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Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection
Open accessAbstract
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.).
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Cited by
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Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis
Curry, M. P., O’Leary, J. G., Bzowej, N., Muir, A. J., Korenblat, K. M., Fenkel, J. M., Reddy, K. R., Lawitz, E., Flamm, S. L., Schiano, T., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1512614 · Cited by 804
Self-citationSpearman, C. W., Dusheiko, G. M., Hellard, M., & Sonderup, M. (2019) · The Lancet · doi:10.1016/s0140-6736(19)32320-7 · Cited by 404
Drug Combinations as a First Line of Defense against Coronaviruses and Other Emerging Viruses
White, J. M., Schiffer, J. T., Bender Ignacio, R. A., Xu, S., Kainov, D., Ianevski, A., Aittokallio, T., Frieman, M., Olinger, G. G., & Polyak, S. J. (2021) · mBio · doi:10.1128/mbio.03347-21 · Cited by 64
Hepatic decompensation during direct-acting antiviral therapy of chronic hepatitis C
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Metadata
- Authors
- Foster, G. R., Afdhal, N., Roberts, S. K., Bräu, N., Gane, E. J., Pianko, S., Lawitz, E., Thompson, A., Shiffman, M. L., Cooper, C., Towner, W. J., Conway, B., Ruane, P., Bourlière, M., Asselah, T., Berg, T., Zeuzem, S., Rosenberg, W., Agarwal, K., Stedman, C. A. M., Mo, H., Dvory-Sobol, H., Han, L., Wang, J., McNally, J., Osinusi, A., Brainard, D. M., McHutchison, J. G., Mazzotta, F., Tran, T. T., Gordon, S. C., Patel, K., Reau, N., Mangia, A., & Sulkowski, M.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-12-31
- Volume
- 373
- Issue
- 27
- Pages
- 2608-2617
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2289667014
- Cited by
- 846
- References
- 0
- FWCI
- 74.53
- Type
- journal article
- Language
- en
- Open access
- bronze
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- CoChat. (2026). Citation check: Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. https://app.cochat.ai/papers/10.1056/nejmoa1512612
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- Foster, G. R., Afdhal, N., Roberts, S. K., Bräu, N., Gane, E. J., Pianko, S., Lawitz, E., Thompson, A., Shiffman, M. L., Cooper, C., Towner, W. J., Conway, B., Ruane, P., Bourlière, M., Asselah, T., Berg, T., Zeuzem, S., Rosenberg, W., Agarwal, K., . . . Sulkowski, M. (2015). Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1512612
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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