Aa
post transplant
Has anyone that has already had a transplant undergone this treatment. My wife will begin hers in the next few weeks and we do not know what to expect.
Thanks for your reply.
So a hepatologist at the transplant center has suggested triple therapy with Telaprevir for recurrence of Hep C and is going to help her with this treatment? Yes?
While there is very little data available (only form very small studies- 10 or less patients) about the improvement of SVR rate over peg-interferon and Ribavirin, it is assumed that SVR rates are higher than with the 2 drug treatment. The SVR rate using only peg-INF and RBV among post transplant patients is only 30%.
The issue with triple treatment is the amount and degree of adverse events and side effects are worse then with just 2 drugs. Therefore triple therapy is only given to select groups of post transplant patients.
Ribavirin dose reduction is common
49% have serious Adverse Events
26 % discontinue treatment before completing the 48 weeks.
57% need Procrit for anemia
15% has transfusions
'Telaprevir Post Liver Transplant
Telaprevir-based triple therapy in liver transplant patients with hepatitis C virus: A 12-week pilot study providing safety and efficacy data, this study was just published in Liver transplantation Dec 7 2012, full text below....."a remarkable number of patients (8/9) had an undetectable viral load at week 12.......triple therapy with TVR has promising antiviral efficacy in LT patients with respect to treatment weeks 4 and 12. The management of drug-drug interactions during TVR exposure is a therapeutic challenge, but they may be more controllable if CSA is used as the main immunosuppressive agent.
Triple therapy has an acceptable safety profile, although the treatment is quite intense with respect to cost and time. Therefore, we recommend that this therapy be conducted only by expert transplant hepatologists with strict surveillance of the patients because of the potential development of severe side effects.......this pilot study provides evidence showing that TVR-based triple therapy is effective within the first 4 to 12 weeks in LT patients suffering from HCV genotype 1 recurrence, and it also provides evidence showing that drug-drug interactions between TVR and immunosuppressants can be handled appropriately through the close monitoring of trough levels and adequate dosage adjustments.....Because both TVR and immunosuppressants (eg, calcineurin inhibitors) are substrates of cytochrome P450 3A4 and this can result in significant drug-drug interactions, the dosages of the immunosuppressants had to be modified during concomitant medication......There is also evidence showing that drug-drug interactions between the PI TVR and immunosuppressants can be controlled if the dosing of the drugs is carefully adapted......the maintenance of stable trough levels of immunosuppressants during the TVR exposure time still remains a challenging problem, especially for TAC and SIR. Thus, the dose reduction factors for the immunosuppressants differed and ranged from 22-fold (for TAC) to 2.5-fold (for CSA)......we suggest CSA as the main immunosuppressive agent to be used in the context of future TVR-based triple therapies."
Vertex, the manufacturer of Telaprevir, currently has two studies on the use of triple therapy in post transplant patients. But the data sets won't be available any time soon.
'An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients' ClinicalTrials.gov Identifier: NCT01467505 - (Ongoing)
'An Efficacy and Safety Study of Telaprevir in Patients With Genotype 1 Hepatitis C Infection After Liver Transplantation (REPLACE)' - (Recruiting) ClinicalTrials.gov Identifier: NCT01571583
Good luck to your wife!
I hope she cures her haptitis C.
Hector
So a hepatologist at the transplant center has suggested triple therapy with Telaprevir for recurrence of Hep C and is going to help her with this treatment? Yes?
While there is very little data available (only form very small studies- 10 or less patients) about the improvement of SVR rate over peg-interferon and Ribavirin, it is assumed that SVR rates are higher than with the 2 drug treatment. The SVR rate using only peg-INF and RBV among post transplant patients is only 30%.
The issue with triple treatment is the amount and degree of adverse events and side effects are worse then with just 2 drugs. Therefore triple therapy is only given to select groups of post transplant patients.
Ribavirin dose reduction is common
49% have serious Adverse Events
26 % discontinue treatment before completing the 48 weeks.
57% need Procrit for anemia
15% has transfusions
'Telaprevir Post Liver Transplant
Telaprevir-based triple therapy in liver transplant patients with hepatitis C virus: A 12-week pilot study providing safety and efficacy data, this study was just published in Liver transplantation Dec 7 2012, full text below....."a remarkable number of patients (8/9) had an undetectable viral load at week 12.......triple therapy with TVR has promising antiviral efficacy in LT patients with respect to treatment weeks 4 and 12. The management of drug-drug interactions during TVR exposure is a therapeutic challenge, but they may be more controllable if CSA is used as the main immunosuppressive agent.
Triple therapy has an acceptable safety profile, although the treatment is quite intense with respect to cost and time. Therefore, we recommend that this therapy be conducted only by expert transplant hepatologists with strict surveillance of the patients because of the potential development of severe side effects.......this pilot study provides evidence showing that TVR-based triple therapy is effective within the first 4 to 12 weeks in LT patients suffering from HCV genotype 1 recurrence, and it also provides evidence showing that drug-drug interactions between TVR and immunosuppressants can be handled appropriately through the close monitoring of trough levels and adequate dosage adjustments.....Because both TVR and immunosuppressants (eg, calcineurin inhibitors) are substrates of cytochrome P450 3A4 and this can result in significant drug-drug interactions, the dosages of the immunosuppressants had to be modified during concomitant medication......There is also evidence showing that drug-drug interactions between the PI TVR and immunosuppressants can be controlled if the dosing of the drugs is carefully adapted......the maintenance of stable trough levels of immunosuppressants during the TVR exposure time still remains a challenging problem, especially for TAC and SIR. Thus, the dose reduction factors for the immunosuppressants differed and ranged from 22-fold (for TAC) to 2.5-fold (for CSA)......we suggest CSA as the main immunosuppressive agent to be used in the context of future TVR-based triple therapies."
Vertex, the manufacturer of Telaprevir, currently has two studies on the use of triple therapy in post transplant patients. But the data sets won't be available any time soon.
'An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients' ClinicalTrials.gov Identifier: NCT01467505 - (Ongoing)
'An Efficacy and Safety Study of Telaprevir in Patients With Genotype 1 Hepatitis C Infection After Liver Transplantation (REPLACE)' - (Recruiting) ClinicalTrials.gov Identifier: NCT01571583
Good luck to your wife!
I hope she cures her haptitis C.
Hector
Allison1965's husband Gary had a transplant and then did triple tx with Incivek.
Advocate1955
Advocate1955
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