Aa
12 or 24 Weeks
A friend has Cirrhosis. Her doctor put her on 12 week Harvoni treatment.
However, I read this article:
People with HCV genotype 1 or 4 who have compensated cirrhosis should take Harvoni without ribavirin for 24 weeks. People with decompensated cirrhosis and those who are awaiting or have received a liver transplant should take Harvoni with twice-daily ribavirin pills for 24 weeks.
Anybody?
Magnum
However, I read this article:
People with HCV genotype 1 or 4 who have compensated cirrhosis should take Harvoni without ribavirin for 24 weeks. People with decompensated cirrhosis and those who are awaiting or have received a liver transplant should take Harvoni with twice-daily ribavirin pills for 24 weeks.
Anybody?
Magnum
"So, this tells me there are variables in treatment that the rules sometimes don't apply" These are not rules just Guidance
For post transplant tx
for GT1 & 4 for Harvoni treatment-naive and -experienced patients
Harvoni for 12 weeks with weight-based RBV
(I noticed that only treatment-naive for the following) ??
Harvoni for 24 weeks who are RBV intolerant or ineligible.
Rating: Class I, Level B
New daclatasvir is now part of many recommendations
http://www.hcvguidelines.org/full-report/unique-patient-populations-patients-who-develop-recurrent-hcv-infection-post-liver
accessed August 17, 2015
The summary of recommendations for patients who develop recurrent HCV infection post–liver transplantation is in the BOX.
go to link for details
Recommended regimens for treatment-naive and -experienced patients with HCV genotype 1 or 4 infection in the allograft, including those with compensated cirrhosis.
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 infection in the allograft, including those with compensated cirrhosis.
Rating: Class I, Level B
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) with weight-based RBV (1000 mg [75 kg]) for 12 weeks is recommended 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-naive patients with HCV genotype 1 or 4 infection in the allograft and with compensated liver disease, who are RBV intolerant or ineligible.
Daily daclatasvir (60 mg), sofosbuvir (400 mg) for 24 weeks is recommended for patients with HCV genotype 1 or 4 infection in the allograft and with compensated liver disease, who are RBV intolerant or ineligible.
Rating: Class IIb, Level C
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is recommended for treatment-naive patients with HCV genotype 1 or 4 infection in the allograft and with compensated liver disease, who are RBV intolerant or ineligible.
Rating: Class I, Level B
Alternative regimen for patients with HCV genotype 1 infection in the allograft, including those with compensated cirrhosis.
Daily sofosbuvir (400 mg) plus simeprevir (150 mg) with or without weight-based RBV 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
Recommended regimens for treatment-naive and -experienced patients with HCV genotype 2 infection in the allograft, including those with compensated cirrhosis.
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 infection in the allograft, including those with compensated cirrhosis.
Rating: Class II, Level A
Daily sofosbuvir (400 mg) and weight-based RBV for 24 weeks is recommended for patients with HCV genotype 2 infection in the allograft, including those with compensated cirrhosis.
Rating: Class IIb, Level C
Recommended regimen for treatment-naive and -experienced patients with HCV genotype 2 infection in the allograft, including those with compensated cirrhosis, who are RBV intolerant or ineligible.
Daily daclatasvir (60 mg), sofosbuvir (400 mg) for 24 weeks is recommended for patients with HCV genotype 2 infection in the allograft, including those with compensated cirrhosis, who are RBV intolerant or ineligible.
Rating: Class IIb, Level C
Recommended regimens for treatment-naive and -experienced patients with HCV genotype 3 infection in the allograft, including those with compensated cirrhosis.
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 3 infection in the allograft, including those with compensated cirrhosis.
Rating: Class II, Level A
Daily sofosbuvir (400 mg) and weight-based RBV for 24 weeks is recommended for treatment-naive and -experienced patients with HCV genotype 3 infection in the allograft, including those with compensated cirrhosis.
