Skip to main content

Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.

Publication ,  Journal Article
Foster, GR; Afdhal, N; Roberts, SK; Bräu, N; Gane, EJ; Pianko, S; Lawitz, E; Thompson, A; Shiffman, ML; Cooper, C; Towner, WJ; Conway, B ...
Published in: N Engl J Med
December 31, 2015

BACKGROUND: In phase 2 trials, treatment with the combination of the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir resulted in high rates of sustained virologic response in patients chronically infected with hepatitis C virus (HCV) genotype 2 or 3. METHODS: We conducted two randomized, phase 3, open-label studies involving patients who had received previous treatment for HCV genotype 2 or 3 and those who had not received such treatment, including patients with compensated cirrhosis. In one trial, patients with HCV genotype 2 were randomly assigned in a 1:1 ratio to receive sofosbuvir-velpatasvir, in a once-daily, fixed-dose combination tablet (134 patients), or sofosbuvir plus weight-based ribavirin (132 patients) for 12 weeks. In a second trial, patients with HCV genotype 3 were randomly assigned in a 1:1 ratio to receive sofosbuvir-velpatasvir for 12 weeks (277 patients) or sofosbuvir-ribavirin for 24 weeks (275 patients). The primary end point for the two trials was a sustained virologic response at 12 weeks after the end of therapy. RESULTS: Among patients with HCV genotype 2, the rate of sustained virologic response in the sofosbuvir-velpatasvir group was 99% (95% confidence interval [CI], 96 to 100), which was superior to the rate of 94% (95% CI, 88 to 97) in the sofosbuvir-ribavirin group (P=0.02). Among patients with HCV genotype 3, the rate of sustained virologic response in the sofosbuvir-velpatasvir group was 95% (95% CI, 92 to 98), which was superior to the rate of 80% (95% CI, 75 to 85) in the sofosbuvir-ribavirin group (P<0.001). The most common adverse events in the two studies were fatigue, headache, nausea, and insomnia. CONCLUSIONS: Among patients with HCV genotype 2 or 3 with or without previous treatment, including those with compensated cirrhosis, 12 weeks of treatment with sofosbuvir-velpatasvir resulted in rates of sustained virologic response that were superior to those with standard treatment with sofosbuvir-ribavirin. (Funded by Gilead Sciences; ASTRAL-2 ClinicalTrials.gov number, NCT02220998; and ASTRAL-3, NCT02201953.).

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

December 31, 2015

Volume

373

Issue

27

Start / End Page

2608 / 2617

Location

United States

Related Subject Headings

  • Young Adult
  • Viral Nonstructural Proteins
  • Treatment Outcome
  • Sofosbuvir
  • Middle Aged
  • Male
  • Liver Cirrhosis
  • Humans
  • Heterocyclic Compounds, 4 or More Rings
  • Hepatitis C, Chronic
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Foster, G. R., Afdhal, N., Roberts, S. K., Bräu, N., Gane, E. J., Pianko, S., … ASTRAL-3 Investigators, . (2015). Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. N Engl J Med, 373(27), 2608–2617. https://doi.org/10.1056/NEJMoa1512612
Foster, Graham R., Nezam Afdhal, Stuart K. Roberts, Norbert Bräu, Edward J. Gane, Stephen Pianko, Eric Lawitz, et al. “Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.N Engl J Med 373, no. 27 (December 31, 2015): 2608–17. https://doi.org/10.1056/NEJMoa1512612.
Foster GR, Afdhal N, Roberts SK, Bräu N, Gane EJ, Pianko S, et al. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. N Engl J Med. 2015 Dec 31;373(27):2608–17.
Foster, Graham R., et al. “Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.N Engl J Med, vol. 373, no. 27, Dec. 2015, pp. 2608–17. Pubmed, doi:10.1056/NEJMoa1512612.
Foster GR, Afdhal N, Roberts SK, Bräu N, Gane EJ, Pianko S, Lawitz E, Thompson A, Shiffman ML, Cooper C, Towner WJ, Conway B, Ruane P, Bourlière M, Asselah T, Berg T, Zeuzem S, Rosenberg W, Agarwal K, Stedman CAM, Mo H, Dvory-Sobol H, Han L, Wang J, McNally J, Osinusi A, Brainard DM, McHutchison JG, Mazzotta F, Tran TT, Gordon SC, Patel K, Reau N, Mangia A, Sulkowski M, ASTRAL-2  Investigators, ASTRAL-3 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. N Engl J Med. 2015 Dec 31;373(27):2608–2617.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

December 31, 2015

Volume

373

Issue

27

Start / End Page

2608 / 2617

Location

United States

Related Subject Headings

  • Young Adult
  • Viral Nonstructural Proteins
  • Treatment Outcome
  • Sofosbuvir
  • Middle Aged
  • Male
  • Liver Cirrhosis
  • Humans
  • Heterocyclic Compounds, 4 or More Rings
  • Hepatitis C, Chronic