As mentioned earlier in this issue of TreatmentUpdate, the duration of HCV therapy is shrinking, from 48 weeks a few years ago to 24 weeks and most recently 12 weeks. These shorter periods of therapy are made possible by the use of increasingly powerful anti-HCV drugs called DAAs (direct acting antivirals).
In a trial called Synergy, researchers at the U.S. National Institutes of Health (NIH) tested different combinations of anti-HCV drugs; with the exception of sofosbuvir, all were experimental agents. The drugs used were as follows:
Here is a list of the regimens used in the study along with the duration of therapy:
None of the participants had previously been exposed to HCV treatment prior to the current study.
Participants' average profile at the time they entered the study was as follows:
Researchers noted that this patient population is reflective of what many doctors consider difficult to treat HCV in the U.S.
The response to therapy was stunning given that many participants had factors that would impair their recovery from therapy had they been treated with interferon, and neither interferon nor ribavirin were used in this study. SVR12 (an undetectable viral load 12 weeks after a course of therapy has ended) is a very strong predictor of SVR24 and highly suggestive of recovery from HCV. SVR12 was observed in the following proportions of participants:
The combination that drove HCV viral load down the fastest was the following:
By the 14th day of therapy, at least 90% of participants had their HCV viral loads suppressed.
According to the researchers, the regimens were well tolerated. No one died during the study.
Common side effects reported were as follows:
Two serious adverse events were reported as follows:
Therefore, it seems unlikely that the study drugs caused these problems.
There were isolated abnormal blood test results from some participants, including the following:
All abnormal test results returned to their pre-study level.
Kohli A, Sims Z, Marti M, et al. Combination oral hepatitis C antiviral therapy for 6 or 12 weeks: Results of the Synergy trial. In: Programs and abstracts of the 21st Conference on Retroviruses and Opportunistic Infections, 3-6 March 2014, Boston, U.S. Abstract 27 LB.
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