Rating: Class I, Level B
Recommended regimen for treatment-naive patients with HCV genotype 3 infection in the allograft, including those with compensated cirrhosis, who are RBV intolerant or ineligible.
Daily daclatasvir (60 mg), sofosbuvir (400 mg) for 24 weeks is recommended for treatment-naive patients with HCV genotype 3 infection in the allograft, including those with compensated cirrhosis, who are RBV intolerant or ineligible.
Rating: Class IIb, Level C
Recommended regimen for treatment-naive and -experienced liver transplant recipients with decompensated cirrhosis (Child Turcotte Pugh [CTP] class B or C) who have HCV genotype 3 infection in the allograft.
Daily sofosbuvir (400 mg) and low initial dose of RBV (600 mg, increased as tolerated) for 24 weeks is recommended for liver transplant recipients with decompensated cirrhosis (CTP class B or C) who have HCV genotype 3 infection in the allograft.
Rating: Class I, Level B
Alternative regimen 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) and weight-based RBV 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
__________________________________
http://www.hcvguidelines.org/full-report/introduction
accessed August 17, 2015
This Guidance should be considered a "living document" in that the Guidance will be updated frequently as new information and treatments become available. This continually evolving report provides guidance on FDA-approved regimens. At times, it may also recommend off-label use of certain drugs or tests or provide guidance for regimens not yet approved by FDA. Readers should consult prescribing information and other resources for further information. Of note, the choice of treatment may, in the future, be further guided by data from cost-effectiveness studies.
For post transplant tx
for GT1 & 4 for Harvoni treatment-naive and -experienced patients
Harvoni for 12 weeks with weight-based RBV
(I noticed that only treatment-naive for the following) ??
Harvoni for 24 weeks who are RBV intolerant or ineligible.
Rating: Class I, Level B
New daclatasvir is now part of many recommendations
http://www.hcvguidelines.org/full-report/unique-patient-populations-patients-who-develop-recurrent-hcv-infection-post-liver
accessed August 17, 2015
The summary of recommendations for patients who develop recurrent HCV infection post–liver transplantation is in the BOX.
go to link for details
Recommended regimens for treatment-naive and -experienced patients with HCV genotype 1 or 4 infection in the allograft, including those with compensated cirrhosis.
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 infection in the allograft, including those with compensated cirrhosis.
Rating: Class I, Level B
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) with weight-based RBV (1000 mg [75 kg]) for 12 weeks is recommended 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-naive patients with HCV genotype 1 or 4 infection in the allograft and with compensated liver disease, who are RBV intolerant or ineligible.
Daily daclatasvir (60 mg), sofosbuvir (400 mg) for 24 weeks is recommended for patients with HCV genotype 1 or 4 infection in the allograft and with compensated liver disease, who are RBV intolerant or ineligible.
Rating: Class IIb, Level C
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is recommended for treatment-naive patients with HCV genotype 1 or 4 infection in the allograft and with compensated liver disease, who are RBV intolerant or ineligible.
Rating: Class I, Level B
Alternative regimen for patients with HCV genotype 1 infection in the allograft, including those with compensated cirrhosis.
Daily sofosbuvir (400 mg) plus simeprevir (150 mg) with or without weight-based RBV 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
Recommended regimens for treatment-naive and -experienced patients with HCV genotype 2 infection in the allograft, including those with compensated cirrhosis.
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 infection in the allograft, including those with compensated cirrhosis.
Rating: Class II, Level A
Daily sofosbuvir (400 mg) and weight-based RBV for 24 weeks is recommended for patients with HCV genotype 2 infection in the allograft, including those with compensated cirrhosis.
Rating: Class IIb, Level C
Recommended regimen for treatment-naive and -experienced patients with HCV genotype 2 infection in the allograft, including those with compensated cirrhosis, who are RBV intolerant or ineligible.
