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Hepatitis C Treatment Appears to Be Declining; People with Hard-to Treat Genotypes Are Half as Likely to Receive Therapy

SUMMARY: The percentage of people who receive interferon-based antiviral therapy for chronic hepatitis C virus (HCV) infection appears to be declining in the U.S., and lack of treatment is most often due to not being diagnosed in a timely manner, according to a study published in the December issue of Hepatology. A related study by researchers at Mount Sinai Medical Center found that individuals with HCV genotypes 1 and 4 -- the most difficult types to treat -- are about half as likely to start treatment as those with genotypes 2 or 3.

By Liz Highleyman

In the first study, Michael Volk, Anna Lok, and colleagues from the University of Michigan at Ann Arbor conducted a study to determine the number of patients being treated with antiviral therapy in the U.S., to estimate the public health impact of these treatment patterns, and to identify barriers to treatment.

The investigators collected data on the number of new prescriptions for pegylated interferon (Pegasys or PegIntron) issued each year from 2002 through 2007. Information was obtained from Wolters Kluwer, Inc., which maintains an electronic audit of pharmacies nationwide. Pegylated interferon plus ribavirin is standard therapy for chronic hepatitis C.

The researchers then constructed a Markov model of the population with chronic hepatitis C in the U.S. from 2002 through 2030, which they used to estimate the number of liver-related deaths due to hepatitis C that would be prevented under current treatment patterns.

Finally, they used the National Health and Nutrition Evaluation Survey (NHANES) Hepatitis C Follow-Up Questionnaire to investigate reasons for lack of treatment and to identify strategies for improving access to care.

The investigators found that 663,000 patients -- out of an estimated 3.9 million Americans with HCV infection -- were prescribed antiviral therapy between 2002 and 2007. During this period, treatment rates appeared to decline, as fewer prescriptions were written in later years, falling from 126,000 in 2002 to 83,000 by 2007.

"If this trend continues," the study authors wrote, "only 14.5% of liver-related deaths caused by hepatitis C from 2002-2030 will be prevented by antiviral therapy." They also projected that fewer than 1.4 million patients in total would be treated by 2030 if this pattern remains stable.

Over time, HCV can lead to liver cirrhosis and hepatocellular carcinoma (liver cancer), and it is a leading indication for liver transplantation. The Centers for Disease Control and Prevention (CDC) estimates that 8000-12,000 people die each year in the U.S. due to HCV-related causes.

Results from the NHANES questionnaire suggested that the primary barrier to treatment is lack of diagnosis, as only about half (49%) of the 133 respondents were previously aware they had HCV prior to the survey.

For 24% of people with HCV, physicians did not recommended treatment. Reasons commonly cited for not advising anti-HCV therapy include patient history of depression or other mental illness (due to side effects of interferon) and current or past drug or alcohol abuse, although current treatment guidelines do not require a period of abstinence.

An additional 9% of survey participants did not follow up with their doctors regarding hepatitis C management and 8% refused treatment. This left only 12% who actually received therapy.

Barriers to treatment included lack of health insurance, limited access to medical care, and the low rate of HCV screening by primary care doctors, the study authors suggested.

"Efforts to improve rates of diagnosis and treatment will be required if the future public health burden of hepatitis C is to be ameliorated," they concluded.

"It is concerning that half of all people with hepatitis C in the U.S. are unaware of their diagnosis," said Dr. Volk in a press release issued by journal publisher Wiley-Blackwell. "Even with the development of new and better medications on the horizon, such medications will have less than optimal impact unless more patients are diagnosed and referred for treatment." He added that the current pattern of care is unfortunate, "since young patients who don't go to the doctor often may be the best candidates for antiviral therapy" -- before they develop advanced liver disease.

Influence of HCV Genotype

In a related study published in the November 2009 issue of the Journal of Health Care for the Poor and Underserved, David Alfandre and colleagues from Mount Sinai Medical Center aimed to identify clinical and socio-demographic characteristics associated with failure to start hepatitis C treatment.

This retrospective study looked at a multi-ethnic cohort of previously untreated HIV negative patients seen at a primary care hepatitis C clinic in New York City between January 2003 and May 2007.

The researchers identified a total of 168 treatment-eligible patients, of whom 41 (24%) began treatment. A multivariate analysis revealed that individuals with HCV genotypes 1 and 4 were half as likely as those with genotypes 2 or 3 to initiate therapy (21% vs 42%, respectively).

Doctors often recommend that people with genotypes 2 or 3 start treatment without liver biopsy, because the course of therapy is short (24 weeks) and the cure rate is high (70%-80%). For genotypes 1 and 4, in contrast, the standard treatment duration is 48 weeks and only about half achieve sustained virological response. Such patients usually undergo biopsies to determine whether they have progressive liver damage -- and therefore should start treatment soon -- or have stable disease, in which case they might wait for new directly-targeted anti-HCV therapies currently in development.

The researchers also found that unmarried people were considerably less likely than married individuals to start treatment (19% vs 49%, respectively). People with more medical co-morbidities (co-existing conditions) were also less likely to begin therapy. Patients who start treatment had an average of 2.9 co-morbidities, compared with a mean 5.2 co-morbidities among those who remained untreated. However, age, sex, race/ethnicity, and language did not significantly influence likelihood of treatment.

"This study confirms that genotype is a major barrier to treatment," said senior author Thomas McGinn in a press release issued by Mount Sinai. "We hope these findings will lead to changes in how physicians approach patient care in a way that increases the rate of treatment initiation."

Some people with genotypes 1 and 4 may avoid treatment because they are concerned about receiving a liver biopsy. As a result of this study, Mount Sinai has started a program called "Biopsy Buddies," which will pair patients who need a biopsy with those who have already had one in order to offer information and support.



ML Volk, R Tocco, S Saini, and AS Lok Public health impact of antiviral therapy for hepatitis C in the United States. Hepatology 50(6): 1750-1755.
December 2009. (Abstract).

D Alfandre, D Gardenier, A Federman, and T McGinn. Hepatitis C in an Urban Cohort: Who's Not Being Treated? Journal of Health Care for the Poor and Underserved 20(4): 1068-1078. November 2009. (Abstract).

Other Sources

Wiley-Blackwell. Alarming Trend -- Antiviral Therapy to Treat Hepatitis C is Declining in the U.S. Press release. November 24, 2009.

Mount Sinai Medical Center. Mount Sinai Study Finds That Patients With More Difficult to Treat Forms of Hepatitis C Are Half as Likely to Treat the Disease. Press release. November 9, 2009.


























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