Hello everyone, today I hope to offer a bit of information to all those brave people waiting for a liver transplant. You may wish to either file the information away for future reference or pass it along.
The Good News
Interferon-free treatments are showing promise for treatment of hepatitis C after liver transplantation, with high SVR rates and few drug related adverse effects, it is nothing short of a miracle.
We start with a review article about treating cirrhosis, recurrent HCV, or treating HCV after liver transplantation.
The Research
Review
Published on Nov 7 2016; World J Gastroenterol
Concise review: Interferon-free treatment of hepatitis C virus-associated cirrhosis and liver graft infection
This concise review gives an overview about most current prospective trials and cohort analyses for treatment of patients with liver cirrhosis and liver graft recipients. In patients with compensated cirrhosis Child-Pugh-Turcotte (CTP) class A, all approved agents are safe and SVR rates do not significantly differ from patients without cirrhosis in general. In patients with decompensated cirrhosis CTP class B or C, daclastasvir, ledipasvir, velpatasvir, and sofosbuvir are approved, and SVR rates higher than 90% can be achieved. Especially for patients with a model of end stage liver disease score higher than 15 and therefore eligible for liver transplantation, data is scarce. Reported SVR rates in patients with cirrhosis CTP class C are lower compared to patients with a less severe liver disease. In liver transplant recipients with a maximum of CTP class A, SVR rates are comparable to patients without LT. Patients with decompensated graft cirrhosis should be treated on an individual basis.
In the May issue of Current Opinion in Gastroenterology, Paul Y Kwo, M.D., reported on five effective all oral therapies for patients who develop recurrent HCV after liver transplantation; Sovaldi, Harvoni, Daklinza, Olysio, and Viekira Pak.
The article is available online for free over at Medscape, here is a summary:
Historically, postliver transplant patients with chronic hepatitis C have had worse outcomes than nonhepatitis C-related causes because of accelerated fibrosis posttransplantation and the lack of effective well tolerated therapies for hepatitis C, and posttransplant hepatitis C patients have been considered a special population. Since 2013, we have entered the era of all oral direct acting antiviral agents for hepatitis C with sustained response rates that are consistently above 90% in nontransplant patients.
Recent findings: The introduction of direct acting antiviral agents to posttransplant patients has demonstrated that sustained virologic response rates that are comparable with nontransplant patients can be achieved with excellent tolerability. The combinations of (Sovaldi) sofosbuvir/ribavirin, (Harvoni) ledipasvir/sofosbuvir/ribavirin, (Daklinza) daclatasvir/sofosbuvir/ribavirin, sofosbuvir/ (Olysio) simeprevir /- ribavirin, and (Viekira Pak) paritaprevir/ombitasvir/dasabuvir/ribavirin have all achieved high sustained response rates posttransplants. The previously dreaded complication of fibrosing cholestatic hepatitis C can now be effectively treated.
Summary:
Author Paul Y Kwo, M.D., professor of medicine at the Indiana University School of Medicine, summed it up nicely, the good doctor wrote; In the era of all oral therapies, no patient who undergoes transplant for hepatitis C-related cirrhosis should have their graft fail because of recurrent hepatitis C. It is expected that long-term survival of those who undergo orthotopic liver transplant for HCV-related cirrhosis will be comparable to those without hepatitis C. Read the full article; Direct Acting Antiviral Therapy After Liver Transplantation
Guidelines
Next a summary for the treatment of Patients who Develop Recurrent HCV Infection Post-Liver Transplantation, updated July 6, 2016 by the AASLD/IDSA.
Last month the American Association for the Study of Liver Diseases (AASLD), Infectious Diseases Society of America and International Antiviral Society-USA updated their hepatitis C guidelines to reflect several important developments, including the treatment of Patients who Develop Recurrent HCV Infection Post-Liver Transplantation. This ever changing document is updated when new HCV drugs are approved, and new real world data is established.
Last Updated
Click here for list of all updated sections.
Current treatment recommendations in liver transplant recipients
Last Updated
Click here for list of all updated sections.
