Hepatitis C Watch

SEPTEMBER 18, 2011

Uninsured Hepatitis C Patients Unable to Get Treatment
Antiviral therapy among hepatitis C patients has the ability to lower morbidity rates, but according to research conducted by Maria Stepanova, PhD, and colleagues, most patients who are eligible for treatment for hepatitis C virus (HCV) do not have the insurance to cover the costs.

The study, published in the March 2011 issue of Hepatology, looked at the health insurance status and treatment candidacy of HCV-positive (HCV ) individuals from data taken in the National Health and Nutrition Examination Survey (NHANES) from 2005 to 2008. After examining 10,582 subjects, researchers found that 1.16% was identified as HCV . Researchers found that the percentage of insured HCV subjects was significantly lower than the percentage of insured HCV-negative individuals (61.2% vs 81.2%; P = .004). Of those with health insurance, HCV subjects were even less likely to have private insurance, whereas there was no difference in coverage by Medicare/ Medicaid or other government-sponsored plans. In total, only 36.3% of HCV individuals were both eligible for treatment and insured.

From multivariate analysis, the study concluded that HCV infection was an independent predictor of the patient not having health insurance and that a high proportion of patients diagnosed with HCV are currently not insured, even when many still have publicly funded health insurance. Those who are possible candidates for the treatment have even lower rates of insurance coverage. The authors point out that the findings amount to important repercussions for health insurance coverage in the United States.

Bringing Viral Hepatitis Federal Action Plan to Life
The Department of Health and Human Services (HHS) issued an action plan called Combating the Silent Epidemic of Viral Hepatitis: Action Plan for the Prevention, Care and Treatment of Viral Hepatitis in May 2011 that calls for better strategies and methods of treating and diagnosing new and existing cases of viral hepatitis. The main goals of the new model are to increase the percentage of people who are aware of their hepatitis B or C virus infections, a 25% reduction in the number of new cases of HCV infection, and the elimination of mother-to-child transmission of HBV.

The plan stresses how 2.7 to 3.9 million people in the United States have hepatitis C and don’t know it, and that viral hepatitis is currently the leading cause of liver transplantation. Over time, researchers have found treatments for HCV and caused the decline of transmissions, but counseling and prevention available for childhood vaccinations for HBV and young adult awareness has not been as affective. By implementing the new plan under the post-reform health care system, HHS is hoping to increase counseling and prevention sessions to go along with an anticipated 2011 licensure of the first agents designed to directly attack and eliminate HCV.

Additionally, the plan builds upon the 2010 Patient Protection and Affordable Care Act and will improve patient access to viral hepatitis health education, testing, vaccination, and treatment. Two of 6 topic areas that correspond to the 2010 Institute of Medicine (IOM) recommendations include (1) education providers and communities to reduce health disparities and (2) protecting patients and workers from health care associated viral hepatitis.

All-Oral Hepatitis C Treatment in Trial
Could treatment for hepatitis C viral infection become an all-oral supplement? Researchers directed under Christophe Hézode, a researcher in the department of hepatology and gastroenterology at the Université Paris-Est, sought to find out if they could create an oral combination therapy that could become an HCV treatment without injections. Hepatitis Foundation International describes the current treatment as consisting of 3 types of interferon, which must be given by injection, plus a combination of interferon and Ribavirin to treat HCV. Many pharmaceutical companies and the National Institutes of Health (NIH) have been conducting research for more effective treatments and cures.

The objective of the double blind trial, first published in the Journal of Hepatology, was to observe a new treatment regimen for chronic HCV that could yield new information towards more successful ways to treat the virus. The 88 patients from New Zealand and Australia who were chronically infected with HCV genotype 1 were randomized into groups and given up to 13 days of oral combination treatment with 2 experimental anti-HCV drugs, RG7128 and danoprevir, or placebo. The primary outcome was HCV RNA concentration from beginning to day 14 in patients who received all 13 days of treatment. The median changed in HCV RNA ranged from -3.2 to -5.2 log(10) IU/ml in this group of patients. Researchers found that the oral combination of RG7128 and danoprevir was well tolerated with no treatment related serious or severe adverse events.

The trial concluded that this oral combination of nucleoside polymerase inhibitor and protease inhibitor hold promising outcomes for an all-oral combination therapy for chronic HCV. Future trials will need to be conducted to test the safety and effectiveness of interferon (IFN) free therapies.