Category Archives: Drug Pipeline

Drug Pipeline

Recently Published Hep C Studies, Articles, and Press Releases

The following highlights a variety of recently published studies, articles, and press releases published about hepatitis C and hepatitis C treatments.

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
Drug Pipeline

Is Epclusa soon-to-be considered for BC PharmaCare coverage?

Epclusa soon-to-be considered for BC PharmaCare coverage?YES. The Hepatitis C Treatment Information Project just received an advance notification from BC’s Ministry of Health that the hepatitis C treatment Epclusa (generic name sofosbuvir / velpatasvir) will soon be considered for BC PharmaCare coverage.

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

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

Drug Pipeline

Sunvepra (Asunaprevir) Final Recommendation Sent to PharmaCare Plans

Sunvepra (asunaprevir) Final RecommendationSunvepra (generic name asunaprevir), developed by Bristol-Myers Sqibb, passed its Common Drug Review with the release of the Canadian Drug Expert Committee (CDEC) Final Recommendation for it.

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.

Drug Pipeline

Viekira XR Received US FDA Approval

Viekira XR Received U.S. FDA ApprovalViekira XR has been FDA approved in America. Viekira XR is an extended-release version of the hepatitis C treatment Viekira Pak (American brand name Viekira Pak / Canadian brand name Holkira Pak). This extended-release version is for patients with chronic genotype 1 hepatitis C, including those with compensated cirrhosis (Child-Pugh A). The treatment includes 3 pills, taken daily with food, that may or may not be combined with ribavirin. It may be prescribed for 12 or 24 weeks of therapy.

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.

Drug Pipeline

Epclusa: An Information Sheet for an Approved Treatment

Epclusa: An Information SheetEpclusa (generic name sofosbuvir / velpatasvir) is the first pan-genotypic hepatitis C treatment* to be approved for use in Canada against all six hep C virus types! In celebration, the Hepatitis C Treatment Information Project has put together the following Epclusa information sheet.

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:

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

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

Clinical Trial Patients Treatment Regimen SVR
ASTRAL-1, ASTRAL-2, ASTRAL-3 1,035 with hep C genotypes 1-6 with or without cirrhosis (Child-Pugh A) EPCLUSA (12 weeks) 98%
ASTRAL-4 267 patients with genotype 1-6 hep C infection, with decompensated cirrhosis (Child-Pugh B) EPCLUSA with Ribavirin (12 weeks) 94%
EPCLUSA without Ribavirin (12 or 24 weeks) 83% or 86%

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

“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.

Drug Pipeline

Epclusa: Approved treatment for all hep C types

Epclusa, the first hep C treatment for all virus types, is approved in CanadaEpclusa (generic name sofosbuvir / velpatasvir), the first pan-genotypic treatment*, has been approved for use in Canada against all six hep C virus types! Health Canada has issued Epclusa a Notice of Compliance!

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.

Drug Pipeline

Global and CTV News Report that Health Canada has Approved Epclusa

Global and CTV News Reports Health Canada Approved EpclusaGlobal News and CTV News are reporting that Health Canada has approved the hepatitis C treatment sofosbuvir / velpatasvir (American brand name Epclusa) for use in Canada. If this news is correct, Health Canada has just approved the first hep C treatment that can cure all 6 hep C virus types with high success rates!

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

Drug Pipeline

U.S. FDA Approved Epclusa (Sofosbuvir/Velpatasvir)

U.S. FDA Approved Epclusa (Sofosbuvir/Velpatasvir)Epclusa (sofosbuvir / velpatasvir), the first hepatitis C treatment able to cure six types of the hep C virus with high success rates against all of the six types, has been approved for use in America for all of those six types!

The hep C treatment sofosbuvir / velpatasvir (American brand name Epclusa) was approved by the U.S. Food and Drug Administration (FDA) yesterday. It was approved for the treatment of adult patients with a chronic hepatitis C virus infection, genotype 1, 2, 3, 4, 5, or 6. This approval means that it can be prescribed to those with or without liver cirrhosis and can be prescribed with or without the drug ribavirin (prescribed with ribavirin for patients with liver cirrhosis, Child-Pugh B or C).

