Chronic Hepatitis C Treatment
Robert Hindes, MD, co-founded Trek Therapeutics in 2014 and serves as the pharmaceutical company’s chief medical officer. At Trek, Robert Hindes, MD, has focused his efforts on developing affordable therapies for patients with chronic hepatitis C.
For many people living with hepatitis C (HCV), dealing with the disease itself is only part of the struggle. Treatments exist for most genotypes of HCV, but these therapies are so expensive and so hard to access that many patients cannot obtain the medical care they need.
Historically, HCV therapies that included interferon required long durations of treatment, brought debilitating side effects, and cured fewer than half the patients who received drug therapy. Many patients avoided treatment because of the side effects and relatively low cure rate of the drug combinations available. Now that safer and more effective treatments are available, many patients cannot afford or have no access to the newer HCV drugs. Pharmaceutical companies and patient advocate groups have recently begun to work together to find a solution for this problem. However, it is likely that access to affordable and effective drug therapies will continue to be unavailable to a large number of patients for at least the next several years, and it is hoped that the drugs being developed by Trek will help to address this unmet medical need.
As the co-founder and chief medical officer of Trek Therapeutics, Robert Hindes, MD, is responsible for designing and managing clinical studies evaluating Trek’s hepatitis C drugs. Robert Hindes, MD, and Trek have recently been focused on trials involving TD-6450 and faldaprevir, two of the company’s most promising in-licensed assets.
In mid-June, Trek Therapeutics began a new study to evaluate the effectiveness of TD-6450 plus faldaprevir against HCV genotype 1b. The study will measure the regimen’s effectiveness both with and without the addition of ribavirin, an antiviral commonly used to treat HCV. These trials are being conducted in both New Zealand and the United States.
Trek’s next generation NS5A inhibitor, TD-6450, is an essential component in the combination drug regimen. TD-6450 was designed to perform better than similar antivirals, especially against the particular strains that were resistant to first generation NS5A inhibitors. So far, TD-6450 and faldaprevir results have been very encouraging, demonstrating rapid and sustained suppression of HCV. If all goes well, these new treatments may be able to improve quality of life for people infected with HCV but with poor access to the expensive regimens being marketed in the US and Europe.
Robert Hindes, MD, co-founded Trek Therapeutics, which is organized as a public benefit corporation that seeks ways of developing innovative yet affordable and accessible antiviral medications. As chief medical officer, Robert Hindes, MD, is engaged with his team in Phase 2a studies of TD-6450 plus faldaprevir.
Faldaprevir, a second generation protease inhibitor, was initially developed for use with ribavirin and pegylated interferon, and it is currently used in new regimens that are interferon-free. In phase 2b and 3 studies in patients with previously untreated genotype 1b hepatitis C virus (HCV), faldaprevir combined with pegylated interferon and ribavirin resulted in SVR rate of 82%.
A 2015 paper published in Liver International evaluated the Phase 2b SOUND-C2 interferon-free study involving a combination of faldaprevir, ribavirin, and deleobuvir. The combination resulted in overall SVR rate of 92%, and was well-tolerated among patients with HCV genotype-1a and 1b. Along with simeprevir, faldaprevir is considered one of the most effective second generation protease inhibitors.
As chief medical officer of Trek Therapeutics, a public benefit corporation, Robert Hindes, MD, heads a clinical team focused on developing affordable antiviral drugs for global markets. In June 2016, Robert Hindes, MD, and his company announced the start of a Phase 2a study of TD-6450 plus faldaprevir, with and without ribavirin, involving patients with genotype 1b (GT 1b) HCV infection at sites in the United States and New Zealand.
The new study follows the analysis of interim results for the same set of drugs being used to treat patients with HCV GT 4. The 16-patient study yielded successful results, with HCV RNA <LLOQ in all patients by Week 3 of treatment, and SVR in all 10 patients who have post-dosing results.
TD-6450 has been designed to provide better antiviral activity results with genotype 1 resistance-associated variants that are resistant to previously developed NS5A inhibitors, such as daclatasvir. Faldaprevir is a protease inhibitor that is highly active against HCV GT 1 and 4.