Hepatitis C testing in Canada: don’t leave baby boomers behind
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* Lianping Ti
* Viviane Lima
* Mark Hull
* Bohdan Nosyk
* Jeffrey Joy
* Julio Montaner
* Mel Krajden
* Richard Harrigan
* Thomas Kerr
* Kate Shannon
* Evan Wood
* Jean Shoveller
* Alnoor Ramji
* Hin Hin Ko
* Eric Yoshida
* David Hall
* Rolando Barrios

The emergence of direct-acting antiviral (DAA) therapy to treat hepatitis C virus (HCV) infection has brought renewed optimism in controlling the HCV epidemic.1 Recent price reductions and the consequent expansion of access to these safer, shorter and highly effective regimens in Canada have made this a tangible goal.2 As a result, the scale-up and roll-out of HCV testing is now an important consideration. Therefore, it is of concern that the Canadian Task Force on Preventive Health Care’s recently published guideline in *CMAJ* failed to acknowledge that people born between 1945 and 1975, commonly referred to as “baby boomers,” are a population with a higher prevalence of HCV infection and should be screened for HCV infection.3 The recommendation against screening for HCV in asymptomatic patients in this population is also inconsistent with guidelines from several international health organizations.4,5

Baby boomers are a key population within the HCV epidemic in Canada. In British Columbia, recent estimates suggest that about 66% of people living with HCV are baby boomers.6 Importantly, previous studies have shown that baby boomers are up to five times more likely to be affected by the consequences of chronic HCV infection than the general population.7 Contrary to a popular misconception that these individuals contracted HCV infection from past high-risk practices (e.g., needle sharing, high-risk sexual practices), there is established research that has shown that many baby boomers who contracted HCV before 1992 did so as a result of nosocomial or iatrogenic practices (e.g., reuse of needles) in health care settings and via donated blood and organs before screening.8

Baby boomers may often be unaware of past health care transmission risks for HCV infection: this advocates for screening based on both demographic and risk factors. Because HCV infection is typically asymptomatic for many decades, unscreened baby boomers living with HCV infection may never have sought testing or treatment and are vulnerable to substantial liver-related complications, including cirrhosis, hepatocellular carcinoma and premature death. Indeed, baby boomers have the largest proportion of advanced liver disease with decompensation and liver cancer.7

In February 2017, the pan-Canadian Pharmaceutical Alliance negotiated substantial price reductions for DAAs with pharmaceutical companies that allowed Canada to advance universal coverage for HCV drugs.2 In response, many provinces have outlined a strategy to remove all restrictions on DAA treatment by 2018, including barriers to access based on comorbidities (e.g., HIV co-infection) and disease severity (i.e., METAVIR fibrosis score of F2). Although prior restrictions would have resulted in challenges for treatment of the entire population with HCV infection, this will no longer be the case in the near future. Therefore, the recommendation put forward by the task force to limit HCV testing for baby boomers is outdated; their rationale against screening this population because of treatment ineligibility and the potential for increased health inequity owing to affordability is not valid. If left untreated, the estimated lifetime cost for an individual living with HCV infection in 2013 is $64 694, and lifetime future costs range from $51 946 for a patient with chronic infection and a fibrosis score of F0 to $327 608 for a patient requiring liver transplantation.9

The task force’s recommendation also contrasts with many international guidelines that proposed one-time HCV screening for baby boomers. The American Association for the Study of Liver Diseases, Infectious Diseases Society of America, US Centers for Disease Control and Prevention, and the Canadian Liver Foundation have all strongly recommended one-time screening for this population.4,5 Among others, a key advantage to offering one-time HCV testing to baby boomers is that it neither requires health care providers to identify risk nor for individuals to recall past exposures that may lead to underreporting. Routine offers of one-time screening also hold promise for decreasing stigma associated with HCV testing, and potentially opens new discourses in clinical and public settings to destigmatize HCV.8

The task force’s guideline also fails to acknowledge consistent and high-quality evidence that one-time screening for baby boomers, followed by appropriate treatment for HCV infection, is cost-effective. Although many of these studies were conducted in the United States and analyses were based on local treatment costs and epidemiological conditions, we expect that the findings would apply in Canada. Similarly, one study in Canada found that birth cohort screening followed by treatment resulted in an incremental cost-effectiveness ratio of up to $44 034 per quality-adjusted life year gained compared with no screening.10 Given recent Canadian policy changes associated with DAA costs, it is likely that there will be higher net benefits.

The task force emphasized the potential for “unnecessary anxiety and/or false reassurances” owing to false-positive and false-negative results for testing for HCV infection. Although the potential for false positives and negatives exists for HCV antibody and uncommonly for HCV RNA, the available HCV infection tests in Canada have been shown to be accurate and reproducible for HCV blood screening.11 These tests have been effective worldwide for enrolling patients in therapeutic registration trials. Therefore, potential harms associated with HCV screening for HCV infection are arguably overstated, especially given that without screening, diagnosis of curable HCV infections would be missed.

Corresponding with the increase in treatment availability, the opportunity to alter the way testing for HCV infection and treatment services are offered to patients is now possible. Unfortunately, the recommendations put forward by the task force will not only hinder access to needed HCV treatment for key populations but will also perpetuate the health and financial burden imposed on society by untreated HCV infection.

The argument that lack of access to DAA treatment is a reason for withholding testing for HCV infection from baby boomers is inconsistent with current guidelines. Because Canada is one of the few countries to have moved toward universal coverage to treat HCV infection, we have an ethical obligation to treat those burdened by this preventable and curable disease. We suggest that this guideline should be revised immediately to incorporate evidence-based screening for HCV infection in asymptomatic baby boomers. As written, the guideline constitutes an impediment to the control of HCV disease in Canada.

## Footnotes

*   **Competing interests:** Mel Krajden has received research contracts/grants from Roche, Siemens, Merck, Hologic and Boerhinger Ingelheim that were paid to his institution. Richard Harrigan has received grants from, served as an ad hoc advisor to or spoke at various events sponsored by Abbott, Merck and Gilead. He has also received and consultant fees from ViiV Health Care and Gilead. Mark Hull has received grant support from the National Institute on Drug Abuse and has received honoraria for speaking engagements and/or consultancy meetings from Bristol Myers Squibb (BMS), Gilead, Merck and Viiv that were paid to his institution. Alnoor Ramji has received grants and served as an investigator to research sponsored by AbbVie, BMS, Gilead, Janssen, Novartis and Merck. He has also received consultant fees from AbbVie, BMS, Gilead, Janssen, Intercept, Lupin and Merck, and speaker fees from AbbVie, BMS, Gilead, Janssen and Merck. Hin Hin Ko has received speaker fees from Merck, Intercept, Lupin, Allergan and Procter and Gamble, has served on the advisory boards of Intercept and Lupin, and has received support as a subinvestigator for studies sponsored by Gilead, Merck and Intercept. Eric Yoshida is an investigator of clinical trials and research studies sponsored by Merck, Gilead Sciences, Janssen and AbbVie. He has also received honoraria for CME lectures/Ad Board lectures sponsored by Merck Canada, Gilead Sciences Canada and AbbVie Canada. Julio Montaner has received support for Treatment as Prevention (TasP) research from the BC Ministry of Health and US National Institutes of Health ( NIDA R01DA036307) that was paid to his institution. He has also received institutional grants from Janssen and Merck, and has served on the Teva Advisory Board.

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