The new hepatitis C treatments are curing many patients, but not all of them. In 2014, the long-awaited Sovaldi (sofosbuvir) was approved. For genotype 2 and 3 patients, it was the first interferon-free hepatitis C treatment, albeit it had to be used with ribavirin. Genotype 1 patients still had to use peginterferon and ribavirin with Sovaldi, but treatment was only for 12 weeks and the cure rates were about 90%.
Some patients jumped in, ready to be rid of hepatitis C. They may feel that waiting for Harvoni (ledipasvir/sofosbuvir) seemed too risky and too far in the future. There were many success stories, but alas, there were those who had to hear those dreaded words, “Your hepatitis C was detectable.”
Then Harvoni was approved to treat hepatitis C genotype 1, and it is completely interferon-free and has higher response rates. Some people only need 8 weeks of treatment. Compared to the old days of peginterferon plus ribavirin or the grueling days of triple therapy, Harvoni is a dream come true. This is the drug many want.
However, patients ran in to problems getting their insurance to cover it. The hassles are monumental, but many prevailed and got Harvoni. However, if they used Sovaldi and did not have cirrhosis, they were out of luck. This is because the hepatitis C treatment guidelines written by the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) initially recommended against treating patients without advanced fibrosis, in whom a previous sofosbuvir-containing regimen has failed. Harvoni (with or without ribavirin) for 24 weeks is recommended for patients with cirrhosis, in whom a previous sofosbuvir-containing regimen has failed. (The updated guidelines clearly state that all patients, regardless of fibrosis stage, will benefit from treatment, unless they are given a non-liver-related terminal diagnosis with a life expectancy of less than one year.)
This leaves noncirrhotic Sovaldi-failures with the choice of waiting or looking for a clinical trial. Retreatment clinical trials are rare. In short, for some there really aren’t any choices.
Data from studies are beginning to emerge. In the June 2015 issue of Hepatology, David Wyles and colleagues concluded that 12 weeks of Harvoni plus ribavirin was a safe and effective treatment for patients who failed Sovaldi. (Ledipasvir-sofosbuvir plus ribavirin for patients with genotype 1 hepatitis C virus previously treated in clinical trials of sofosbuvir regimens). This was a small study (51 subjects), and it included 14 subjects with cirrhosis. All the genotype 1 patients achieved SVR12. The only treatment-failure was a genotype 3 patient who was enrolled by mistake.
The study makes a convincing case for retreatment, enough so that if your doctor is willing to devote the unpaid hours to dealing with the insurance company, it may be worth a try. Fortifying this study are the updated HCV Guidelines that list several regimens for retreating patients who previously failed sofosbuvir-based treatments.
The annual Liver Meeting will take place in November, and we will likely see results from many studies. There are new drugs in the pipeline, which will also generate more choices for patients. In the meantime, keep your spirits up, stay healthy, eat well, exercise every day, get enough sleep, avoid alcohol, and wear your seat belts. Hope is around the corner.