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Dose-ranging trial indicated sofosbuvir safe, effective in HCV genotype 1 patients

Patients with hepatitis C genotype 1 were more likely to experience rapid and sustained virologic response when treated with sofosbuvir in addition to pegylated interferon and ribavirin than peginterferon and ribavirin with placebo in a recent study.

In a double blind, multicenter, dose-ranging trial, researchers randomly assigned 64 adult, treatment-naive patients with chronic hepatitis C genotype 1 in a 1:1:1:1 ratio to receive peginterferon alfa-2a and ribavirin (PEG/RBV) with either placebo or 100 mg, 200 mg or 400 mg sofosbuvir once a day for 28 days, followed by PEG/RBV alone for 44 weeks.

After 28 days, patients in all three treated groups experienced a greater decline in HCV RNA than placebo recipients (mean change –5.3 log₁₀ IU/mL in the 100-mg group; –5.1 log₁₀ IU/mL in the 200-mg group and –5.3 log₁₀ IU/mL in the 400-mg group). Treated patients had significantly higher rates of rapid virologic response, ranging from 88% to 94% across the three groups, compared with 21% in the placebo group. Rates of sustained virologic response (SVR)at 24 weeks also were higher among treated patients (56% for the 100-mg group, 83%, 200 mg; 80%, 400 mg vs. 43%, placebo).

No patients experienced virologic breakthrough during the 28-day period, but breakthrough occurred in four 100-mg group patients, and two each in the 400-mg and placebo groups during the 44-week period. Relapse occurred in five patients in the 100-mg group, three in the placebo group and one each in the 200-mg and 400-mg groups.

Adverse events occurred in 54 patients during the 28-day period. Nausea, fatigue, headache, chills and arthralgia were the most common events and were similar in frequency and intensity between all groups. Five patients discontinued treatment and five experienced serious adverse events during the 44-week period.

“The marked antiviral activity and SVR rates observed with 28 days of sofosbuvir in combination with PEG/RBV suggest that sofosbuvir may be a beneficial component of a treatment regimen for patients with HCV,” the researchers concluded. “Further studies are warranted to determine the optimal sofosbuvir treatment duration, efficacy of sofosbuvir in other genotypes of HCV infection (2 to 6), and whether sofosbuvir can play a role in interferon-sparing treatment regimens.”

Disclosure: See the study for a full list of relevant disclosures.