New medication combinations are giving Hep C cure rates of up to 75% with genotype 1, traditionally the toughest to treat. This is exciting news for the estimated 3.4 million people in the U.S. infected with the Hep C virus.
My last blog entry contained some general information about Hepatitis C viral infection, and the proper steps to take after a patient has screening tests that’s positive. If the second test, called a qualitative test, shows positive for the presence of the Hep C virus, what’s next?
In the past, many people didn’t get any further follow up testing done to see if they needed treatment, because cure rates were low, medication expensive, and the medication makes many people ill. Only about15% of people with hepatitis C go on to have cirrhosis, but the sheer number of people infected in the U.S. means there will be many people diagnosed with cirrhosis.
Now that much higher cure rates are being achieved, patients with Hep C infection need to get themselves to a liver specialist. Since cure rates are much improved, if treatment is needed, it may be time to get on with it.
To see if treatment is needed, most specialists still want to do a liver biopsy to determine the amount of damage, if any, that the Hep C virus is doing to the patients. The liver biopsy is relatively simple, with a complication rate of less than half of one percent even for patients with liver damage.
This liver tissue sample is studied under the microscope and given a Metavir score. This score, ranging from 0 to 4, tells us how much damage there has been to the liver. A “0” score shows no damage at all, a very good thing. A score of 1 means there’s a small amount of fibrosis, or scarring, and so on until the score of 4 which means cirrhosis with much scarring is seen.
Most hepatologists (liver specialists) have not been treating patients with a Metavir score of 0 through 2, and most do recommend treatment for patients with a score of 3 or 4, since these higher scores mean there is ongoing liver damage. If the patient is already in end-stage liver disease, he may be unable to tolerate the treatment. In such a case, the hepatologist may not recommend treatment even for a patient with a Metavir score of 4.
In the past, treatment consisted of interferon and ribavirin, two agents that worked on the patient’s immune system. This treatment gave response rates of around 40 to 50%, at least with Hep C genotype 1. Genotypes 2 and 3, seen less commonly in the U.S., are easier to treat and had higher response rates.
Now there are two directly-acting agents that can be used with interferon and ribavirin: boceprevir and telaprevir. They are both protease inhibitors, and act directly on the virus, instead of on the patient’s immune system. This triple therapy is, at present, only indicated for the treatment of patients with genotype 1.
In a recent Phase II trial, telaprevir, combined with ribavirin and interferon and taken for 24 weeks, gave sustained viral response rates of 75%. This was in the group of patients who had never been treated. In patients who had been previously been treated for Hep C with just interferon and ribavirin, an new course of treatment with all three medications resulted in sustained responses in 88% of patients.
This is big news. These results are the best seen to date in the treatment of Hep C.
Some specialists still argue whether a sustained response means the same thing as a cure, but we now have long-term studies on patients who respond to interferon-based treatments. A recent study of 344 patients showed that when studied more than three years after successful treatment, the virus remained undetectable in 98.3% of these patients. Even more exciting, regression of cirrhosis was seen in 64% of these patients. This means that not only did these patients still have no detectable Hep C virus, the liver scarring improved.
This combination of three medications that work in different ways probably works better because the Hep C virus tends to change and mutate in small ways, and can become resistant if only one type of anti-viral medication is used.
Now for the bad news: both of these medications do have significant side effects. Treatment with just interferon and ribavirin is hard enough, but addition of either of these new medications makes treatment even more difficult. For example, telaprevir must be taken with large amounts of fat for better absorption, and can cause rectal pain and burning if it’s not well-absorbed. Many patients have lowered counts of red and white blood cells as well as low platelets. Some people can get a potentially fatal rash.
Even in view of the added difficulty, the markedly improved response rates, which appear to be cure rates, may make it worthwhile to consider treatment. In the future, specialists predict drug regimens that don’t have to include interferon. Soon there may be specific direct-acting agents for all of the genotypes of Hep C, with cure rates predicted to be as high as 90%. Courses of medications are expected to become ever shorter with fewer side effects.
Because we have better treatments, and because the Center for Disease Control and Prevention is recommended expanded testing for Hep C to include all baby boomers, it’s likely we’ll uncover many more cases of active Hep C.
My only worry is that diagnosing patients won’t help anyone unless it’s linked to coverage for further testing and treatment.
Patients at my clinics who screen positive for Hep C can’t even afford the confirmatory testing that they need to see if they have an active infection, if they have no insurance. Their local Health Department isn’t set up to do this kind of testing. Local doctors can’t afford to give this free care. There are some low-cost community clinics, but they don’t seem to be set up to afford the expensive testing needed for these patients. And what if they do have the virus? How can they pay to see the liver specialist and get the biopsy? Who pays for the very expensive treatment if they have no insurance?
When I worked at an opioid treatment program near a teaching hospital, it was possible to get an appointment for that patient in the resident physicians’ general medicine clinic, where they could get further testing and be referred for specialty care if needed. It’s a much bigger challenge for patients who live where there are few low-cost options for medical for the uninsured.
Because of the exciting new developments in the treatment of Hep C, there are many ongoing clinical trials. For patients with no insurance, enrolling in a clinical trial may be a way to get some medication for free, though you probably wouldn’t be able to pick which treatment regimen you get.
If you have Hep C, and are fortunate enough to afford it, it’s definitely worth consulting – or re-consulting – with a liver specialist to see what your best options are.
Though the new hepatitis medications do have some serious drug interactions, they aren’t a problem with either methadone or buprenorphine.