Daily daclatasvir (60 mg), sofosbuvir (400 mg) for 24 weeks is recommended for patients with HCV genotype 2 infection in the allograft, including those with compensated cirrhosis, who are RBV intolerant or ineligible.
Rating: Class IIb, Level C
Recommended regimens for treatment-naive and -experienced patients with HCV genotype 3 infection in the allograft, including those with compensated cirrhosis.
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 3 infection in the allograft, including those with compensated cirrhosis.
Rating: Class II, Level A
Daily sofosbuvir (400 mg) and weight-based RBV for 24 weeks is recommended for treatment-naive and -experienced patients with HCV genotype 3 infection in the allograft, including those with compensated cirrhosis.
Rating: Class I, Level B
Recommended regimen for treatment-naive patients with HCV genotype 3 infection in the allograft, including those with compensated cirrhosis, who are RBV intolerant or ineligible.
Daily daclatasvir (60 mg), sofosbuvir (400 mg) for 24 weeks is recommended for treatment-naive patients with HCV genotype 3 infection in the allograft, including those with compensated cirrhosis, who are RBV intolerant or ineligible.
Rating: Class IIb, Level C
Recommended regimen for treatment-naive and -experienced liver transplant recipients with decompensated cirrhosis (Child Turcotte Pugh [CTP] class B or C) who have HCV genotype 3 infection in the allograft.
Daily sofosbuvir (400 mg) and low initial dose of RBV (600 mg, increased as tolerated) for 24 weeks is recommended for liver transplant recipients with decompensated cirrhosis (CTP class B or C) who have HCV genotype 3 infection in the allograft.
Rating: Class I, Level B
Alternative regimen 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) and weight-based RBV 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
__________________________________
http://www.hcvguidelines.org/full-report/introduction
accessed August 17, 2015
This Guidance should be considered a "living document" in that the Guidance will be updated frequently as new information and treatments become available. This continually evolving report provides guidance on FDA-approved regimens. At times, it may also recommend off-label use of certain drugs or tests or provide guidance for regimens not yet approved by FDA. Readers should consult prescribing information and other resources for further information. Of note, the choice of treatment may, in the future, be further guided by data from cost-effectiveness studies.
http://www.hcvguidelines.org/full-report/unique-patient-populations-patients-decompensated-cirrhosis
accessed August 17, 2015
BOX info go to links for details
Decompensated Cirrhosis: Genotype 1 and 4 HCV Infection
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
accessed August 17, 2015
BOX info go to links for details
Decompensated Cirrhosis: Genotype 1 and 4 HCV Infection
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
FYI This is a link I use now to quickly check if there are new updates. - bookmark link. The updated sections have direct links to the updated pages. Plus the updated text is highlighted in Yellow for at least 30 days after the date of the update.
http://www.hcvguidelines.org/news
Accessed August 13, 2015
What’s New and Updates/Changes
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.
It's a good procedure to always revisit hcvguidelines before quoting, discussing and considering using the recommendation.
Please confirm my excerpts to verify for copying error (just in case)
GT1 tx naive Harvoni only No RBV or 24 weeks
"Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is recommended for treatment-naive patients with HCV genotype 1a infection." or 1b
Rating: Class I, Level A
ION 1
"Sixteen percent of subjects enrolled were classified as having cirrhosis. There was no difference in SVR12 rate in those with cirrhosis (97%) versus those without cirrhosis (98%)"
See the other treatment drugs (including Daclatasvir just added)as some situation mention RBV can be added and or tx extended to 24 weeks.
_______________________________
Tx Experienced GT1 - Harvoni
For GT1 in whom prior PEG-IFN and RBV treatment has failed WITHOUT cirrhosis
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is recommended
-----------------
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is recommended for patients with HCV genotype 1a or 1b infection who have compensated cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.
Rating: Class I, Level A
OR
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) plus weight-based RBV for 12 weeks is recommended for patients with HCV genotype 1a or 1b infection who have compensated cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.
