US-based biopharmaceutical firm Gilead Sciences has reported positive data from two Phase II trials and a compassionate access study of Sovaldi indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients with advanced liver disease.
In these trials patients were given a regimen containing once-daily Sovaldi (sofosbuvir) 400mg for the treatment of chronic HCV.
The first study called ‘Study GS-US-334-0125’ is an ongoing open-label Phase II trial assessing HCV patients with cirrhosis and portal hypertension, with or without decompensation.
The trial is evaluating patients who were randomised 1:1 to an immediate treatment arm in which Sovaldi and ribavirin (RBV) was administered for 48 weeks or to a deferred treatment arm in which this regimen was started after a 24-week observation period.
The company said that out of the 22 patients who completed 24 weeks of therapy, 95% achieved virologic suppression on treatment.
In addition, patients taking Sovaldi-based therapy experienced trends in clinical and laboratory parameter improvements compared with patients in the observation arm, and the therapy was well-tolerated in the trial, with only one patient discontinued treatment due to an adverse event.
Most common adverse events occurring in over 25% of patients included nausea and pruritis.
According to the company, patients in both arms of the trial will be followed to determine their 12-week sustained virologic response rates (SVR12) after 48 weeks of Sovaldi-based therapy.
The second study called ‘GS-US-334-0126’ was a single-arm open-label Phase II trial where patients with established recurrent HCV infection following liver transplantation received up to 24 weeks of therapy with Sovaldi plus RBV (escalating doses starting at 400mg/day).
In this trial, the majority of patients had genotype 1-HCV infection and 88% were treatment-experienced.
While 70% of them achieved SVR12, the most common adverse events occurring in over 20% of patients were fatigue, headache, arthralgia (joint pain) and diarrhoea.
In the compassionate access study Sovaldi therapy was evaluated among 104 post-transplant patients with severe recurrent HCV, including fibrosing cholestatic hepatitis, who had exhausted all other treatment options and received pre-approval access to Sovaldi via the company’s compassionate use programme.
In this trial, patients received up to 48 weeks of Sovaldi plus RBV, with some patients also receiving pegylated interferon (peg-IFN) at their physician’s discretion.
Most of patients in the trial experienced clinical improvements on treatment, with 62% achieving SVR12.
Gilead Sciences executive vice-president of research and development and chief scientific officer Norbert Bischofberger said the patients included in these analyses are historically among the most difficult to cure, and many have had no appropriate treatment options until now.
"This data demonstrates that Sovaldi-based oral therapy can improve outcomes, has a favourable safety profile and is well-tolerated among hepatitis C patients with severe liver disease," Bischofberger said.
Image: In the two Phase II trials and compassionate access study, patients were given once-daily Sovaldi 400mg to treat chronic HCV. Photo: courtesy of TimVickers.