San Diego—In the next decade, the proportion of people with hepatitis C who have cirrhosis, decompensation, and hepatocellular carcinoma is expected to increase. The complications will primarily affect people between 60 and 80 years of age.
To deal with the issue, the FDA announced in August that adults born between 1945 and 1965 should be tested for hepatitis C, even if they do not meet the risk factors associated with the disease. It was the latest step that the healthcare industry has taken to address and better understand hepatitis C. In fact, 75% of patients who have hepatitis C are unaware that they have the disease.
Pharmaceutical companies are taking notice, as well. The FDA approved 2 new drugs, boceprevir and telaprevir, which are direct-acting antivirals, to treat hepatitis C in 2011, and several more drugs are in the late stages of the pipeline.
Last year, the American Association for the Study of Liver Diseases (AASLD) recommended the use of boceprevir or telaprevir in combination with pegylated interferon and ribavirin as the standard of care for treatment-naïve genotype 1 chronic hepatitis C.
Two industry leaders discussed the treatment advances and challenges associated with hepatitis C at DDW during a satellite symposium titled “DAA Treatment: A Guide for Managing the HCV Epidemic.”
From 1999 through 2002, the National Health and Nutrition Evaluation Survey (NHANES) found that 4.1 million people (1.6% of the population) in the United States were exposed to hepatitis C and 3.2 million (1.3%) had chronic hepatitis C. Of those people, 65.6% were born in the years 1945 to 1964. The highest prevalence was in people who were between 40 and 49 years of age.
Hashem B. El-Serag, MD, MPH, chief of the section of gastroenterology and hepatology at Baylor College of Medicine, in Houston, Texas, said the overall prevalence of hepatitis C infection in the United States peaked around 2000 and will continue to decline. However, the number of people who are infected for ≥20 years will continue to rise for the next decade, leading to an increasing incidence of cirrhosis, which typically develops 20 years after people are first infected by hepatitis C.
In 2010, half of the people with hepatitis C had cirrhosis. By 2020, healthcare professionals predict most people with hepatitis C will have cirrhosis, according to Dr. El-Serag.
“It is an ominous picture,” Dr. El-Serag said.
In recent years, deaths related to hepatitis C have increased more rapidly than in similar diseases. Dr. El-Serag said the age-adjusted rates of mortality associated with hepatitis C in 2007 were higher than for HIV and hepatitis B. More than 70% of the deaths among hepatitis C-infected individuals in 2007 were between 45 and 64 years of age. Between 1994 and 2003, liver cancer had the fastest growing death rate in the United States for all cancers. In fact, the death rates for most cancers declined during that time period.
Dr. El-Serag cited an Institute of Medicine (IOM) report that found there was a lack of knowledge and awareness about chronic viral hepatitis among healthcare and social service providers, at-risk populations, policy makers, and the public. He added there was an insufficient understanding regarding the extent and seriousness of hepatitis C.
The IOM report also revealed 75% of people who have hepatitis C were unaware that they have the virus. Meanwhile, the 2009 NHANES found that of the 133 patients diagnosed with hepatitis C, 49% said they were unaware they had the virus, 24% said their clinician did not recommend treatment, 9% did not follow up with their clinician, and 6% refused treatment. Only 12% received treatment.
Dr. El-Serag said healthcare workers, sex workers, and intravenous drug users were the largest groups of people with hepatitis C. One study from 2007 found 64% of men who injected drugs had hepatitis C. The rate was similar for women, according to Dr. El-Serag. He said that the prevalence of hepatitis C can decrease with an increased use of syringe/needle exchanges, high rates of hepatitis C testing, and knowledge of hepatitis C status to guide sharing practices.
When screening for hepatitis C, the Centers for Disease Control and Prevention (CDC) recommends healthcare professionals screen to determine whether people have ever injected illegal drugs, received clotting factors made prior to 1987, received blood or organs prior to July 1992, received blood from a donor who tested positive for hepatitis C, or had persistently elevated alanine aminotransferase.
Still, Dr. El-Serag acknowledged there were several barriers to hepatitis C testing, including a lack of health insurance, a lack of medical care, patient concerns, physician’s lack of knowledge, and management of comorbidities.
The most effective way to deal with hepatitis C may be screening all people, according to Dr. El-Serag. He cited an economic model of 102 million people born between 1946 and 1970 with the assumption that 100% of the population was screened for hepatitis C over 5 years. By screening all patients, there was an incremental cost-effectiveness ratio of $37,700 per quality-adjusted life year gained compared with screening patients who were assumed to be at risk of contracting hepatitis C.
Nancy S. Reau, MD, associate professor in the University of Chicago’s department of medicine, provided an overview of the new treatment options. In 2011, boceprevir and telaprevir were the first direct-acting antivirals to gain FDA approval for hepatitis C.
Both are protease inhibitors used in combination with pegylated interferon and ribavirin and indicated for genotype 1 infection. The drugs are approved for treatment-naïve adults with compensated liver disease who failed previous interferon-based therapy. The safety and efficacy are not established for organ transplantation, end-stage liver disease, or HIV or hepatitis B co-infection.
“This is really a paradigm shift,” Dr. Reau said.
Common adverse events in treatment-naïve patients who took boceprevir in phase 3 trials were anemia, neutropenia, and dysgeusia, while common adverse events in treatment-naïve and experienced patients who took telaprevir in phase 3 trials were rash, anemia, and anorectal effects.
Dr. Reau also cited the 2011 AASLD guidelines. She said boceprevir or telaprevir in combination with pegylated interferon and ribavirin is appropriate therapy for non-cirrhotic treatment-naïve patients. The AASLD recommends 48 weeks of therapy for all patients with cirrhosis. In addition, Dr. Reau said patient education and compliance are important to ensuring patients receive the best treatment.