Hepatitis C therapy: The revolution continues
28.08.2015 20:56
More and more patients with chronic hepatitis C can hope for a cure. Since the European Medicines Agency approved the first highly effective drug for interferon-free therapy against the liver disease in January 2014, physicians in this field have witnessed rapid progress. With the recent approvals for "ledipasvir/sofosbuvir" as a single tablet, as well as "paritaprevir/r plus ombitasvir" and "dasabuvir," the German Society for Gastroenterology, Digestive and Metabolic Diseases (DGVS) has now updated its treatment recommendations for the fourth time in a very short period. The current addendum to the "S3 Guideline Hepatitis C" is available on the DGVS website. The professional society recommends that physicians treating patients with hepatitis C stay informed about the latest developments.
„With each new medication, the range of treatment options expands,“ says Professor Dr. Thomas Berg, Head of the Hepatology Section at the Department of Gastroenterology and Hepatology at Leipzig University Hospital. „A cure is now possible for more than 90 percent of all hepatitis C patients.“ The recently approved combination therapies are one of four treatment options for patients with hepatitis C viruses of genotypes 1 or 4. Berg also notes a positive development regarding the high and much-discussed treatment costs for hepatitis C patients. At the end of the first year after approval, manufacturers and the National Association of Statutory Health Insurance Funds (GKV) have, for the first time, agreed on lower costs for a medication. Instead of the previous cost of approximately €100,000, a twelve-week combination treatment with the new active ingredients now costs between €56,000 and €68,000. By reducing the treatment duration to eight weeks, which is possible for many patients without prior treatment and without advanced disease, therapy costs fall below €50,000. The costs will also decrease further with annual price reductions. "We expect this development to serve as a model for other medications," says Berg. Pharmaceutical companies are only allowed to freely set prices in the first year after approval.
Until 2011, combination therapy with the drugs ribavirin and interferon was the standard treatment for hepatitis C infection. "Taking interferon, in particular, was associated with severe side effects for many patients," explains DGVS expert Berg. As a result, patients often had to discontinue treatment prematurely. When the first drugs directly targeting the virus, boceprevir and telaprevir, came onto the European market in 2011, some patients subsequently received an expanded "triple therapy." "This resulted in a significant increase in cure rates for some patients," comments Berg. "But this is nothing compared to the progress made in the past 14 months." Since then, seven new drugs have received regulatory approval. These newly approved medications also directly target the viral replication cycle and can be used without interferon. "Unlike before, there are hardly any side effects," says Berg.
In continuously updating their treatment recommendations, the experts consider not only new approvals but also the growing body of knowledge resulting from large clinical trials. "The database on new treatment options is growing daily," says Professor Dr. Christoph Sarrazin, Deputy Director of the Department of Internal Medicine I at Frankfurt University Hospital.
Together with the other organizations involved in the guideline, the German Society for Gastroenterology, Digestive and Metabolic Diseases (DGVS) established an expert group to monitor developments and promptly update the recommendations. "Normally, updating a guideline takes at least two years," explains Sarrazin. "With changes of such significant clinical importance as in this case, it makes sense to deviate from the standard procedures." In collaboration with the Association of Scientific Medical Societies in Germany (AWMF), the experts succeeded in quickly providing physicians and patients with a treatment update. "It was important to us to consider the methodological requirements that guarantee the quality of the guideline and to involve all participating professional societies," emphasizes Sarrazin. "I can easily imagine that this approach could serve as a model for other areas as well.".