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Cirrhosis of the Liver Community
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Latest AASLD Guidelines for Treating HCV Cirrhotics

Latest AASLD Guidelines for Treating Cirrhotics with Hepatitis C – August 25, 2015

Pretreatment Optimization of the Cirrhotic Patient

Management of Hepatitis C Infection
• Authors: Jordan J. Feld, MD, MPH; Hemant Shah, MD, MScCH)
• Editors In Chief: Nezam H. Afdhal, MD, FRCPI; Stefan Zeuzem, MD

Summary
• Treatment-naive patients with compensated cirrhosis should be treated in the same manner as patients without cirrhosis, although regimens and treatment duration differ
• Antiviral treatment in patients with cirrhosis is associated with increased risk of complications and lower rates of SVR when compared with patients without cirrhosis using peginterferon-containing regimens
• Combination therapy with ledipasvir/sofosbuvir, sofosbuvir plus simeprevir, ombitasvir/paritaprevir/ritonavir plus dasabuvir, plus ribavirin, or sofosbuvir and ribavirin may be considered in patients with compensated cirrhosis awaiting liver transplantation or those with recurrent HCV after liver transplantation
• Patients with decompensated cirrhosis should be referred for liver transplantation
- Expert clinicians may consider antiviral therapy in patients with decompensated cirrhosis (Child-Pugh stage B or C. Interferon, monotherapy, or PIs should not be used in this setting

Although cirrhotic patients have lower response rates to hepatitis C virus (HCV) therapy than noncirrhotic patients with some currently available regimens, achievement of sustained virologic response (SVR) in this group has a marked effect on the risk of liver-related mortality.Guidance published by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America recommend that treatment-naive patients with compensated cirrhosis (including patients with hepatocellular carcinoma) should be treated in largely the same manner as patients without cirrhosis, although the length of treatment may need to be extended with some regimens and/or ribavirin may be added  

In settings where newer therapies are not available, management of cirrhotic patients remains more complicated. Hepatic decompensation during therapy is a significant risk in patients with more advanced disease when using peginterferon-based therapy. The risk of complications during therapy in patients with cirrhosis appears to be further increased with the addition of the first-generation protease inhibitors (PI), boceprevir and telaprevir.

Patients with decompensated cirrhosis should be referred for liver transplantation. However, clinicians experienced in the treatment of HCV may consider treatment with antiviral therapy in some patients. In decompensated patients, interferon-based therapy is tolerated poorly, with high discontinuation rates a high incidence of infection, and a risk of further hepatic decompensation. Treatment may precipitate the need for liver transplant. If viremia is suppressed to undetectable levels at the time of transplant, the rate of posttreatment-recurrent HCV is reduced. In one study, sofosbuvir combined with ribavirin was given to 61 patients with compensated cirrhosis awaiting liver transplantation for hepatocellular carcinoma. At 12 weeks posttransplantation, therapy prevented posttransplantation HCV recurrence in 70% of patients with undetectable HCV RNA before engraftment. Of those with HCV RNA suppression for 30 days or more, only 1 of 24 developed recurrent HCV following transplantation. Notably, these patients had well-compensated liver disease, and although this regimen may be safe and effective in patients with decompensated cirrhosis, there are few data in this population currently. Preliminary studies with ledipasvir/sofosbuvir plus ribavirin in patients with decompensated liver disease have shown high SVR rates (87% to 89%) whether given for 12 or 24 weeks.  Patients tolerated therapy well with improvements in MELD score in most patients. However longer-term follow-up is required to assess the clinical benefits of therapy in this setting.

Guidelines from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America (Management Guidelines) recommend that patients with decompensated cirrhosis should be referred to a practitioner with expertise in managing such patients. Recommended antiviral therapies for patients with decompensated cirrhosis include ledipasvir/sofosbuvir with ribavirin if not anemic, and sofosbuvir plus ribavirin depending on genotype and other patient factors. These treatments should only be administered by highly experienced physicians. It should be noted that data on the use of direct-acting antivirals in this setting are limited. The use of interferon-based therapy, monotherapy, or PI-based regimens is not recommended in decompensated patients.

Before receiving HCV therapy, optimization of overall health status is essential for decompensated patients. Specific measures that may minimize the risk of complications during treatment include prophylactic banding or initiation of beta-blocker therapy for patients with large esophageal varices, control of ascites (or use of antibiotic prophylaxis on treatment if complete control is not possible and interferon is to be used), and administration of lactulose for encephalopathy prevention. Although the clinical impact of these strategies on the outcomes of therapy in decompensated patients has not been studied prospectively, they are used in many centers treating decompensated cirrhotics.

