Advancements in Treatment for Hepatitis C, Part One

Our latest newsletter addressed the new advancements being made in the treatment of Hepatitis C. The text of our newsletter is below,  and part two of the newsletter will feature our discussion on treatment options.

This is an exciting time in the world of treatment for chronic hepatitis C (HCV). We have all been patiently waiting for improved oral therapies to arrive to treat chronic HCV. Well, that day has arrived with the recent FDA approval of Sofosbuvir. All oral regimens herald the beginning of the end of using Pegylated interferon (PEG) which is administered by injection and associated with significant side effects. Moreover, the duration of therapy as well as efficacy have improved noticeably with all oral therapy regimens. We thought it was timely to discuss the current array of both FDA approved treatments and emerging treatments. The treatment for HCV has advanced over the past few years with the introduction of the protease inhibitors, Boceprevir and Telaprevir in 2011, and recently with the FDA approval of the oral polymerase inhibitor Sofosbuvir. The introduction of Sofosbuvir represents a treatment advancement and marks the beginning of all oral therapy regimens.

Epidemiology, Diagnosis and Evaluation 

It is estimated that 3.2 million people in the United States have chronic HCV. Chronic HCV develops in 75% of patients who are exposed to HCV. The other 25% of patients will spontaneously clear the infection. Most people with chronic HCV are unaware of their diagnosis because it takes years for liver damage to occur. Baby boomers (anyone born between 1945-1965) account for 75% of all HCV infections in the U.S. and have the highest risk of developing cirrhosis and liver cancer. There are 810,000 cases among baby boomers. It is estimated that by identifying and treating this group, 121,000 deaths can be averted. In 2012, the CDC made the recommendation that all baby boomers be screened for HCV. Other groups who should be screened for HCV include: those with abnormal liver enzymes, current or past IV drug users, incarcerated individuals, healthcare workers, children born to HCV-infected mothers, those with an HCV-infected sexual partner, HIV patients, recipients of donated blood or organs before 1992, those on hemodialysis and those with a needle stick injury.

Chronic HCV can be diagnosed with an HCV antibody. A positive HCV antibody test should be followed by an HCV RNA by PCR quantitative test (viral load). If the HCV quantitative test is positive, then the diagnosis is confirmed and additional evaluation should include a liver panel, INR, CBC, abdominal ultrasound as well as an HCV genotype since treatment is tailored to genotype. Because patients coinfected with hepatitis B and/or HIV are at risk for increased liver disease progression, hepatitis B surface antigen and an HIV test should also be performed. A liver biopsy is not required to diagnose chronic HCV, but can be used for the staging and prognosis of liver disease. Results of the biopsy are particularly useful if treatment will be deferred. Non-invasive methods for assessing fibrosis, such as the biomarker test FibroSure, are best for differentiating between extremes of fibrosis. Recently, the FDA has approved the FibroScan or elastography, in which a shear wave is generated and tracked through the liver to measure stiffness using ultrasound. The FibroScan does well at identifying cirrhosis vs non-cirrhosis and advanced vs. early fibrosis.

Please stay tuned for part two of our latest newsletter which will detail the latest treatments options for Hepatitis C, including future therapies.