Yesterday’s Press Releases about Sofosbuvir / Velpatasvir’s FDA Approval

  • The FDA’s news release about sofosbuvir / velpatasvir’s approval, FDA approves Epclusa for treatment of chronic Hepatitis C virus infection
  • The press release about the approval by Gilead, sofosbuvir / velpatasvir’s developer

Sofosbuvir / Velpatasvir (American Brand Name Epclusa)

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

It is the first once daily pill treatment for patients with hep C genotype 2 and 3, without the need for ribavirin.

Approved for in the States: Epclusa taken for 12 weeks was approved in patients without liver cirrhosis or with compensated liver cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with more serious  liver cirrhosis (Child-Pugh B or C).

Common Side Effects: The most common side effects of sofosbuvir / velpatasvir are headache and fatigue. However, If it is combined with ribavirin, patients may experience side effects from the ribavirin.

Sofosbuvir / Velpatasvir in Canada

Sofosbuvir / velpatasvir isn’t approved for use in Canada yet.

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,” said Dr. Jordan Feld, a liver specialist at Toronto Western Hospital.

Drug Pipeline

Recently Published Hep C Studies, Articles, and Press Releases

Recently Published Hep C Studies, Articles, and Press ReleasesThe following highlights a variety of recently published studies, articles, and press releases  published about hepatitis C and hepatitis C treatments.

Clinical Care Options (June 2016)

  • Key Studies Influencing My Practice Following EASL 2016 by David R. Nelson

Summary: A downloadable audio about the clinical impact of new data reported at the EASL’s International Liver Congress, held in Barcelona, in April. (47 minutes)

  • Non–Genotype 1 HCV Now and in the Near Future by Jordan J. Feld, et al.

Summary: A downloadable slide set.

International Journal of Hepatology (May 2016)

  • Elbasvir/Grazoprevir: A Review of the Latest Agent in the Fight against Hepatitis C by Allison M. Bell, et al.

Summary: A review of the current literature about elbasvir/grazoprevir.

Journal of Hepatology (July 2016)

  • Doing the math on hepatitis C virus treatment by Shruti H. Mehta and David L. Thomas

Summary: A list of the benefits of hepatitis C treatment.

  • Sofosbuvir/velpatasvir improves patient-reported outcomes in HCV patients: Results from ASTRAL-1 placebo-controlled trial by Zobair M. Younoss, et al. (Published online: March 5 2016)

Summary: Hep C symptoms and treatment side effects can affect quality of life. This study looked at quality of life during and after treatment with sofosbuvir/velpatasvir. The trial concluded that quality of life was better during and after treatment with sofosbuvir/velpatasvir when compared with a treatment placebo.

  • Sustained virologic response to interferon-free therapies ameliorates HCV-induced portal hypertension

Conclusion:  Curing hepatitis C decreases portal pressure, which drives liver-related complications. However, the more damage patients have, the less it heals.

The Lancet Gestroenterology & Hepatology (June 2016)

  • Ombitasvir, paritaprevir, and ritonavir plus ribavirin for chronic hepatitis C virus genotype 4 infection in Egyptian patients with or without compensated cirrhosis (AGATE-II): a multicentre, phase 3, partly randomised open-label trial by Imam Waked, et al. (AbbVie funded study)

Summary: Treated 160 patients with hep C genotype 4, with or without liver cirrhosis, for 12 or 24 weeks. Headaches and fatigue were the most common side effects. The study found that the treatment was well tolerated and that longer treatment times didn’t improve cure rate.

  • Ombitasvir, paritaprevir, and ritonavir plus ribavirin in adults with hepatitis C virus genotype 4 infection and cirrhosis (AGATE-I): a multicentre, phase 3, randomised open-label trial by Tarik Asselah, et al. (AbbVie funded study)

Summary: The study looked at the treatment Technivie (ombitasvir/ paritaprevir/ ritonavir) and ribavirin taken for 12 and 16 weeks by patients with hep C genotype 4 and liver cirrhosis. The extended treatment between 12 and 16 weeks didn’t seem to benefit patients.

Recent Pharmaceutical Press Releases

  • Enanta Pharmaceuticals Initiates Proof-of-Concept Study with Pan-genotypic Cyclophilin Inhibitor EDP-494 in Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C Virus
Drug Pipeline

Digestive Disease Week 2016 in San Diego Part II

Digestive Disease Week 2016 in San Diego Part IIDigestive Disease Week 2016

Digestive Disease Week 2016 (DDW2016, #DDW16) took place in San Diego last month. According to its website, it is the world’s largest gathering of doctors and researchers in the fields of gastroenterology, hepatology, endoscopy, and geastrointestinal surgery. This blog post is a collection of just some of the research about hep C treatments discussed at the Digestive Disease Week 2016.

Research Presented at the Digestive Disease Week 2016 about Hepatitis C Treatment Topics

  • 100% Svr4 and Favorable Safety of Abt-493 + Abt-530 Administered for 12 Weeks in Non-Cirrhotic Patients With Genotypes 4, 5, or 6 Infection (Surveyor-I) by Edward Gane, et al.

Summary: The combination of the antivirals ABT-493 and ABT-530 was well tolerated and resulted in 100% SVR/”cure rate” when tested 4 weeks after treatment in non-cirrhotic patients with a genotype 4, 5, or 6 hep C infection.

  • Age No Bar With New Anti-HCV Directly Acting Anti-Viral Agents: Real World Experience at a Single Tertiary Care Center in Rural Pennsylvania by Amir N. Rezk, et al.

Summary: This study looked at hep C treatment results of patients 70 to 90 years of age, with a mean age of 75 years old. The study concluded that age doesn’t affect success rates of DAA treatments.

  • Clinical Benefits of Successful Treatment in HCV Infected Patients With Decompensated Cirrhosis Treated With Sofosbuvir/Velpatasvir (Sof/VEL) by Robert S Brown, et al.

Summary: Patients with decompensated cirrhosis achieved high SVR12 with sofosbuvir/velpatasvir. These patients “…had a higher probability of clinical improvement if they had a higher MELD score, lower (<30) BMI or the absence of ascites and encephalopathy at the time of enrollment.” (Robert S Brown, et al.)

  • Comparative Effectiveness of Ledipasvir/Sofosbuvir±Ribavirin and Ombitasvir/Paritaprevir/Ritonavir+Dasabuvir±Ribavirin in 6,961 Genotype 1 Patients Treated in Routine Medical Practice by Lisa I Backus, et al.

Summary: A large real-world study looking at patients with hep C genotype 1 infections that had been treated. It concluded that SVR rates were similar to those found in clinical trials.

  • Daclatasvir Plus Sofosbuvir Plus Ribavirin for 12 or 16 Weeks in Treatment-Experienced Patients With HCV Genotype 3 Infection and Advanced Fibrosis or Cirrhosis by Christophe Hezode, et al.

Summary: Daclatasvir + sofosbuvir + ribavirin for 12 or 16 weeks resulted with SVR12 100% in patients with hep C genotype 3 infections and advanced fibrosis and  SVR12 87% in patients with liver cirrhosis who  failed previous interferon- or sofosbuvir-based therapies.

  • Genotype Subtype and Gender Influence SVR12 Rate With Directing Antiviral Therapy in Well Compensated Hepatitis C Related Cirrhosis by Amitkumar Patel, et al.

Summary: The study tried to evaluate cure rates in cirrhotic patients undergoing DAA therapy and identify predictors of response/non response to treatment. It concluded by finding that those with compensated cirrhosis were experiencing high cure rates when treated and that “Genotype 1a infection and male gender may be significant negative predictors of response to DAA in cirrhotic populations.” (Amitkumar Patel, et al.) Further investigation is required.

Additional information about the abstracts listed above or other abstracts that were part of Digestive Disease Week 2016 can be found in the Digestive Disease Week 2016’s online planner (click the abstracts tab and then the hepatitis C abstract category).