Hepatitis C Update Selected Highlights: Key new HCV drugs

Written for NATAP by Jules Levin:

Currently approved are 2 protease inhibitors telaprevir & boceprevir. In phase 3 now are 4 drugs: 2 proteases TMC435 & BI1335; nucleotide GS7977; and NS5A BMS052. Also in phase 3 is Peg Lambda, a peginterferon that has showed in trials similar efficacy to current Peginterferons with little of the side effect. Phase 3 for these drugs should be finished in about one year with varying finish timelines between these drugs. Abbott is about to start phase 3 studies, they have 4 drugs in 3 classes: protease, NS5A, HCV polymerase nonnucleoside inhibitors (NNIs). Gilead has drugs in 4 classes: nucleotide, protease, HCV polymerase nonnucleoside inhibitors (NNIs), NS5A. BMS has drugs in 4 clases: NS5A, HCV polymerase nonnucleoside inhibitors (NNIs), nucleotide (trial just suspended, evaluating), protease; Roche/Genentech has drugs in 3 classes: protease, nuke, HCV polymerase nonnucleoside inhibitors (NNIs). Vertex has drugs in 3 classes: protease, nucleotide, HCV polymerase nonnucleoside inhibitors (NNIs). Merck has drugs in 2 classes: protease in development in addition to boceprevir, NS5A. Tibotec has protease TMC435 in phase 3 now with other drugs further back in development.

So in about 1 year we will have 2 brand new classes of drugs BMS052 the potent NS5A, GS7977 the potent nucleotide, plus the 2 new proteases currently in phase 3 BI1335 & TMC435. At this time we don't know if patients & clinicians will be able to combine the NS5A+GS7977 or a 3-drug combination of a protease TMC435 or BI1335 + the NS5A BMS052+GS7977. A small phase 2 study at EASl in April of about 40 patients showed SVR rates of 100% using GS7977+BMS5435, but there is not a followup study ongoing with these 2 drugs. There is an ongoing study now in null responders lookimg at TMC435+GS7977, we await these data, expecting good results. For null responders we have some data below in small studies finding that 2 BMS orals, the protease+NS5A + peg/RBV could cure 100% of patients.

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