New Canadian guideline expands HCV screening to baby boomers

The Canadian Association for the Study of the Liver, or CASL, released a guideline today that now recommends screening patients born between 1945 and 1975 for hepatitis C virus.

The recommendation, published in the Canadian Medical Association Journal, corresponds with current guidance from other national and international organizations, including the European Association for the Study of the Liver (EASL), the American Association for the Study of Liver Disease and the Infectious Diseases Society of America. However, it differs from guidance issued by the Canadian Task Force on Preventive Health Care (CTFPH) in April 2017, which does not recommend HCV screening in low-risk patients, including baby boomers.

Previously, the CTFPH said its decision to recommend against screening baby boomers was based on several factors, including the low prevalence (between 0.64% and 0.71%) of HCV in the Canadian population not at an elevated risk for chronic infection and the lack of direct evidence of the benefits and harms of screening. However, Hemant Shah, MD, MScCH(HPTE), co-author of the new CASL guideline, said new developments have emerged since this recommendation, warranting a change in guidance.

“After considering many factors, we proposed a screening approach that is simple, destigmatizing, implementable and evidence-based,” Shah, who is assistant professor and clinical director of the Toronto Centre for Liver Disease, told Infectious Disease News. “While there is a difference in guidance compared to the CTFPH [guideline], a major reason for that is we had the benefit of seeing how the landscape for access to therapy has evolved. In particular, earlier this year, most jurisdictions in Canada have made treatment available to all infected patients thanks to aggressive negotiating with manufacturers. Given [that] treatment is readily accessible, our recommendation to screen more broadly is the one I hope that physicians will follow.”

According to recent data, approximately 252,000 people in Canada were chronically infected with HCV in 2013. Prevalence is highest among baby boomers, who account for 62.7% of all HCV infections in Canada, Shah and colleagues reported. However, up to 70% of these patients are unaware of their infection.

In addition to screening baby boomers, as well as other individuals at risk for infection, CASL recommends:

  • anti-HCV antibody testing for initial HCV screening;
  • RNA PCR testing to confirm positive antibody results, as well as for patients with suspected acute infections or history of spontaneous or treatment-induced HCV clearance;
  • antiviral therapy for all patients with chronic infection;
  • determining genotype and subtype to better manage patients with chronic infection;
  • assessing patients for liver fibrosis;
  • ongoing screening for hepatocellular carcinoma among patients with cirrhosis; and
  • retreating patients who do not achieve SVR with a salvage regimen.

CASL said it no longer recommends prescribing treatment containing pegylated interferon-alpha, given the safety and efficacy of interferon-free direct-acting antiviral agent (DAA) regimens. The organization also suggests annual RNA testing for patients with ongoing risk exposures.

“Our hope is that screening rates for hepatitis C will rise in Canada, so that we can identify those Canadians who are living with the infection but are unaware they have it,” Shah said. “At an individual level, it will ensure that these individuals get the care and attention they deserve. At the population level, it will ensure better population liver health. The screening of baby boomers and treatment of hepatitis C according to these guidelines is cost-effective and beneficial.”

In a related editorial, assistant professor James F. Crismale, MD, and professor Jawad Ahmad, MD, of Mount Sinai’s Icahn School of Medicine, agreed with the new guidance. In particular, the authors supported birth cohort-based screening and a “universal treatment” strategy, in which all patients who test positive for HCV receive DAA therapy. Although universal treatment has been countered by a Cochrane review, which concluded that DAA drugs have not been shown to reduce risks for HCV-related morbidity or all-cause mortality, Crismale and Ahmad noted that the methodology and results of the review were “strongly criticized” by the American Association for the Study of Liver Diseases, IDSA and EASL. Further, the findings contradict data from studies conducted in the “interferon era” showing that SVR improves liver-related and all-cause mortality.

“We therefore agree with the response letter published by [EASL], which states that this review should not ‘affect policymaking, [nor] constrain the gathering momentum for diagnosis, testing and linkage to care for individuals with hepatitis C,” they wrote. “The updated [CASL] guideline takes an important step in continuing the fight against HCV in Canada, expanding screening indications to the baby boomer cohort and recommending curative therapy to all individuals affected by HCV.” – by Stephanie Viguers

References:

Cochrane. Direct-acting antivirals for chronic hepatitis C. http://www.cochrane.org/CD012143/LIVER_direct-acting-antivirals-chronic-hepatitis-c. Accessed June 1, 2018.

Crismale JF, Ahmad J. Can Med Assoc J. 2018;doi:10.1503/cmaj.170931.

EASL. J Hepatol. 2017. http://www.journal-of-hepatology.eu/pb/assets/raw/Health%20Advance/journals/jhepat/CochraneEASLJMP003.pdf. Accessed June 1, 2018.

Shah H, et al. Can Med Assoc J. 2018;doi:10.1503/cmaj.170453.

Disclosures: Ahmad and Crismale report no relevant financial disclosures. Shah reports receiving personal fees from AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, Intercept, Lupin, Merck and Roche, as well as grants from Boehringer Ingelheim and Janssen for research outside of the submitted work. Please see the study for all other authors’ relevant financial disclosures.

