The DOI matches its Crossref record; 45 of the 45 references it cites were found in a registry or an index.
Oral Direct-Acting Agent Therapy for Hepatitis C Virus Infection: A Systematic Review
Open accessAbstract
BACKGROUND: Rapid improvements in hepatitis C virus (HCV) therapy have led to the approval of multiple oral direct-acting antiviral (DAA) regimens by the U.S. Food and Drug Administration (FDA) for treatment of chronic HCV infection. PURPOSE: To summarize published literature on the efficacy and safety of oral DAAs for treatment of persons with chronic HCV infection. DATA SOURCES: MEDLINE and EMBASE from inception through 1 November 2016. STUDY SELECTION: 42 English-language studies from controlled and single-group registered clinical trials of adults with HCV infection that evaluated at least 8 weeks of an FDA-approved interferon-free HCV regimen that included at least 2 DAAs. DATA EXTRACTION: Two investigators abstracted data on study design, patient characteristics, and virologic and safety outcomes sequentially and assessed quality independently. DATA SYNTHESIS: Six DAA regimens showed high sustained virologic response (SVR) rates (>95%) in patients with HCV genotype 1 infection without cirrhosis, including those with HIV co-infection. Effective treatments for HCV genotype 3 infection are limited (2 DAA regimens). Patients with hepatic decompensation, particularly those with Child-Turcotte-Pugh class C disease, had lower SVR rates (78% to 87%) than other populations. The addition of ribavirin was associated with increased SVR rates for certain DAA regimens and patient groups. Overall rates of serious adverse events and treatment discontinuation were low (<10% in the general population); regimens that included ribavirin had more mild or moderate adverse events than those without. LIMITATIONS: Twenty-three studies had moderate risk of bias (10 were open-label single-group trials, 11 had limited information on concealment of the allocation scheme, and 5 had selective outcome reporting). All but 1 of the studies were industry-funded. Heterogeneity of interventions precluded pooling. CONCLUSION: Multiple oral DAA regimens show high rates of safety, tolerability, and efficacy for treatment of HCV genotype 1 infection, particularly among persons without cirrhosis. PRIMARY FUNDING SOURCE: Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42014009711).
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Cites
ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions
Sterne, J. A., Hernán, M. A., Reeves, B. C., Savović, J., Berkman, N. D., Viswanathan, M., Henry, D., Altman, D. G., Ansari, M. T., Boutron, I., et al. (2016) · BMJ · doi:10.1136/bmj.i4919 · Cited by 20,329
Pharmaceutical industry sponsorship and research outcome and quality: systematic review
Lexchin, J., Bero, L. A., Djulbegovic, B., & Clark, O. (2003) · BMJ · doi:10.1136/bmj.326.7400.1167 · Cited by 2,147 · cited 1×
“Most of the studies were industry-funded; such studies are more likely to be published if results are favorable (58), but we are not aware of large, unpublished studies in this field and the risk of bias with the objective outcome of SVR is low.”
BackgroundThe Prevalence of Hepatitis C Virus Infection in the United States, 1999 through 2002
Armstrong, G. L., Wasley, A., Simard, E. P., McQuillan, G. M., Kuhnert, W. L., & Alter, M. J. (2006) · Annals of Internal Medicine · doi:10.7326/0003-4819-144-10-200605160-00004 · Cited by 1,955
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
Global distribution and prevalence of hepatitis C virus genotypes
Messina, J. P., Humphreys, I., Flaxman, A., Brown, A., Cooke, G. S., Pybus, O. G., & Barnes, E. (2015) · Hepatology · doi:10.1002/hep.27259 · Cited by 1,589
van der Meer, A. J., Veldt, B. J., Feld, J. J., Wedemeyer, H., Dufour, J.-F., Lammert, F., Duarte-Rojo, A., Heathcote, E. J., Manns, M. P., Kuske, L., et al. (2012) · JAMA · doi:10.1001/jama.2012.144878 · Cited by 1,510
Ledipasvir and Sofosbuvir for Previously Treated HCV Genotype 1 Infection
Afdhal, N., Reddy, K. R., Nelson, D. R., Lawitz, E., Gordon, S. C., Schiff, E., Nahass, R., Ghalib, R., Gitlin, N., Herring, R., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1316366 · Cited by 1,307
Self-citationDaclatasvir plus Sofosbuvir for Previously Treated or Untreated Chronic HCV Infection
Sulkowski, M. S., Gardiner, D. F., Rodriguez-Torres, M., Reddy, K. R., Hassanein, T., Jacobson, I., Lawitz, E., Lok, A. S., Hinestrosa, F., Thuluvath, P. J., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1306218 · Cited by 1,190
Self-citationSofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection
Feld, J. J., Jacobson, I. M., Hézode, C., Asselah, T., Ruane, P. J., Gruener, N., Abergel, A., Mangia, A., Lai, C.-L., Chan, H. L. Y., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1512610 · Cited by 1,106
Ghany, M. G., Morgan, T. R., & Panel, A. H. C. G. (2020) · Hepatology · doi:10.1002/hep.31060 · Cited by 955
Cited by
Integrated Proteogenomic Characterization of HBV-Related Hepatocellular Carcinoma
Gao, Q., Zhu, H., Dong, L., Shi, W., Chen, R., Song, Z., Huang, C., Li, J., Dong, X., Zhou, Y., et al. (2019) · Cell · doi:10.1016/j.cell.2019.08.052 · Cited by 1,096
Calvaruso, V., Cabibbo, G., Cacciola, I., Petta, S., Madonia, S., Bellia, A., Tinè, F., Distefano, M., Licata, A., Giannitrapani, L., et al. (2018) · Gastroenterology · doi:10.1053/j.gastro.2018.04.008 · Cited by 361
Global Elimination of Chronic Hepatitis
Thomas, D. L. (2019) · New England Journal of Medicine · doi:10.1056/nejmra1810477 · Cited by 325
Kresevic, S., Giuffrè, M., Ajcevic, M., Accardo, A., Crocè, L. S., & Shung, D. L. (2024) · npj Digital Medicine · doi:10.1038/s41746-024-01091-y · Cited by 207
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
Metadata
- Authors
- Falade-Nwulia, O., Suarez-Cuervo, C., Nelson, D. R., Fried, M. W., Segal, J. B., & Sulkowski, M. S.
- Venue
- Annals of Internal Medicine
- Publisher
- American College of Physicians
- Published
- 2017-05-02
- Volume
- 166
- Issue
- 9
- Pages
- 637-648
- ISSN
- 0003-4819 (ISSN-L)
- 1539-3704
- OpenAlex
- W2602169852
- Cited by
- 688
- References
- 45
- FWCI
- 48.05
- Type
- journal article
- Language
- en
- Open access
- green
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