Tag Archives: direct-acting antiviral

Strategies to Address Reimbursement Restrictions

Strategies to address reimbursement restrictionsClick here to view a recording of the February 6th webinar Strategies to address reimbursement restrictions for Hep C treatment: Lessons from Australia.

In collaboration with CanHepC, CTAC, and The Kirby Institute in Australia, CATIE organized this webinar to look at strategies to address Canada’s current restrictive and inconsistent approach to direct-acting antiviral (DAA) access and the lessons we can learn from the Australian model.

Learn from experts like Alison Marshall and Greg Dore of Australia’s The Kirby Institute; and Helen Tyrell of Hepatitis Australia. Listen to a discussion between Adam Cook of CTAC and Action Hepatitis Canada’s Community Organizer, Zoe Dodd.

 

Treatment Access Webinar February 6th at 12-1:30pm

Treatment Access Webinar February 6th at 12-1:30pmClick here for more information and to register for the webinar on February 6th at 12-1:30pm PST.

In collaboration with CanHepC, CTAC, and the Kirby Institute in Australia, CATIE is organizing a webinar looking at strategies to address Canada’s current restrictive and inconsistent approach to direct-acting antiviral (DAA) access and lessons we can learn from the Australian model.

Register now and learn from experts such as Alison Marshall and Greg Dore of Australia’s The Kirby Institute; and Helen Tyrell of Hepatitis Australia. Engage in discussion with Adam Cook of CTAC and Action Hepatitis Canada; Community Organizer Zoe Dodd.

The PHCN‘s News in Review Newsletter (06/12/16)

The PHCN‘s News in Review Newsletter (06/12/16)Welcome to the Pacific Hepatitis C Network (PHCN)‘s second Hepatitis C News in Review Newsletter. This is where we review all of the major current issues and events around hepatitis C and hep C treatments. It is an email that includes links to our recent blog posts—including links to blog posts about Public Health Agency of Canada funding.

HEALTH CANADA SUMMARY SAFETY REVIEW – DAAs – ASSESSING THE POTENTIAL RISK OF HEPATITIS B VIRUS REACTIVATION

Please click here for more information.

WHAT WOMEN WITH HEPATITIS C EXPERIENCE NEEDS TO BE IMPROVED NOW

“Although our research on the experience of diagnosis was undertaken prior to the present major advances of interferon-free HCV treatment, which have given new hope of speedy and less burdensome treatment, these new treatments alone will not solve the burden of HCV.” (Mitchell, et al. 2016)

Therefore, it is still critical to examine how women with hepatitis C are cared for and then strive to improve that care. The findings of a new study, published in a recent issue of the Canadian Journal of Nursing Research, are interesting and a good start. Click here to read more.

HEPATITIS C ADVOCACY HIGHLIGHTS

Recently the Public Health Agency of Canada (PHAC) announced that community-based projects that lost funding in the October changes to the HIV and Hepatitis C Community Action Fund‘s Letter of Intent (LOI) funding process will now, on a case-by-case basis, have transitional project funding until March 31, 2018. Click here for more information.

On December 1st, World AIDS Day, the HIV and HCV communities stood together in solidarity with organizations who were denied funding going forward as part of the changes to the PHAC Community Action Fund LOI process. More information about the rally is here.

Daryl Luster was at the World AIDS Day rally and wrote and gave a speech entitled: We Have Not Abandoned the Principles or Communities We Serve, Neither Should PHAC.

In addition, November began with Daryl meeting with BC NDP MLA Shane Simpson. They spoke about the landscape of hepatitis C in BC, local testing shortfalls, and hep C treatments and cures. See a picture here.

HEP C HIGHLIGHTS FROM THE CANADIAN DRUG APPROVAL PIPELINE AND THE LIVER MEETING 2016

The Liver Meeting 2016, the American Association for the Study of Liver Diseases (AASLD)‘s 67th annual meeting, was held last month. Exciting and important hep C clinical results were presented. Some of these highlights can be found in the following posts:

For more information about the topics in this newsletter, please click on the links, visit PHCN’s Hepatitis C Treatment Information Project, or email us.

Health Canada Summary Safety Review – DAAs – Assessing the Potential Risk of Hepatitis B Virus Reactivation

December 1, 2016

Product

Direct-acting antivirals (DAAs)

Potential Safety Issue

Hepatitis B virus (HBV) reactivation

Key Messages

  • Direct-acting antivirals (DAAs) are drugs authorized for sale in Canada to treat chronic hepatitis C virus (HCV) infection, a serious condition that can result in decreased liver function, serious scarring of the liver (cirrhosis) and liver cancer.
  • Health Canada carried out a review of the potential risk of hepatitis B virus (HBV) reactivation with the use of DAAs. The review was triggered by reports that patients infected with both HBV and HCV may experience a reactivation of their HBV infection if DAAs are used to treat their HCV infection. These reports were identified by the European Medicines Agency (EMA).
  • Health Canada’s review concluded that there is a potential risk of HBV reactivation in patients co-infected with both HBV and HCV, and the use of DAAs. Health Canada has recommended that the safety information for all DAAs be updated to inform about this potential risk.

Overview

Health Canada carried out this safety review after becoming aware of reports of HBV reactivation in patients infected with both HBV and HCV treated with DAAs. Reactivation refers to the return of an active infection and, in the case of HBV, it can lead to serious complications such as liver disease (hepatitis).

