In a press release from Achillion Pharmaceuticals, Inc., the Phase 2a study results were announced. The goal of the study was to understand the safety and to determine an effective dose of the combination of odalasvir, AL-335 with and without simeprevir to treat HCV genotype 1 treatment-naïve patients. Listed in the table below are the results.
|400 mg QD||50 mg QD||100 mg QD||8 weeks||100% (20 of 20 pts)|
|800 mg QD||50 mg QOD||none||8 weeks||90% (18 of 20 pts)|
|800 mg QD||50 mg QOD||75 mg QD||8 weeks||100% (20 of 20 pts)|
|800 mg QD||50 mg QOD||75 mg QD||6 weeks||100% (20 of 20 pts)|
The combination of drugs was safe and well-tolerated. The most common side effects were headache, fatigue and an upper respiratory tract infection. There was one serious adverse event that resolved when treatment ended. Based on the results of this trial, the combination of odalasvir (25mg), AL-335 (800 mg), and simeprevir (75 mg) is being advanced into Phase 2b studies. The clinical development of these drugs will eventually be expanded to treat genotypes 1, 2, 3, 4, 5 and 6. The clinical trials identifier is NCT02765490 on www.clinicaltrials.gov. The trial is listed as active, but it is not currently recruiting patients. When it becomes active it will be listed on HCV Advocate Clinical Trials Reference Guide – http://hcvclinical.hcvadvocate.org/
The difficult task is to achieve a 100% cure rate with a short treatment duration when and if it enters into Phase 3 clinical trials.
Is this the new blockbuster HCV therapy? The bar now is set so high that an HCV drug has to have high cure rates, low side effects and have ease of use. The cost of a new drug is another important factor to bring a blockbuster HCV drug to market.
Still, we need more HCV medications to treat hepatitis C, so that people living with hepatitis C have more treatment choices. I’m pulling for this combination to make it!
Source: Achillion Press ReleaseShare This Page