sovaldi and olaysio on transplant?

[marso]

hi to everyone, its good to hear all the good news and good feed back for those who started the sovaldi and olysio. My question is does the meds also effective for post liver transplant and presently has diabetic? My husband was 7 yrs post transplant and has found out late last year hepC recurring, dr prescribed him the meds. but not yet avail to our country, we're still trying to look for how we can avail the meds or we can go direct to united states and go to any hospital that prescribe these meds. Also we dont here yet if ok for my husband situation.

best regards
marso

[heart_in_the_keyes]

Well here's one for you guys....as you know I am on transplant list... geno 1 ...stage 4 ESLD...decompensated liver...Meld 13...super high HCV viral load and a non-responder to all other drug studies I have ever been on.  They are starting me on Sovaldi and Olaysio...got approved this week.  Totally against some of the above recommends... Maybe it also depends on the patient.  ???'

[flyinlynn]

Good luck to you and your husband as well Marso.

Just a thought does your husbands doctor have any recommendation on who you could contact? That could be the best way to go.

Lynn

[marso]

hi lyn and hector!
first of all thank you very much for your time
effort and concern, its highly appreciated =)
My husband doctor already recommended to him the olysio and sovaldi, but as of now they are still waiting for it to be available in egypt, so he told us if we have access
to country where it is already available then we have to go ahead, then he's doctor will be much willing to assist us through the medication. But unfortunately we dnt have direct access to any hospital in the U.S.A., I will try my best to contact all the numbers that lynn gave me., then ill keep you guys updated.

best regards,
marso

[flyinlynn]

Hi Hector

I was trying to get it all in there as she had not said if her husband had recurrent cirrhosis so I included that info as well but yeah probably too much information.

As always you are the best. I am still battling Express Scripts for Solvaldi/Olysio off label usage per the AASLD recommendations for null responder w cirrhosis.

All the best to you
Lynn

[HectorSF]

Lynn, I think you mistakenly posted the recommendations for patients with cirrhosis. Marso is asking about treating recurrent hep C after transplant. I totally different condition.

"My question is does the meds also effective for post liver transplant and presently has diabetic?
My husband was 7 yrs post transplant and has found out late last year hep C recurring"

Sovaldi and Olsio is the recommend treatment for genotype 1 post-transplant patients with recurrent hep C. See the recommendations below.

The bottom line is... any post-transplant patient needs to contact the transplant center that is monitoring and managing his post transplant liver status (his monthly labs and managing his immunosuppressants, etc.) regarding possible treatment for recurrent hepatitis C. The transplant center doctors are the only ones who are aware of his particular current health status including his liver (diabetes and any other particulars) and his immunosuppression status. Only they can decide, if, when and what treatment a patient can safely take while caring of their donor liver.

Marso, contact your husband's transplant center and seek their advice on your husband's recurrent hepatitis C and what should be done. If you are having issue with getting the meds or anything else, tell them. They are responsible for your husband's health and any treatment for his recurrent hep C.
---------------------------------------------------------------------------------------------
Here is the correct American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA ) hepatitis C recommendation  for your treating doctor not you.

"Unique Patient Population: Post-Liver Transplantation Box. The summary of recommendations for patients who develop recurrent HCV infection post-liver transplantation"

Recommended regimen for treatment-naive patients with HCV genotype 1 in the allograft liver, including those with compensated cirrhosis

Daily sofosbuvir (400 mg) plus simeprevir (150 mg), with or without RBV (initial dose 600 mg/day, increased monthly by 200 mg/day as tolerated to weight-based dose of 1000 mg [<75 kg] to 1200 mg [≥75 kg] 1200 mg), for 12 weeks to 24 weeks is recommended for patients with compensated allograft HCV genotype 1 infection.
Rating: Class IIb, Level C

Recommended regimen for treatment-naive patients with HCV genotype 2 or 3 in the allograft liver, including those with compensated cirrhosis

Daily sofosbuvir (400 mg) and RBV (initial dose 600 mg/day, increased monthly by 200 mg/day as tolerated to weight-based dose of 1000 mg [<75 kg] to 1200 mg [≥75 kg] 1200 mg) with consideration of the patient's CrCl value and hemoglobin level for 24 weeks is recommended for patients with
compensated allograft HCV genotype 2 or 3 infection.
Rating: Class IIb, Level C

