Gilead presents new Sovaldi data
pharmafile | April 23, 2015 | News story | Sales and Marketing | GS-5816, GS-9857, Gilead, NS3/4A, SVR12, hepatitis C, sofosbuvir, sovaldi
Gilead is looking to several new studies to support future new Sovaldi combinations and broadened treatment groups for its hepatitis C drug.
The US firm says the data, presented at the International Liver Congress in Vienna this week, supports the development of an investigational regimen of Sovaldi (sofosbuvir), in combination with two investigational hep C treatments – a NS5A inhibitor GS-5816 and GS-9857, and NS3/4A protease inhibitor.
The combination would be suitable for people with any genotype of hepatitis C, and could potentially have a shorter treatment course than is currently recommended for Sovaldi, which is used for twelve weeks in patients with genotypes 1-4.
A small Phase II study of triple-combination therapy with a fixed-dose combination of the three drugs among genotype 1 patients demonstrated a sustained response after six weeks of treatment.
Some 93% of untreated patients without liver cirrhosis showed a sustained response, as did 87% of untreated patients with cirrhosis, and 67% of those who had failed therapy with two or more direct-acting antiviral agents (DAAs).
The most frequent adverse events were nausea (25%), headache (24%) and fatigue (16 per cent).
“These data support the potential for an all-oral, triple combination therapy containing Sovaldi to attempt to further reduce treatment duration for hepatitis C patients,” says Norbert Bischofberger, executive vice president of R&D and chief scientific officer at Gilead Sciences.
“We are encouraged by the six-week rates, and have recently initiated additional Phase II studies to further evaluate the appropriate treatment duration of this regimen for all patients”, he adds.
The company also presented Phase II study data on Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) and other Sovaldi-based combinations on people with hepatitis C who have different forms of advanced liver disease.
In the SOLAR-2 Study, 328 genotype 1 or 4 HCV patients with decompensated liver disease before liver transplantation or recurrent HCV infection following liver transplantation received either 12 or 24 weeks of Harvoni plus ribavirin.
The rate of sustained responses after 12 weeks was 86-96%, and 85-98% after 24 weeks. The most common adverse events were fatigue, anaemia, nausea and headache.
“The patients included in these analyses are among the most difficult to both treat and cure and, until now, have had limited or no treatment options,” says Michael Manns, from the Hannover Medical School in Germany.
“These data demonstrate that, even among these difficult-to-treat patient groups, sofosbuvir-based oral therapy offers the potential of high cure rates, improves outcomes and is generally well tolerated with a favourable safety profile.”
The results come as a survey, conducted by the European Association for the Study of the Liver, found that as many as half of people infected with viral hepatitis have suffered discrimination – even from friends and family.
Stigma and discrimination was also found to heavily impact the workplace. Some 10% of those who told work colleagues. The survey indicates that a quarter of people with hepatitis C said their health professionals have maintained a certain distance and 7% said they have been denied care.
Lilian Anekwe
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