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what are the latest treatments for Hep C genotype 3
what are the latest treatments for Hep C genotype 3 and are they expensive? I have employer based health insurance but dont know if its covered? I have read about Solvaldi and Ribavirin but dont know what other options I have for treating geno 3. I am at a level 3 for fibrosis and my viral load is 17.9 million?? Do I need to do anything to prepare for this treatment?? I have an appointment with my Gastro in two weeks to discuss treatment and want to be educated as much as possible when I speak with him so I can start a treatment ASAP!! Any info is appreciated. Thanks
The latest AASLD/IDSA (American Association for the Study of Liver Diseases and Infectious Disease society of America) latest recommended treatments for hepatitis C can be found at this website.
http://www.hcvguidelines.org/full-report-view
Genotype 3 (treatment-naive patients)
Recommended regimen for treatment-naive patients with HCV genotype 3, regardless of eligibility for IFN therapy:
Daily sofosbuvir (400 mg) and weight-based RBV (1000 mg [75 kg]) for 24 weeks is recommended for treatment-naive patients with HCV genotype 3 infection.
Rating: Class I, Level B
The VALENCE study assessed the efficacy and safety of sofosbuvir (400 mg daily) plus RBV for 24 weeks in 250 treatment-naive (42%) and treatment-experienced (58%) subjects with HCV genotype 3 infection. The overall SVR12 was 84% and was higher among treatment-naive than treatment-experienced patients (93% versus 77%, respectively). These results suggest higher response rates can be achieved with a 24-week duration of sofosbuvir plus RBV than those reported for the 12- or 16-week durations studied in the FISSION (Lawitz, 2013b) (12 weeks, SVR12: 63%), POSITRON, (Jacobson, 2013c) (12 weeks, SVR 12: 61%) and FUSION (12 weeks, SVR12: 30%, 16 weeks, SVR12: 62%) trials. The primary reason for the higher SVR with extended therapy among treatment-naive patients was a reduction in the relapse rate from 40% to 5%. In sub-analysis, response rates were similarly high among those with (n=45) and without (n=100) cirrhosis (92% and 93%, respectively).
Alternative regimens for treatment-naive patients with genotype 3 who are eligible to receive IFN.
Daily sofosbuvir (400 mg) and weight-based RBV (1000 mg [75 kg]) plus weekly PEG for 12 weeks is an acceptable regimen for IFN-eligible persons with HCV genotype 3.
Rating: Class IIa, Level A
The combination of sofosbuvir plus PEG/RBV has been evaluated in patients with genotype 3 infection. In 2 phase 2 clinical trials, PROTON and ELECTRON, 38 of 39 (97%) treatment-naive patients with genotype 3 infection achieved SVR with sofosbuvir plus PEG (4 to 12 weeks of therapy)/RBV. (Gane, 2013b) For many patients with genotype 3, the adverse effects and increased monitoring requirements of PEG make this less acceptable than the recommended regimen of sofosbuvir plus weight-based RBV.
The following regimens are NOT recommended for treatment-naive patients with HCV genotype 3.
◾PEG/RBV for 24 to 48 weeks
Rating: Class IIb, Level A
◾Monotherapy with PEG, RBV, or a DAA
Rating: Class III, Level A
◾Telaprevir-, boceprevir-, or simeprevir-based regimens should not be used for patients with genotype 3 HCV infection.
Rating: Class III, Level A
Although the combination of PEG/RBV is an FDA-approved regimen for HCV genotype 3, its less acceptable adverse effect profile, requirement for more intensive monitoring, and overall lower efficacy make it less desirable than the recommended regimen.
Because of their limited in vitro and in vivo activity against genotype 3, boceprevir, telaprevir, and simeprevir should not be used as therapy for patients with HCV genotype 3 infection.
----------------------------------------------------------------------------------------
Genotype 3 (treatment experienced)
Recommended regimen for HCV genotype 3 PEG/RBV nonresponders.
Daily sofosbuvir (400 mg) and weight-based RBV (1000 mg [75 kg]) for 24 weeks is recommended for retreatment of HCV genotype 3 infection.
Rating: Class IIa, Level A
The phase 3 FUSION trial compared 12 weeks (n=103) with 16 weeks (n=98) of daily sofosbuvir (400 mg) and weight-based RBV (1000 mg to 1200 mg) in genotype 2 or 3 HCV-infected patients in whom previous PEG/RBV therapy had failed. Of patients, 63% had genotype 3; 34% of all patients had cirrhosis. Because persons who had experienced prior relapses to IFN-based therapy accounted for 75% of patients, the number of patients with a prior nonresponse in the study was limited. The SVR rate for genotype 3 patients in the 12-week arm was 30% (19% among patients with cirrhosis and 37% among those without cirrhosis). Extending therapy to 16 weeks increased the SVR rate among genotype 3 patients to 62% (61% among patients with and 63% in those without cirrhosis).
