Eight weeks of ledipasvir/sofosbuvir is effective for selected patients with genotype 1 hepatitis C virus infection

Hepatology

Volumn 65, Issue 4, 2017, Pages 1094-1103

  Kowdley, Kris V ^a   Sundaram, Vinay ^b   Jeon, Christie Y ^b   Qureshi, Kamran ^c   Latt, Nyan L ^d   Sahota, Amandeep ^d   Lott, Stephen ^e   Curry, Michael P ^f   Tsai, Naoky ^g   Chaiyakunapruk, Nathorn ^h,i,j,k   Lee, Yoori ^l   Petersen, Jorg ^m   Buggisch, Peter ^m  

^a SWEDISH MEDICAL CENTER   (United States)

^b CEDARS SINAI MEDICAL CENTER   (United States)

^c TEMPLE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d KAISER PERMANENTE MEDICAL CENTER   (United States)

^e Diplomat Specialty Pharmacy   (United States)

^f BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^g UNIVERSITY OF HAWAII   (United States)

^h MONASH UNIVERSITY MALAYSIA   (Malaysia)

ⁱ NARESUAN UNIVERSITY   (Thailand)

^j UNIVERSITY OF QUEENSLAND   (Australia)

^k UNIVERSITY OF WISCONSIN MADISON   (United States)

^l Trio Health Analytics   (United States)

^m DEPARTMENT OF CARDIOLOGY   (Germany)

more..

Author keywords

[No Author keywords available]

Indexed keywords

LEDIPASVIR PLUS SOFOSBUVIR; BENZIMIDAZOLE DERIVATIVE; FLUORENE DERIVATIVE; LEDIPASVIR; SOFOSBUVIR;

ARTICLE; COHORT ANALYSIS; DISEASE DURATION; ETHNICITY; FOLLOW UP; HEPATITIS C; HEPATITIS C VIRUS GENOTYPE 1; HUMAN; LIVER CIRRHOSIS; META ANALYSIS; MIXED INFECTION; RISK FACTOR; SUSTAINED VIROLOGIC RESPONSE; SYSTEMATIC REVIEW; TRANSIENT ELASTOGRAPHY; TREATMENT DURATION; VIRUS LOAD; ADULT; COMBINATION DRUG THERAPY; COMPARATIVE STUDY; CONFIDENCE INTERVAL; DOSE RESPONSE; DRUG ADMINISTRATION; DRUG EFFECTS; FEMALE; GENETICS; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; IMMUNOHISTOCHEMISTRY; MALE; MIDDLE AGED; NEEDLE BIOPSY; PATHOLOGY; PATIENT SELECTION; PREDICTIVE VALUE; RECURRENT DISEASE; RISK ASSESSMENT; SEVERITY OF ILLNESS INDEX; TIME FACTOR; TREATMENT OUTCOME;

ADULT; BENZIMIDAZOLES; BIOPSY, NEEDLE; COHORT STUDIES; CONFIDENCE INTERVALS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; FLUORENES; FOLLOW-UP STUDIES; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; IMMUNOHISTOCHEMISTRY; MALE; MIDDLE AGED; PATIENT SELECTION; PREDICTIVE VALUE OF TESTS; RECURRENCE; RISK ASSESSMENT; SEVERITY OF ILLNESS INDEX; SOFOSBUVIR; TIME FACTORS; TREATMENT OUTCOME;

EID: 85014101785     PISSN: 02709139     EISSN: 15273350     Source Type: Journal    
DOI: 10.1002/hep.29005     Document Type: Article

References (31)

