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LifeGuide [Hep Talk]

New HCV Meds Are on the Horizon, but Affordability May Still Remain a Challenge
by Larry Buhl

Dr. Zobair Younossi
This column has covered several antiviral meds in the pipeline to treat hepatitis C, the most common cause of chronic liver disease, liver cancer, and liver transplantation in the U.S. When these meds become available they promise improved health-related quality of life and reduced morbidity and mortality, provided they are taken as recommended.

And provided patients can afford them. That’s a big problem given their expense and given new research showing patients in the U.S. with hepatitis C virus (HCV) are twice as likely to not have health insurance coverage compared with those without the disease.

In fact researchers found only a third of HCV infected Americans have access to antiviral therapy; the remaining are either uninsured or not candidates for therapy due to treatment contraindications. Details of this study are published in the March issue of Hepatology, a peer-reviewed journal of the American Association for the Study of Liver Diseases (AASLD).

Treating and monitoring hepatitis C can be cost-prohibitive for most people because it can cost up to $48,000 per year, according to Zobair Younossi, MD, MPH, from the Center of Liver Diseases at Inova Fairfax Hospital in Virginia and lead author of the study.

“In the study we found that hepatitis C-infected patients were less likely to have any kind of insurance, whether private or governmental, such as Medicare or Medicaid,” Dr. Younossi tells A&U. “We also found that a large number of hepatitis C-infected patients don’t qualify for the meds available now due to ongoing medical problems such as active cardiac disease, severe depression or renal failure. The side-effect profile of the current antiviral therapy requires careful selection of treatment candidates with a number of chronic conditions like these.”

Dr. Younossi and researchers analyzed health insurance status and treatment candidacy of HCV-positive individuals using 2005–2008 data collected from the National Health and Nutritional Examination Survey (NHANES). This information was collected via household interviews, physical examinations, and extensive laboratory sample data from subjects who were eighteen years of age or older and living in the U.S.

Analysis showed that 1.16 percent of study subjects were infected with HCV. Among those with HCV only sixty-one percent were insured compared to eighty-one percent of HCV-negative individuals. HCV infection was an independent predictor of being uninsured even after adjusting for demographic disparity in the HCV-positive group. Approximately sixty-seven percent of HCV-positive patients were eligible for treatment, however only fifty-four percent of those treatment candidates had insurance coverage.

The study showed that only thirty-six percent of HCV-positive patients who were eligible for antiviral therapy had health insurance. But if the barrier of insurance were removed, Dr. Younossi says, two-thirds of hepatitis C patients can be treated.

“Even with private insurance, many of these patients are not fully covered when there is a high co-payment. In addition to the cost of the new drugs, hepatitis C and its treatment must be monitored closely to observe the drugs’ efficacy and to manage the side effects.”

Dr. Younossi said the study did not identify why so many patients did not have any coverage, but suggested that those with low incomes either didn’t qualify for Medicare or Medicaid or didn’t apply.

“Access to care for HCV patients is critical, for both the perspective of the patient and society,” Dr. Younossi says. “Many of these uninsured patients need treatment early in the course of hep C infection. If they don’t get that, and they develop liver cancer as the disease progresses, then they will become eligible for Medicare or Medicaid.” By then the treatment will be very expensive, and the disease will have devastated the patient.

The study did not profile patients coinfected with HIV.

Ironically, coinfected patients may be in more “luck” than those who only have hepatitis C, at least when it comes to affording treatment. Although state cutbacks in HIV/AIDS funding are becoming worse, there is still the Ryan White CARE Act, the largest federally funded program in the U.S., a “payer of last resort” for low income, uninsured and under-insured patients with HIV/AIDS.

Doctors familiar with the program say that when a patient with HIV is covered through Ryan White and coinfected with hep C, they are covered for both diseases as part of a comprehensive strategy for HIV treatment. Hepatitis C can be a great threat to those with HIV. Coinfected patients tend to experience more rapid liver disease progression than those with hepatitis C alone, and physicians specializing in HIV treatment are well aware of this.

But right now, there is no equivalent Ryan White CARE Act for hep C, nor is there any on the horizon.

Lary Buhl is a freelance journalist and screenwriter living in Los Angeles.

April 2011