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Olysio and Sovaldi treatment hep c
Hi just a few questions my mom has been on Olysio and Sovaldi treatment 8 weeks now started treatment 2 months after living doner liver transplant has had severe fatigue nausea and i am worried dont konw if it is the treatment or something going on with transplant has any one had that problem on this treatment? Her hep c went from 1.5 million to undetectable after 4 weeks has anyone on this site completed the treatment and stayed hep c free? what are the chances of it coming back after she compleats treatment ? Genotype 1 and failed teatment around 1995. Thank you!!
Still having bile duct problems they put 4 more stents in today on the right side of liver but the left side has never needed any stents can this be fixed with stenting or will this be a problem that will cause her to need new liver it is the ducts up in her liver on right side dr won't say just said wait and see
Could you explain your post that said "12 weeks and the hep c was back".Are you saying that after your 12 week treatment of sovaldi-olysio that you went right back to being positive?
Hepatitis C Management in Special Populations
Author: Mark S. Sulkowski, MD (More Info)
Editors In Chief: Nezam H. Afdhal, MD, FRCPI; Stefan Zeuzem, MD
Last Reviewed: 2/26/14 (What's New)
Summary
Sofosbuvir and simeprevir are now recommended in the 2014 AASLD/IDSA guidelines (Management Guidelines)[AASLD-IDSA HCV] as part of preferred or alternative regimens for the treatment of recurrent HCV infection in posttransplanted patients (Table 11)
The recommended standard of care for liver transplant recipients is treatment of confirmed recurrent liver disease, based either on persistent, unexplained elevated ALT levels or on histologically confirmed fibrosis once rejection, biliary obstruction, and vascular damage have been ruled out (Table 12)[Ghany 2009; Ponziani 2011]
https://www.inpractice.com/Textbooks/Hepatology/ch9_Hep_C_Management_in_Special_Populations/Chapter-Pages/Page-5/Subpage-1.aspx
Author: Mark S. Sulkowski, MD (More Info)
Editors In Chief: Nezam H. Afdhal, MD, FRCPI; Stefan Zeuzem, MD
Last Reviewed: 2/26/14 (What's New)
Summary
Sofosbuvir and simeprevir are now recommended in the 2014 AASLD/IDSA guidelines (Management Guidelines)[AASLD-IDSA HCV] as part of preferred or alternative regimens for the treatment of recurrent HCV infection in posttransplanted patients (Table 11)
The recommended standard of care for liver transplant recipients is treatment of confirmed recurrent liver disease, based either on persistent, unexplained elevated ALT levels or on histologically confirmed fibrosis once rejection, biliary obstruction, and vascular damage have been ruled out (Table 12)[Ghany 2009; Ponziani 2011]
https://www.inpractice.com/Textbooks/Hepatology/ch9_Hep_C_Management_in_Special_Populations/Chapter-Pages/Page-5/Subpage-1.aspx
Unfortunately her treatment has never been used on post transplant patients. Sovaldi combined with Ribavirin has been used in clinical trials but I am guessing the doctors decided that treating without Ribavirin was probably safer for your mom. Particularly so soon after transplant.
No one can say if your mom’s virus will reemerge after the treatment is completed. Let’s hope for the best. She is on arguably the best treatment for her situation. Also the good news is if she fails this treatment, there will be better treatments coming in the near future. (Later this year and beyond).They will be even more effective against the virus with less side effects. Let’s hope this will be her last battle with hep C.
I am also post transplant (4 months) and may need to treat my hep C as well. So I may be in the same boat soon.
Don’t worry; failing treatment before with interferon treatment is irrelevant to her chances now. These drugs work in a different manner then interferon based treatments.
Best of luck to you and your mom!
Congratulations on her transplant and second chance at life!
Hector
No one can say if your mom’s virus will reemerge after the treatment is completed. Let’s hope for the best. She is on arguably the best treatment for her situation. Also the good news is if she fails this treatment, there will be better treatments coming in the near future. (Later this year and beyond).They will be even more effective against the virus with less side effects. Let’s hope this will be her last battle with hep C.
I am also post transplant (4 months) and may need to treat my hep C as well. So I may be in the same boat soon.
Don’t worry; failing treatment before with interferon treatment is irrelevant to her chances now. These drugs work in a different manner then interferon based treatments.
Best of luck to you and your mom!
Congratulations on her transplant and second chance at life!
Hector
The success rates were high in the Cosmos trial with Sofosbuvir (Sovaldi) and Olysio (Simeprevir). However, these were not patients who have had liver transplants. Therefore, I do not know exactly how effective the treatment would be in people who have had liver transplants. I am not sure that it has been studied in liver transplant patients. Hector may know the answer to that question. He may also know what the success rate is. Hopefully he will see your question and respond.
