AbbVie and Merck Competition to Gilead’s Wonder Trio Combination for Hepatitis C
Yesterday, we let you know about the ‘Wonder Trio Combination‘ of Gilead Sciences against hepatitis C, which was revealed at the International Liver Congress 2016 in Barcelona demonstrating the unprecedented results of its trio SOF/VEL plus GS9857. The competitive counterparts Abbvie and Merck also came up with the clinical trial results of their investigational drugs.
The U.S. based Abbvie’s investigational drug, ABT-493 and ABT-530 with Ribavirin (RBV) demonstrated sustained virologic response (SVR12) in 91% of chronic genotype 1 hepatitis C virus infected patients in 12 weeks of the primary intent-to-treat analysis. It is noteworthy that these patients had failed previous therapy with direct acting antivirals.
These results were achieved and confirmed in the MAGELLAN-1 study of AbbVie under its once daily investigational pan-genotypic regimen of ABT-493 (300mg) and ABT-530 (120mg).
“Retreatment options for those patients who have previously failed therapy are limited, and present a particular challenge for treating physicians,” said Fred Poordad, M.D., vice president of academic and clinical affairs at the Texas Liver Institute in San Antonio. “The high SVR rates seen in the ongoing MAGELLAN-1 study are significant as they show promise in addressing this particular clinical challenge.”
Apparently MAGELLAN-1 is a Phase II study of evaluation of the efficiency and safety of ABT-493 and ABT-530 with and without RBV in adults with GTI HCV on a random basis. The study followed the following approach; In the part I of the study, 50 patients with GTI but without cirrhosis were randomly selected to receive once daily ABT-493 and ABT-530 at doses 200/80 mg, 300/120mg with 800 mg RBV or 300/120 mg without RBV for 12 weeks. These were those patients who had earlier failed the therapy containing protease inhibitor and / or NS5A inhibitor. First six patients of the once daily ABT-493 at 206/80 mg showed 100% achievement of SVR12.
Part 2 of the study is still undergoing examination of once daily ABT-493 (300mg) and ABT-530 (120mg) without RBV. The results of this phase III study are still awaited.
Merck (known as MSD outside of the United States and Canada) also announced the results of its two Phase III clinical trials evaluating Zepatier (elbasvir and grazoprevir) tablets for chronic hepatitis C (CHC). The drug is given to patients who have, in addition to hepatitis C, inherited blood disorders (C-EDGE IBLD) and have history of intravenous drug use who are receiving opioid agonist therapy (C-EDGE CO STAR). The results of the C-EDGE IBLD study showed high rates of SVR after 12 weeks of the completion of the treatment. Likewise the results from the C-EDGE CO STAR showed high rates of SVR after 24 weeks of completion of treatment.
Zepatier once daily fixed dose combination indicated with or without RBV for the treatment of chronic genotype 1 hepatitis C virus infection in adults was approved by FDA in January this year. The phase III study results were published in the ILC this year.
“To reduce the global burden and potential spread of chronic hepatitis C, it is important that we develop evidence about meaningful options for those patients for whom treatment may be challenging,” said Dr. Eliav Barr, vice president, infectious diseases, Merck Research Laboratories. “These data from Merck’s broad clinical development program underscore the company’s commitment to evaluating ZEPATIER in historically underserved and understudied chronic hepatitis C populations, such as patients with inherited blood disorders or those receiving opioid agonist therapy.”
C EDGE IBLD is a Phase III study evaluating treatment with Zepatier in patients with chronic HCV GT and inherited blood disease. After 12 weeks of treatment with Zepatier, 93% patients in the ITG achieved SVR12. C EDGE CO STAR is a Phase III double blind study evaluating treatment with Zepatier in patients with chronic HCV GT1 and who are on opoid agonist therapy.
Following 12 weeks of treatment with Zepatier, 94% patients achieved SVR24.
“Injection drug use is one of the leading contributors to the spread of hepatitis C infection around the world. Many current or former injection drug users with chronic hepatitis C infection are on opioid agonist therapy, but historically there has been reluctance to treat these patients due to concerns about reinfection and compliance with treatment,” said Dr. Barr. “These results from C-EDGE CO-STAR help contribute to our understanding of the incidence of hepatitis C reinfection in these patients following treatment with ZEPATIER.”