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AASLD 2015: Liver Doctors and Advocates Call for Wider Treatment of People with Hepatitis C

A growing body of research underlines the importance of timely treatment, showing that the benefits of curing hepatitis C are greater if done before advanced liver disease develops. In fact, it appears that people who wait too long for treatment may reach a "point of no return" where complications of advanced disease cannot be resolved.

"Direct-acting antivirals will reduce hepatocellular carcinoma risk, and the way they will do that is by treating patients before end-stage cirrhosis -- before getting cirrhotic," AASLD President Gyongyi Szabo said at the conference's opening press conference. "If we treat patients who already have cirrhosis, we can make the liver a little better, but the risk of liver cancer will remain."

Furthermore, people who are cured of hepatitis C can no longer transmit the virus -- a concept dubbed "treatment as prevention" in the HIV field.

The newest interferon-free direct acting antiviral (DAA) regimens can now cure more than 90% of people with HCV -- and sustained response rates are improving even for more difficult-to-treat patients such as those with HCV genotype 3, pre-existing cirrhosis, or prior treatment failure.

But several barriers to widespread treatment remain, including a large number of undiagnosed people who are not aware they have HCV, a shortage of knowledgeable providers, stigma against peopele who inject drugs, and especially the high cost of the new antiviral drugs, which can approach $100,000 per course of treatment.

The large cumulative expense of treating everyone with HCV is straining the budgets of public payers and private insurers, and has led some to impose restrictions such as requiring patients to have advanced fibrosis or to be abstinent from drugs and alcohol before they can be treated. Earlier this month the federal Centers for Medicare & Medicaid Services issued a letter to state Medicaid programs stating that they are expected to cover interferon-free treatment for hepatitis C without undue restrictions, as well as a letter to pharmaceutical companies asking about discount purchasing arrangements.

Advocates with the San Francisco Hepatitis C Task Force, Oasis Clinic, Treatment Action Group, and individuals living with hepatitis C held 2 protests outside the Liver Meeting demanding lower drug prices and more patient assistance, especially from Gilead Sciences (maker of Sovaldi and Harvoni), which activists say recently tightened eligibility for its hepatitis C patient assistance program.

Below is an edited excerpt from an AASLD statement calling for wider hepatitis C treatment.

Leading Liver Doctors: Hepatitis C Patients Must Be Treated

November 16 2015 -- Over the past two-plus years, the Food and Drug Administration has approved multiple new treatments for hepatitis C virus (HCV) that offer nearly universal cure rates with minimal side effects. It is a remarkable success story for medical science. Unfortunately, many insurers -- both private and public -- are delaying access to new HCV treatments to patients until their disease has progressed and the liver is further damaged. There is no medical evidence to justify that position and much to justify treating all patients.

AASLD endorses treating patients with HCV as the standard of care. In the regularly revised HCV Practice Guidance of AASLD and Infectious Diseases Society of America we recommend early treatment of chronic HCV infection before the development of severe liver disease and other complications to improve overall survival rates. Studies demonstrate that new treatments cure more than 99 percent of patients followed for five years.

HCV treatment that leads to a cure is the only evidence-based intervention to prevent liver disease progression. A significant proportion of people living with HCV who have no or mild fibrosis (commonly described as F0-F2) will progress to cirrhosis in the absence of treatment. Currently, there is no way to predict who will develop advanced liver disease.

Inaction is harmful to patients. Untreated HCV has been linked to many causes of death, such as liver cancer and kidney problems. Delaying treatment for patients until they develop advanced liver disease leads to higher costs and higher demand for liver transplants. Patients who are unable to obtain curative treatment are at high risk for anxiety, illness uncertainty (the inability to determine the meaning of illness-related events), and depression, regardless of fibrosis stage. Patients who are cured of HCV report a significant improvement in their mental well-being.

Failure to treat leads to other medical problems. Among them are HCV-associated heart disease, lymphatic cancers, particularly non–Hodgkin Lymphoma, kidney damage in many patients and evidence of immune related disease when tested for rheumatoid factors. Studies show that HCV infection increases the risk of insulin resistance and diabetes by almost four times. Diabetes increases the risk of liver cancer in people living with HCV.

Access to curative therapies is the most effective way to eliminate the virus at a population level. The Department of Health and Human Services has cited an “emerging epidemic of HCV infection among young persons who inject drugs.” Providing treatment to injection drug users is crucial to reducing the HCV burden within networks and preventing new transmissions. In addition, curing HCV is the best way to guarantee that women of childbearing potential do not transmit the virus to their developing fetus if they become pregnant.

11/17/15

Source

AASLD. Leading Liver Doctors: Hepatitis C Patients Must Be Treated. Press release. November 16, 2015.