Alternate regimen for treatment-naive patients with genotype 1 HCV in the allograft liver, including those with compensated cirrhosis.
Daily sofosbuvir (400 mg) and RBV (initial dose 600 mg/day, increased monthly by 200 mg/day as tolerated to weight-based dose of 1000 mg [<75 kg] to 1200 mg [≥75 kg] 1200 mg) with consideration
of the patient's CrCl value and hemoglobin level, with or without PEG (in the absence of contraindication to its use), for 24 weeks is recommended for patients with compensated allograft HCV genotype 1 infection.
Rating: Class IIb, Level C
------------------------------------------------------------------------------------------------------
The following regimens are NOT recommended for treatment-naive patients with compensated allograft hepatitis C infection
* Monotherapy with PEG, RBV, or a DAA
Rating: Class III, Level A

* Telaprevir- or boceprevir- based regimens should not be used for patients with compensated allograft hepatitis C infection.
Rating: Class III, Level A

Treatment-naive patients with decompensated allograft HCV infection should receive the same treatment as recommended for patients with decompensated cirrhosis (moderate or severe hepatic impairment; CTP class B or C).
Rating: Class I, Level C
-----------------------------------------------------------------------------------------------------------

Best of luck to your husband!
Hector

[flyinlynn]

Hi again Marso

Actually Olysio is not being recommended for treatment for post transplant if your husband has cirrhosis now and any treatment may depend on your husbands Genotype.

What treatment does your husbands doctor recommend he take on the basis of his recurrent Hepatitis C and his diabeties?

Has he treated before? What happened when he treated did he respond and relapse or was he a null responder? What is the condition on his new liver now? Does he have cirrhosis in the new liver?

Per the Recommendations for Testing, Managing, and Treating Hepatitis C from the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) http://www.hcvguidelines.org/sites/default/files/full_report.pdf

"Recommendations for patients who develop recurrent HCV infection post-liver transplantation"

"Treatment-naive patients with compensated cirrhosis, including those with hepatocellular carcinoma,
should receive the same treatment as recommended for patients without cirrhosis."

If he is compensated the recommended treatments are:

Genotype 1 Sovaldi with Peginterferon and Ribavirin 12 weeks or Sovaldi with Olysio with or without Ribavirin 12 weeks

Genotype 2 Sovaldi and Ribavirin 12 weeks

Genotype 3 Sovaldi and Ribavirin 24 weeks

Genotype 4 Sovaldi with Peginterferon and Ribavirin 12 weeks or Sovaldi and Ribavirin 24 weeks

Genotype 5 or 6 Sovaldi with Peginterferon and Ribavirin 12 weeks

"Patients with decompensated cirrhosis (moderate or severe hepatic impairment; CTP class B or C) should be referred to a medical practitioner with expertise in that condition (ideally in a liver transplant
center)."

"The recommended regimen for patients with any HCV genotype who have decompensated cirrhosis (moderate or severe hepatic impairment; CTP class B or C) who may or may not be candidates for liver transplantation,
including those with hepatocellular carcinoma. This regimen should be used only by highly experienced HCV providers" "Daily sofosbuvir (400 mg) plus weight-based RBV (with consideration of the patient's creatinine
clearance and hemoglobin level) for up to 48 weeks"

The following regimens are NOT recommended for patients with decompensated cirrhosis (moderate or severe hepatic impairment; CTP class B or C):
 Any IFN-based therapy

 Monotherapy with PEG, RBV, or a DAA

 Telaprevir-, boceprevir-, or simeprevir-based regimens

Simeprevir is Olysio and is specifically said to be NOT recommended if your husband has decompensated cirrhosis in his new liver

Have you tried to contact the hospital I provided information for before?

University of California San Francisco Liver Disease and Liver Transplant Clinic

Liver Disease and Liver Transplant
350 Parnassus Ave., Suite 300
San Francisco, CA 94143
Phone: [phone]
Fax: [phone]


Have you tried to contact the drug providers I provided contact information to you?

Gilead Sciences to find out further information on how to get Sovaldi in the Philippines. Call 1-855-7-MYPATH (1-855-769-7284) to speak with a Support Path specialist for Sovaldi

http://www.sovaldi.com/default.aspx

OLYSIO Support
Phone: 1-855-5-OLYSIO (1-855-565-9746)
Fax: [phone]
Hours: Monday-Friday
8:00 AM-8:00 PM ET

http://www.olysio.com/hcp/

What did they say?

Bottom line follow what his doctor recommends.

Good luck
Lynn