Notes on Hepatitis C treatment and research

A few links on current and future treatment:

1. Roche has filed an application to the Food and Drugs Administration to approve Pegasys (pegylated interferon) and Copegus (ribavirin) for treatment of hepatitis C in people co-infected with HIV (see press release). This filing is based on results of the APRICOT study (discussed here and here), which found that Pegasys/Copegus was more effective in co-infected people than Pegasys alone or standard interferon/ribavirin. The FDA has granted fast-track status to the application, with a decision expected in early 2005.

The value of this application is largely symbolic -- people co-infected with HIV can already take Pegasys and Copegus for hepatitis C treatment -- but may increase awareness of treatment options and efficacy in co-infected people and their health care providers. Roche has also requested FDA approval for the use of Pegasys in hepatitis B treatment (see press release). Roche's Pegasys currently has over 57% of the U.S. market for pegylated interferon, trailed by Schering-Plough's Peg-Intron (see Reuters article).

2. Vertex Pharmaceuticals announced the successful completion of the dosing phase of the first human study of VX-950, an investigational hepatitis C protease inhibitor (see press release). VX-950 was studied at a range of single doses in 'healthy volunteers' (people not infected with hepatitis C). Based on blood levels, the company believes the drug will achieve concentrations needed to suppress hepatitis C replication, and may be suitable for twice-daily dosing. Further studies in people with hepatitis C, given for up to 14 days, are expected to begin by the end of 2004.

Vertex recently met with a few community advocates and treatment writers to discuss their development plans for VX-950 and merimepodib, another drug being investigated for hepatitis C treatment in combination with pegylated interferon and ribavirin. I'll be writing in more detail about this meeting later. For more on hepatitis C protease inhibitors, see this article; for more on merimepodib, see here under 'IMPDH inhibitors'.

3. A new review published in the Journal of Hepatology suggests that amantadine may be useful as part of triple-combination therapy (with interferon and ribavirin) for people who do not respond to standard combination therapy (abstract here). Amantadine is an antiviral drug, like ribavirin, that has been researched extensively in hepatitis C treatment, with conflicting results. The authors of the review combined data from all available trials, finding that amantadine shows a marginal benefit in non-responders, but not in people who were treatment naive, or who initially responded to therapy but subsequently relapsed without achieving a sustained virologic response.

The authors conclude that these findings should be confirmed in new trials. For more on amantadine, see here.

Comments

[Bill Ward]

HI, hope you can help. I am 10 yr post orthotopic liver transplant. I know most of the meaning of lab results for hcv. my last set of tests showed hcv of 9 million ? per ?. Could you give me the norm for reoccurent hcv load. Thanks in advance.

[Daniel Raymond]

Hi Bill,

My understanding is that hepatitis C viral load levels can span a wide range -- anything below 2 million copies (or 800,000 International Units [IUs]) is considered a low viral load.

HCV viral loads tend to be much higher in people after liver transplant than the pre-transplant level, perhaps due to the effects of immunosuppressants.

So it sounds like your viral load is fairly high -- that doesn't necessarily mean more liver damage, but it does lower your chances somewhat of responding to hepatitis C treatment.

For a review of research on hepatitis C treatment after liver transplant, see this section of the Treatment Action Group's new Hepatitis C and HIV/HCV Coinfection report.

Good luck!

Daniel

Daniel Raymond
Hepatitis C Policy Analyst
Harm Reduction Coalition