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Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1
Open accessAbstract
BACKGROUND: Effective treatment for hepatitis C virus (HCV) in patients coinfected with human immunodeficiency virus type 1 (HIV-1) remains an unmet medical need. METHODS: We conducted a multicenter, single-group, open-label study involving patients coinfected with HIV-1 and genotype 1 or 4 HCV receiving an antiretroviral regimen of tenofovir and emtricitabine with efavirenz, rilpivirine, or raltegravir. All patients received ledipasvir, an NS5A inhibitor, and sofosbuvir, a nucleotide polymerase inhibitor, as a single fixed-dose combination for 12 weeks. The primary end point was a sustained virologic response at 12 weeks after the end of therapy. RESULTS: Of the 335 patients enrolled, 34% were black, 55% had been previously treated for HCV, and 20% had cirrhosis. Overall, 322 patients (96%) had a sustained virologic response at 12 weeks after the end of therapy (95% confidence interval [CI], 93 to 98), including rates of 96% (95% CI, 93 to 98) in patients with HCV genotype 1a, 96% (95% CI, 89 to 99) in those with HCV genotype 1b, and 100% (95% CI, 63 to 100) in those with HCV genotype 4. Rates of sustained virologic response were similar regardless of previous treatment or the presence of cirrhosis. Of the 13 patients who did not have a sustained virologic response, 10 had a relapse after the end of treatment. No patient had confirmed HIV-1 virologic rebound. The most common adverse events were headache (25%), fatigue (21%), and diarrhea (11%). No patient discontinued treatment because of adverse events. CONCLUSIONS: Ledipasvir and sofosbuvir for 12 weeks provided high rates of sustained virologic response in patients coinfected with HIV-1 and HCV genotype 1 or 4. (Funded by Gilead Sciences; ION-4 ClinicalTrials.gov number, NCT02073656.).
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Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection
Afdhal, N., Zeuzem, S., Kwo, P., Chojkier, M., Gitlin, N., Puoti, M., Romero-Gomez, M., Zarski, J.-P., Agarwal, K., Buggisch, P., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1402454 · Cited by 1,705
Self-citationLedipasvir and Sofosbuvir for Previously Treated HCV Genotype 1 Infection
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Self-citationLedipasvir and Sofosbuvir for 8 or 12 Weeks for Chronic HCV without Cirrhosis
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Cited by
Spearman, C. W., Dusheiko, G. M., Hellard, M., & Sonderup, M. (2019) · The Lancet · doi:10.1016/s0140-6736(19)32320-7 · Cited by 404
Ingiliz, P., Martin, T. C., Rodger, A., Stellbrink, H.-J., Mauss, S., Boesecke, C., Mandorfer, M., Bottero, J., Baumgarten, A., Bhagani, S., et al. (2017) · Journal of Hepatology · doi:10.1016/j.jhep.2016.09.004 · Cited by 173
Nijmeijer, B. M., Koopsen, J., Schinkel, J., Prins, M., & Geijtenbeek, T. B. (2019) · Journal of the International AIDS Society · doi:10.1002/jia2.25348 · Cited by 100
Lockart, I., Matthews, G. V., & Danta, M. (2019) · Current Opinion in Infectious Diseases · doi:10.1097/qco.0000000000000515 · Cited by 37
Metadata
- Authors
- Naggie, S., Cooper, C., Saag, M., Workowski, K., Ruane, P., Towner, W. J., Marks, K., Luetkemeyer, A., Baden, R. P., Sax, P. E., Gane, E., Santana-Bagur, J., Stamm, L. M., Yang, J. C., German, P., Dvory-Sobol, H., Ni, L., Pang, P. S., McHutchison, J. G., Stedman, C. A. M., Morales-Ramirez, J. O., Bräu, N., Jayaweera, D., Colson, A. E., Tebas, P., Wong, D. K., Dieterich, D., & Sulkowski, M.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-08-20
- Volume
- 373
- Issue
- 8
- Pages
- 705-713
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2332403844
- Cited by
- 470
- References
- 20
- FWCI
- 51.51
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Naggie, S., Cooper, C., Saag, M., Workowski, K., Ruane, P., Towner, W. J., Marks, K., Luetkemeyer, A., Baden, R. P., Sax, P. E., Gane, E., Santana-Bagur, J., Stamm, L. M., Yang, J. C., German, P., Dvory-Sobol, H., Ni, L., Pang, P. S., McHutchison, J. G., . . . Sulkowski, M. (2015). Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1501315
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