Hepatitis C Research Opportunities in Houston: Greater New Drug Availability

Herman Ortiz-Hepatitis C Research Meeting

Over the past several weeks, those of you interested in the new hepatitis C treatments that have been recently FDA approved, have been delighted with the opportunity to finally have new options to treat your hepatitis C infection. The release of  Boceprevir (marketed as Victrelis by Merck) and Telaprevir (Incivek by Vertex) has marked a major breakthrough in managing hepatitis C. Despite this breakthrough in care, research continues in developing new, and more potent anti-virals to eliminate the hepatitis c virus. The breakthroughs made with the newly release protease inhibitors Boceprevir and Telaprevir are being followed by continued research and development of second generation protease inhibitors, polymerase inhibitors, and an assortment of novel drugs and compounds.

I returned yesterday from an investigators meeting in Denver, where we discussed a new drug against hepatitis C developed by Bristol-Meyers Squibb. The compound, BMS-790052, is a once a day NS5A inhibitor, combined with interferon and ribavirin. The study we are conducting with this drug is titled:

 

Open-Label, Single Arm Evaluation of BMS-790052 in Combination with Peg-Interferon Alfa-2a and Ribavirin in Black-African Americans, Latinos, and White-Caucasians with Chronic Hepatitis C Genotype 1 Infection.

This is an important study because it is looking at African Americans and Latino patients with chronic hepatitis C infection. Many important questions will be answered during the course of this study. I am pleased to be participating in this study.

If you are interested in participating in this study, or any other hepatitis C research studies we are participating in, fill out the form located at this link.

Listed below is a complete list of studies we are participating in. Feel free to contact usfor more information on these studies and hepatitis C.