Cheers
Hector
2 Responses
Avatar universal
Great info Hector
Thanks for posting.
.....Kim
Avatar universal
Thank you, HectorSF

General FYI for anyone
Always check the hcvguidlines for any updates before commenting, posting  or discussing.

Personally I start here
http://hcvguidelines.org/news
accessed September 15, 2015 (hcvguidelines mentions using the source link with the date you accessed it.)

for example when scrolling found
Guidance Sections Updated
Friday, August 7, 2015
The Initial, Retreatment, Monitoring, and Unique Populations (HIV/HCV Coinfection, Decompensated Cirrhosis, Post-Liver Transplantation, and Renal Impairment) sections have been revised based on newly available therapies and data.
There are text hot links to these updated sections.  You can also go to the full report to access the particular section your interested in.

The following is only from one section
http://hcvguidelines.org/full-report/unique-patient-populations-patients-decompensated-cirrhosis
accessed September 15, 2015

Box recommendations excerpt - see complete text for reasoning, trial info etc. at the linked page.
Patients with HCV genotype 1 or 4 infection with decompensated cirrhosis (moderate or severe hepatic impairment; Child Turcotte Pugh [CTP] class B or C) should be referred to a medical practitioner with expertise in that condition (ideally in a liver transplant center).

Rating: Class I, Level C

Recommended regimens for patients with genotype 1 or 4 HCV infection with 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.
Daily daclatasvir (60 mg), sofosbuvir (400 mg), and low initial dose of RBV (600 mg, increased as tolerated) for 12 weeks is recommended for patients with HCV genotype 1 or 4 with decompensated cirrhosis.

Rating: Class II, Level A

Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) and low initial dose of RBV (600 mg, increased as tolerated) for 12 weeks is recommended for patients with HCV genotype 1 or 4 with decompensated cirrhosis.

Rating: Class IIb, Level C
Recommended regimen for patients with genotype 1 or 4 HCV infection with decompensated cirrhosis who are RBV intolerant or ineligible.
Daily daclatasvir (60 mg) and sofosbuvir (400 mg) for 24 weeks is recommended for patients with decompensated cirrhosis who are RBV intolerant or ineligible.

Rating: Class IIb, Level C
Recommended regimen patients with genotype 1 or 4 HCV infection with decompensated cirrhosis in whom prior sofosbuvir-based treatment has failed.
Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) and low initial dose of RBV (600 mg, increased as tolerated) for 24 weeks is recommended for patients with genotype 1 or 4 HCV infection with decompensated cirrhosis in whom prior sofosbuvir-based treatment has failed.

Rating: Class IIb, Level C

Decompensated Cirrhosis: Genotype 2 and 3 HCV Infection

Patients with HCV genotype 2 or 3 infection with decompensated cirrhosis (moderate or severe hepatic impairment; Child Turcotte Pugh [CTP] class B or C) should be referred to a medical practitioner with expertise in that condition (ideally in a liver transplant center).
Rating: Class I, Level C

Recommended regimens for patients with HCV genotype 2 or 3 infection who have decompensated cirrhosis (moderate or severe hepatic impairment; CTP class B or C) and who may or may not be candidates for liver transplantation, including those with hepatocellular carcinoma.
Daily daclatasvir (60 mg), sofosbuvir (400 mg), and low initial dose of RBV (600 mg, increased as tolerated) for 12 weeks is recommended for patients with HCV genotype 2 or 3 infection who have decompensated cirrhosis and who may or may not be candidates for liver transplantation, including those with hepatocellular carcinoma.

Rating: Class II, Level A

Daily sofosbuvir (400 mg) and weight-based RBV (1000 mg [75 kg]) (with consideration of the patient’s creatinine clearance rate and hemoglobin level) for up to 48 weeks is recommended for patients with HCV genotype 2 or 3 infection who have decompensated cirrhosis and who may or may not be candidates for liver transplantation, including those with hepatocellular carcinoma.

Rating: Class IIb, Level B
_________________________________

http://hcvguidelines.org/
lower home page
NOTICE: Guidance for hepatitis C treatment in adults is changing constantly with the advent of new therapies and other developments. A static version of this guidance, such as printouts of this website material, booklets, slides, and other materials, may be outdated by the time you read this. We urge you to review this guidance on this website (www.hcvguidelines.org) for the latest recommendations.
_______________________________

By using date webpage was accessed, it informs readers that information quoted was current as of that date on the source link (In my situation the same date as my reply post.  You should always check the information by going to the link to verify if it's still current and if there were any copying errors.

HectorSF, It's just fantastic how you manage to spend so much time offing support, advice and love to many here after all you have been through.  Plus the hours helping at the transport center.  I hope you get some time to relax and enjoy other activities.

I will be posting soon about my cirrhosis class A after 15 months SVR. My labs , tests and any questions I should ask my Gastro before my Oct 15th appointment.
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