Sofosbuvir plus velpatasvir combination therapy for treatment- Experienced patients with genotype 1 or 3 hepatitis c virus infection

Annals of Internal Medicine

Volumn 163, Issue 11, 2015, Pages 809-817

  Pianko, Stephen ^a   Flamm, Steven L ^b   Shiffman, Mitchell L ^c   Kumar, Sonal ^d   Strasser, Simone I ^e   Dore, Gregory J ^f   McNally, John ^g   Brainard, Diana M ^g   Han, Lingling ^g   Doehle, Brian ^g   Mogalian, Erik ^g   McHutchison, John G ^g   Rabinovitz, Mordechai ^h   Towner, William J ⁱ   Gane, Edward J ^j   Stedman, Catherine A M ^k   Rajender Reddy, K ^l   Roberts, Stuart K ^d  

^a MONASH UNIVERSITY   (Australia)

^b Kovler Center   (United States)

^c Bon Secours Health System   (United States)

^d Division of Gastroenterology and Hepatology ^*  (Australia)

^e ROYAL PRINCE ALFRED HOSPITAL   (Australia)

^f UNIVERSITY OF NEW SOUTH WALES   (Australia)

^g GILEAD SCIENCES   (United States)

^h UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

ⁱ KAISER PERMANENTE MEDICAL CENTER   (United States)

^j AUCKLAND CITY HOSPITAL   (New Zealand)

^k UNIVERSITY OF OTAGO   (New Zealand)

^l UNIVERSITY OF PENNSYLVANIA   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

RIBAVIRIN; SOFOSBUVIR; VELPATASVIR; ANTIVIRUS AGENT; CARBAMIC ACID DERIVATIVE; FUSED HETEROCYCLIC RINGS; VIRUS RNA;

ADULT; ANTIVIRAL ACTIVITY; ANTIVIRAL THERAPY; ARTICLE; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; FATIGUE; FEMALE; GENOTYPE; HEADACHE; HEPATITIS C; HEPATITIS C VIRUS GENOTYPE 1; HEPATITIS C VIRUS GENOTYPE 1 INFECTION; HEPATITIS C VIRUS GENOTYPE 3; HEPATITIS C VIRUS GENOTYPE 3 INFECTION; HUMAN; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NEW ZEALAND; OPEN STUDY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; TREATMENT RESPONSE; UNITED STATES; AGED; BLOOD; CLINICAL TRIAL; COMBINATION DRUG THERAPY; COMPLICATION; DRUG ADMINISTRATION; GENETICS; HEPACIVIRUS; HEPATITIS C, CHRONIC; LIVER CIRRHOSIS; MIDDLE AGED; VIROLOGY; YOUNG ADULT;

ADULT; AGED; ANTIVIRAL AGENTS; CARBAMATES; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HETEROCYCLIC COMPOUNDS WITH 4 OR MORE RINGS; HUMANS; LIVER CIRRHOSIS; MALE; MIDDLE AGED; RIBAVIRIN; RNA, VIRAL; SOFOSBUVIR; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84948662474     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/M15-1014     Document Type: Article

References (18)

1. Gower E, Estes C, Blach S, Razavi-Shearer K, Razavi H. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol. 2014;61:S45-57. [PMID: 25086286]
2. American Association for the Study of Liver Diseases, Infectious Diseases Society of America. HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. Accessed at www .hcvguidelines.org on 28 July 2015.
3. European Association for Study of Liver. EASL recommendations on treatment of hepatitis C 2015. J Hepatol. 2015;63:199-236. [PMID: 25911336]
4. Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, et al; ION-2 Investigators. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014;370:1483-93. [PMID: 24725238]
5. Goossens N, Negro F. Is genotype 3 of the hepatitis C virus the new villain? Hepatology. 2014;59:2403-12. [PMID: 24155107]
6. Buti M, Esteban R. Hepatitis C virus genotype 3: a genotype that is not easy-To-Treat'. Expert Rev Gastroenterol Hepatol. 2015;9:375-85. [PMID: 25222289]
7. van der Meer AJ, Veldt BJ, Feld JJ, Wedemeyer H, Dufour JF, Lammert F, et al. Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis. JAMA. 2012;308:2584-93. [PMID: 23268517]
8. Kanwal F, Kramer JR, Ilyas J, Duan Z, El-Serag HB. HCV genotype 3 is associated with an increased risk of cirrhosis and hepatocellular cancer in a national sample of U.S. veterans with HCV. Hepatology. 2014;60:98-105. [PMID: 24615981]
9. Cheng G, Yu M, Peng B, Lee YJ, Trejo-Martin A, Gong R, et al. 1191 GS-5816, a second generation HCV NS5A inhibitor with potent antiviral activity, board genotypic coverage and a high resistance barrier. J Hepatol. 2013;58(Suppl 1):S484-5.
10. Doehle B, Dvory-Sobol H, Hebner C, Gontcharova V, Chodavarapu K, Ouyang W, et al. Deep sequencing of HCV NS5A from a 3-day study of GS-5816 monotherapy confirms the potency of GS-5816 against pre-existing genotype 1-3 NS5A resistanceassociated variants. Presented at The Liver Meeting 2013: 64th Annual Meeting of the American Association for the Study of Liver Diseases, Washington, DC, 1-5 November 2013.
11. Lawitz E, Freilich B, Link J, German P, Mo H, Han L, et al. A phase 1, randomized, dose-ranging study of GS-5816, a once-daily NS5A inhibitor, in patients with genotype 1-4 hepatitis C virus. J Viral Hepat. 2015. [PMID: 26183611]
12. Mogalian E, German P, Brainard D, Link J, McNally J, Han L, et al. Lack of a clinically significant pharmacokinetic drug-drug interaction between sofosbuvir and GS-5816 in healthy volunteers. Presented at The Liver Meeting 2013: 64th Annual Meeting of the American Association for the Study of Liver Diseases, Washington, DC, 1-5 November 2013.
13. Everson GT, Towner WJ, Davis MN, Wyles DL, Nahass RG, Thuluvath PJ, et al. Sofosbuvir with velpatasvir in treatment-naive noncirrhotic patients with genotype 1 to 6 hepatitis C virus infection. A randomized trial. Ann Intern Med. 2015;163:818-26. doi:10.7326/M15-1000.
14. Gao M. Antiviral activity and resistance of HCV NS5A replication complex inhibitors. Curr Opin Virol. 2013;3:514-20. [PMID: 23896281]
15. Clopper CJ, Pearson ES. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika. 1934;26:404-13.
16. Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, et al; VALENCE Investigators. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014;370:1993-2001. [PMID: 24795201]
17. Foster GR, Pianko S, Brown A, Forton D, Nahass RG, George J, et al; BOSON Study Group. Efficacy of sofosbuvir plus ribavirin with or without peginterferon-Alfa in patients with HCV genotype 3 infection and treatment-experienced patients with cirrhosis and HCV genotype 2 infection. Gastroenterology. 2015. [PMID: 26248087]
18. Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, et al; ALLY-3 Study Team. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology. 2015;61:1127-35. [PMID: 25614962] doi:10.1002/hep.27726