Mr. Jules Levin is the founder of NATAP, an Internet resource for global HIV and hepatitis conference coverage and scientific information. For almost two decades Mr. Levin has kept the HCV community informed on the development of investigational drugs and FDA approved drugs to treat hepatitis C by providing breaking news, data on clinical studies, newsletters and exceptional conference coverage.
You won't want to miss this years coverage of The International Liver Congress 2013. Check out Mr. Levin's three part series which include slides and commentary. View new data on treatment-naive patients, null responders, patients with cirrhosis, genotypes 1-3, in addition to interferon (IFN)-free therapies on the horizon. Once again the conference coverage at NATAP is outstanding.
EASL 48th Annual Meeting
April 24th - 28th 2013
The Netherlands, Amsterdam
Links and Summary:
Abbvie reported results from a phase 2b study of their oral IFN-free 4-drug regimen with 99% SVR rate with 12 weeks therapy in genotype 1 and 98% SVR with 24 weeks in null responders.
SVR results with the BMS 3-oral drug IFN/-Rbv free regimen including their protease Asunaprevir+the NS5A BMS052 (declatavir)+ their non-nuc polymerase inhibitor BMS325 showing high SVR rates of 94%
Both Janssen & Gilead have just recently submitted New Drug Applications to the FDA for indications for the use of GS7977 and for TMC435 with approvals expected by the end of the year. Other companies are completing phase 3 now & will be submitting NDAs to the FDA soon...
This report is an updated version that was originally distributed live in real-time from EASL on April 28.
Daclatasvir, TMC435, Faldaprevir and MK5172
- GS7977(nucleotide)+Peg/Rbv for 12 weeks for genotypes 1/4/5/6 in the phase 3 NEUTRINO Study
- TMC435 (protease)+Peg/Rbv for GT1 in the phase 3 QUEST-2 Study
- Faldaprevir (BI335, protease)+Peg/Rbv in the phase 3 study STARTVERS01
- NS5A BMS052+GS7977 in GT1 patients who previously did not achieve an SVR with boceprevir or telaprevir (this captured a lot of attention)
- Daclatasvir (BMS052) + Peg/Rbv for GT2/3 for 12 or 16 weeks
- Phase 2 study on MK5172 (Merck 2nd generation protease) + Peg/Rbv for Gt1
ELECTRON Study phase 2: GS7977+Rbv GT1 -The ELECTRON Study is a phase 2 of about 94 patients looking at both treatment-naives & null responders with each of 3 treatment arms for 12 weeks therapy: GS7977+Rbv, GS7977+GS5885 (NS5A)+Rbv and GS7977+GS9669 (non-nuc)+Rbv. These were 90% Gt1a patients without cirrhosis, phase 3 will include cirrhotics. You can view the ELECTRON slide presentation here at EASL with the link above. Here is the results slide just below showing 100% in naives (25/25) with the 3-drug regimen of GS7977+GS5885+Rbv & 100% in nulls with the same regimen, phase 3 ION studies will look at with & without Rbv with the coformulation of GS7977+GS5885. You can see this study also looked at GS7977+GS9669 (non-nuc)+Rbv with 92% SVR in naives (23/25) & 3/3 SVR in nulls all with 12 weeks, ION-2 will look at treatment-experienced with 12 and 24 weeks therapy.
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