Six or eight weeks of Achillion’s odalasvir and Janssen’s AL-335 with or without Janssen’s Olysio (simeprevir) have shown promise in treating hepatitis C virus (HCV), FierceBiotech reports. The interim findings from a mid-stage trial support more advanced research into the triple combination.
Researchers released interim findings from the ongoing Phase IIa trial of the regimen in advance of the upcoming European Association for the Study of the Liver (EASL) Special Conference in Paris. The data presented at this time concern people with genotype 1 of hep C who have not been treated for the virus before. The data included in the abstract cover follow-up through July 2016. Researchers will present updated results, including data on all cohorts through 12 weeks post-treatment, at the conference on September 23.
Odolasvir is an NS5A inhibitor, AL-335 is a nucleotide-based polymerase inhibitor and Olysio is an NS3/4A protease inhibitor. AL-335 has been developed by Alios BioPharma, which Janssen recently acquired.
The study includes four cohorts taking different doses and combinations of tablets for different lengths of time. All participants took AL-335 and Olysio once a day (except cohort 2 which did not take Olysio); cohort 1 took odalasvir once a day, and the other three cohorts took that drug every other day.
The 20 people in cohort 1 took 400 milligrams of AL-335, 50 mg of odalasvir and 100 mg of Olysio for eight weeks. All of them achieved a sustained virologic response 24 weeks after completing therapy (SVR24, considered a cure). The 20 people in cohort 2 took 800 mg of AL-335 and 50 mg of odalasvir for eight weeks. Eighteen of them (90 percent) achieved an SVR12, which is also considered a cure. The 20 people in cohort 3 took 800 mg of AL-335, 50 mg of odalasvir and 75 mg of Olysio for eight weeks. All of them achieved an SVR4, which is a very good indication that each individual will pass another eight weeks without developing a detectable viral load and will then be pronounced cured. The 20 people in cohort 4 took the same doses as cohort 3, but for six weeks. All of them had an undetectable viral load when finishing treatment, which bodes well for their chances of eventually achieving an SVR12.
The treatment was generally safe and well tolerated. The majority of adverse health events were mild; the most common were headache, fatigue and upper respiratory tract infection. One person in cohort 1 experienced an ECG abnormality that was attributed to treatment and that resolved after stopping treatment.
The triple combo will now enter Phase II research, with participants taking 800 mg of AL-335, 25 mg of odalasvir and 75 mg of Olysio once daily. The study will include both those who have and those who have not been treated before who do not have cirrhosis and who have genotypes 1, 2, 4, 5 and 6. Meanwhile, the Phase IIa will be expanded and will focus on those with and without compensated cirrhosis and those with genotypes 2 and 3.
To read a press release about the study, click here.
To read the FierceBiotech article, click here.