferon, and ribavirin, has been tested on those with hep C genotype 1 or 4 who were non-responders (patients who tried treatment but it failed to achieve SVR/a cure) with great results. The cure rate when treating patients with hep C genotype 1 is 93.2%. The cure rate when treating patients with hep C genotype 4 is 100%. (Health Canada)

Lastly, doctors are able to prescribe Sunvepra to patients, but the hepatitis C treatment isn’t covered by PharmaCare yet.

The post Sunvepra (Asunaprevir) Final Recommendation Sent to PharmaCare Plans appeared first on Hepatitis C Treatment Information Project.

For those not Living in Canada’s Major Cities

There are clinical trials currently or about to be looking for participates in cities beyond Canada’s major cities. If you are interested in clinical trials for hep C treatments, but don’t live in Toronto or Vancouver, this may be the time for you to wonder about participating in a clinical trial.

Examples of Canadian Cities Hosting Hep C Clinical Trials

Wondering about Participating in Clinical Trials?

Those participating in clinical trials must meet certain criteria, and, in addition to taking the drugs, are asked to complete questionnaires and submit blood work and other lab results for research purposes. As well as a commitment to the course of treatment, there is also a time commitment to complete all of the data collection required as a participant in the clinical trial.

For those considering participating in clinical trials, talk with a health care provider you trust about your options. Try to gather as much research as you can, and talk with other people who have also participated in clinical trials.

More Information

Interested in clinical trials? Beyond the Hepatitis C Treatment Information Project’s Clinical Trials Currently Recruiting in Canada page, there is also addition information about clinical trials on our Considering Treatment page and our Participating in Clinical Trials page. ClinicalTrials.gov is also a great resource and includes additional information about clinical trials being planned or taking place around the world.

The post The Hepatitis C Treatment Information Project has been Updated appeared first on Hepatitis C Treatment Information Project.

Free Journal Articles Published by Gastroenterology & Hepatology

Hepatitis C Disease Burden in the United States in the Era of Oral Direct-Acting Antivirals

Immunological aspects of antiviral therapy of chronic hepatitis B virus and hepatitis C virus infections

Antiviral therapy for chronic hepatitis B viral infection in adults: A systematic review and meta-analysis

Cost-effectiveness of hepatitis C treatment for patients in early stages of liver disease

Screening for hepatitis B virus to prevent viral reactivation — who and when?

Review article: safety and tolerability of direct-acting anti-viral agents in the new era of hepatitis C therapy

Systematic review: current concepts and challenges for the direct-acting antiviral era in hepatitis C cirrhosis

Early events in hepatitis B virus infection: From the cell surface to the nucleus

JSH Guidelines for the Management of Hepatitis C Virus Infection: A 2016 update for genotype 1 and 2

Hepatitis E: an emerging global disease – from discovery towards control and cure

Hepatitis B virus: new therapeutic procedures

Toll-like receptor (tlr)-2 exacerbates murine acute viral hepatitis

Hepatitis C virus-induced myeloid-derived suppressor cells regulate T-cell differentiation and function via the signal transducer and activator of transcription 3 pathway

Free Journal Articles Published by The Lancet

Editorial: Towards elimination of viral hepatitis by 2030

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*Gastroenterology & Hepatology content from http://onlinelibrary.wiley.com/subject/code/000059/homepag/world_hepatitis_day.htm?elq_mid=11083&elq_cid=2613383 retrieved on July 28th, 2016.

The post Celebrate World Hepatitis Day with Free Journal Articles appeared first on Hepatitis C Treatment Information Project.

An extended-release therapy is a treatment made up of pills that were created to slowly release over time. This slow release gives the drugs more time to work and may allow the levels of the drugs in the body to be more consistent than they may be with other treatment types. This may help lower side effects.

For more information about this FDA approval or about the hepatitis C treatment, please see the press release by AbbVie, the developer of Viekira Pak/Holkira Pak and Viekira XR.

The post Viekira XR Received US FDA Approval appeared first on Hepatitis C Treatment Information Project.

