Article: Sofosbuvir/Velpatasvir Improves Patient-Reported Outcomes in HCV Patients: Results from ASTRAL-1 Placebo-Controlled Trial—Y M Younossi et al.
Source: Gastroenterology OI: http://dx.doi.org/10.1016/j.jhep.2016.02.042
Study Aims and Results
The study was to assess the patient-reported outcomes from the phase 3 studies of ASTRAL-1 of sofosbuvir plus velpatasvir to treat HCV genotype 1, 2, 4, 5 and 6 compared to placebo (sugar pills) for 12 weeks.
A total of 624 patients were treated—618 were cured. One hundred and sixteen patients received the placebo drug. A variety of patient-reported outcome (PRO) tests were given at baseline and at certain time points during and after treatment. The PRO scores were similar among both groups at the beginning of therapy.
By treatment week 4 the patients who were receiving sofosbuvir plus velpatasvir experienced improvement in general health, emotional well-being, fatigue scale, and all areas of health-related quality of life. In the placebo group, the only improvement was the worry domain. The improvements in all areas of PRO scores continued during treatment and after achieving a cure. There was no improvement in PRO scores seen in the placebo group during or after treatment. The conclusion of the study authors was that sofosbuvir plus velpatasvir during treatment and after being cured significantly improved patient-reported outcomes.
In the “olden days” of interferon and ribavirin therapy the quality of life of people on treatment was more like a miserable quality of life. Some people, unfortunately, believe this is still the case. It’s difficult to change people’s long held beliefs.
It’s important to dispel these old beliefs and reassure patients that the direct-acting antiviral therapies are now much easier to tolerate and have greatly improved quality of life during treatment and after being cured.
These types of scientific studies are needed to document the results to mandate that insurance companies and government agencies pay for these life-saving drugs.Share This Page