Current treatment recommendations in liver transplant recipients
All of the AASLD/IDSA recommended regimens for post-transplant treatment of HCV are interferon-free regimens. For a summary of the recommendations see the summary boxes, or read the recommendations here.
Summary Box
Genotype 1 or 4
Recommended Regimens for Treatment-naïve and -Experienced Patients with HCV Genotype 1 or 4 Infection in the Allograft, Including Those with Compensated Cirrhosis
Recommended regimens are listed in groups by level of evidence, then alphabetically.
Recommended regimens are listed in groups by level of evidence, then alphabetically.
- Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) with weight-based ribavirin for 12 weeks is a Recommended regimen for patients with HCV genotype 1 or 4 infection in the allograft, including those with compensated cirrhosis.
Rating: Class I, Level A
- Daily daclatasvir (60 mg) plus sofosbuvir (400 mg) with low initial dose of ribavirin (600 mg, increased as tolerated) for 12 weeks is a Recommended regimen for patients with HCV genotype 1 or 4 infection in the allograft, including those with compensated cirrhosis.
Rating: Class I, Level B
Recommended Regimens for Treatment-naïve Patients with HCV Genotype 1 or 4 Infection in the Allograft and with Compensated Liver Disease, Who Are Ribavirin Ineligible
Recommended regimens are listed in groups by level of evidence, then alphabetically.
Recommended regimens are listed in groups by level of evidence, then alphabetically.
- Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 1 or 4 infection in the allograft and with compensated liver disease, who are ribavirin ineligible.
Rating: Class I, Level B
- Daily daclatasvir (60 mg) plus sofosbuvir (400 mg) for 24 weeks is a Recommended regimen for patients with HCV genotype 1 or 4 infection in the allograft and with compensated liver disease, who are ribavirin ineligible.
Rating: Class II, Level C
Recommended Regimen for Treatment-naïve and -Experienced Liver Transplant Recipients with Decompensated Cirrhosis (Child Turcotte Pugh [CTP] Class B or C) Who Have HCV Genotype 1 or 4 Infection in the Allograft
- Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) with low initial dose of ribavirin (600 mg, increased as tolerated) for 12 weeks is a Recommended regimen for liver-transplant recipients with decompensated cirrhosis (CTP class B or C) who have HCV genotype 1 or 4 infection in the allograft.
Rating: Class I, Level B
Alternative Regimens for Patients with HCV Genotype 1 Infection in the Allograft, Including Those with Compensated Cirrhosis
- Daily simeprevir (150 mg) plus sofosbuvir (400 mg) with or without weight-based ribavirin for 12 weeks is an Alternative regimen for patients with HCV genotype 1 infection in the allograft, including those with compensated cirrhosis.
Rating: Class I, Level B
Alternative Regimens for Patients with HCV Genotype 1 Infection in the Allograft, Including Those with Early-stage Fibrosis (Metavir Stage F0-F2)
- Daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) plus twice-daily dosed dasabuvir (250 mg) with weight-based ribavirin for 24 weeks is an Alternative regimen for patients with HCV genotype 1 infection in the allograft, who have early-stage fibrosis (Metavir stage F0-F2).
Rating: Class I, Level B
Recommended Regimens for Treatment-naïve and -Experienced Patients with HCV Genotype 2 Infection in the Allograft, Including Those with Compensated Cirrhosis
Recommended regimens are listed in groups by level of evidence, then alphabetically.
Recommended regimens are listed in groups by level of evidence, then alphabetically.
- Daily daclatasvir (60 mg) plus sofosbuvir (400 mg), with low initial dose of ribavirin (600 mg, increased as tolerated) for 12 weeks is a Recommended regimen for patients with HCV genotype 2 infection in the allograft, including those with compensated cirrhosis.
Rating: Class II, Level A
- Daily sofosbuvir (400 mg) and weight-based ribavirin for 24 weeks is a Recommended regimen for patients with HCV genotype 2 infection in the allograft, including those with compensated cirrhosis.
