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FDA Approves Sofosbuvir, Ledipasvir Combination
In early October, the FDA announced approval of the first combination pill for the treatment of chronic hepatitis C virus genotype 1 infection that does not require interferon or ribavirin for administration, according to an agency release.
The combination pill, which will be marketed by Gilead as Harvoni, combines ledipasvir and sofosbuvir (Sovaldi).
The therapy has been evaluated across the ION-1, ION-2 and ION-3 studies. The participants were randomly assigned the combination pill with or without ribavirin and monitored until 12 weeks after treatment to determine whether the infection was eliminated.
Treatment-naive and treatment-experienced patients with and without cirrhosis showed high sustained virologic response rates. According to the release, the most common adverse effects reported were fatigue and headache.
Perspective
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Michael S. Saag
Sofosbuvir and ledipasvir, when used together, are getting roughly about 95% success rates in genotype 1 infection and also work well in genotypes 3 and 4. So the thought is that this combination pill will be used as a ‘go-to’ regimen for a lot of people. The biggest barriers that we are finding to these drugs is not the side effects or efficacy, it is the cost. To my knowledge, the actual pricing for this drug has not been released yet, but I am sure it will be [soon]. Hopefully the drug will be priced in a way that, No. 1, will be affordable by the payers and that there will be some negotiated rates where more patients can gain access to the medicines. This is the first in a new wave of drugs. It is an exciting time and there are even more drugs in the pipeline.
– Michael S. Saag, MD