Hepatitis C | Drug Pipeline update.
Sofosbuvir efficacy shows promise
By Michael Haydock, Lead Analyst
15 August 2013
I am the Lead Analyst of the immunology and inflammation and infectious diseases and vaccines teams at Datamonitor Healt...
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A review of key pipeline products, pipeline trends, and future treatment paradigms for hepatitis C across the US, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK).
Sofosbuvir is the most promising pipeline candidate, demonstrating impressive efficacy against the majority of viral genotypes, good tolerability, and a high barrier to resistance. Sofosbuvir as an adjuvant to peginterferon-alfa and ribavirin therapy will rapidly replace the current protease inhibitors in genotype 1 patients, while an interferon-sparing regimen will become the new standard for genotype 2/3 subjects.
In anticipation of the shift towards an interferon-free treatment paradigm, the pipeline is largely focused on all-oral combinations of protease inhibitors, NS5A inhibitors, and NS5B inhibitors. Such combinations show high efficacy and suppress the generation of resistant viral variants by targeting multiple stages of viral replication. Trials of these combinations frequently enroll difficult to treat subgroups to address key unmet needs.
Collaborative trials between developers of late-stage pipeline products are increasingly common as companies attempt to incorporate their products into efficacious and tolerable combinations with the most clinically attractive candidates of each mechanism of action. Convenient once-daily dosing and the removal of ribavirin will become differentiating factors as late-stage competition intensifies.
Datamonitor Healthcare has assessed key products in late-stage development for hepatitis C. Novel therapies are assessed against marketed products, considering their clinical and commercial attributes.
This is an Hepatitis C analysis update from the Datamonitor Healthcare service, which provides regular and event-senstive research for key drugs and companies, treatment trends, patient populations and strategic issues.
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