Rating: Class II, Level C
Recommended Regimen for Treatment-naïve and -Experienced Patients with HCV Genotype 2 Infection in the Allograft, Including Those with Compensated Cirrhosis, Who Are Ribavirin Ineligible
- Daily daclatasvir (60 mg) plus sofosbuvir (400 mg) for 24 weeks is a Recommended regimen for patients with HCV genotype 2 infection in the allograft, including those with with compensated cirrhosis, who are ribavirin ineligible.
Rating: Class II, Level C
Recommended Regimen for Treatment-naïve and -Experienced Liver-Transplant Recipients with Decompensated Cirrhosis (Child Turcotte Pugh [CTP] Class B or C) Who Have HCV Genotype 2 Infection in the Allograft
- Daily sofosbuvir (400 mg) and ribavirin (initial dose 600 mg/day, increased monthly by 200 mg/day as tolerated to weight-based dose) for 24 weeks is a Recommended regimen for liver-transplant recipients with decompensated cirrhosis (CTP class B or C) who have HCV genotype 2 infection in the allograft.
Rating: Class II, Level C
Recommended Regimen for Treatment-naïve and -Experienced Patients with HCV Genotype 3 Infection in the Allograft, Including Those with Compensated Cirrhosis
- Daily daclatasvir (60 mg) plus sofosbuvir (400 mg) with low initial dose of ribavirin (600 mg, increased as tolerated) for 12 weeks is a Recommended regimen for patients with HCV genotype 3 infection in the allograft, including those with compensated cirrhosis.
Rating: Class II, Level A
Recommended Regimen for Treatment-naïve and -Experienced Patients with HCV Genotype 3 Infection in the Allograft, Including Those with Compensated Cirrhosis, Who Are Ribavirin Ineligible
- Daily daclatasvir (60 mg) plus sofosbuvir (400 mg) for 24 weeks is a Recommended regimen for patients with HCV genotype 3 infection in the allograft, including those with compensated cirrhosis, who are ribavirin ineligible.
Rating: Class II, Level C
Last but not least patient friendly articles written by and for transplant recipients.
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By Karen Hoyt
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Established in 1999, the TransplantBuddies site provides information about the transplant process, resources covering drugs and side effects, and daily discussions about living life as a transplant patient. The site also includes members' photos and life stories covering experiences of both transplant recipients and donors.
Of Interest
Sept 22
Sovaldi shows high SVR12 in patients with HCV after transplant
Sovaldi-based combination therapies led to 12-week sustained virologic response in nearly 93% of patients who were reinfected with hepatitis C virus and had severe fibrosis after receiving a liver transplant, according to findings published in Liver Transplantation
Sovaldi-based combination therapies led to 12-week sustained virologic response in nearly 93% of patients who were reinfected with hepatitis C virus and had severe fibrosis after receiving a liver transplant, according to findings published in Liver Transplantation
Aug 18
“We suggest designing long-term multinational observational studies on patients who have been listed for decompensated [HCV] cirrhosis and subsequently delisted because of clinical improvement,” Belli and researchers wrote. – by Janel Miller
Aug 16, 2016
May 23, 2016
What is the safest and most effective way to treat patients with chronic hepatitis C with cirrhosis?
Update
Watch the livestreamed EASL updated HCV recommendations with a follow-up Q&A session.
The new recommendations add Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) and Zepatier (grazoprevir/elbasvir, Merck)
May your journey be safe and successful.
Tina
Hi,
ReplyDeleteI was transplanted at IU in March 2010. Dr Kwo was one of the hepatologists that took care of me pre transplant. I came back to Houston in July of 2010, and proceeded to undergo interferon/ribavirin treatment, then Incevik/intereferon/ribavirin, then Sovaldi and ribavirin, and finally, about 2 years ago, Harvoni. I have been HCV free for 1.5.years! And there were NO side effects from the Harvoni like there were from all the others. My new liver (Tex---it came from Ft Worth, via Indianapolis) is a happy liver, finally!
May you and Tex remain healthy - Congratulations!!!
ReplyDelete