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Hepatitis C Retreatment for Genotype 1 Patients Who Failed Sovaldi

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.

dead-endHowever, 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.

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  • Jerry Mahlberg February 9, 2016, 9:28 PM

    Harvoni failed. 4wks no virus detected, 12wks no virus detected 10/26/15.
    Now VL 101610 and AST/ALT 42/32 10/26/15 to now 02/01/16 128/106.
    Very disappointed as never before treated and no virus detected throughout
    perfect treatment period and within months of completion readings worse
    than before treatment with what appears to be side effects.

    • Lucinda Porter February 10, 2016, 7:03 AM

      So sorry Jerry. That is a big disappointment. A couple of comments: 1) As your virus returns, the number will be quite high. Not only is this normal, it is a good thing. It says your immune system and liver are doing what they are supposed to do. It’s very much like an initial infection, although most people don’t know that their body is doing that since most people don’t know exactly when they were infected. Second, since it appears you are resistant, your doc may want to test you for mutations (they are called polymorphisms). There are many other choices of treatment, a few of which are ahead in a relatively short time. You may also qualify for a clinical trial. Hang in there, and take good care of your health. You can beat this.

    • Jack April 13, 2017, 5:14 PM

      I failed my 12 week treatment of Viekira. 34 years old, healthy, no cirossis. Didn’t work. Makes me wonder if these cure rates are a bit inflated. If i was charging 85 grand per treatment i guess i’d have to bullshit the numbers a bit wouldn’t I? 98% cure rate and i happen to be that 2%. An otherwise healthy person. Besides the liver destroying desease that i still have alive and well inside me. 98% sure that this is all bullshit.

      • Lucinda Porter April 26, 2017, 3:58 PM

        There are a number of factors to consider. 1) The cure rates are determined by clinical trial data, which uses the healthiest people. 2) Were you prescribed the right drug for you (genotype 1) 3) Did you take it correctly 4) Did you take a drug or supplement that might have interfered with Viekira?
        Bottom line, is that even if you took it perfectly, there are some people that have resistant strains. So very sorry that you didn’t succeed. I had a similar experience (48 weeks of peginterferon + ribavirin), but was cured on my 3rd go-round. I know someone who did 8 treatments. Hope you are willing to try it again. It’s worth it.