1. Kowdley KV, Gordon SC, Reddy KR, Rossaro L, Bernstein DE, Lawitz E, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med 2014;370:1879-1888.
2. Hoofnagle JH, Sherker AH. Therapy for hepatitis C—the costs of success. N Engl J Med 2014;370:1552-1553.
3. Lawitz E, Flamm S, Yang J, Pang P, Zhu Y, Svarovskaia E, et al. Retreatment of patients who failed 8 or 12 weeks of ledipasvir/sofosbuvir-based regimens with ledipasvir/sofosbuvir for 24 weeks. J Hepatol 2015;62:S192.
4. O'Brien TR, Feld JJ, Kottilil S, Pfeiffer RM. No scientific basis to restrict 8 weeks of treatment with ledipasvir/sofosbuvir to patients with hepatitis C virus RNA <6,000,000 IU/mL. Hepatology 2016;63:28-30.
5. Gordon SC, Muir AJ, Lim JK, Pearlman B, Argo CK, Ramani A, et al. Safety profile of boceprevir and telaprevir in chronic hepatitis C: real world experience from HCV-TARGET. J Hepatol 2015;62:286-293.
6. Shiffman ML, James AM, Long AG, Alexander PC. Treatment of chronic HCV with sofosbuvir and simeprevir in patients with cirrhosis and contraindications to interferon and/or ribavirin. Am J Gastroenterol 2015;110:1179-1185.
7. Sulkowski MS, Vargas HE, Di Bisceglie AM, Kuo A, Reddy KR, Lim JK, et al. Effectiveness of simeprevir plus sofosbuvir, with or without ribavirin, in real-world patients with HCV genotype 1 infection. Gastroenterology 2016;150:419-429.
8. O'Brien TR, Lang Kuhs KA, Pfeiffer RM. Subgroup differences in response to 8 weeks of ledipasvir/sofosbuvir for chronic hepatitis C. Open Forum Infect Dis 2014;1:ofu110. doi: 10.1093/ofid/ofu110. http://ofid.oxfordjournals.org/content/1/3/ofu110.full.
9. Wilder JM, Jeffers LJ, Ravendhran N, Shiffman ML, Poulos J, Sulkowski MS, et al. Safety and efficacy of ledipasvir–sofosbuvir in black patients with hepatitis C virus infection: a retrospective analysis of phase 3 data. Hepatology 2016;63:437-444.
10. Reddy KR, Bourliere M, Sulkowski M, Omata M, Zeuzem S, Feld JJ, et al. Ledipasvir and sofosbuvir in patients with genotype 1 hepatitis C virus infection and compensated cirrhosis: an integrated safety and efficacy analysis. Hepatology 2015;62:79-86.
11. Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis of Observational Studies in Epidemiology (MOOSE) group. JAMA 2000;283:2008-2012.
12. Afdhal N, Bacon B, Curry M, Dieterich D, Flamm S, Guest L, et al. No effect of proton pump inhibitor (PPI) use on SVR with ledipasvir/sofosbuvir (LDV/SOF): real world data from 2034 genotype 1 patients in the Trio network. J Hepatol 2016;64:S222.
13. Backus LI, Belperio PS, Shahoumian TA, Loomis TP, Mole LA. Real-world effectiveness of ledipasvir/sofosbuvir in 4,365 treatment-naive, genotype 1 hepatitis C–infected patients. Hepatology 2016;64:405-414.
14. Sterne J, Higgins J, Reeves B, ACROBAT-NRSI. obotdgf. A Cochrane Risk of Bias Assessment Tool: For Non-Randomized Studies of Interventions (ACROBAT-NRSI), Version 1.0.0, September 24, 2014. http://www.riskofbias.info. Accessed June 2, 2016.
15. Schünemann H, Brozek J, Guyatt G, Oxman G, eds. Handbook for grading the quality of evidence and the strength of recommendations using the GRADE approach, 2013. http://www.guidelinedevelopment.org/handbook/. Accessed June 5, 2016.
16. Stang A. Critical evaluation of the Newcastle-Ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses. Eur J Epidemiol 2010;25:603-605.
17. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986;7:177-188.
