no doubt in honor of Jim's return, one of his heroes, K. Lindahl, the Iron Lady of Extreme Ribavirin, is presenting new results at the upcoming AASLD. Abstract 814 (with a few editorial comments in CAPS):
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BACKGROUND:Gt 1 infected patients, previous non-responders (NR)to treatment with pegylated interferon (peg-INF) and ribavirin (RBV) are a difficult-to-treat population. We have previously shown that high doses of RBV (2550 mg/d) offered high treament response (SVR) in treatment-naïve patients with hepatitis C genotype 1. The aim of this study was to evaluate the efficacy, safety and tolerability of individualized concentration monitored high doses of RBV in combination with standard dosed peg-INF in previous NR. METHODS:This prospective, open label, singel-centre, pilot study investigates efficacy, safety and tolerance of RBV concentrations of more than 15 mmol/L in combination with standard dosed PEG-IFN in patients who previously failed treatment with PEG-IFN and RBV. 20 patients with HCV gt 1 were treated with individualized high dose of RBV in combination with peg-INF a-2a 180mg/week for 48 weeks. NR were defined as not achieving HCV-RNA <50 IU/mL at any time during previous treatment. The initial RBV dose was individualized and calculated from a pharmacokinetic formula based mainly on renal function aiming at a high steady state concentration of RBV of 16 mmol/L. Plasma RBV concentrations were measured by HPLC and the RBV dose was adjusted to reach target concentration. All patients received erythropoietin (epo) at doses 10,000-60,000 IU/week, from 2 weeks prior to initiation of antiviral treatment. RESULTS:We enrolled 20 patients, mean age 52 yr and 12 patients with fibrosis F3,F4. The mean initial RBV dose was 2130 mg/d (range 1600-3000) [THAT WAS JUST THE START !?! ] The mean baseline HB level was 16.3 g/dL, at treatment week 12 mean HB level was 11.0 g/dL. Two patients required blood transfusions. [SEE EGGS, OMELETTES, ETC.] Mean baseline viral load was 6.6 x 106 IU/mL, at treatment week 12 the mean viral drop was 3.1 log, vs previously standard treatment 2.0 log (p<0.001). [HOW'S THAT FOR RESPONSE!] Sixteen patients reached an EVR. Three patients stopped treatment at w15-17 due to lack of viral response (n=2) and side effects (n=1). Twelve patients were neg in HCV-RNA (<15 IU/mL,COBAS TaqMan) at w24 and 1 patient reached SVR. [A MINOR PROBLEM, BUT ALL ARE STILL ALIVE, WE THINK] CONCLUSION:Individualized high-dosed RBV in combination with peg-INF alfa-2a resulted in a mean 3.1 log HCV-RNA decline within 12 weeks in previous non-responders to standard-dosed combination therapy. High-dosed RBV treatment is feasible and seems to be safe[ WHAT EXACTLY DOES "SEEMS" MEAN ?] but requires attention regarding anemia. Erythropoietin probably contributes to tolerability[ MAYBE ASK THE PATIENTS?] In previous NR this treatment model did not significantly improve treatment outcome in SVR but the viral on-treatment response is significantly increased (p<0.001) supporting that the antiviral effect of RBV is related to plasma concentrations.
jokes aside, the unsettling aspect of this seems to be that, by extreme dosing, you can squeeze response out of a non-responder and still get nowhere. Unfortunate they don't give EOT/relapse rates but presumably relapse was high.
Ha! Good to see that you are still kicking Jim. I surmised that while rebooting your computer you had watched the end of "Good Will Hunting" and decided that you too could take a road trip. I pictured a nicer car than Will had, but anyway, a happy ending, a sabbatical, a leave of absence; a vacation
Anyways..... I figured that you got swept up in life and I hoped that it was a good thing.
I'm glad to know that you are still on the planet and that your disappearance was not mattress related, although I suppose that could also be a good thing. : )
Take care amigo,
Willy
So it's true....there's a jmjm post!!!!
Thanks for stopping by and letting us know how you've been. Glad to hear HCV's on your back burner. I can totally relate, especially with the part about all the friends we've made here during some pretty difficult times.
Sorry to break the news, but some of us have offered out your inflatable lady over on the Social side. All for a good cause, tho.
Take care and continue to enjoy!!!
Isobella
yeah, wonder what 4C's up to. If she qualifies as tx naive notwithstanding that short stretch there's a number of non-ifn trials she'd be eligible for at this point.
Had to check the date twice when I saw your name there! Great you popped in,
all the best,
dointime
Hiya Jim. Have thought about you often and missed you lots. Don't take this wrong but not sure I'm glad to see you back here. :) I kinda liked the idea that you were out there flying free and it was alot of fun to be thinking what kind of adventures you might be up to and to be thinking you were out there getting your life back and I hope that's been the case. You've certainly been missed by many around here. Your evenhandedness and innate concern for everyone has been missed, not to mention your depth and knowledge in many a discussion. Myself....I'm happy to see your name up there and I hope life has been treating you very well. You surely deserve it. Very good to see your name there, Jim.
Trish