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      Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis.

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          Abstract

          As the population that is infected with the hepatitis C virus (HCV) ages, the number of patients with decompensated cirrhosis is expected to increase.

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          Aging of hepatitis C virus (HCV)-infected persons in the United States: a multiple cohort model of HCV prevalence and disease progression.

          Gary L Davis, Miriam J Alter, Hashem El-Serag … (2010)
          The prevalence of chronic hepatitis C (CH-C) remains high and the complications of infection are common. Our goal was to project the future prevalence of CH-C and its complications. We developed a multicohort natural history model to overcome limitations of previous models for predicting disease outcomes and benefits of therapy. Prevalence of CH-C peaked in 2001 at 3.6 million. Fibrosis progression was inversely related to age at infection, so cirrhosis and its complications were most common after the age of 60 years, regardless of when infection occurred. The proportion of CH-C with cirrhosis is projected to reach 25% in 2010 and 45% in 2030, although the total number with cirrhosis will peak at 1.0 million (30.5% higher than the current level) in 2020 and then decline. Hepatic decompensation and liver cancer will continue to increase for another 10 to 13 years. Treatment of all infected patients in 2010 could reduce risk of cirrhosis, decompensation, cancer, and liver-related deaths by 16%, 42%, 31%, and 36% by 2020, given current response rates to antiviral therapy. Prevalence of hepatitis C cirrhosis and its complications will continue to increase through the next decade and will mostly affect those older than 60 years of age. Current treatment patterns will have little effect on these complications, but wider application of antiviral treatment and better responses with new agents could significantly reduce the impact of this disease in coming years.
          Article 0 comments Cited 165 times – based on 0 reviews     Review now
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            Sofosbuvir compassionate use program for patients with severe recurrent hepatitis C after liver transplantation.

            Xavier Forns, Michael Charlton, Jill Denning … (2015)
            Recurrent hepatitis C virus (HCV) infection after liver transplantation (LT) is associated with accelerated progression of liver disease, frequently leading to graft loss and early death. Existing treatment options for severe recurrent HCV infection are limited by suboptimal efficacy, poor tolerability, and numerous drug interactions. We provided sofosbuvir (SOF) and ribavirin (RBV) on a compassionate-use basis to patients with severe recurrent hepatitis C, including those with fibrosing cholestatic hepatitis (FCH) and decompensated cirrhosis who had a life expectancy of 1 year or less. All patients were to receive 24-48 weeks of SOF plus RBV. Investigators could add pegylated interferon to the regimen at their discretion. Data from the first 104 patients who completed or prematurely discontinued treatment by January 1, 2014 are presented. Of the 104 patients analyzed, 52 had an early severe recurrence (diagnosed 12 months after LT). Twelve patients who underwent retransplantation were excluded from our efficacy analysis. Of the 92 patients assessed, 54 (59%) achieved sustained virological response (SVR) at 12 weeks after the end of treatment, with a higher rate (73%; 35 of 48) in patients with early severe recurrence. Of the 103 patients assessed for clinical outcome, 59 (57%) reported clinical improvement at the last study visit, 23 (22%) were unchanged, 3 (3%) had a worsened clinical status, and 13 (13%) died. Overall, 123 serious adverse events (SAEs) occurred in 49 patients (47%). SAEs associated with hepatic decompensation were the most frequent, with 26 SAEs occurring in 19 patients (18%).
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              Improvement of liver function parameters in advanced HCV-associated liver cirrhosis by IFN-free antiviral therapies.

              K Deterding, C Höner zu Siederdissen, Friedrich Port … (2015)
              Successful antiviral treatment of decompensated hepatitis B with HBV polymerase inhibitors is associated with improvement of liver function. To what extent liver function also improves in cirrhotic patients with chronic hepatitis C receiving novel interferon-free (IFN-free) therapies is unknown.
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                Author and article information

                Journal
                Journal ID (iso-abbrev): N. Engl. J. Med.
                Title: The New England journal of medicine
                ISSN (Electronic): 1533-4406
                ISSN (Print): 0028-4793
                Publication date (Electronic): Dec 31 2015
                Volume: 373
                Issue: 27
                Affiliations
                [1 ] From the Beth Israel Deaconess Medical Center, Boston (M.P.C.); Baylor University Medical Center, Dallas (J.G.O.), and Texas Liver Institute, University of Texas Health Science Center, San Antonio (E.L.) - both in Texas; Ochsner Medical Center, New Orleans (N.B.); Duke University, Durham (A.J.M.), and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.F.) - both in North Carolina; Washington University School of Medicine, St. Louis (K.M.K.); Thomas Jefferson University (J.M.F.) and University of Pennsylvania School of Medicine (K.R.R.) - both in Philadelphia; Northwestern University, Chicago (S.L.F.); Mount Sinai Hospital (T.S.), New York University School of Medicine (L.T.), and Weill Cornell Medical College (R.S.B.) - all in New York; University of Michigan, Ann Arbor (R.F.); University of Miami, Miami (E.S.); Gilead Sciences, Foster City, CA (B.D., D.A., J.M., A.O., D.M.B., J.G.M.); and Intermountain Medical Center, Salt Lake City (M.C.).
                Article
                DOI: 10.1056/NEJMoa1512614
                PubMed ID: 26569658
                SO-VID: 200c2661-c40c-432b-880b-3f5a548d4d26
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