Treatment for Hepatitis C, which once included weekly injections of interferon in combination of twice daily ribavirin for six months to a year, was a difficult regimen for many patients to follow. Nearly half of all patients had to discontinue therapy due to side effects. And cure rates were only 40 to 60 percent.
New directly acting antiviral agents (DAAs) have changed everything. Today, FDA-approved treatment for the most common type of Hepatitis C is a 12-week course of weekly interferon injections, coupled with ribavirin and sofosbuvir, one of two new DAAs. Cure rates for this triple therapy are 70 to 90 percent, depending on the patient's level of disease such as cirrhosis, and past treatment history.
"This is a significant leap from a year of treatment that offered a 40 percent cure rate, or the complicated, toxic regimens that were necessary for prior DAAs to be effective," says Glen Lutchman, MD, clinical assistant professor, gastroenterology-hepatology. "It's a remarkable progression in terms of how well these medications work."
Late last year, simeprevir and sofosbuvir received FDA approval, which created a "sea change" in the care of Hepatitis C. these two new medications inhibit the mechanism by which the virus replicates, and attack the virus in two different locations.
"It's exciting to see patients in clinic who have been living with this disease for decades and we're now curing their disease," says Jeff McKinney, NP, who manages hepatology patients on treatment at Stanford.
The Stanford protocol
Stanford has treated nearly 300 patients with all types of chronic Hepatitis C using DAAs, including those who are healthy otherwise, as well as patients with liver failure or disease recurrence post liver transplant. "We looked at the published data on all the different drug regimens, the different subtypes of patients and the different subtypes of virus, and created a treatment algorithm for each type," says Lutchman. left untreated, Hepatitis C can cause progressive liver disease and liver cancer, and is the most common cause of liver transplantation in the US.
"For patients who cannot tolerate interferon, Stanford uses an off-label, all-oral protocol that is in the guidelines of the American Association of liver disease," says lutchman. the cure rate for this regimen is more than 90 percent, but because it is not FDA approved yet, it can be difficult to get insurance coverage, and it is expensive.
Lutchman and McKinney are looking forward to FDA approval of more all-oral treatments which may come as early as this fall. And both clinicians say the research pipeline for new medications is rich, and the "Holy Grail" of Hepatitis C treatment may soon become available — one tablet, once a day, for a short period of time.
To refer a patient for an evaluation for Hepatitis C treatment, please contact the referral center at 866-742-4811 or fax 650-320-9443.