The Canadian Association for the Study of the Liver, or CASL, released a guideline today that now recommends screening patients born between 1945 and 1975 for hepatitis C virus.

The recommendation, published in the Canadian Medical Association Journal, corresponds with current guidance from other national and international organizations, including the European Association for the Study of the Liver (EASL), the American Association for the Study of Liver Disease and the Infectious Diseases Society of America. However, it differs from guidance issued by the Canadian Task Force on Preventive Health Care (CTFPH) in April 2017, which does not recommend HCV screening in low-risk patients, including baby boomers.

Previously, the CTFPH said its decision to recommend against screening baby boomers was based on several factors, including the low prevalence (between 0.64% and 0.71%) of HCV in the Canadian population not at an elevated risk for chronic infection and the lack of direct evidence of the benefits and harms of screening. However, Hemant Shah, MD, MScCH(HPTE), co-author of the new CASL guideline, said new developments have emerged since this recommendation, warranting a change in guidance.

“After considering many factors, we proposed a screening approach that is simple, destigmatizing, implementable and evidence-based,” Shah, who is assistant professor and clinical director of the Toronto Centre for Liver Disease, told Infectious Disease News. “While there is a difference in guidance compared to the CTFPH [guideline], a major reason for that is we had the benefit of seeing how the landscape for access to therapy has evolved. In particular, earlier this year, most jurisdictions in Canada have made treatment available to all infected patients thanks to aggressive negotiating with manufacturers. Given [that] treatment is readily accessible, our recommendation to screen more broadly is the one I hope that physicians will follow.”

According to recent data, approximately 252,000 people in Canada were chronically infected with HCV in 2013. Prevalence is highest among baby boomers, who account for 62.7% of all HCV infections in Canada, Shah and colleagues reported. However, up to 70% of these patients are unaware of their infection.

In addition to screening baby boomers, as well as other individuals at risk for infection, CASL recommends:

  • anti-HCV antibody testing for initial HCV screening;
  • RNA PCR testing to confirm positive antibody results, as well as for patients with suspected acute infections or history of spontaneous or treatment-induced HCV clearance;
  • antiviral therapy for all patients with chronic infection;
  • determining genotype and subtype to better manage patients with chronic infection;
  • assessing patients for liver fibrosis;
  • ongoing screening for hepatocellular carcinoma among patients with cirrhosis; and
  • retreating patients who do not achieve SVR with a salvage regimen.

CASL said it no longer recommends prescribing treatment containing pegylated interferon-alpha, given the safety and efficacy of interferon-free direct-acting antiviral agent (DAA) regimens. The organization also suggests annual RNA testing for patients with ongoing risk exposures.

“Our hope is that screening rates for hepatitis C will rise in Canada, so that we can identify those Canadians who are living with the infection but are unaware they have it,” Shah said. “At an individual level, it will ensure that these individuals get the care and attention they deserve. At the population level, it will ensure better population liver health. The screening of baby boomers and treatment of hepatitis C according to these guidelines is cost-effective and beneficial.”

In a related editorial, assistant professor James F. Crismale, MD, and professor Jawad Ahmad, MD, of Mount Sinai’s Icahn School of Medicine, agreed with the new guidance. In particular, the authors supported birth cohort-based screening and a “universal treatment” strategy, in which all patients who test positive for HCV receive DAA therapy. Although universal treatment has been countered by a Cochrane review, which concluded that DAA drugs have not been shown to reduce risks for HCV-related morbidity or all-cause mortality, Crismale and Ahmad noted that the methodology and results of the review were “strongly criticized” by the American Association for the Study of Liver Diseases, IDSA and EASL. Further, the findings contradict data from studies conducted in the “interferon era” showing that SVR improves liver-related and all-cause mortality.

“We therefore agree with the response letter published by [EASL], which states that this review should not ‘affect policymaking, [nor] constrain the gathering momentum for diagnosis, testing and linkage to care for individuals with hepatitis C,” they wrote. “The updated [CASL] guideline takes an important step in continuing the fight against HCV in Canada, expanding screening indications to the baby boomer cohort and recommending curative therapy to all individuals affected by HCV.” – by Stephanie Viguers

References:

Cochrane. Direct-acting antivirals for chronic hepatitis C. http://www.cochrane.org/CD012143/LIVER_direct-acting-antivirals-chronic-hepatitis-c. Accessed June 1, 2018.

Crismale JF, Ahmad J. Can Med Assoc J. 2018;doi:10.1503/cmaj.170931.

EASL. J Hepatol. 2017. http://www.journal-of-hepatology.eu/pb/assets/raw/Health%20Advance/journals/jhepat/CochraneEASLJMP003.pdf. Accessed June 1, 2018.

Shah H, et al. Can Med Assoc J. 2018;doi:10.1503/cmaj.170453.

Disclosures: Ahmad and Crismale report no relevant financial disclosures. Shah reports receiving personal fees from AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, Intercept, Lupin, Merck and Roche, as well as grants from Boehringer Ingelheim and Janssen for research outside of the submitted work. Please see the study for all other authors’ relevant financial disclosures.