Patients chronically infected with hepatitis C virus ( HCV ) genotype 2 or 3 for whom treatment with Peginterferon is not an option, or who have not had a response to prior interferon treatment, currently have no approved treatment options.
In phase 2 trials, regimens including the oral nucleotide polymerase inhibitor Sofosbuvir ( Sovaldi ) have shown efficacy in patients with HCV genotype 2 or 3 infection.
Researchers have conducted two randomized, phase 3 studies involving patients with chronic HCV genotype 2 or 3 infection.
In one trial, patients for whom treatment with Peginterferon was not an option received oral Sofosbuvir and Ribavirin ( 207 patients ) or matching placebo ( n=71 ) for 12 weeks.
In a second trial, patients who had not had a response to prior Interferon therapy received Sofosbuvir and Ribavirin for 12 weeks ( 103 patients ) or 16 weeks ( n=98 ).
The primary endpoint was a sustained virologic response at 12 weeks after therapy.
Among patients for whom treatment with Peginterferon was not an option, the rate of a sustained virologic response was 78% with Sofosbuvir and Ribavirin, as compared with 0% with placebo ( P less than 0.001 ).
Among previously treated patients, the rate of response was 50% with 12 weeks of treatment, as compared with 73% with 16 weeks of treatment ( difference, -23 percentage points; P less than 0.001 ).
In both studies, response rates were lower among patients with genotype 3 infection than among those with genotype 2 infection and, among patients with genotype 3 infection, lower among those with cirrhosis than among those without cirrhosis.
The most common adverse events were headache, fatigue, nausea, and insomnia; the overall rate of discontinuation of Sofosbuvir was low ( 1 to 2% ).
The study has shown that, in patients with HCV genotype 2 or 3 infection for whom treatment with Peginterferon and Ribavirin was not an option, 12 or 16 weeks of treatment with Sofosbuvir and Ribavirin was effective.
Efficacy was increased among patients with HCV genotype 2 infection and those without cirrhosis.
In previously treated patients with genotype 3 infection, 16 weeks of therapy was significantly more effective than 12 weeks. ( Xagena )
Jacobson IM et al, N Engl J Med 2013; 368:1867-1877