Breaking Down Restrictions

For many years, the standard plan for treating hepatitis C infections called for excluding active drug users. Experts at the 5th International Symposium on Hepatitis Care in Substance Users who recently met in Oslo, aim to revise what is considered standard care. New research was discussed at the symposium, specifically a series of studies by Merck based on patients infected with hepatitis C virus (HCV) who inject drugs and are receiving opioid agonist therapy.

These studies, called the C-EDGE CO-STAR clinical trials provide a once-daily pill of Zepatier™ (elbasvir/grazoprevir) to treat HCV. Phase 3 clinical trial results show that 95% of patients (189 out of 198 patients) were cured of HCV infection (genotypes 1, 4, or 6) after 12 weeks, according to sustained virologic response. Zepatier showed high adherence rates, with 97% of patients completing 95% of medication. Again, this population was drug users.

This means that, for the first time, even people actively using illicit drugs could effectively be treated. The importance of this is highlighted by the fact that, in Western countries, most (80%) of new HCV infections occur in injection drug users. If these patients continue to be excluded from treatment, then it will be much harder to make headway in eradicating this disease. Based on the new research, there is no reason for continuing the exclusion, since illicit drug users showed cure rates similar to other populations and they only had a 4% reinfection rate.

Summing it up, the researchers at the symposium stated: “We strongly recommend that all restrictions on access to new hepatitis C treatments based on drug or alcohol use or opioid substitution treatment be removed. There is no good ethical or health based evidence for such discriminations. Nor do the restrictions make clinical, public health, or health economic sense.”

Stephen C. Vogt, Pharm.D.
President and CEO
BioPlus Specialty Pharmacy |

Press release. No treatment, no elimination says new research. 5th International Symposium on Hepatitis Care in Substance Users Sept 7, 2016.

International Network for Hepatitis C in Substance Users. New research supports hep C treatment for people who use drugs. Drug Discovery & Development Sept 7, 2016.

Experts recommend removal of restrictions in accessing new hepatitis C therapies for drug users. News-Medical.Net Sept 7, 2016.

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