Aa
Hep C
I started the 3 drug treatment with Incinvik Jan.04 of this year.March 9 my viral load came back undetected, on March 21, I took my last Incinvik.The Insurance Company only cover 12 weeks. What are my chances of testing SVR?
PS: If the insurance company denies coverage for the remainer of the Interferon and Ribavirin, you may be able to get some financial assistance from the drug companies.
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Are you stating the insurance covers 12 weeks of Incivek OR 12 weeks of total treatment.
Incivek is given for 12 weeks along with Interferon and Ribavirin. After 12 weeks, Incivek stops, but Interferon and Ribavirin are continued for another 12 weeks if you were undetected at week 4 (total 24 weeks). However, if you were detected at week 4, you need to do a total of 48 weeks of treatment (12 weeks Incivek, Interferon and Riba, and 36 weeks of Interferon and Riba).
If the insurance covers 12 weeks of Incivek, that would be normal protocol. But the insurance should cover the Interferon and the Ribavirin for a total of 24 weeks if you are undetected at week 4 (48 weeks if you are detected at 4 weeks). That is the normal treatment time and it would make no sense for an insurance company to cover only half of the treatment and risk treatment failure.
If your insurance company is denying coverage for the final 12 weeks of Interferon and Ribavirin, you should contact the insurance company and your doctor. Keep calling them. The doctor needs to impress upon the insurance coumpany that you need to continue Interferon and Ribavirin. You need to do the same. Don't take no for an answer.
If the insurance company is denying coverage for the recommended treatment time, they need to provide the reason (in writing) why they are denying treatment to you.
Best of luck.
Incivek is given for 12 weeks along with Interferon and Ribavirin. After 12 weeks, Incivek stops, but Interferon and Ribavirin are continued for another 12 weeks if you were undetected at week 4 (total 24 weeks). However, if you were detected at week 4, you need to do a total of 48 weeks of treatment (12 weeks Incivek, Interferon and Riba, and 36 weeks of Interferon and Riba).
If the insurance covers 12 weeks of Incivek, that would be normal protocol. But the insurance should cover the Interferon and the Ribavirin for a total of 24 weeks if you are undetected at week 4 (48 weeks if you are detected at 4 weeks). That is the normal treatment time and it would make no sense for an insurance company to cover only half of the treatment and risk treatment failure.
If your insurance company is denying coverage for the final 12 weeks of Interferon and Ribavirin, you should contact the insurance company and your doctor. Keep calling them. The doctor needs to impress upon the insurance coumpany that you need to continue Interferon and Ribavirin. You need to do the same. Don't take no for an answer.
If the insurance company is denying coverage for the recommended treatment time, they need to provide the reason (in writing) why they are denying treatment to you.
Best of luck.
The minimum treatment time with incivek is 24 weeks, 12 weeks of all 3 drugs followed by 12 more weeks of 2 drugs, interferon and ribavirin. Total treatment time depends on many factors.
2.7.1 Duration of Treatment in Treatment-Naive Subjects
In subjects who have had no previous treatment for HCV (treatment-naive), treatment with telaprevir must be initiated in combination with Peg-IFN and RBV and administered for 12 weeks.
• Subjects with undetectable HCV RNA at Weeks 4 and 12 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 receive an additional 36 weeks of Peg-IFN and RBV alone for a total treatment duration of 48 weeks HCV-RNA levels should be monitored at Weeks 4 and 12 to determine treatment duration. Treatment with telaprevir should be discontinued in subjects who do not have an adequate viral response during treatment.
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
Treatment Futility Rules: All Patients
HCV-RNA Week 4 or Week 12: Greater than 1000 IU/mL Discontinue INCIVEK and peginterferon alfa and ribavirin (INCIVEK treatment complete at 12 weeks)
Week 24: Detectable Discontinue peginterferon alfa and ribavirin
Laboratory Tests
HCV-RNA levels should be monitored at weeks 4 and 12 and as clinically indicated. Use of a sensitive real-time RT-PCR assay for monitoring HCV-RNA levels during treatment is recommended. The assay should have a lower limit of HCV-RNA quantification equal to or less than 25 IU/mL and a limit of HCV-RNA detection of approximately 10-15 IU/mL. For the purpose of assessing response-guided therapy eligibility, an “undetectable” HCV-RNA result is required; a confirmed “detectable but below limit of quantification” HCV-RNA result should not be considered equivalent to an “undetectable” HCVRNA result.
http://pi.vrtx.com/files/uspi_telaprevir.pdf
2.7.1 Duration of Treatment in Treatment-Naive Subjects
In subjects who have had no previous treatment for HCV (treatment-naive), treatment with telaprevir must be initiated in combination with Peg-IFN and RBV and administered for 12 weeks.
• Subjects with undetectable HCV RNA at Weeks 4 and 12 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 receive an additional 36 weeks of Peg-IFN and RBV alone for a total treatment duration of 48 weeks HCV-RNA levels should be monitored at Weeks 4 and 12 to determine treatment duration. Treatment with telaprevir should be discontinued in subjects who do not have an adequate viral response during treatment.
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
Treatment Futility Rules: All Patients
HCV-RNA Week 4 or Week 12: Greater than 1000 IU/mL Discontinue INCIVEK and peginterferon alfa and ribavirin (INCIVEK treatment complete at 12 weeks)
Week 24: Detectable Discontinue peginterferon alfa and ribavirin
Laboratory Tests
HCV-RNA levels should be monitored at weeks 4 and 12 and as clinically indicated. Use of a sensitive real-time RT-PCR assay for monitoring HCV-RNA levels during treatment is recommended. The assay should have a lower limit of HCV-RNA quantification equal to or less than 25 IU/mL and a limit of HCV-RNA detection of approximately 10-15 IU/mL. For the purpose of assessing response-guided therapy eligibility, an “undetectable” HCV-RNA result is required; a confirmed “detectable but below limit of quantification” HCV-RNA result should not be considered equivalent to an “undetectable” HCVRNA result.
http://pi.vrtx.com/files/uspi_telaprevir.pdf
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