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8 Promising Hepatitis C Drugs

February 23, 2009

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Learn about the eight drug strategies that offer great promise for a new and improved Hepatitis C treatment regimen.

by Nicole Cutler, L.Ac.

Currently, pegylated interferon and ribavirin are the standard of treatment for Hepatitis C. Because these medications only boast an approximate success rate of 50 percent, the pharmaceutical companies are racing to come up with more efficient alternatives.

Even though reports of successful Hepatitis C trials appear to dot the news reels each week, there are a series of hurdles a potential new drug must pass before it is can enter the market. Subsequently, there are just a handful of Hepatitis C drugs that have made it past initial screening processes and are churning out encouraging safety and efficacy data.

Although the listed drugs in development are by no means the only contenders, the following are some of the most promising as of February 2009:

1. Albuferon – Human Genome Sciences and Novartis are studying albuferon, a longer acting form of interferon alfa-2b fused with the human blood protein albumin. While albuferon is in ongoing Phase III clinical trials evaluating safety, tolerability and effectiveness compared to Pegasys, pulmonary complications have required researchers lower the albuferon dosage.

2. R7128 – In a collaborative effort to develop nucleoside polymerase inhibitors for the treatment of chronic Hepatitis C, R7128 is being developed by Pharmasset and Roche. In January 2009, the manufacturers announced launching a large Phase 2b study of varying doses of R7128, in combination with Pegasys and ribavirin. Primary data from the new study is expected to be released late in 2009.

3. ITMN-191 – In January of 2009, InterMune reported on the results from a small Phase I study of protease inhibitor ITMN-191 in combination with Pegasys and ribavirin. While the results from this trial were encouraging, a Phase 2b study of ITMN -191 at various doses, at different intervals with different durations is expected to begin in the second quarter of 2009. Note: ITMN-191 was formerly known as R7227.

4. INFORM-1 – R7128 and ITMN-191, together with ribavirin, are being tested as the first interferon-free combination therapy. Expected to be compiled, analyzed and released in 2009, INFORM-1’s results will yield great understanding into the effectiveness of these polymerase and protease inhibitors as well us divulge any synergistic effects from combining these antiviral compounds.

5. IDX184 – In January of 2009, Idenix Pharmaceuticals announced initiating a small Phase II/III proof-of-concept study of IDX184, a Hepatitis C nucleotide polymerase inhibitor. This will be a small, double-blinded, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and antiviral activity of IDX184 in HCV genotype 1 treatment-naïve patients.

6. Telaprevir – Vertex Pharmaceuticals has several Phase III trials underway to determine safety, tolerability, antiviral activity and dosing guidelines for telaprevir. In 2008, telaprevir demonstrated promising antiviral results in large Phase 2b studies of treatment-naïve and treatment-failure patients, and also demonstrated the potential to be dosed in a twice-daily regimen.

7. Boceprevir – In January 2009, Schering-Plough reported completing patient enrollment in the boceprevir HCV SPRINT-2 study, a pivotal Phase III study in treatment-naïve patients. Together with a previous Phase III study in patients who failed prior treatment, over 1,500 patients are enrolled in Schering-Plough’s lead investigational oral Hepatitis C protease inhibitor.

8. PEG-Interferon Lambda – Bristol-Myers Squibb and ZymoGenetics are co-developing this longer acting form of interferon. Currently in Phase I studies, early data generated by PEG-Interferon lambda suggest the drug might be safer and better tolerated than the current long-acting interferons.

The preceding eight drugs (or drug combinations) are among the most hopeful for improving Hepatitis C treatment. However, this list is not exhaustive, as there are many more substances that scientists are currently examining. Until the FDA concludes that one of these drugs is superior to pegylated interferon and ribavirin for the treatment of Hepatitis C, we’ll have to sit patiently and wait for the next generation of Hepatitis C medications to be approved.

References:

http://investors.vrtx.com/releasedetail.cfm?ReleaseID=364268, Vertex Pharmaceuticals Provides HCV and Cystic Fibrosis Update and Reports 2008 Financial Results, Retrieved February 19, 2009, Vertex Pharmaceuticals, February 2009.

http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-newsArticle
&ID=1243000&highlight=, InterMune Reports Results from Triple Combination Study of ITMN-191, Retrieved February 19, 2009, InterMune, Inc., 2009.

http://www.hcvadvocate.org/news/newsLetter/2009/advocate0209.html#4, HCV Snapshots – Drugs in Development, Alan Franciscus, Retrieved February 17, 2009, HCV Advocate, Hepatitis C Support Project, February 2009.

http://www.hivandhepatitis.com/hep_c/news/2008/012508_a.html, Albuferon Dose in Ongoing Trials is Lowered Due to Safety Concerns, Retrieved February 19, 2009, hivandhepatitis.com, January 2008.

http://www.hivandhepatitis.com/hep_c/news/2009/012009_b.html, New Hepatitis C Treatment Trials: HCV Polymerase Inhibitor R7128, Nucleotide Prodrug IDX184, and Albumin Interferon (Albuferon), Retrieved February 19, 2009, hivandhepatitis.com, January 2009.

http://www.medicalnewstoday.com/articles/128826.php, Roche, InterMune And Pharmasset Announce Initiation Of INFORM-1, The First Dual-Combination Clinical Trial With Oral Antivirals In Hepatitis C, Retrieved February 19, 2009, MediLexicon International, Ltd, November 2008.

http://www.pharmasset.com/pipeline/R7128.asp, R7128, a prodrug of PSI-6130, Retrieved February 18, 2009, Pharmasset, Inc., 2009.

Posted by Editors at February 23, 2009 4:13 PM

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