Management of HCV in Patients With Genotype 3 HCV Infection
(From Clinical Care Options HVC website)
AASLD/IDSA Guidance for Treatment-Naive or Treatment-Experienced Genotype 3 Patients
Treatment options for patients with genotype 3 HCV infection include a regimen of sofosbuvir and daclatasvir, which was recently approved by the FDA specifically for the treatment of genotype 3 HCV infection, OR a regimen of Sofosbuvir and Ribavirin, with Peginterferon if possible. (Not Sofosbuvir and Ribavirin alone due to poor SVR data).
The current AASLD/IDSA guidance recommends that patients with genotype 3 HCV infection and No Cirrhosis receive daclatasvir and sofosbuvir for 12 weeks, regardless of peginterferon/ribavirin experience.
* * Those with Compensated Cirrhosis should have this regimen extended to 24 weeks, with Ribavirin (optional if treatment naïve) and recommended if peginterferon/ribavirin experienced.
Those with previous sofosbuvir and ribavirin failure should receive daclatasvir and sofosbuvir for 24 weeks with ribavirin, and those with decompensated cirrhosis should receive daclatasvir and sofosbuvir for 12 weeks with a low initial dose of ribavirin.
The AASLD/IDSA guidelines also recommend sofosbuvir plus ribavirin and peginterferon for 12 weeks in treatment-naive and treatment-experienced patients with genotype 3 HCV infection who are eligible to receive interferon, including those with compensated cirrhosis.
For treatment-naive patients who cannot tolerate interferon, an alternate regimen is sofosbuvir and ribavirin for 24 weeks. Efficacy after 24 weeks is lower in patients with decompensated cirrhosis, and extending sofosbuvir with a low initial dose of ribavirin for up to 48 weeks (but without peginterferon) is recommended at the discretion of the care provider.
* * Despite these recommendations, SVR rates with sofosbuvir and ribavirin in genotype 3 are reduced when compared with other genotypes, particularly for Treatment-Experienced Cirrhotic patients for whom the 24-week Sofosbuvir plus Ribavirin regimen has led to an SVR12 rate of 62% in clinical trials. (!)
Improved management of genotype 3 HCV infection is of particular importance because data indicate that fibrosis progression occurs most rapidly in patients infected with this genotype.Indeed, infection with genotype 3 HCV is listed in treatment guidelines as a viral factor for consideration when prioritizing treatment of patients with chronic hepatitis C virus infection.The importance of viral eradication is clearly demonstrated in a retrospective Veterans Affairs study that analyzed the impact of SVR on all-cause mortality in HCV-infected patients treated with peginterferon and ribavirin between January 2001 and June 2007. Regardless of genotype, patients who achieved SVR had a lower risk of all-cause mortality compared with patients who did not achieve SVR. For patients infected with genotype 3 HCV, however, the slope of the curve shows that the mortality risk of not achieving SVR is even higher in this population. Thus, the availability of effective treatment options in this population is critical.
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The combination of Sofosbuvir plus Ribavirin for 24 weeks has moved from the "Recommended Category" to the "Alternative Category" as an option for interferon-ineligible individuals.
Hector
Hello and welcome to the Cirrhosis of the Liver Community.
Since you have cirrhosis you are someone who should be treated soon with the hope of curing the virus and reversing your liver disease.
Which hepatitis treatment someone is most appropriate for someone is based upon a number of factors. In your case… your genotype, having cirrhosis, and having treated before (treatment experienced). Also that fact that you have been anemic and may be prone to anemia which can be a side effect of ribavirin.
All of standards for treating someone with hepatitis C are listed online at the AASLD & IDSA “HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C”. For people with genotype 3, with cirrhosis and are treatment experienced at http://hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed.
As you can read …
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"Recommended regimens for patients with HCV genotype 3 infection with cirrhosis, in whom prior treatment with PEG-IFN and RBV has failed.