"COSMOS – Efficacy Summary"
"In cohort 1, the SVR12 rate was 93 percent in genotype 1 null-responder patients with METAVIR scores of F0-F2 treated with simeprevir and sofosbuvir for either 12 or 24 weeks.
In an interim analysis of cohort 2, the SVR4 rate was 100 percent in both genotype 1 treatment-naive patients and prior null-responder patients with METAVIR scores of F3-F4 treated with simeprevir and sofosbuvir for 12 weeks.
In a pooled analysis of the 12-week treatment arms in cohorts 1 and 2, SVR4 was achieved among patients treated with simeprevir and sofosbuvir with or without ribavirin, in 96 percent of patients with IL28B non-CC genotype, 91 and 100 percent of patients with a METAVIR score of F4, respectively, and 95 percent of prior null responders.
All patients who completed treatment were HCV RNA undetectable at end of treatment and there were no viral breakthroughs in either cohort 1 or 2. The COSMOS study interim results show no benefit from adding ribavirin to simeprevir and sofosbuvir in this difficult to treat groups of hepatitis C patients and that 12 week treatment may confer similar clinical benefit to 24 week treatment. "
"COSMOS – Efficacy Summary"
"In cohort 1, the SVR12 rate was 93 percent in genotype 1 null-responder patients with METAVIR scores of F0-F2 treated with simeprevir and sofosbuvir for either 12 or 24 weeks.
In an interim analysis of cohort 2, the SVR4 rate was 100 percent in both genotype 1 treatment-naive patients and prior null-responder patients with METAVIR scores of F3-F4 treated with simeprevir and sofosbuvir for 12 weeks.
In a pooled analysis of the 12-week treatment arms in cohorts 1 and 2, SVR4 was achieved among patients treated with simeprevir and sofosbuvir with or without ribavirin, in 96 percent of patients with IL28B non-CC genotype, 91 and 100 percent of patients with a METAVIR score of F4, respectively, and 95 percent of prior null responders.
All patients who completed treatment were HCV RNA undetectable at end of treatment and there were no viral breakthroughs in either cohort 1 or 2. The COSMOS study interim results show no benefit from adding ribavirin to simeprevir and sofosbuvir in this difficult to treat groups of hepatitis C patients and that 12 week treatment may confer similar clinical benefit to 24 week treatment. "
Only 4 weeks to go! That's great!
I hope she has an easier time in the remaining weeks ahead.
I hope she has an easier time in the remaining weeks ahead.
I am a little surprised that treatment was started so soon after transplant, particularly when the hcv guidelines say the following:
"Simeprevir has not been studied with sofosbuvir in the post-transplant setting; however, drug interaction studies in non-infected participants indicate that simeprevir can be dosed safely in conjunction with calcineurin inhibitors. Based on these data, clinicians may consider the use of sofosbuvir plus simeprevir as described for non-transplant patients..."
http://www.hcvguidelines.org/full-report/unique-patient-populations
On the other hand, I am so sorry that these drugs were not available for my husband sooner. He did not start treatment until 21 months after the transplant. His recurrent Hep C and bile duct problems post-transplant
have now caused cirrhosis in the new liver. He is restricted to taking sovaldi/ribavarin for 24 weeks because of this advanced liver disease. I have been writing about some problems he has been having on this treatment on other threads.
I can understand why your mother is severely fatigued and nauseous. Recovering from transplant is hard enough without adding these powerful new drugs to the mix so soon after her surgery.
On the positive side, it is wonderful that she is undetectable since week 4. How long will she be on treatment - 12 or 24 weeks?
I assume the transplant team keeping a very close eye on her. I am hoping her treatment will be over soon and she will start feeling better very soon.
Nan
"Simeprevir has not been studied with sofosbuvir in the post-transplant setting; however, drug interaction studies in non-infected participants indicate that simeprevir can be dosed safely in conjunction with calcineurin inhibitors. Based on these data, clinicians may consider the use of sofosbuvir plus simeprevir as described for non-transplant patients..."
http://www.hcvguidelines.org/full-report/unique-patient-populations
On the other hand, I am so sorry that these drugs were not available for my husband sooner. He did not start treatment until 21 months after the transplant. His recurrent Hep C and bile duct problems post-transplant
have now caused cirrhosis in the new liver. He is restricted to taking sovaldi/ribavarin for 24 weeks because of this advanced liver disease. I have been writing about some problems he has been having on this treatment on other threads.
I can understand why your mother is severely fatigued and nauseous. Recovering from transplant is hard enough without adding these powerful new drugs to the mix so soon after her surgery.
On the positive side, it is wonderful that she is undetectable since week 4. How long will she be on treatment - 12 or 24 weeks?
I assume the transplant team keeping a very close eye on her. I am hoping her treatment will be over soon and she will start feeling better very soon.
Nan
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