3-Week Response-Guided Therapy
An important study was recently published in Lancet Gastroenterology & Hepatology. The study—Efficacy and safety of 3-week response-guided Triple direct-acting antiviral therapy for chronic hepatitis C: a phase 2, open-label, proof-of-concept study—holds the promise of changing the way that people with hepatitis C are treated.
The study evaluated a 3-week treatment duration of a combination of HCV medications. Patients were enrolled between April 05, 2015 and April 15, 2015. All of the 26 patients enrolled in the study were HCV genotype 1b treatment naïve without cirrhosis. The patients were randomly assigned to three treatment groups.
- Twelve patients were treated with sofosbuvir, ledipasvir and asunaprevir;
- Six patients were treated with sofosbuvir, daclatasvir and simeprevir;
- Eight patients were treated with sofosbuvir, daclatasvir and asunaprevir.
Note: Ultrarapid virological response is defined as less than 500 IU/mL HCV RNA or viral load at day 2 of treatment.
Six patients in each group achieved an ultrarapid virological response. Patients who achieved an ultrarapid virological response were continued on their current medications for a total of 3 weeks.
The patients who did not achieve an ultrarapid virological response by day 2 were switched to sofosbuvir plus ledipasvir for either 8 or 12 weeks.
All of the patients who achieved the ultrarapid virological response who received 3 weeks of treatment were cured. The patients are still being followed and as of March 2016 there has not been any adverse events or treatment-related relapse.
The most common side effects in all of the 3-week patient groups were fatigue and headache. There were no serious side effects.
This was presented at the Liver Conference 2015, but little information was provided. Now that it is published in a prestigious journal—The Lancet—it provides more information and credibility. The current group of scientists is planning a larger study in Mongolia. I hope this approach is being studied elsewhere including the United States. It could have the potential to reduce the treatment duration, lower the side effects, improve drug adherence and greatly reduce the cost of therapy.
A couple of caveats:
- Genotype 1b is one of the easiest genotypes/subtypes to cure. This approach—or a similar approach—needs to be studied in other genotypes/subtypes.
- This is a small proof of concept clinical trial. There is a need for larger studies with a diverse patient population.
Source: Efficacy and safety of 3-week response-guided triple direct-acting antiviral therapy for chronic hepatitis C infection: a phase 2, open-label, proof-of-concept study—G Lau et al. Volume 1, Issue 2, October 2016, Pages 97–104Share This Page