Dr. Galati in Denver

  1. A Multi-Center, Open Label  Trial to Evaluate the Long-Term Safety and Tolerability of Rifaximin 550 mg BID in Subjects with A History of Hepatic Encephalopathy. Salix
  2. Protocol HGS1008-C1060:  A Phase 3, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b (alb-IFN) in Combination with Ribavirin Compared with Peginterferon Alfa-2a (PEGASYS or PEG-IFNα2a) in Combination with Ribavirin in Interferon Alfa Naïve Subjects with Chronic Hepatitis C Genotype 1 (ACHIEVE-1)-. Human Genome Sciences
  3. Long-Term Follow-up of Subjects in a Phase 2 or 3 Clinical Trial in Which SCH 503034 was Adminsitered for the Treatment of Chronic Hepatitis C.
    Schering-Plough/Merck
  4. A Phase 3b, Randomized, Double-Blind, Double Dummy Study Evaluating the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy versus Emtriciabine plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects with Chronic Hepatitis B who are resistant to Lamivudine. Gilead
  5. A Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD).  Eisai
  6. A Phase 3 Safety and Efficacy Study of Boceprevir in Subjects with Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment with Peginterferon/Ribavirin. Schering-Plough/Merck
  7. A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects with Chronic Hepatitis C Genotype 1.  Schering-Plough/Merck
  8. A Randomized, Double-Blind, Placebo-controlled, Phase III trial of 2 regimens of Telaprevir (with and without delayed start) combined with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) in subjects with Chronic genotype 1 Hepatitis C infection who failed prior pegylated interferon plus Ribavirin treatment.  Tibotec
  9. A Single-Arm Study to Provide Boceprevir Treatment in Subjects with Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin in Previous Schering-Plough Boceprevir Studies.  Schering-Plough/Merck
  10. A Phase 2 Study of SCH 900518 in Previously Untreated Subjects with Genotype 1 Chronic Hepatitis C.  Schering- Plough/Merck
  11. A Phase 3 Safety and Efficacy Study of Boceprevir in Combination with Peginterferon Alfa-2a and Ribavirin in Subjects with Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment with Peginterferon/Ribavirin.  Schering-Plough/Merck
  12. A 52 week, open-label, single-arm, multicenter study of Tyzeka™(telbivudine) in nucleos(t)ide-naïve subjects of Black/African American and/or Hispanic/Latino origin with compensated chronic hepatitis B virus (HBV) infection.  Gilead
  13. A Phase I/II, Double-Blind, Dose-Escalation Study to Evaluate the Safety and Antiviral Activity of IDX184 in Treatment-Naïve Subjects Infected with Genotype 1 Chronic Hepatitis C.  Idenix
  1. Boceprevir/Peginterferon/Ribavirin for the Treatment of Chronic Hepatitis C in Treatment-Naïve Subjects: A Comparison of Erythropoietin Versus Ribavirin Dose Reduction for the Management of Anemia. Schering-Plough/Merck
  2. A randomized, open-label, Phase 3 study of telaprevir administered twice daily or every 8 hours in combination with pegylated interferon alfa-2a and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C virus infection. – active    Substudy – A substudy to investigate telaprevir-related rash in a selected number of subjects enrolled in Study VX-950-C211.  Tbotec
  3. A Phase III, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of TMC435 versus placebo as part of a treatment regimen including peginterferon α-2a (Pegasys®) and ribavirin (Copegus®) or peginterferon α-2b (PegIntron®) and ribavirin (Rebetol®) in treatment-naïve, genotype 1, hepatitis C-infected subjects.  Tibotec
  4. A Phase III, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of TMC435 vs. placebo as part of a treatment regimen including peginterferon alfa-2a and ribavirin in hepatitis C, genotype 1 infected subjects who relapsed after previous interferon-based therapy. Tibotec
  5. A multicentre, randomized, double-blind, placebo-controlled, parallel-group phase II study on the efficacy and safety of DEB025 combined with peg-IFN alfa-2a and ribavirin in chronic hepatitis C genotype 1 patients who are previous peg-IFN alfa-2 plus ribavirin treatment-non-responders.  Novartis
  6. A multicenter, randomized, open label, parallel-group phase IIB study on the efficacy and safety of oral regimens of DEB025 alone or in combination with ribavirin versus Standard of Care (peg-IFNα2a plus ribavirin) in treatmentnaïve hepatitis C genotype 2 and 3 patients.  Novartis 
  1. A Phase II Multicenter, Randomize, Open-Label, Active-Control, Dose-Ranging Study of Interferon alfa-2b Given via Continuous Subcutaneous Infusion in Subjects with Hepatitis C Virus Genotype 1 Infection.  Medtronics
  2. An open-label, single-arm, roll-over trial of telaprevir in combination with pegylated interferon alfa-2a (Pegasys®) and ribavirin (Copegus®) for subjects from the control group of the VX 950 TiDP24 C216 trial who failed therapy for virologic reasons. Tibotec
  3. A Phase 1, Multi-center, Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 in Hepatitis C-infected Patients Unresponsive to Standard Treatment with Pegylated Interferon and Ribavirin.  Idera
  4. A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Trial of Safety, Efficacy, and Pharmacokinetics of ANA598 Administered with Pegylated Interferon and Ribavirin in Treatment-Naïve Genotype 1 Patients with Chronic Hepatitis C Infection.  Anadys
  5. A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly with Pegylated Interferon and Ribavirin in Treatment-Experienced Patients with Chronic Genotype 1 Hepatitis C Virus Infection.  Merck
  6. A Phase 2b, Randomized, Double-Blind, Placebo Controlled Trial Evaluating 16 and 24 Weeks of a Four-Drug Regimen and 24 Weeks of a Three-Drug Regimen of GS-9451, Peginterferon Alfa 2a (PEG, Pegasys®) and Ribavirin (RBV, Copegus®) With and Without Tegobuvir (GS-9190) Followed by Response Guided PEG and RBV in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection. Gilead
  7. A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of ANA598 Administered with Pegylated Interferon and Ribavirin in Genotype 1 Patients with Chronic Hepatitis C Infection.  Anadys
  8. CTS-1027-05: A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of Pegylated Interferon Plus Ribavirin With or Without CTS-1027 in HCV Null-Responders.  Conatus
  9. A Phase 2 Randomized, Open-Label Study of GS-5885 Administered Concomitantly with GS‑9451, Tegobuvir and Ribavirin (RBV) to Treatment-Naive Subjects with Chronic Genotype 1 HCV Infection  Gilead
  10. A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial  Evaluating Response Guided Therapy with GS 5885 Alone or in  Combination with GS-9451 or GS-9256 with Peginterferon Alfa 2a and  Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1. Gilead
  11. A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy using Combinations of Oral Antivirals (GS-5885, tegobuvir, and/or GS-9451) with Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects with Chronic Genotype 1 Hepatitis C Virus Infection . Gilead
  12. A Phase 2 Randomized, Open-Label, Exploratory Trial of GS-5885, GS-9451 with Peginterferon Alfa 2a (PEG) and Ribavirin (RBV) in Treatment-Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection and IL28B CC Genotype. Gilead
  13. A Randomized, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly with Peginterferon alfa-2b and Ribavirin in Treatment-Naïve Patients with Chronic Genotype 1 Hepatitis C Virus Infection. Merck
  14. A Randomized, double-blind, placebo-controlled trial of the efficacy and  Safety of DEB025/Alisporovir in combination with standard of care in Hepatitis C genotype1 treatment-naïve patients.  Novartis
  15. Open-Label, Single Arm Evaluation of BMS-790052 in Combination with Peg-Interferon Alfa-2a and Ribavirin in Black-African Americans, Latinos, and White-Caucasians with Chronic Hepatitis C Genotype 1 Infection.  Bristol-Meyers Squibb

 

 

 

 

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