Daily daclatasvir (60 mg) and sofosbuvir (400 mg) for 24 weeks with weight based RBV is recommended for patients with cirrhosis and HCV genotype 3 infection, in whom prior treatment with PEG-IFN and RBV has failed and who are IFN ineligible."
NOT, sofosbuvir and ribavirin alone!
Your doctor doesn’t seem to be aware of the latest treatments for hepatitis C. Unfortunately hepatitis C is the most difficult genotype to cure and until this new treatment cure rates were low especially in treatment experienced cirrhotics which are the most difficult to cure genotype 3s. Luckily were now have recently FDA approved Daclatavir to help genotype 3s. As a cirrhotic you want to give yourself the best odds of curing your hepatitis C now and stopping your cirrhosis before it becomes irreversible. So getting the best treatment available currently is critical to your future well-being.
Previous trials showed that in genotype 3s treated with sofosbuvir and ribavirin for 24 weeks, who were treatment experienced, and had cirrhosis had a SVR rate of just of only 68%. Recent studies have shown the problems (low SVR rates) with treating genotype 3s with just sofosbuvir and ribavirin alone. I think you want to have better odds than this while going through a 6 month treatment! As you can read with only 12 weeks of daclatasvir and sofosbuvir and ribavirin you can achieve the same SVR rate.
Here is some info on why 24 weeks of this treatment is recommended.
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“In the ALLY-3 study, the safety and efficacy of treatment with daclatasvir plus sofosbuvir for 12 weeks was evaluated in 51 treatment-experienced patients. (Nelson, 2015b) The majority of these patients were previously treated with IFN-based regimens. Among patients without cirrhosis, 32 of 34 (94%) achieved SVR12. Patients with cirrhosis had lower response rates, with 9 of 13 (69%) achieving SVR12.
These data support the use of daclatasvir and sofosbuvir for 12 weeks in patients without cirrhosis, but this is likely a suboptimal regimen for patients with cirrhosis.
Although data are very limited, treatment with daclatasvir and sofosbuvir for 24 weeks with or without RBV should be considered in treatment-experienced HCV genotype 3-infected patients with cirrhosis, especially in those who are ineligible for IFN.”
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Another advantage of this treatment with this treatment is that modifying the dose of the ribavirin, should you have issues with anemia, would have less impact on achieving SVR because you have 3 drugs fighting the virus not just two in the case of sofosbuvir and ribavirin.
While the data is still being gathered it is obvious that daclatasvir, sofosbuvir +_ ribavirin is more effective treatment than sofosbuvir and ribavirin alone for someone with your factors of being treatment experienced and having cirrhosis. Personally I think you would want to best odds of curing your hep C once and for all. Going through 6 months of treatment were you may have some side effects from treatment only to fail is a rough experience that I don’t want to see anyone have to deal with. Now that we have a better treatment for genotype 3 we should take advantage of it.
I don’t know were you live but I personally would recommend that if you are in or near a liver transplant center I would seek treatment there. They are aware of all of the latest treatments and data and would make sure you got the best treatment available. They are also experienced with managing the side effects of these treatments including anemia. For years with interferon based treatments the doctors learned how to manage the treatment of cirrhotics with hepatitis C and its side effects. While a local gastroenterologist can have good intentions no gastroenterologist is an expert at treating hepatitis C or treating someone with cirrhosis.
As to my own experience... I treated my hepatitis C twice before my transplant. First with Peg-interferon and ribavirin in 2008 and then I was in a clinical trial where I was one of the first 61 cirrhotics to ever treat with sofosbuvir and ribavirin. I treated for 48 weeks and ended up relapsing within 4 weeks of stopping treatment. So I think I have some insight into your situation.
I hope this helps.
Let me know how I can further help.
Hector
1200 mg riba - it's normal dose for body weight more then 75kg.
You should do blood work every 2 weeks and,in case of hemolytica anemia, hepatologist shoud decrease dose .