The AASLD/IDSA HCV Guidance Panel has updated the guidelines for management of HCV infection which have been Published in Hepatology. The speed of hepatitis C virus (HCV) drug development in recent years has accelerated dramatically. The practitioners require access to the most up-to-date data and advice from experienced experts in order to benefit patients by these impressive advances. approval of the fixed-dose combination drug sofosbuvir-velpatasvir for the treatment of HCV infection.The fixed dose combination is available as Sofosbuvir 400 mg plus Velpatasvir 100 mg q24h dosage.
Summary of Updated Recommendations:
Successful hepatitis C treatment is achievable in nearly all infected patients and is reflected by a sustained virological response (SVR), defined as the continued absence of detectable HCV RNA for 12 or more weeks after completion of therapy.
- All treatment-naïve persons with HCV genotypes 1–6 without cirrhosis or with compensated cirrhosis:
Daily fixed-dose combination of sofosbuvir-velpatasvir for 12 weeks
- In patients in whom previous treatment has failed:
- HCV Genotypes 1a, 1b, 2, 3, 4, 5, and 6 with previous failure with all regimens (except genotype 1, as mentioned below): fixed dose combination of sofosbuvir-velpatasvir for 12 weeks is recommended.
- HCV Genotype 1 with simeprevir-sofosbuvir and HCV-NS5A inhibitor treatment-experienced patients:
- Deferral of treatment in recommended in whom prior treatmen with HCV protease inhibitor, who do not have cirrhosis and do not have reasons for urgent retreatment.
- Testing for resistance-associated variants that confer decreased susceptibility to NS3 protease inhibitors and to NS5A inhibitors is recommended for patients with HCV genotype 1 infection, regardless of subtype, in whom prior treatment with the HCV protease inhibitor simeprevir plus sofosbuvir has failed (no prior NS5A treatment), who have compensated cirrhosis, or have reasons for urgent retreatment. The specific drugs used in the retreatment regimen should be tailored to the results of this testing as described below.
- When using nucleotide-based (eg, sofosbuvir) dual DAA therapy a treatment duration of 24 weeks is recommended, and weight-based ribavirin, unless contraindicated, should be added.
- If available, nucleotide-based (eg, sofosbuvir) triple or quadruple DAA regimens may be considered. In these settings treatment duration ranges from 12 weeks to 24 weeks (see text), and weight-based ribavirin, unless contraindicated, are recommended.
- Decompensated cirrhosis in HCV Genotypes 1 and 4 infection:
- Moderate to severe hepatic impairment, Child-Turcot-Pugh (CTP) class B or C, who may or may not be eligible candidates for liver transplantation, including those with HCC:
- Daily fixed-dose combination of sofosbuvir-velpatasvir with weight-based ribavirin (low intial dose of 600 mg is recommended in CTP class C patients) for 12 weeks
- For those who are ribavirin-ineligible:
- Daily fixed-dose combination of sofosbuvir-velpatasvir for 24 weeks
- In whom prior sofosbuvir-based treatment has failed:
- Daily fixed dose combination of sofosbuvir-velpatasvir with weight-based ribavirin (initial low-dose of ribavirin of 600 mg in persons with CTP class C) for 24 weeks
- Decompensated cirrhosis in HCV genotypes 2 and 3 infection: Moderate of severe hepatic impairment, CTP class B or C, and who may or may not be candidate for liver transplantation, including those with HCC:
Daily fixed-dose combination of sofosbuvir-velpatasvir with weight-based ribavirin for 12 weeks
- Patients with Renal Impairment:
Mild to Moderate Renal Impairment (CrCl 30–80 mL/min): No dose adjustment is required for the use of fixed-dose combination of sofosbuvir-velpatasvir for treatment or retreatment
- Patients with HIV/HCV coinfection
Daily fixed dose combination of sofosbuvir-velpatasvir can be used with most antivirals, but SHOULD NOT be used with efavirenz, etravirine, or nevirapine.
- Because velpatasvir increases tenofovir levels, when given as tenofovir disoproxil fumarate (TDF), concomitant use mandates consideration of renal function and should be avoided in those with CrCl below 60 mL/min.
- In patients with CrCl >60 mL/min concomitant dosing of velpatasvir and TDF with ritonavir-boosted or cobicistat-boosted regimens did not result in renal toxicity in 56 subjects.
- Renal monitoring is recommended during the dosing period.
- Tenofovir alafenamide (TAF) may be an alternative to TDF during sofosbuvir-velpatasvir treatment for patients who take cobicistat or ritonavir as part of their antiretroviral therapy.
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