Based on results from FUSION, the phase 3 multicenter, randomized placebo-controlled VALENCE trial was amended to evaluate the effect of extending sofosbuvir plus RBV therapy to 24 weeks in all patients with HCV genotype 3. As with the FUSION study, most (65%) treatment-experienced patients had relapsed. The SVR12 rates after 24 weeks of therapy for treatment-experienced patients with genotype 3 was 79% (60% among patients with and 87% in those without cirrhosis). The increased efficacy with 24 weeks of sofosbuvir plus RBV therapy across all fibrosis stages combined with a favorable safety and tolerability profile supports the recommendation to use 24 weeks of sofosbuvir plus RBV in all genotype 3 patients despite the minimal number of patients studied to date. The response rate for HCV genotype 3-infected patients with cirrhosis treated for 24 weeks in the VALENCE trial (60%) was similar to that observed after 16 weeks of treatment in the FUSION trial (61%). Although longer treatment duration with a well-tolerated regimen may potentially be more successful in these more difficult-to-treat patients, data remain limited. Either duration of treatment is considered acceptable at this time (see below).
Alternate regimen for HCV genotype 3 PEG/RBV nonresponder patients who are eligible to receive IFN.
Retreatment with daily sofosbuvir (400 mg) and weight-based RBV (1000 mg [75 kg]) plus weekly PEG for 12 weeks is an alternative for IFN-eligible persons with HCV genotype 3 infection.
Rating: Class IIa Level B
Choice of specific regimen may be influenced by previous or anticipated tolerance to PEG or the presence of advanced fibrosis or cirrhosis. For most patients, the ease of administration and tolerability of sofosbuvir plus RBV will outweigh any potential benefit associated with the addition of PEG. However, for HCV genotype 3-infected patients who have cirrhosis, responses to sofosbuvir and RBV alone for 24 weeks were suboptimal.
In the LONESTAR-2 study, adding 12 weeks of PEG to the sofosbuvir and RBV regimen resulted in numerically higher response rates among persons with HCV genotype 3 than those obtained with sofosbuvir and RBV for 24 weeks. Of HCV genotype 3-infected patients with and without cirrhosis, 10 (83%) of 12 achieved SVR. Given the limited number of patients in this demographic in both the VALENCE and LONESTAR-2 studies, these differences in response rates should be interpreted with caution.
The following regimens are NOT recommended for nonresponder patients with HCV genotype 3 infection.
◾PEG/RBV with or without telaprevir, boceprevir or simeprevir
Rating: Class IIb, Level A
◾Monotherapy with PEG, RBV, or a DAA
Rating: Class III, Level A
No HCV protease inhibitors have been approved or are indicated for the treatment of genotype 3 HCV infection. Although PEG/RBV has been the mainstay of treatment of genotype 3 HCV, it is less efficacious and has more adverse effects than the recommended regimens.
Hector
http://www.hcvguidelines.org/full-report-view
Genotype 3 (treatment-naive patients)
Recommended regimen for treatment-naive patients with HCV genotype 3, regardless of eligibility for IFN therapy:
Daily sofosbuvir (400 mg) and weight-based RBV (1000 mg [75 kg]) for 24 weeks is recommended for treatment-naive patients with HCV genotype 3 infection.
Rating: Class I, Level B
The VALENCE study assessed the efficacy and safety of sofosbuvir (400 mg daily) plus RBV for 24 weeks in 250 treatment-naive (42%) and treatment-experienced (58%) subjects with HCV genotype 3 infection. The overall SVR12 was 84% and was higher among treatment-naive than treatment-experienced patients (93% versus 77%, respectively). These results suggest higher response rates can be achieved with a 24-week duration of sofosbuvir plus RBV than those reported for the 12- or 16-week durations studied in the FISSION (Lawitz, 2013b) (12 weeks, SVR12: 63%), POSITRON, (Jacobson, 2013c) (12 weeks, SVR 12: 61%) and FUSION (12 weeks, SVR12: 30%, 16 weeks, SVR12: 62%) trials. The primary reason for the higher SVR with extended therapy among treatment-naive patients was a reduction in the relapse rate from 40% to 5%. In sub-analysis, response rates were similarly high among those with (n=45) and without (n=100) cirrhosis (92% and 93%, respectively).
Alternative regimens for treatment-naive patients with genotype 3 who are eligible to receive IFN.
Daily sofosbuvir (400 mg) and weight-based RBV (1000 mg [75 kg]) plus weekly PEG for 12 weeks is an acceptable regimen for IFN-eligible persons with HCV genotype 3.
Rating: Class IIa, Level A
The combination of sofosbuvir plus PEG/RBV has been evaluated in patients with genotype 3 infection. In 2 phase 2 clinical trials, PROTON and ELECTRON, 38 of 39 (97%) treatment-naive patients with genotype 3 infection achieved SVR with sofosbuvir plus PEG (4 to 12 weeks of therapy)/RBV. (Gane, 2013b) For many patients with genotype 3, the adverse effects and increased monitoring requirements of PEG make this less acceptable than the recommended regimen of sofosbuvir plus weight-based RBV.
The following regimens are NOT recommended for treatment-naive patients with HCV genotype 3.
◾PEG/RBV for 24 to 48 weeks
Rating: Class IIb, Level A
◾Monotherapy with PEG, RBV, or a DAA
Rating: Class III, Level A
◾Telaprevir-, boceprevir-, or simeprevir-based regimens should not be used for patients with genotype 3 HCV infection.
