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The recent advent of new treatments for hepatitis C prompted organizations including the Centers for Disease Control and Prevention, the U.S. Preventive Services Task Force, and the World Health Organization to recommend expanded hepatitis C screening, but such screening may be premature, according to a subject analysis.
Too much uncertainty exists regarding the validity of surrogate markers for treatment efficacy that were used in trials, and evidence regarding clinical outcomes and screening strategies is lacking, according to Dr. Ronald L. Koretz of the University of California, Los Angeles, and his colleagues, who evaluated the current understanding of the incidence and natural course of hepatitis C infection, treatment efficacy, and potential harms of treatment for their analysis.
The best available data suggest that 80%-85% of patients with chronic hepatitis C will die of nonhepatic causes; thus screening could lead to unnecessary treatment. This is important, as safety data for newer drugs are limited, and the existing data suggest a small but concerning rate of serious adverse events associated with the use of some treatments and treatment regimens; the risk-benefit profile of treatment cannot be adequately evaluated because of the lack of data regarding treatment benefits, the investigators reported online Jan. 13 in the British Medical Journal ([doi:10.10036/bmj.g7809]).
Clinical trials to determine the outcomes of treatment in screen-detected patients, as well as the long-term hazards of treatment, are needed, they said, noting that currently available trials included small numbers of patients and/or only short-term follow-up. Until data from such trials are available, physicians should not be pressured to enforce recommended screening strategies “out of enthusiasm for new treatments that have not yet been shown to cause long-term clinical improvement,” they concluded.
Dr. Koretz is a member of the editorial board of the Cochrane Hepato-Biliary Group. The authors reported having no other financial conflicts.
The authors question the merits of hepatitis C (HCV) screening despite the endorsement of the Centers for Disease Control and Prevention, U.S. Preventive Services Task Force, and World Health Organization. They suggest HCV does not lead to sufficient mortality, treatment may cause harm, sustained virologic response (SVR) does not represent a ‘cure’ and question if treating HCV truly reduces long term morbidity/mortality. While it is true the majority of patients with HCV will not develop cirrhosis or death attributable to their liver disease, the authors downplayed the morbidity and mortality related to HCV and the significant cost to the health care system as well (Ann. Intern. Med. 2012;156:271; Hepatology 2013;57:2164]. The authors also downplayed the importance of sustained viral response (SVR), suggesting that it does not represent a cure, yet neglect to mention several studies demonstrating late recurrence in only 1%-3% of patients who have achieved SVR. Furthermore, the authors describe the “harms of treatment,” yet they largely reference therapies that are no longer used and make minimal comment on the clear safety and efficacy of the current interferon-free regimens. Additionally, they report that while clearing HCV may reduce the risk of decompensated cirrhosis and hepatocellular carcinoma, it does not completely eliminate these risks and therefore treatment may not be of value. This brings us back to the motivation of the CDC, USPSTF, and WHO to recommend screening for HCV – identifying asymptomatic infection to allow for administration of safe, effective antiviral therapies before the development of cirrhosis and all of its complications.
Dr. Sean Koppe is director of hepatology, University of Illinois Hospital & Health Sciences System. He has no conflicts of interest.
The authors question the merits of hepatitis C (HCV) screening despite the endorsement of the Centers for Disease Control and Prevention, U.S. Preventive Services Task Force, and World Health Organization. They suggest HCV does not lead to sufficient mortality, treatment may cause harm, sustained virologic response (SVR) does not represent a ‘cure’ and question if treating HCV truly reduces long term morbidity/mortality. While it is true the majority of patients with HCV will not develop cirrhosis or death attributable to their liver disease, the authors downplayed the morbidity and mortality related to HCV and the significant cost to the health care system as well (Ann. Intern. Med. 2012;156:271; Hepatology 2013;57:2164]. The authors also downplayed the importance of sustained viral response (SVR), suggesting that it does not represent a cure, yet neglect to mention several studies demonstrating late recurrence in only 1%-3% of patients who have achieved SVR. Furthermore, the authors describe the “harms of treatment,” yet they largely reference therapies that are no longer used and make minimal comment on the clear safety and efficacy of the current interferon-free regimens. Additionally, they report that while clearing HCV may reduce the risk of decompensated cirrhosis and hepatocellular carcinoma, it does not completely eliminate these risks and therefore treatment may not be of value. This brings us back to the motivation of the CDC, USPSTF, and WHO to recommend screening for HCV – identifying asymptomatic infection to allow for administration of safe, effective antiviral therapies before the development of cirrhosis and all of its complications.
Dr. Sean Koppe is director of hepatology, University of Illinois Hospital & Health Sciences System. He has no conflicts of interest.