2016 World Hepatitis Day

Community Forum: Hepatitis C and HIV Co-Infection – Transmission to Treatment

“Hepatitis C and HIV Co-Infection – Transmission to Treatment is the focus of Positive Living BC’s community forum on July 28. This event is free and open to everyone, no RSVP is required. You are invited to drop in to learn about advances in hepatitis C care in Canada, and to meet new people and share your own experiences. Snacks and lunch will be provided. The event will run from 10:30 am to 12 pm.

“The forum will take place at the Carnegie Centre (401 Main St). Dr. Alexandra King, MD, FRCPC, Lu’ma Medical Centre and Suzan Krieger, Access and Assistance Coordinator at Positive Living BC will be presenting. The forum is produced in co-operation with the Pacific Hepatitis C Network.” (Positive Living BC, 2016)

Community Forum’s Details

Date: July 28th

Time: 10:30 am – 12:00 pm

Where: Carnegie Centre, 401 Main Street, Vancouver

For more information, please contact Brandon or phone 604-893-2239.

All are Welcome!

World Hepatitis Day

“Did you know? July 28 is World Hepatitis Day. In 2010, the World Health Organization (WHO) made World Hepatitis Day one of only 4 official disease-specific world health days, to be celebrated each year on the 28th of July. Millions of people across the world now take part in World Hepatitis Day, to raise awareness about viral hepatitis, and to call for access to treatment, better prevention programs and government action. The theme for World Hepatitis Day Canada 2016 is ‘Know Your Status? Get Tested – Learn Your Options’.” (Positive Living BC, 2016)

Please visit World Hepatitis Day Canada or World Hepatitis Day for more information about the global event. Please visit our blog post, 2016 World Hepatitis Day Events Around British Columbia, for information about World Hepatitis Day events taking place around BC.

The post HCV and HIV Co-Infection – Transmission to Treatment Forum appeared first on Hepatitis C Treatment Information Project.

Epclusa (PDF)

Treatment Description: Epclusa is a short-course, interferon-free, hepatitis C treatment. It is one pill taken once a day and can be prescribed with or without ribavirin.

Targeted Genotypes: 1-6

Doses and Treatment Lengths:

• 12 weeks of the once-daily pill Epclusa for patients without liver cirrhosis and patients with compensated liver cirrhosis
• 12 weeks of the once-daily pill Epclusa and ribavirin for patients with more serious liver cirrhosis

Possible Side Effects when Taken Without Ribavirin:

• Headache
• Fatigue (Tiredness)

Possible Side Effects when Taken With Ribavirin:

Usage Warning: Patients with Bradycardia taking amiodarone can not take Epclusa. There have been reports of severe bradycardia (slow heart rate) or heart block (problems with conduction of electrical signals in the heart). Don’t take rifampin, St. John’s wort, or carbamazepine while taking Epclusa.

Clinical Trial Results for Epclusa

Momentum Support Program

Epclusa has been added to Gilead Canada’s Momentum Support Program. This support program provides information to patients and healthcare providers to help patients access Epclusa and Gilead’s other hepatitis C treatments. In Canada, please call 1-855-447-7977 for more information.

More Information

• Epclusa: Approved treatment for all hep C types
• Gilead Canada‘s press release about receiving a Notice of Compliance (NOC) from Health Canada for Epclusa
• Epclusa’s Canadian product monograph will be posted shortly

“We can now cure the majority of HCV-infected patients with a simple, safe and effective 12-week treatment, regardless of genotype or treatment history.” ~Dr. Jordan Feld

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*A pan-genotypic treatment is a treatment able to cure all six of the hep C virus types with high success rates against all six.

The post Epclusa: An Information Sheet for an Approved Treatment appeared first on Hepatitis C Treatment Information Project.

The Importance of a Notice of Compliance (NOC)

Receiving a Notice of Compliance from Health Canada allows a treatment to be sold in Canada with official approval. If a drug has a Notice of Compliance, a doctor may prescribe it – but at this stage the new drug is still not available on public drug plans, like BC PharmaCare, just private insurers. Private insurers each decide company coverage of the new drug (i.e. what percentage of the drug costs they will cover).