Rating: Class I, Level B
_________________________
Recommended regimens for patients in whom a previous sofosbuvir plus RBV with or without PEG-IFN treatment has failed.
No Cirrhosis
Daily fixed-dose combination of ledipavir (90 mg)/sofosbuvir (400 mg) with weight-based RBV for 12 weeks is recommended for patients without cirrhosis, in whom a previous sofosbuvir plus RBV–containing regimen with or without PEG-IFN has failed.
Rating: Class IIb, Level C
--------------------
Cirrhosis
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) with weight-based RBV for 24 weeks is recommended for patients with cirrhosis, in whom a previous sofosbuvir-containing regimen has failed.
Rating : Class IIa, Level C
__________________________
Recommemdations in whom prior treatment with an HCV protease inhibitor, plus PEG-IFN and RBV has failed.
No Cirrhosis
Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is recommended for retreatment of patients with HCV genotype 1 infection, regardless of subtype, who do not have cirrhosis, in whom prior treatment with an HCV protease inhibitor, plus PEG-IFN and RBV has failed.
Based on limited data, the addition of weight-based RBV to ledipasvir/sofosbuvir is recommended for patients without cirrhosis, in whom prior treatment with the HCV protease inhibitor simeprevir plus sofosbuvir has failed.
Rating: Class I, Level A
Cirrhosis
Recommended for patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom prior treatment with an HCV nonstructural protein 3 (NS3) protease inhibitor (telaprevir, boceprevir, or simeprevir) plus PEG-IFN and RBV or simeprevir plus sofosbuvir has failed (no prior NS5A treatment).
Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is recommended for retreatment of patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior treatment with an HCV protease inhibitor plus PEG-IFN and RBV has failed. Based on limited data, the addition of weight-based RBV to ledipasvir/sofosbuvir is recommended for patients with cirrhosis, in whom prior treatment with the HCV protease inhibitor simeprevir plus sofosbuvir has failed.
Rating: Class I, Level A
______________________________________
Recommended regimen for patients in whom previous treatment with any HCV nonstructural protein 5A (NS5A) inhibitors has failed (including daclatasvir plus sofosbuvir, ledipasvir/sofosbuvir, or paritaprevir/ritonavir/ombitasvir plus dasabuvir).
For patients with minimal liver disease, deferral of treatment is recommended, pending availability of data.
Rating: Class IIb, Level C
For patients with cirrhosis or other patients who require retreatment urgently, testing for resistance-associated variants that confer decreased susceptibility to NS3 protease inhibitors and to NS5A inhibitors is recommended. The specific drugs used in the retreatment regimen should be tailored to the results of this testing as described below. Treatment duration of 24 weeks is recommended and, unless contraindicated, weight-based RBV should be added.
Rating: Class IIb, Level C
"For patients with cirrhosis or other patients who require retreatment urgently, testing for RAVs that confer decreased susceptibility to NS3 protease inhibitors (eg, Q80K) and to NS5A inhibitors should be performed using commercially available assays prior to selecting the next HCV treatment regimen. For patients with no NS5A inhibitor RAVs detected, retreatment with ledipasvir/sofosbuvir and RBV for 24 weeks is recommended. For patients who have NS5A inhibitor RAVs detected and who do not have NS3 inhibitor RAVs detected, treatment with simeprevir, sofosbuvir, and RBV for 24 weeks is recommended. For patients who have both NS3 and NS5A inhibitor RAVs detected, retreatment should be conducted in a clinical trial setting, as an appropriate treatment regimen cannot be recommended at this time."
I believe I have included all the Harvoni treatments for GT1 Naive or experienced (any tx Drugs failure) for Non -cirrhosis and cirrhosis (Class A well compensated only) with limited details other treatment drugs other genotypes, Unique Populations, other are at the source links.
