AASLD Position on Treating Patients with Chronic Hepatitis C Virus
HCV Guidance FAQ
The American Association for the Study of Liver Diseases (AASLD) is the leading organization of scientists and health care professionals committed to preventing and curing liver disease, and to promoting liver health and quality patient care. AASLD has always put the patient first by providing clinicians with the latest rigorous data on the best treatments for patients with liver diseases, including hepatitis C.
Our recent addition to the Guidance prepared by a committee of leading liver experts from AASLD and The Infectious Diseases Society of America (IDSA) proposed that the sickest patients be treated first, but all patients who receive advice from their doctor to take newest medications should not be denied. The decision across the board should be in the hands of the clinician and the patient to make the decision. Unfortunately payers across America are denying treatment when a doctor has prescribed it for their patient. We adamantly disagree with this decision.
Our Guidance is not intended to be used by payers to deny access to treatment. In no way does this position contradict the evidence evaluated to produce the Guidance and the recommendation made in the Guidance to treat the sickest first, but recognizes need to treat all.
Some confusion exists about our process of advising physicians. The Guidance committee relied on the best available published evidence and expert opinion. AASLD has produced numerous Practice Guidelines, which require a tremendous amount of time and level of evidence. The Guidance was released based on a thorough review of current scientific evidence along with expert opinion. To wait for further evidence to appear in the literature as opposed to assessing what currently exists and relying on expert opinion -- which is what the committee did -- would be irresponsible to patients and clinicians.
AASLD remains committed to its partnership with IDSA and to continuing to fund and write the practice Guidance. As the only organization solely dedicated to the prevention and cure of liver disease, we applaud the seminal research of our members who made recent treatment options possible. We are concerned about cost, but we also recognize the value of this drug to patients with hepatitis C. It's a one-time treatment, with minimal side effects and a great cure rate.
Treatments currently available and those we are confident will soon receive FDA-approval should be heralded as remarkable advances in curing a disease that was once fatal.
Background on the Development of the Guidance
On September 24, 2014, AASLD and IDSA published online one of the final two sections of their practice Guidance for hepatitis C -- Monitoring Patients Who Are Starting Hepatitis C Treatment, Are in Treatment, or Have Completed Therapy. The other section, Management of HCV Infection, has been approved and will be released in the next few weeks. The Guidance is now complete; however, it will be updated regularly. The online, easily updateable format was created to allow for us to change the Guidance as new drugs are approved by the Food and Drug Administration.
AASLD and IDSA recognized there was a need for clinical guidance. Our Federal partners such as the National Institutes of Health, Centers for Disease Control and Prevention, and the US Department of Health and Human Services were also aware of this need and supported the creation of a practice Guidance to help clinicians who treat patients with hepatitis C. AASLD and IDSA stepped forward to fund and create this Guidance independent of any industry financial support.