The Importance of Epclusa

Epclusa, the first hep C pan-genotypic treatment, is amazing as it has the power to make hep C treatment much easier than it is now. As Dr. Jordan Feld, a liver specialist at Toronto Western Hospital, explained, a treatment that can be used for every virus type “…eliminates the need for [virus type/genotype] testing, which often delayed treatment and can be difficult to access for those living in rural or remote regions of the country….” (Ubelacker, The Canadian Press)

Also, Epclusa is the first treatment for patients with a hep C genotype 2 or 3 infection that doesn’t need ribavirin to achieve best treatment results.

Response by the Pacific Hepatitis C Network’s President, Daryl Luster

“The Pacific Hepatitis C Network is certainly pleased to hear that the first hepatitis C pan-genotypic, single pill, treatment has been approved for use in Canada.” said Daryl Luster, president of the Pacific Hepatitis C Network. “It is our hope that this approval signifies an end to interferon-based therapies. We also hope that this drug approval will lead to more people being able to access interferon-free treatment, regardless of their hep C genotype, treatment histories, or their access to local hepatitis C specialists.”

Epclusa

Epclusa is a short-course (12 weeks), interferon-free, hepatitis C treatment that can be prescribed with or without ribavirin. It is one pill taken once a day. With or without ribavirin, it cured 83-98% of patients in clinincal trials, it also cured 94% of those with  moderate to severe liver cirrhosis.

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*A pan-genotypic treatment is a treatment able to cure all six of the hep C virus types with high success rates against all six.

The post Epclusa: Approved treatment for all hep C types appeared first on Hepatitis C Treatment Information Project.

A treatment able to cure all virus types is amazing as it has the power to make hep C treatment much easier than it is now. As Dr. Jordan Feld, a liver specialist at Toronto Western Hospital, explains, a treatment that can be used for every virus type “…eliminates the need for [virus type/genotype] testing, which often delayed treatment and can be difficult to access for those living in rural or remote regions of the country….” (Ubelacker, The Canadian Press)

News Reports Remain Unverified

The Hepatitis C Treatment Information Project tried to double check that this treatment has indeed been approved, and approved as the articles have said. However, we were unable to reach Gilead, the treatment’s developer, and Health Canada before this blog post was published. This failure to reach the two parties was probably because it was early evening in BC and so passed business hours in the East when this post was written.

We will follow this story and share additional information as it becomes available.

Sofosbuvir / Velpatasvir

Description: Sofosbuvir / velpatasvir is a short-course, interferon-free, hepatitis C treatment that can be prescribed with or without ribavirin. It is one pill taken once a day.

Treatment Lengths Approved in America:

• 12 weeks for patients without liver cirrhosis and patients with compensated liver cirrhosis (Child-Pugh A)
• 12 weeks for patients with more serious  liver cirrhosis (Child-Pugh B or C) when it is combined with ribavirin.

Most Common Side Effects when Treatment is Taken Without Ribavirin:

• Headache
• Fatigue (Tiredness)

Most Common Side Effects when Treatment is Taken With Ribavirin:

• Fatigue (Tiredness)
• Anemia
• Nausea
• Headache
• Insomnia (Can’t sleep)
• Diarrhea

Clinical Trial Results for Sofosbuvir / Velpatasvir

In Phase III clinical trials, the treatment’s safety and effectiveness as a 12 week treatment was evaluated on 1,558 patients without liver cirrhosis or with mild cirrhosis. With or without ribavirin, it cured 95–99% of those patients. In trials, it also cured 94% of those with  moderate to severe liver cirrhosis.

“This drug regimen changes the standard of care in treating patients with HCV. We can now cure almost everyone with a very simple treatment.” ~Dr. Jordan Feld, a liver specialist at Toronto Western Hospital

The post Global and CTV News Report that Health Canada has Approved Epclusa appeared first on Hepatitis C Treatment Information Project.