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need help to take decision regarding hep c treatment
need help to take informed decision:
hi,my mother was diagnosed hep c 5 year ago.she took peg interferon fro 12 month 2yr ago fro genotype 1b.initially she got response after 6 month but on complition of treatment she was again reactive.now drs advice her for peg interferon for another 12 month.i heard about new treatment like telaperavir,and some one telling me about infergin or concensu.what should i do what will you recpmmend.which injection are best for her and most effective for her disease..b/c last treatment she took she developed lots of side effects.so now she made her mind after lots of councelling.so we want the best injection and which have good response.
kindley give me your expert opinion.
thanks.
tehmina
hi,my mother was diagnosed hep c 5 year ago.she took peg interferon fro 12 month 2yr ago fro genotype 1b.initially she got response after 6 month but on complition of treatment she was again reactive.now drs advice her for peg interferon for another 12 month.i heard about new treatment like telaperavir,and some one telling me about infergin or concensu.what should i do what will you recpmmend.which injection are best for her and most effective for her disease..b/c last treatment she took she developed lots of side effects.so now she made her mind after lots of councelling.so we want the best injection and which have good response.
kindley give me your expert opinion.
thanks.
tehmina
Best Answer
I think her best bet is the new protease inhibitor (telaprevir) when it is approved. Unfortunately she will have to take it with interferon and ribavirin. Infergen is a possibility but it is a hard interferon to take. Many people have much worse side effects on infergen and it doesn't work on non-responders to pegylated interferon all that frequently.
Actually, the drug already received "fast Track" status, now they are seeking priority review. Much of the material was submitted prior to seeking the NDA through the "rolling review" process. 80 % of companies seeking priority review get it, if previously fast tracked. Perfect world, maybe June..It's odd, we've discussed this drug for so long I beleive some may be jaded to the concept of finally being approved. Well, wake up folks, the time is nigh!!..For those waiting, time to start rounding up those scattered ducks...........;^)
very soon, early January, the FDA will announce whether or not Telaprevir gets fast track application for approval. If Vertex is successful, then it will be 6 months for final approval (or not.) It has taken Vertex 15 years to get this point. Those of us needing treatment and whose type of Hec C this med works for, should be very pleased and hopeful, as am I.
Hi Tehmina,
Sorry to hear of your mother’s dilemma; unfortunately, viral relapse occurs in roughly half of genotype 1 patients.
The decision to undergo therapy is best driven by the patient’s degree of scarring, or fibrosis that they’ve sustained over the course of their disease. Has your mother had a liver biopsy to assess fibrosis? If so, what was the numerical stage of damage?
If she currently has little liver damage, a case could be made to postpone therapy in favor of more effective treatments such as Telaprevir/Boceprevir. Vertex Pharmaceutical formally applied to the U.S. FDA last month; they’ll hopefully receive approval sometime in 2011.
Infergen/Consensus interferon is a possibility; although her odds of success are thought to be less than 32%, assuming her fibrosis is F1-F3: [Thanks Trish…]
“Patients achieving the greatest reduction in baseline viral load with peg-IFN/RBV therapy, especially in patients demonstrating > 1-log drop with initial therapy
Patients with fibrosis scores of F0 to F3 at baseline demonstrated SVRs of 7.8% in the 9 mcg arm and 13.1% in the 15 mcg arm
Patients maintaining full dose of INFERGEN/RBV therapy had SVRs of 7% and 17% for the 9 mcg and 15 mcg arms respectively
Patients demonstrating partial response (>2-log drop) with previous treatment and low fibrosis scores F0-F3 had SVRs of 10.7% and 31.6% for the 9 mcg and 15 mcg arms”
http://www.ncbi.nlm.nih.gov/pubmed/19291790?dopt=Abstract
Good luck to you and your mother—
--Bill
Sorry to hear of your mother’s dilemma; unfortunately, viral relapse occurs in roughly half of genotype 1 patients.
The decision to undergo therapy is best driven by the patient’s degree of scarring, or fibrosis that they’ve sustained over the course of their disease. Has your mother had a liver biopsy to assess fibrosis? If so, what was the numerical stage of damage?
If she currently has little liver damage, a case could be made to postpone therapy in favor of more effective treatments such as Telaprevir/Boceprevir. Vertex Pharmaceutical formally applied to the U.S. FDA last month; they’ll hopefully receive approval sometime in 2011.
Infergen/Consensus interferon is a possibility; although her odds of success are thought to be less than 32%, assuming her fibrosis is F1-F3: [Thanks Trish…]
“Patients achieving the greatest reduction in baseline viral load with peg-IFN/RBV therapy, especially in patients demonstrating > 1-log drop with initial therapy
Patients with fibrosis scores of F0 to F3 at baseline demonstrated SVRs of 7.8% in the 9 mcg arm and 13.1% in the 15 mcg arm
Patients maintaining full dose of INFERGEN/RBV therapy had SVRs of 7% and 17% for the 9 mcg and 15 mcg arms respectively
Patients demonstrating partial response (>2-log drop) with previous treatment and low fibrosis scores F0-F3 had SVRs of 10.7% and 31.6% for the 9 mcg and 15 mcg arms”
http://www.ncbi.nlm.nih.gov/pubmed/19291790?dopt=Abstract
Good luck to you and your mother—
--Bill
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