Use in Canada

  • DAAs are prescription drugs authorized for sale in Canada to treat chronic HCV infection in adult patients.
  • This review included the following products available in Canada and they contain either a single DAA or multiple DAAs together: Daklinza (daclatasvir), Sovaldi (sofosbuvir), Harvoni (sofosbuvir, ledipasvir), Epclusa (sofosbuvir, velpatasvir), Holkira Pak (dasabuvir, paritaprevir, ombitasvir, ritonavir), Technivie (paritaprevir, ombitasvir, ritonavir), Galexos (simeprevir), Sunvepra (asunaprevir), and Zepatier (grazoprevir, elbasvir).
  • The first DAA available in Canada was Galexos (simeprevir), introduced in 2013.

Safety Review Findings

  • At the time of the review, Health Canada had not received any Canadian reports of HBV reactivation related to DAA use in patients infected with both HBV and HCV.
  • A total of 13 international reports of HBV reactivation were retrieved from different sources. Of these, 12 reports were considered to be possibly related to the use of these DAAs: 11 reports where sofosbuvir or sofosbuvir with ledipasvir was used and one report where daclatasvir was used. The remaining report (with sofosbuvir use) could not be reviewed further because it did not provide enough information. Of the reports, 3 described symptoms of moderate HBV reactivation. One of the cases reported severe HBV reactivation resulting in liver failure and the patient needed a liver transplant.
  • Potential processes have been proposed in the scientific literature to explain how HBV infection could become reactivated in patients that are being treated for their HCV infection.
  • Two studies of the use of DAAs in patients infected with both HCV and HBV reported an increase in viral genes (HBV DNA) in some of the patients. This could lead to a reactivation of the HBV infection.

Conclusions and Actions

  • Health Canada’s review concluded that there may be a link between the risk of HBV reactivation in patients infected with both HBV and HCV that have been treated with certain DAAs.
  • Health Canada has recommended that the safety information for all DAAs be updated to inform about this risk, as a precaution. In addition, an Information Update will be published to further inform Canadians and health care professionals.
  • Health Canada will continue to monitor safety information involving DAAs, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

Original Health Canada post, posted December 1, 2016, can be found here.

Additional Information about this Not from Health Canada

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).

Digestive Disease Week 2016 in San Diego Part I

Digestive Disease Week 2016 in San Diego Part IDigestive 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 hep C topics discussed at the Digestive Disease Week 2016 that weren’t specifically about clinical trials for hep C treatment.

Hepatitis C Topics Presented at the Digestive Disease Week 2016

  • Access to Therapy in Era of All DAA Regimens: Real-World Experience From the TRIO Network by Douglas Dieterich, et al.

Summary: (American) The study looked at patients who  had been denied treatment access and found that more than 33% of them had stage 3 or 4 liver fibrosis and were at risk of liver related health issues. The study’s abstract didn’t list the reasons why treatment had been denied.

  • Caffeine is Associated with Decreased Risk of Advanced Hepatic Fibrosis in Patients with Chronic Hepatitis C: A Systematic Review and Meta-Analysis by Sikarin Upala, et al.

Summary: This review found that caffeine intake is significantly connected with a decreased risk of advanced fibrosis in hep C patients. This “…might be due to the antioxidant properties of caffeine and this substance also can reduce expression of expression of CYP1A2, which is correlated with fibrosis progression.” (Sikarin Upala, et al.) In conclusion, the review advised further study into this subject.

  • Chronic Hepatitis C and Increased Risk of Gastrointestinal Malignancies by Sulieman Abdal Raheem, et al.
  • HIV Coinfected Patients Have a Slow Regression of Fibrosis After Achieving SVR12 by Melinda S. Brown, et al.

Summary: The study found that in those co-infected with HIV/HCV liver fibrosis reversed at a slower rate after ‘curing’ hep C than it does in those who were only infected with hep C.

  • Renal Function Decline Is Frequent in Patients Undergoing Hepatitis C Treatment Post Kidney Transplant by Kalyan R. Bhamidimarri, et al.

Conclusions: “HCV treatment with DAAs is feasible and effective post KT even in those who received HCV + graft. Renal function decline was frequent requiring tacrolimus dose adjustments in two thirds of the patients and there was 20% biopsy proven antibody mediated rejection. Close monitoring of renal graft function is necessary post KT while patients undergo HCV treatment.” (Kalyan R. Bhamidimarri, et al.)

  • The Additional Impact of Hepatitis C Infection on Cardiovascular Outcomes and Death Among Patients With Chronic Kidney Disease by Sara Tartof, et al.

Summary: Hep C adds to health issues and some cardiovascular outcomes in those with chronic kidney disease. Future assessments into whether new hep C treatments change this should be done.

  • The Hepatitis C and HIV Co-Infected Patient: Time to Scale Up HCV Therapy at a Local Level by Alireza Meighan, et al.

Summary: (American) The study found that patients co-infected with HIV/HCV are under treated even after newer hep C treatments, able to treat patients co-infected demonstrated higher success rates, have been developed.

  • Trends in Health Care Utilization for Hepatitis C Virus Infection in the United States by Vaibhav Wadhwa, et al.

Summary: The number of inpatient discharges for hepatitis C grew between 1998 and 2012, but the mortality rate has decreased. This has increased hospital admissions due to hep C in the US.

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).