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      Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1

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          Abstract

          The combination of daclatasvir, a hepatitis C virus (HCV) NS5A inhibitor, and the NS5B inhibitor sofosbuvir has shown efficacy in patients with HCV monoinfection. Data are lacking on the efficacy and safety of this combination in patients coinfected with human immunodeficiency virus type 1 (HIV-1).

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          Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis.

          Kris V Kowdley, Stuart Gordon, K Rajender Reddy … (2014)
          High rates of sustained virologic response were observed among patients with hepatitis C virus (HCV) infection who received 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor ledipasvir. This study examined 8 weeks of treatment with this regimen. In this phase 3, open-label study, we randomly assigned 647 previously untreated patients with HCV genotype 1 infection without cirrhosis to receive ledipasvir and sofosbuvir (ledipasvir-sofosbuvir) for 8 weeks, ledipasvir-sofosbuvir plus ribavirin for 8 weeks, or ledipasvir-sofosbuvir for 12 weeks. The primary end point was sustained virologic response at 12 weeks after the end of therapy. The rate of sustained virologic response was 94% (95% confidence interval [CI], 90 to 97) with 8 weeks of ledipasvir-sofosbuvir, 93% (95% CI, 89 to 96) with 8 weeks of ledipasvir-sofosbuvir plus ribavirin, and 95% (95% CI, 92 to 98) with 12 weeks of ledipasvir-sofosbuvir. As compared with the rate of sustained virologic response in the group that received 8 weeks of ledipasvir-sofosbuvir, the rate in the 12-week group was 1 percentage point higher (97.5% CI, -4 to 6) and the rate in the group that received 8 weeks of ledipasvir-sofosbuvir with ribavirin was 1 percentage point lower (95% CI, -6 to 4); these results indicated noninferiority of the 8-week ledipasvir-sofosbuvir regimen, on the basis of a noninferiority margin of 12 percentage points. Adverse events were more common in the group that received ribavirin than in the other two groups. No patient who received 8 weeks of only ledipasvir-sofosbuvir discontinued treatment owing to adverse events. Ledipasvir-sofosbuvir for 8 weeks was associated with a high rate of sustained virologic response among previously untreated patients with HCV genotype 1 infection without cirrhosis. No additional benefit was associated with the inclusion of ribavirin in the regimen or with extension of the duration of treatment to 12 weeks. (Funded by Gilead Sciences; ION-3 ClinicalTrials.gov number, NCT01851330.).
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            Epidemiology of viral hepatitis and HIV co-infection.

            Miriam J Alter (2006)
            Worldwide, hepatitis B virus (HBV) accounts for an estimated 370 million chronic infections, hepatitis C virus (HCV) for an estimated 130 million, and HIV for an estimated 40 million. In HIV-infected persons, an estimated 2-4 million have chronic HBV co-infection and 4-5 million have HCV co-infection. HBV, HCV and HIV share common routes of transmission, but they differ in their prevalence by geographic region and the efficiency by which certain types of exposures transmit them. Among HIV-positive persons studied from Western Europe and the USA, chronic HBV infection has been found in 6-14% overall, including 4-6% of heterosexuals, 9-17% of men who have sex with men (MSM), and 7-10% of injection drug users. HCV infection has been found in 25-30% of HIV-positive persons overall; 72-95% of injection drug users, 1-12% of MSM and 9-27% of heterosexuals. The characteristics of HIV infected persons differ according to the co-infecting hepatitis virus, their epidemiologic patterns may change over time, and surveillance systems are needed to monitor their infection patterns in order to ensure that prevention measures are targeted appropriately.
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              Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect

              Min Gao, Richard Nettles, Makonen Belema … (2010)
              New drugs for hepatitis C The development of direct-acting antiviral agents to treat chronic hepatitis C virus (HCV) infection, much needed clinically, has focused largely on inhibitors of two viral enzymes, the protease NS3 and NS5B, an RNA-dependent RNA polymerase essential for HCV replication. BMS-790052, identified using chemical genetics as a powerful specific HCV inhibitor, is a small-molecule inhibitor of a third viral molecule that has no known enzyme activity, the non-structural protein 5A (NS5A). A research team from Bristol-Myers Squibb this week reports on the discovery and virological profile of BMS-790052 and discloses clinical trial observations with this compound in normal healthy volunteers and HCV-infected subjects. These results establish proof-of-concept for HCV NS5A inhibition as a clinically relevant mechanism. In vitro data point to synergistic interactions with known HCV inhibitors, suggesting that cocktails of antiviral agents may be a viable therapeutic approach. Supplementary information The online version of this article (doi:10.1038/nature08960) contains supplementary material, which is available to authorized users.
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                Author and article information

                Journal
                Title: New England Journal of Medicine
                Abbreviated Title: N Engl J Med
                Publisher: Massachusetts Medical Society
                ISSN (Print): 0028-4793
                ISSN (Electronic): 1533-4406
                Publication date Created: August 20 2015
                Publication date (Print): August 20 2015
                Volume: 373
                Issue: 8
                Pages: 714-725
                Article
                DOI: 10.1056/NEJMoa1503153
                PubMed ID: 26196502
                SO-VID: 2ed5b7d2-7714-4a8c-ab22-c58a6852c267
                Copyright © © 2015
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