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.
目前治療丙肝藥物只有Pegylated Interferon和Ribavirin，其療效也僅僅有50%成功率，很多製藥公司在爭先恐後的研製新的藥物。
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.
雖然每週都有治療丙肝的新臨床試驗刊登在新聞上，但是這些新藥必須通過審核才能上市。因爲安全和數據問題，事實上只有極少數治療丙肝的藥物通最基本的篩檢過程。
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:下面所列幾種藥物並不是唯一有希望的藥物，只是到2009年2月爲止最有期望的。
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.
所列8种藥物~或聯合藥物是治療丙肝最有希望的藥物其中一部分。但不是僅有的，很多其它藥物也都在科學實驗和檢驗中。直到FDA認同其中某個藥物可以和治療丙肝的Pegylated Interferon和Ribavirin相差不已或超過其效益，我們只能靜等下一代治療丙肝的藥物被通過認可。
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.
