Treatment regimens based on the use of interferon-alpha (IFN-alpha) remain the cornerstone of therapy for chronic hepatitis C virus infection, which affects nearly 170 million people worldwide. Treatment options include unmodified IFN-alpha given three times weekly or pegylated IFNs given once weekly. The albumin-fusion platform takes advantage of the long half-life of human albumin to provide a new treatment approach that allows the dosing frequency of IFN-alpha to be reduced in individuals with chronic hepatitis C. Albinterferon alpha-2b (alb-IFN), a recombinant polypeptide composed of IFN-alpha2b genetically fused to human albumin, has an extended half-life and early evidence indicates that it is efficacious and well tolerated. Pharmacodynamic modeling supports treatment with alb-IFN at 2- or 4-week intervals. Phase 3 registration trials are in progress. The albumin-fusion platform is currently being applied to other important bioactive peptides with short half-lives. These fusion proteins, which are at present in different phases of clinical development, might lead to improved therapies across a broad range of diseases.

Albinterferon alpha-2b: a genetic fusion protein for the treatment of chronic hepatitis C.

The main goal of therapy in hepatitis C virus (HCV) infection is to achieve a sustained virological response currently defined as undetectable HCV-RNA in peripheral blood determined with the most sensitive polymerase chain reaction technique 24 weeks after the end of treatment. This goal is practically equivalent with eradication of HCV infection and cure of the underlying HCV-induced liver disease. The current standard in hepatitis C treatment consists in combination regimens of pegylated interferon-alpha (Peg-INF-alpha) with Ribavirin (RBV). Such treatment schemes are quite successful in patients with HCV genotypes 2 and 3 infections achieving HCV eradication rates of 75-90%. However, they are much less effective in patients with genotypes 1 and 4 infections with eradication rates ranging between 45% and 52%. Moreover, they have several, and sometimes severe, adverse effects and contraindications, further limiting their efficacy and applicability in an appreciable number of patients with chronic HCV-induced liver disease. Therefore, the need for improvement of existing therapies and for development of new effective, safe and tolerable drugs is a matter of great clinical relevance and importance. In this article, recent improvements in the current standard of therapy with IFN-alpha and RBV in various subsets of patients with chronic hepatitis C and in the clinical development of new emerging drugs, particularly small molecules, will be reviewed and commented. The article is divided in two main parts: (i) improvements in the standard combination therapies and schemes of approved Peg-INF-alpha with RBV and expectations from new interferons, interferon inducers and alternatives to RBV; (ii) new drugs for HCV in clinical development focusing mostly on specific inhibitors of HCV and less so on other drugs including immune therapies.

Old and emerging therapies in chronic hepatitis C: an update.

Hepatitis C virus (HCV) infection affects 180 million people worldwide with the predominant prevalence being infection with genotype 1, followed by genotypes 2 and 3 Standard anti-HCV therapy currently aims to enhance natural immune responses to the virus, whereas new therapeutic concepts directly target HCV RNA and viral enzymes or influence host-virus interactions Novel treatment options now in development are focused on inhibitors of HCV-specific enzymes, NS3 protease and NS5B polymerase These agents acting in concert represent the concept of specifically targeted antiviral therapy for HCV (STAT-C) STAT-C is an attractive strategy in which the main goal is to increase the effectiveness of antiviral responses across all genotypes, with shorter treatment duration and better tolerability However, the emergence of resistant mutations that limit the use of these compounds in monotherapy complicates the regimens Thus, a predictable scenario for HCV treatment in the future will be combinations of drugs with distinct mechanisms of action For now, it seems that interferon will remain a fundamental component of any new anti-HCV therapeutic regimens in the near future; therefore, there is pressure to develop forms of interferon that are more effective, less toxic, and more convenient than pegylated interferon

/pdf/specifically-targeted-antiviral-therapy-for-hepatitis-c-4qof9yz4en.pdf

Specifically targeted antiviral therapy for hepatitis C virus

In 2007, the world celebrated the 50th anniversary of the discovery of interferon (IFN) by Isaacs and Lindenmann. Subsequently, the IFN-alpha gene was cloned, fully sequenced and IFN-alpha was produced in recombinant form. Recombinant IFN-alpha is now used as the basis for treatment of chronic hepatitis C virus infection and can also be used to treat certain forms of chronic hepatitis B virus infections. IFNs have also been used in other viral infections, although with less success. The antiviral mechanisms of IFNs are reviewed in this chapter as well as the utility of IFNs in the treatment of persistent viral infections.

/pdf/interferons-and-their-use-in-persistent-viral-infections-1z9ibm8xhk.pdf

Interferons and their use in persistent viral infections.

https://www.liver.theclinics.com/article/S1089-3261(08)00042-1/pdf

Novel Hepatitis C Drugs in Current Trials

[779] ANTIVIRAL RESPONSE AT WEEK 12 FOLLOWING COMPLETION OF TREATMENT WITH ALBINTERFERON a-2b PLUS RIBAVIRIN IN GENOTYPE 1, IFN-NAIVE, CHRONIC HEPATITIS C PATIENTS

733 Interim (week 12) phase 2b virological efficacy and safety results of albumin interferon Alpha-2b combined with ribavirin in genotype 1 chronic hepatitis C infection

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[779] ANTIVIRAL RESPONSE AT WEEK 12 FOLLOWING COMPLETION OF TREATMENT WITH ALBINTERFERON a-2b PLUS RIBAVIRIN IN GENOTYPE 1, IFN-NAIVE, CHRONIC HEPATITIS C PATIENTS

733 Interim (week 12) phase 2b virological efficacy and safety results of albumin interferon Alpha-2b combined with ribavirin in genotype 1 chronic hepatitis C infection