Rating: Class III, Level A
Although the combination of PEG/RBV is an FDA-approved regimen for HCV genotype 3, its less acceptable adverse effect profile, requirement for more intensive monitoring, and overall lower efficacy make it less desirable than the recommended regimen.
Because of their limited in vitro and in vivo activity against genotype 3, boceprevir, telaprevir, and simeprevir should not be used as therapy for patients with HCV genotype 3 infection.
----------------------------------------------------------------------------------------
Genotype 3 (treatment experienced)
Recommended regimen for HCV genotype 3 PEG/RBV nonresponders.
Daily sofosbuvir (400 mg) and weight-based RBV (1000 mg [75 kg]) for 24 weeks is recommended for retreatment of HCV genotype 3 infection.
Rating: Class IIa, Level A
The phase 3 FUSION trial compared 12 weeks (n=103) with 16 weeks (n=98) of daily sofosbuvir (400 mg) and weight-based RBV (1000 mg to 1200 mg) in genotype 2 or 3 HCV-infected patients in whom previous PEG/RBV therapy had failed. Of patients, 63% had genotype 3; 34% of all patients had cirrhosis. Because persons who had experienced prior relapses to IFN-based therapy accounted for 75% of patients, the number of patients with a prior nonresponse in the study was limited. The SVR rate for genotype 3 patients in the 12-week arm was 30% (19% among patients with cirrhosis and 37% among those without cirrhosis). Extending therapy to 16 weeks increased the SVR rate among genotype 3 patients to 62% (61% among patients with and 63% in those without cirrhosis).
Based on results from FUSION, the phase 3 multicenter, randomized placebo-controlled VALENCE trial was amended to evaluate the effect of extending sofosbuvir plus RBV therapy to 24 weeks in all patients with HCV genotype 3. As with the FUSION study, most (65%) treatment-experienced patients had relapsed. The SVR12 rates after 24 weeks of therapy for treatment-experienced patients with genotype 3 was 79% (60% among patients with and 87% in those without cirrhosis). The increased efficacy with 24 weeks of sofosbuvir plus RBV therapy across all fibrosis stages combined with a favorable safety and tolerability profile supports the recommendation to use 24 weeks of sofosbuvir plus RBV in all genotype 3 patients despite the minimal number of patients studied to date. The response rate for HCV genotype 3-infected patients with cirrhosis treated for 24 weeks in the VALENCE trial (60%) was similar to that observed after 16 weeks of treatment in the FUSION trial (61%). Although longer treatment duration with a well-tolerated regimen may potentially be more successful in these more difficult-to-treat patients, data remain limited. Either duration of treatment is considered acceptable at this time (see below).
Alternate regimen for HCV genotype 3 PEG/RBV nonresponder patients who are eligible to receive IFN.
Retreatment with daily sofosbuvir (400 mg) and weight-based RBV (1000 mg [75 kg]) plus weekly PEG for 12 weeks is an alternative for IFN-eligible persons with HCV genotype 3 infection.
Rating: Class IIa Level B
Choice of specific regimen may be influenced by previous or anticipated tolerance to PEG or the presence of advanced fibrosis or cirrhosis. For most patients, the ease of administration and tolerability of sofosbuvir plus RBV will outweigh any potential benefit associated with the addition of PEG. However, for HCV genotype 3-infected patients who have cirrhosis, responses to sofosbuvir and RBV alone for 24 weeks were suboptimal.
In the LONESTAR-2 study, adding 12 weeks of PEG to the sofosbuvir and RBV regimen resulted in numerically higher response rates among persons with HCV genotype 3 than those obtained with sofosbuvir and RBV for 24 weeks. Of HCV genotype 3-infected patients with and without cirrhosis, 10 (83%) of 12 achieved SVR. Given the limited number of patients in this demographic in both the VALENCE and LONESTAR-2 studies, these differences in response rates should be interpreted with caution.
The following regimens are NOT recommended for nonresponder patients with HCV genotype 3 infection.
◾PEG/RBV with or without telaprevir, boceprevir or simeprevir
Rating: Class IIb, Level A
◾Monotherapy with PEG, RBV, or a DAA
Rating: Class III, Level A
No HCV protease inhibitors have been approved or are indicated for the treatment of genotype 3 HCV infection. Although PEG/RBV has been the mainstay of treatment of genotype 3 HCV, it is less efficacious and has more adverse effects than the recommended regimens.
Hector
You can do Sova and Riba for 24 weeks now or wait for Declatasvir + Riba next year if everything goes well. Giliad also has combination pill with Sofa and their own medicine similar to Declatasvir in stage 2 trials.
Here is an article about our medicine: http://hepatitiscnewdrugs.blogspot.com/search/label/GS-7977%20now%20Sofosbuvir%2FBMS-790052%20now%20Daclatasvir
.
Here is an article about our medicine: http://hepatitiscnewdrugs.blogspot.com/search/label/GS-7977%20now%20Sofosbuvir%2FBMS-790052%20now%20Daclatasvir
.
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