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Hepatitis C
Treatment Options

• Overview
• Pegylated Interferons
• Emerging Therapies
• Side Effects
• Therapy Goals
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Treatment Options

Overview

Chronic hepatitis C infection may result in severe liver damage leading to liver failure, HCC and death. As a consequence, therapeutic intervention that can arrest, and perhaps even reverse, the disease before irreversible liver damage occurs.

Early treatment and eradication of hepatitis C virus is desirable, to prevent the spread of infection and to reduce the risk of disease progression. ^{(Davis, 2001, p.1141)}

There are two goals of treatment:

Cure the infection by eradicating the virus – determined to have been reached when no hepatitis C virus is detectable in the serum by PCR test 6 months after completing therapy (defined as Sustained Virological Response or SVR).

Delay or stop the disease progression - determined by halting or lessening the degree of liver damage (fibrosis and inflammation), even if eradication of the virus is not achieved.

Treatment options:

Alfa-Interferons

Interferon is a natural cytokine that is produced by cells once infected by viruses. Administered by subcutaneous injection, the cytokine has a potent antiviral activity against HCV. There are two forms of interferon available:

Conventional interferon
Currently licensed therapies for chronic hepatitis C are based on the use of the antiviral protein recombinant human interferon-alpha, or derivatives of it. The use of conventional interferon for this purpose was first described in 1986 ^{(Hoofnagle, 1986)} and required subcutaneous injection three times a week. This regimen gave a sustained virological response (or SVR as defined earlier) rate of only 12-16%.  Conventional interferons are now rarely used in the treatment of HCV, having been surpassed by pegylated interferons (see below).

“Pegylated” interferon
A further improvement in therapy has been achieved with polyethylene-glycol (PEG)-modified, or “pegylated” interferons. The PEG molecule is an inert substance that is used to optimise the pharmacological activity of a range of pharmaceuticals. Adding a PEG group to interferon prolongs its residence time in the circulation, making it possible to give it only once a week, instead of three times (as required with unmodified, conventional interferon).

The degree of optimisation is found to be product-specific and can vary according to the structure of the PEG, the strength of the bond holding the PEG to the interferon. Therefore, depending on the pegylation technology used, very different products can result - not only in how they need to be used, but also in their therapeutic properties.

Ribavirin

Ribavirin (COPEGUS^®, Rebetol^®) is a nucleoside analogue with broad activity against a number of both RNA and DNA viruses. Ribavirin is taken orally twice a day and used in combination with interferon treatment. Its mode of action against HCV is unclear, but studies have shown that it is crucial in the treatment since ribavirin improves the virologic response of the interferon treatment and reduces the risk of relapse (both conventional or pegylated) when used in combination. Given as monotherapy, ribavirin is not able to clear HCV.

Figure 3-1: Higher SVR rates with increasing cumulative ribavarin exposure (weeks 1-12)

Figure 3-2: Higher SVR rates with increasing cumulative ribavarin exposure (weeks 13-48)

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