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9. Evolving Hepatitis C Therapy Guidelines and Treatment Cascade

The first U.S. hepatitis C treatment guidelines incorporating interferon-free direct-acting antiviral regimens were issued in January 2014 and periodically updated to reflect new drug approvals and emerging data from studies and real-world use. The new therapies have cure rates above 90%, but cost and other barriers have limited their use.

The latest revision of the guidelines from the American Association for the Study of Liver Diseases, Infectious Diseases Society of America, and International Antiviral Society-USAinclude newly approved interferon-free therapy for people with hepatitis C virus (HCV) genotype 1, the most common type in the U.S. The guidelines list 3 options with similar high efficacy for initial treatment and retreatment of prior non-responders; all may be used with or without ribavirin for 12 or 24 weeks, depending on factors including HCV subtype (1a or 1b), presence of liver cirrhosis, and prior treatment history:

• Gilead Science's sofosbuvir/ledipasvir coformulation (Harvoni);
• AbbVie's paritaprevir/ritonavir/ombitasvir plus dasabuvir regimen (Viekira Pak, formerly "3D");
• Gilead's sofosbuvir (Sovaldi) plus Janssen's simeprevir (Olysio).

The European Association for the Study of the Liver (EASL) and the World Health Organization also issued hepatitis C treatment guidelines incorporating direct-acting antivirals in 2014.

An August revision of the AASLD/IDSA guidelines focused on who should be treated and when. Traditionally, interferon-based therapy was reserved for patients with advanced liver disease. With the advent of well-tolerated interferon-free regimens, many now think that everyone living with HCV can benefit from treatment, but some public payers and private insurers have imposed restrictions due tothe drugs' high cost.

The guidelines state that if treatment cannot be provided for everyone, "highest priority" should be given to people with advanced fibrosis, compensated cirrhosis, and liver transplant recipients, while "high priority" should given to patients at high risk for liver-related complications and severe extra-hepatic complications. A study presented at the AASLD Liver Meeting estimated that around 1 million people in the U.S. meet the "high" or "highest" priority criteria.

Some researchers have started to apply a cascade or continuum of care concept -- developed to describe gaps in care for people with HIV -- to hepatitis C. One meta-analysis found that of the 3.5 million people estimated to have chronic hepatitis C in the U.S., 50% were diagnosed, 27% received HCV RNA testing, 16% were prescribed antiviral treatment, and only 9% were cured -- but this was before the advent of highly effective interferon-free therapy.

NEXT: 10. Hepatitis C Cures for HIV/HCV Coinfected and Advanced Liver Disease