This study summary is an excerpt from the book 2 Minute Medicine’s The Classics in Medicine: Summaries of the Landmark Trials
1. This trial demonstrated that in patients with hepatitis C virus (HCV) rates of virologic response were high in those who received sofosbuvir–ribavirin (93%) as compared to placebo (85%) 12 weeks post-treatment.
2. Virologic response rates in HCV genotype 3 infection were increased in participants without liver cirrhosis (91%) as compared to those who had a liver cirrhosis diagnosis (68%).
Original Date of Publication: May 2014
Study Rundown: The VALENCE trial assessed the impact of the combination nucleotide polymerase inhibitor and antiviral agent sofosbuvir–ribavirin on sustained virologic response in patients with HCV genotypes 2 and 3. Patients with HCV genotype 2 in the sofosbuvir-ribavirin group had significant improvements in virologic response as compared to placebo, sustained 12 weeks after a 12-week treatment period. Similarly, patients who received sofosbuvir-ribavirin in the HCV genotype 3 group had significantly improved virologic response as compared to placebo at 12 weeks after an extended treatment time (24 weeks). In patients with HCV genotype 3, presence of liver cirrhosis was associated with reduced efficacy of sofosbuvir-ribavirin. In summary, the VALENCE trial demonstrated that sofosbuvir-ribavirin improves viral response in patients with HCV genotypes 2 and 3 as compared to placebo.
In-Depth [randomized control trial]: In the VALENCE trial, patients diagnosed with chronic infection with HCV genotypes 2 or 3 were randomized into receiving either sofosbuvir-ribavirin (n = 334) or a placebo (n = 85). After 12 weeks, the study was unblinded and placebo participation was discontinued. Patients with HCV genotype 2 had significant improvements in viral response as compared to placebo 12 weeks after a 12-week treatment regimen (93%; 95%CI 85-98). Patients with HCV genotype 3 also demonstrated significant improvement in viral response 12 weeks following an extended 24-week treatment period (85%; 95%CI 80-89). Response rate did not differ across HCV genotype 2 subgroups, although in HCV genotype 3 patients with liver cirrhosis treatment response in the study group was blunted (87% versus 62% viral response). No significant difference in adverse events was seen across study groups.
Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, et al. Sofosbuvir and Ribavirin in HCV Genotypes 2 and 3. New England Journal of Medicine. 2014 May 22;370(21):1993–2001..
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