Hepatitis C: New Treatments in the Pipeline - CD8 T cells - The Body

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26 Table 6 . STEALTH-C: HCV Genotype 4 Study Design and Interim Results Study Arm and N Triple: N=40 (Tx naïve=29; Tx experienced=11) 12-week lead-in of nitazoxanide 500mg/twice daily, followed by 36 weeks of nitazoxanide + 180μg PEG-IFN + RBV Dual: N=40 (Tx naïve=29; Tx experienced=11) 12-week lead-in of nitazoxanide, 500mg/twice daily, followed by 36 weeks of nitazoxanide + 180μg PEG-IFN Standard of Care: N=40 (Tx naïve only) 180μg PEG-IFN + RBV for 48 weeks RVR HCV RNA Undetectable at Week 4 Tx naïve = 72% Tx experienced = 27% Tx naïve = 62% Tx experienced = 27% ETR HCV RNA Undetectable at end of Tx Tx naïve = 93% Tx experienced = 36% Tx naïve = 69% Tx experienced = 45% SVR 12 HCV RNA Undetectable 12 weeks after completion of Tx Tx naïve = 79% Tx experienced = 25% Tx naïve = 68% Tx experienced = 8% Tx naïve = 35% Tx naïve = 50% Tx naïve = 45% Sources: Korba BE, Monerto AB, Glenn JS, et al. (abstract 21) Nnitazoxanide: a potent antiviral agent against HBV and HCV. Frontiers in Drug Development in Viral Hepatitis (HEP-DART). Lahaina, Hawaii. December 9–13, 2007. Romark Laboratories, press release. Available on-line at: http://www.romark.com/news/11022007.aspx (accessed 2 March 2008). Rossignol J-F, Elfert A, El-Gohary Y, Keefe EB. (abstract 178) Interim data from a randomized controlled trial of nitazoxanidepeginterferon-ribavirin, nitazoxanide-peginterferon, and peginterferon-ribavirin in the treatment of patients with chronic hepatitis C genotype 4. 58th Annual Meeting of the American Association for the Study of Liver Diseases. Boston, MA. November 2–6, 2007. Without more information on study population (liver histology, baseline viral load, body mass index), adverse events, side effects, and SVR, it is difficult to fully and accurately evaluate these results; hopefully, data from STEALTH-2 will address gaps in data. Ribavirin Substitute • Taribavirin Taribavirin, the ribavirin prodrug formerly known as viramidine, went back to the drawing board after disappointing efficacy results from phase III studies, VISER 1 and VISER 2. Ribavirin Substitute (oral) Product Manufacturer Status Taribavirin Valeant Phase II
An ongoing phase II study is evaluating safety and efficacy of weight-based viramidine (20, 25, and 30 mg/kg/day) vs. weight-based ribavirin, administered in combination with peginterferon alfa-2b to therapy-naïve patients with chronic HCV–genotype 1 infection. Anti-Fibrotics While attention has mainly been focused on viral eradication, some therapies are being developed to slow or prevent additional liver scarring. Anti-Fibrotics (oral) Product Manufacturer Status Farglitazar GlaxoSmithKline Phase II GS 9450 (LB84451) Gilead Phase IIa MitoQ Antipodean Phase II PF-3491390 (IDN-6556) Pfizer Phase II • Caspase Inhibitors (GS 9450 and PF-03491390) GS 9450 and PF-03491390 are caspase inhibitors. Caspase inhibitors block a crucial step in programmed cell death (also called apoptosis), a process that occurs in the liver at higherthan-normal levels in people with chronic hepatitis C and other liver diseases. Inhibiting caspase may lead to decreased fibrosis. A study of safety, tolerability, efficacy, and pharmacokinetics of GS 9450, Gilead’s once-daily caspase inhibitor, in people with hepatitis C is ongoing in Europe. In a 14-day study of PF-03491390, liver enzyme levels (ALT: alanine aminotransferase; and AST: aspartate amino transferase) decreased significantly at all doses above 5 mg/twice daily, and normalized in some people who received the drug twice or three times daily. There were no serious adverse events (Pokros 2007a). A larger study is ongoing. • MitoQ MitoQ was created to protect mitochondria (cellular structures that produce energy). A 28-day phase II study in people with hepatitis C was launched in February 2007 in New Zealand. • Farglitazar Farglitazar is a peroxisome proliferator-activated receptor (PPAR) gamma agonist. Among their many other functions, PPARs control inflammatory responses in the liver and other parts of the body. An ongoing phase II study is evaluating antifibrotic activity of Farglitazar in persons who could not tolerate, or did not respond to, HCV treatment. 27
Page 1 and 2: Hepatitis C: New Treatments in the
Page 3: Table of Contents Foreword . . . .
Page 6 and 7: 4 and from non-strategic prescribin
Page 9 and 10: Introduction Preventing new infecti
Page 11 and 12: Doses of promising candidates have
Page 13 and 14: Table 2 . Re-treatment Trials in No
Page 15 and 16: • HCV researchers have much to ga
Page 17 and 18: Oral Antivirals: HCV Protease and P
Page 19 and 20: naïve people initially, then in th
Page 21 and 22: Table 4. PROVE 2: Interim Results b
Page 23 and 24: Figure 5 . Telaprevir Phase III Tri
Page 25 and 26: Table 5 . Results from a Phase IIa
Page 27: cyclophilin inhibitors have immunos
Page 31 and 32: • Civacir An ongoing, phase II st
Page 33 and 34: Table 9 . Week 12 Results from SELE
Page 35 and 36: • PEV2A PEV2B PEV2A PEV2B uses ma
Page 37 and 38: and ribavirin. Sometimes, HCV re-tr
Page 39 and 40: with hepatitis C. 58th Annual Meeti
Page 43: A-831 • Albuferon • Bavituximab

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