18. Higgins JPT, Green S, eds. Cochrane handbook for systematic reviews of interventions, version 5.1.0, updated March 2011. The Cochrane Collaboration, 2011. http://training.cochrane.org/handbook. Accessed May 11, 2016.
19. Macaskill P, Walter SD, Irwig L. A comparison of methods to detect publication bias in meta-analysis. Stat Med 2001;20:641-654.
20. Buggisch P, Boker K, Gunther R, Teuber G, Klinker H, Pathil A, et al. Ledipasvir/sofosbuvir treatment for 8 weeks in treatment-naive HCV genotype 1 infected patients under real life conditions: data from the German hepatitis-C registry (DHC-R). J Hepatol 2016;64(Suppl.):S810.
21. Crespo J, Fernandez I, Cabezas J, Albillos A, Perello C, Garcia-Samaniego J, et al. Effectiveness and safety of sofosbuvir/ledipasvir treatment for monoinfected genotype 1 HCV patients in real-life clinical practice: results from Spanish HEPA-C cohort. J Hepatol 2016;64(Suppl.):S217-S218.
22. Gill K, Fante G, Nafisi S, Moore A, Hepner A, Reynolds JA, et al. Sofosbuvir and ledipasvir for the treatment of HCV GT-1, cirrhotics and non-cirrhotics: real-world effectiveness [Abstract]. Hepatology 2015;62(Suppl.):757A. Abstract 1111.
23. Lai J, Witt M, Witt D. Real-world effectiveness of 8, 12, and 24 weeks of ledipasvir (LDV)/sofosbuvir (SOF)–based therapy for hepatitis C virus (HCV) genotype 1: analysis in a large integrated health care system [Abstract]. J Hepatol 2016;64(Suppl.):S778. Abstract SAT-177.
24. Ioannou GN, Beste LA, Chang MF, Green PK, Lowey E, Tsui JI, et al. Effectiveness of sofosbuvir, ledipasvir/sofosbuvir, or paritaprevir/ritonavir/ombitasvir and dasabuvir regimens for treatment of patients with hepatitis C in the Veterans Affairs National Health Care System. Gastroenterology 2016;151:457-471.
25. Terrault NA, Zeuzem S, Di Bisceglie AM, Lim JK, Pockros PJ, Frazier LM, et al. Effectiveness of ledipasvir-sofosbuvir combination in patients with hepatitis C virus infection and factors associated of sustained virologic response. Gastroenterology 2016;151:1131-1140.
26. American Association for the Study of Liver Diseases, Infectious Diseases Society of America. HCV guidance: recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Accessed June 25, 2016.
27. Ingiliz P, Christensen S, Kimhofer T, Hueppe D, Lutz T, Schewe K, et al. Sofosbuvir and ledipasvir for 8 weeks for the treatment of chronic hepatitis C virus infection in HCV-mono-infected and HIV-HCV co-infected individuals—results from the German hepatitis C cohort (GECCO-01). Clin Infect Dis 2016;63:1320-1324.
28. Younossi ZM, Park H, Gordon SC, Ferguson JR, Ahmed A, Dieterich D, et al. Real-world outcomes of ledipasvir/sofosbuvir in treatment-naive patients with hepatitis C. Am J Manag Care 2016;22:SP205-SP211.
29. Tapper EB, Bacon BR, Curry MP, Dieterich DT, Flamm SL, Guest LE, et al. Evaluation of proton pump inhibitor use on treatment outcomes with ledipasvir and sofosbuvir in a real-world cohort study. Hepatology 2016;64:1893-1899.
30. Roytman M, Tang AL, Wu C, Piotrowski JI, Hong LK, Trujillo R, et al. Real life experience with sofosbuvir and ledipasvir fixed does regemine in the multicentric cohort of patients with chronic hepatitis C [Abstract]. Hepatology 2015;62(Suppl.):761A. Abstract 1121.
31. Marshall VJ, Rife K, Hirsch A, Silveira MG, Compan A, Moreland AL, et al. Real life treatment outcomes with 8 week course treatment for hepatitis C without cirrhosis confirmed by transient elastography [Abstract]. Hepatology 2015;62(Suppl.):779A. Abstract 1154.