NOTICE This Information is excerpts from hcvguidelines.org as I summarized and excerpt quotes that was accessed by me on August 13, 2015. The information may contain errors or have updated by the time you read this
Please visit hcvguidelines.org to confirm and for additional information
http://www.hcvguidelines.org/news
Accessed August 13, 2015
What’s New and Updates/Changes
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.
It's a good procedure to always revisit hcvguidelines before quoting, discussing and considering using the recommendation.
Please confirm my excerpts to verify for copying error (just in case)
GT1 tx naive Harvoni only No RBV or 24 weeks
"Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is recommended for treatment-naive patients with HCV genotype 1a infection." or 1b
Rating: Class I, Level A
ION 1
"Sixteen percent of subjects enrolled were classified as having cirrhosis. There was no difference in SVR12 rate in those with cirrhosis (97%) versus those without cirrhosis (98%)"
See the other treatment drugs (including Daclatasvir just added)as some situation mention RBV can be added and or tx extended to 24 weeks.
_______________________________
Tx Experienced GT1 - Harvoni
For GT1 in whom prior PEG-IFN and RBV treatment has failed WITHOUT cirrhosis
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is recommended
-----------------
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is recommended for patients with HCV genotype 1a or 1b infection who have compensated cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.
Rating: Class I, Level A
OR
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) plus weight-based RBV for 12 weeks is recommended for patients with HCV genotype 1a or 1b infection who have compensated cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.
Rating: Class I, Level B
_________________________
Recommended regimens for patients in whom a previous sofosbuvir plus RBV with or without PEG-IFN treatment has failed.
No Cirrhosis
Daily fixed-dose combination of ledipavir (90 mg)/sofosbuvir (400 mg) with weight-based RBV for 12 weeks is recommended for patients without cirrhosis, in whom a previous sofosbuvir plus RBV–containing regimen with or without PEG-IFN has failed.
Rating: Class IIb, Level C
--------------------
Cirrhosis
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) with weight-based RBV for 24 weeks is recommended for patients with cirrhosis, in whom a previous sofosbuvir-containing regimen has failed.
Rating : Class IIa, Level C
__________________________
Recommemdations in whom prior treatment with an HCV protease inhibitor, plus PEG-IFN and RBV has failed.
No Cirrhosis
Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is recommended for retreatment of patients with HCV genotype 1 infection, regardless of subtype, who do not have cirrhosis, in whom prior treatment with an HCV protease inhibitor, plus PEG-IFN and RBV has failed.
Based on limited data, the addition of weight-based RBV to ledipasvir/sofosbuvir is recommended for patients without cirrhosis, in whom prior treatment with the HCV protease inhibitor simeprevir plus sofosbuvir has failed.
Rating: Class I, Level A
Cirrhosis
Recommended for patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom prior treatment with an HCV nonstructural protein 3 (NS3) protease inhibitor (telaprevir, boceprevir, or simeprevir) plus PEG-IFN and RBV or simeprevir plus sofosbuvir has failed (no prior NS5A treatment).
Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is recommended for retreatment of patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior treatment with an HCV protease inhibitor plus PEG-IFN and RBV has failed. Based on limited data, the addition of weight-based RBV to ledipasvir/sofosbuvir is recommended for patients with cirrhosis, in whom prior treatment with the HCV protease inhibitor simeprevir plus sofosbuvir has failed.
Rating: Class I, Level A
______________________________________
Recommended regimen for patients in whom previous treatment with any HCV nonstructural protein 5A (NS5A) inhibitors has failed (including daclatasvir plus sofosbuvir, ledipasvir/sofosbuvir, or paritaprevir/ritonavir/ombitasvir plus dasabuvir).
For patients with minimal liver disease, deferral of treatment is recommended, pending availability of data.
Rating: Class IIb, Level C
For patients with cirrhosis or other patients who require retreatment urgently, testing for resistance-associated variants that confer decreased susceptibility to NS3 protease inhibitors and to NS5A inhibitors is recommended. The specific drugs used in the retreatment regimen should be tailored to the results of this testing as described below. Treatment duration of 24 weeks is recommended and, unless contraindicated, weight-based RBV should be added.
