AI
Wednesday, April 14, 2010 7:42:07 PM
ITMN:
The one thing I would worry about as far as safety is the dreaded word "preliminary" and them only noting Grade 4 elevations (I wouldn't be happy seeing a bunch of grade 3's in the lower doses).
It looks like tomorrow we should get data on the ritonavir boosting. This is out of my league to speculate but though I may be better off keeping my mouth shut I will speculate. If they say go with a QD dose of 200-300mg or a BID dose of 100-200mg that is roughly 1/3 of the low dose tested. And the abstact said "
RG7227/r AUC and Cmax were approximately 6- to 9-fold and 4- to 10-fold lower, respectively, than previously observed for 900 mg BID un-boosted." So not withstanding your warning about ritonavir I would speculate the opportunity for a safer delivery with comparable efficacy exists. Just speculating I know once its tested on patients for 6-8+ weeks the real test will come as far as any AE's popping up. They have been vague on when/if the 1B boosting study was amended given their timeline I would imagine tomorrow they may announce they've already dosed patients in the 12 week arm(s) and maybe we will get a better idea of what they look like (I guess 1B studies don't need to be on clinicaltrials.gov).
One thing I found intriguing is the mention that most in the high dose did not receive the full 12 weeks yet the RVR and EVR numbers look quite good. I recall Vertex speculating on shorter durations and I wonder if in a large subset of patients a substantially shorter treatment period may be possible. I guess the risk is the virus isn't totally cleared and after a longer time period becomes detactable again. I believe you and dewophile (and others?) have had this discussion a while back about SVR (maybe even a few years out) the numbers drop off a bit with these PI's.
By results I was referring to efficacy. If you took results as the whole package (safety+efficacy) I could understand (though not agree with
) your opinion on them not being satisfactory but if it is efficacy I would appreciate if you could elaborate a bit more. TIA.
Ref:
#msg-47860488 Ritonavir boosting Abstract
The one thing I would worry about as far as safety is the dreaded word "preliminary" and them only noting Grade 4 elevations (I wouldn't be happy seeing a bunch of grade 3's in the lower doses).
It looks like tomorrow we should get data on the ritonavir boosting. This is out of my league to speculate but though I may be better off keeping my mouth shut I will speculate. If they say go with a QD dose of 200-300mg or a BID dose of 100-200mg that is roughly 1/3 of the low dose tested. And the abstact said "
RG7227/r AUC and Cmax were approximately 6- to 9-fold and 4- to 10-fold lower, respectively, than previously observed for 900 mg BID un-boosted." So not withstanding your warning about ritonavir I would speculate the opportunity for a safer delivery with comparable efficacy exists. Just speculating I know once its tested on patients for 6-8+ weeks the real test will come as far as any AE's popping up. They have been vague on when/if the 1B boosting study was amended given their timeline I would imagine tomorrow they may announce they've already dosed patients in the 12 week arm(s) and maybe we will get a better idea of what they look like (I guess 1B studies don't need to be on clinicaltrials.gov).
One thing I found intriguing is the mention that most in the high dose did not receive the full 12 weeks yet the RVR and EVR numbers look quite good. I recall Vertex speculating on shorter durations and I wonder if in a large subset of patients a substantially shorter treatment period may be possible. I guess the risk is the virus isn't totally cleared and after a longer time period becomes detactable again. I believe you and dewophile (and others?) have had this discussion a while back about SVR (maybe even a few years out) the numbers drop off a bit with these PI's.
By results I was referring to efficacy. If you took results as the whole package (safety+efficacy) I could understand (though not agree with
) your opinion on them not being satisfactory but if it is efficacy I would appreciate if you could elaborate a bit more. TIA. Ref:
#msg-47860488 Ritonavir boosting Abstract
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