The authors question the merits of hepatitis C (HCV) screening despite the endorsement of the Centers for Disease Control and Prevention, U.S. Preventive Services Task Force, and World Health Organization. They suggest HCV does not lead to sufficient mortality, treatment may cause harm, sustained virologic response (SVR) does not represent a ‘cure’ and question if treating HCV truly reduces long term morbidity/mortality. While it is true the majority of patients with HCV will not develop cirrhosis or death attributable to their liver disease, the authors downplayed the morbidity and mortality related to HCV and the significant cost to the health care system as well (Ann. Intern. Med. 2012;156:271; Hepatology 2013;57:2164]. The authors also downplayed the importance of sustained viral response (SVR), suggesting that it does not represent a cure, yet neglect to mention several studies demonstrating late recurrence in only 1%-3% of patients who have achieved SVR. Furthermore, the authors describe the “harms of treatment,” yet they largely reference therapies that are no longer used and make minimal comment on the clear safety and efficacy of the current interferon-free regimens. Additionally, they report that while clearing HCV may reduce the risk of decompensated cirrhosis and hepatocellular carcinoma, it does not completely eliminate these risks and therefore treatment may not be of value. This brings us back to the motivation of the CDC, USPSTF, and WHO to recommend screening for HCV – identifying asymptomatic infection to allow for administration of safe, effective antiviral therapies before the development of cirrhosis and all of its complications.
Dr. Sean Koppe is director of hepatology, University of Illinois Hospital & Health Sciences System. He has no conflicts of interest.
The recent advent of new treatments for hepatitis C prompted organizations including the Centers for Disease Control and Prevention, the U.S. Preventive Services Task Force, and the World Health Organization to recommend expanded hepatitis C screening, but such screening may be premature, according to a subject analysis.
Too much uncertainty exists regarding the validity of surrogate markers for treatment efficacy that were used in trials, and evidence regarding clinical outcomes and screening strategies is lacking, according to Dr. Ronald L. Koretz of the University of California, Los Angeles, and his colleagues, who evaluated the current understanding of the incidence and natural course of hepatitis C infection, treatment efficacy, and potential harms of treatment for their analysis.
The best available data suggest that 80%-85% of patients with chronic hepatitis C will die of nonhepatic causes; thus screening could lead to unnecessary treatment. This is important, as safety data for newer drugs are limited, and the existing data suggest a small but concerning rate of serious adverse events associated with the use of some treatments and treatment regimens; the risk-benefit profile of treatment cannot be adequately evaluated because of the lack of data regarding treatment benefits, the investigators reported online Jan. 13 in the British Medical Journal ([doi:10.10036/bmj.g7809]).
Clinical trials to determine the outcomes of treatment in screen-detected patients, as well as the long-term hazards of treatment, are needed, they said, noting that currently available trials included small numbers of patients and/or only short-term follow-up. Until data from such trials are available, physicians should not be pressured to enforce recommended screening strategies “out of enthusiasm for new treatments that have not yet been shown to cause long-term clinical improvement,” they concluded.
Dr. Koretz is a member of the editorial board of the Cochrane Hepato-Biliary Group. The authors reported having no other financial conflicts.
The recent advent of new treatments for hepatitis C prompted organizations including the Centers for Disease Control and Prevention, the U.S. Preventive Services Task Force, and the World Health Organization to recommend expanded hepatitis C screening, but such screening may be premature, according to a subject analysis.
Too much uncertainty exists regarding the validity of surrogate markers for treatment efficacy that were used in trials, and evidence regarding clinical outcomes and screening strategies is lacking, according to Dr. Ronald L. Koretz of the University of California, Los Angeles, and his colleagues, who evaluated the current understanding of the incidence and natural course of hepatitis C infection, treatment efficacy, and potential harms of treatment for their analysis.
The best available data suggest that 80%-85% of patients with chronic hepatitis C will die of nonhepatic causes; thus screening could lead to unnecessary treatment. This is important, as safety data for newer drugs are limited, and the existing data suggest a small but concerning rate of serious adverse events associated with the use of some treatments and treatment regimens; the risk-benefit profile of treatment cannot be adequately evaluated because of the lack of data regarding treatment benefits, the investigators reported online Jan. 13 in the British Medical Journal ([doi:10.10036/bmj.g7809]).
Clinical trials to determine the outcomes of treatment in screen-detected patients, as well as the long-term hazards of treatment, are needed, they said, noting that currently available trials included small numbers of patients and/or only short-term follow-up. Until data from such trials are available, physicians should not be pressured to enforce recommended screening strategies “out of enthusiasm for new treatments that have not yet been shown to cause long-term clinical improvement,” they concluded.
Dr. Koretz is a member of the editorial board of the Cochrane Hepato-Biliary Group. The authors reported having no other financial conflicts.
Key clinical point: Evidence to support expanded hepatitis C screening is lacking.
Major finding: An estimated 80%-85% of patients with chronic hepatitis C will die from nonhepatic causes.
Data source: An analysis of existing evidence.
Disclosures: Dr. Koretz is a member of the editorial board of the Cochrane Hepato-Biliary Group. The authors reported having no other relevant financial disclosures.