Rating: Class IIb, Level C
"For patients with cirrhosis or other patients who require retreatment urgently, testing for RAVs that confer decreased susceptibility to NS3 protease inhibitors (eg, Q80K) and to NS5A inhibitors should be performed using commercially available assays prior to selecting the next HCV treatment regimen. For patients with no NS5A inhibitor RAVs detected, retreatment with ledipasvir/sofosbuvir and RBV for 24 weeks is recommended. For patients who have NS5A inhibitor RAVs detected and who do not have NS3 inhibitor RAVs detected, treatment with simeprevir, sofosbuvir, and RBV for 24 weeks is recommended. For patients who have both NS3 and NS5A inhibitor RAVs detected, retreatment should be conducted in a clinical trial setting, as an appropriate treatment regimen cannot be recommended at this time."
I believe I have included all the Harvoni treatments for GT1 Naive or experienced (any tx Drugs failure) for Non -cirrhosis and cirrhosis (Class A well compensated only) with limited details other treatment drugs other genotypes, Unique Populations, other are at the source links.
NOTICE This Information is excerpts from hcvguidelines.org as I summarized and excerpt quotes that was accessed by me on August 13, 2015. The information may contain errors or have updated by the time you read this
Please visit hcvguidelines.org to confirm and for additional information
I believe there have been some recent rule changes for that population group.
I treated for 24 weeks of Harvoni and 15 weeks because we got a late start of Ribavirin because of my treatment history 3 time null respondet to interferon based and sovaldi olysio 12 week treatment relapse GT 1a with cirrhosis for almost 8 years now. Basically treating me like a child B cirrhotic as opposed to a Child A.
Good news fotr me is I am 12 weeks post and still not detected so I am cured but still hard to get my head around that concept but happy none the less
I treated for 24 weeks of Harvoni and 15 weeks because we got a late start of Ribavirin because of my treatment history 3 time null respondet to interferon based and sovaldi olysio 12 week treatment relapse GT 1a with cirrhosis for almost 8 years now. Basically treating me like a child B cirrhotic as opposed to a Child A.
Good news fotr me is I am 12 weeks post and still not detected so I am cured but still hard to get my head around that concept but happy none the less
This statement:
"People with decompensated cirrhosis and those who are awaiting or have received a liver transplant should take Harvoni with twice-daily ribavirin pills for 24 weeks".
It mentions post transplantees should treat using Harvoni with Ribavirin. I am post transplant and my doctor prescribed Harvoni without Ribavirin for me for the 24 weeks and I'm cured. So, this tells me there are variables in treatment that the rules sometimes don't apply...
Magnum
"People with decompensated cirrhosis and those who are awaiting or have received a liver transplant should take Harvoni with twice-daily ribavirin pills for 24 weeks".
It mentions post transplantees should treat using Harvoni with Ribavirin. I am post transplant and my doctor prescribed Harvoni without Ribavirin for me for the 24 weeks and I'm cured. So, this tells me there are variables in treatment that the rules sometimes don't apply...
Magnum
I believe the treatment for treatment nieve with cirrhosis is 12 weeks and for treatment experienced is 24.
There are many threads that talk about this very issue
Here's one:
http://www.medhelp.org/posts/Hepatitis-C/SVR-rates-for-Harvoni--Ribavirin/show/2631962#post_12789272
My personal opinion is that Riba will go the way of Interferon. Those of us who added Riba were the "difficult to cure" ones
Here's one:
http://www.medhelp.org/posts/Hepatitis-C/SVR-rates-for-Harvoni--Ribavirin/show/2631962#post_12789272
My personal opinion is that Riba will go the way of Interferon. Those of us who added Riba were the "difficult to cure" ones
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Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
