Overcoming Patent barriers to hepatitis C treatment The Hepatitis C Treatment Revolution Expanding Access to HIV Co-Infected and Beyond UNITAID, MSF, WHO. IAC, Melbourne 21 July, 2014. Drugs of Interest - Hepatitis C. Sofosbuvir Will likely be backbone of HCV all-oral pan-genotypic regimens
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Overcoming Patent barriers to hepatitis C treatment The Hepatitis C Treatment Revolution Expanding Access to HIV Co-Infected and BeyondUNITAID, MSF, WHO
IAC, Melbourne 21 July, 2014
Will likely be backbone of HCV all-oral pan-genotypic regimens
MSF planning to use in our treatment programs
Significantly strengthens sofosbuvir regimens and likely reduces duration
Potential component (e.g. with sofosbuvir) of pan-genotypic all oral regimen
Very good activity in genotype 3
Potential for pan-genotypic all-oral regimen (e.g. with sofosbuvir) – but need to
evaluate further studies that are on-going
potential for FDC with sofosbuvir for GT 1 and 4 – data already available
Very good pan-genotypic potential, but need to see results of on-going studies
High prices of
Access to low cost
24 Nov 2013: opposition to the patent application on the pro-drug
The opposition, filed at the Kolkata Patent Office by I-MAK targets Gilead’s patent application 3658/KOLNP/2009 (WO2008/121634).
19 March 2014: opposition to the patent application on the base compound
The opposition, filed at the Delhi Patent Office by I-MAK and the Delhi Network of Positive People (DNP+) targets Gilead’s patent application 6087/DELNP/2005
Lack of novelty - The base compound has been disclosed in variousearlier
patents, whichalreadyreveal the free base compound that is used
The complete patent opposition documents are available.
In what form?
What are governments doing about this?
More and more patients failing current treatment regimen (Peg inf+Ribavirin) are being prescribed new DAAs (Sofosbuvir) and asked to import from US if possible (cost 26,000 canadian $ for 28 tablets)
There are three steps to this process: