Guest Blog: Nick Maroulis, Pharm.D., Director of Pharmacy at BioPlus Specialty Pharmacy
It’s an exciting time in the hepatitis C research world – with new treatments and new understanding of this disease. There’s never been more hope for patients with this infection than there is today, which was the underlying message at the 7th Annual Update in Liver & Gastrointestinal Diseases: Hot Topics for Clinical Practice Program sponsored by the University of Florida Department of Medicine – Division of Gastroenterology, Hepatology, and Nutrition held on July 26-27, 2013. Approximately 150 gastroenterologists, hepatologists, nurses, physician assistants, fellows, and allied healthcare professionals were in attendance to hear the latest updates in liver and gastrointestinal disease.
During the Liver Session “What’s Hot in Hepatology!” two great speakers stood out. First was David R. Nelson, M.D., Professor of Medicine and Associate Dean for Clinical Research, Director Division of Gastroenterology, Hepatology, and Nutrition from the University of Florida in Gainesville who shared the latest insights about the management of hepatitis C infection in our current era of direct acting antivirals.
Dr. Nelson pointed out many interesting aspects of the current management of hepatitis C and what we have learned since the release of protease inhibitors in 2011 (the third drug in the HCV triple therapy treatment), including:
- Since the introduction of new protease inhibitors, the drugs are doing as well as they were expected to and there is currently a high sustained virologic response (SVR) in select populations, namely patients infected with the genotype 1 hepatitis C virus (HCV).
- SVR can reach 79 percent in treatment naïve genotype 1 patients and 83 percent in genotype 1 relapse patients with the use of either boceprevir or telaprevir with Peg-IFN/RBV.
- Key viral time points have been shown to be at week 4 for telaprevir and week 12 for boceprevir.
- Half of the patients currently treated for HCV have cirrhosis, 9 percent of these patients develop virus breakthrough and do not have as good of a response to treatment.
- Patients with cirrhosis are clearly more at risk for decompensation (12 percent vs. the 1 percent occurrence in non-cirrhotic patients).
- In terms of which type of patient is more likely to achieve SVR, the odds are more favorable for a patient who is: Caucasian, genotype 1b, with only mild fibrosis, and naïve to treatment. In such a patient, SVR can reach 90 percent.
- Anemia is a larger issue than previously believed, especially in the elderly and patients with cirrhosis being treated for HCV.
- Current treatments are very dependent on interferon response.
- Some patients and physicians are waiting (when their conditions will allow) to initiate treatment until new therapies become available.
Dr. Nelson gave a glimpse of what is on the horizon for treatment of HCV:
- There are many direct acting antivirals in active phase 3 development.
- The Nucleoside Inhibitor (NI) class of drugs will be one of the most important classes of drugs in the treatment of HCV.
- The first new expected drug approval should be available to market in early 2014.
- New drugs will be incorporated into the current standard of care treatment (NI + Peg-IFN/RBV).
- Newer agents will continue to come out in 2014.
- Cure rates are expected to increase and length of treatment required is expected to shorten.
- Genotype 1a and 1b will become the easiest types of HCV to cure.
- An all oral (no injection) regimen is likely to become available in 2014 and physicians will be incorporating interferon-free regimens into clinical practice for treatment of some genotypes of HCV.
- A very personalized approach to treatment of HCV will become standard.
- Expect 100 percent cure rate very soon in HCV!
Second, Virginia C. Clark, M.D., M.S., Assistant Professor of Medicine from the University of Florida Health discussed Current Challenges and Future Treatment Directions for Cirrhosis.
- As mentioned above, patients with cirrhosis do not respond to HCV treatment as well as those without cirrhosis.
- In 20 years, the number of patients being treated for HCV who also have cirrhosis will double.
- Fatty liver disease will become the second largest cause of cirrhosis in America.
- Cirrhosis brings a risk of portal hypertension in the decompensation stage, evidenced by ascites, variceal bleeding, and hepatic encephalopathy. Once in decompensation, survival is greatly reduced for patients.
- Portal hypertension remains the strongest predictor of clinical decompensation.
- Nutrition is a very important consideration in patients with cirrhosis complications which may cause patients not to eat, absorb, and experience altered metabolism.
- There is potential for preventing decompensation with lifestyle modifications (e.g., no alcohol, no smoking).
- Coffee consumption may be helpful; there is some evidence of a decreased risk of disease progression in chronic liver disease, cirrhosis, and HCV.
- Obesity is a risk factor for decompensation and diabetes should be treated closely.
- New research suggests that beta blockers can reduce the risk of ascites, however beta blockers reduce survival through a negative effect on cardiac compensatory reserve.
For patients with hepatitis C, along with their physicians, a cure for this disease has never been closer than it is today.Source 7th Annual Update in Liver & Gastrointestinal Diseases: Hot Topics for Clinical Practice Program, University of Florida, Clearwater, Florida, July 26-27, 2013.