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PA gives new directiions regarding EOT for triple therapy
Hello Warriors,
Went to see PA on this Wednesday when she said how are you? I answered: "I am in the abyss between the empty nest and deceased parents." There was no answer, just a dull silence. Once again, I said something completely out of place. "Who said that?, I thought". Riba has me emotionally fragile these days. I hope you out there are fairing better.
The PA informed me that since I was undetectable at wk 4, 8, and 12; that if I would also be undetectable at week 24, that even though I was a "relapser", I could stop treatment after 6 months instead of 11 months. She said these changes just came down the pike. Wow I am pinching myself but a little nervous - I was committed to the long haul. Can this be true for relapsers?????? This is great news Yes????? Any one else out there get this change of plans? (Incivek, wk 19) Thanx
Went to see PA on this Wednesday when she said how are you? I answered: "I am in the abyss between the empty nest and deceased parents." There was no answer, just a dull silence. Once again, I said something completely out of place. "Who said that?, I thought". Riba has me emotionally fragile these days. I hope you out there are fairing better.
The PA informed me that since I was undetectable at wk 4, 8, and 12; that if I would also be undetectable at week 24, that even though I was a "relapser", I could stop treatment after 6 months instead of 11 months. She said these changes just came down the pike. Wow I am pinching myself but a little nervous - I was committed to the long haul. Can this be true for relapsers?????? This is great news Yes????? Any one else out there get this change of plans? (Incivek, wk 19) Thanx
thanx Jasmine (love your name) and horsepwrman for imparting such excellent information and sources to boot. I will just keep pinching myself.
2.7.2 Duration of Treatment—Previously Treated Subjects
In subjects who have had previous treatment for HCV, treatment with telaprevir must be initiated in combination with Peg-IFN and RBV and administered for 12 weeks. Subjects who had a partial response to previous treatment (partial responders) or minimal response
(null responders) to Peg-IFN plus RBV receive an additional 36 weeks of Peg-IFN and RBV treatment alone for a total treatment duration of 48 weeks.
In subjects who had relapse after previous treatment to Peg-IFN plus RBV, a responseguided regimen is recommended.
• Subjects with undetectable HCV RNA at Weeks 4 and 12 of telaprevir-based treatment receive an additional 12 weeks of Peg-IFN and RBV alone for a total treatment duration of 24 weeks
• Subjects with detectable HCV RNA at either Weeks 4 or 12 of telaprevir-based treatment receive an additional 36 weeks of Peg-IFN and RBV alone for a total treatment duration of 48 weeks
Telaprevir must be dosed with Peg-IFN and RBV to prevent treatment failure.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562.
In subjects who have had previous treatment for HCV, treatment with telaprevir must be initiated in combination with Peg-IFN and RBV and administered for 12 weeks. Subjects who had a partial response to previous treatment (partial responders) or minimal response
(null responders) to Peg-IFN plus RBV receive an additional 36 weeks of Peg-IFN and RBV treatment alone for a total treatment duration of 48 weeks.
In subjects who had relapse after previous treatment to Peg-IFN plus RBV, a responseguided regimen is recommended.
• Subjects with undetectable HCV RNA at Weeks 4 and 12 of telaprevir-based treatment receive an additional 12 weeks of Peg-IFN and RBV alone for a total treatment duration of 24 weeks
• Subjects with detectable HCV RNA at either Weeks 4 or 12 of telaprevir-based treatment receive an additional 36 weeks of Peg-IFN and RBV alone for a total treatment duration of 48 weeks
Telaprevir must be dosed with Peg-IFN and RBV to prevent treatment failure.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562.
Hi libzo, Guidance for relapsers who are und at 4 and 12 has always been to treat 24 weeks since FDA approval. See the incivek duration chart here for more info. http://www.natap.org/2011/PDF/NurseMary.pdf. Maybe you doc didn't want you to have your hopes up.
Its actually probably the interferon that has you such a mess. It's hitting me hard too.
Congratulations on the good news for a 24 week tx. I know how wonderful those words are to hear.
Its actually probably the interferon that has you such a mess. It's hitting me hard too.
Congratulations on the good news for a 24 week tx. I know how wonderful those words are to hear.
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