On-treatment HCV RNA as a predictor of sustained virological response in HCV genotype 3–infected patients treated with daclatasvir and sofosbuvir

Liver International

Volumn 36, Issue 11, 2016, Pages 1611-1618

  Kowdley, Kris V ^a   Nelson, David R ^b   Lalezari, Jacob P ^c   Box, Terry ^d   Gitlin, Norman ^e   Poleynard, Gary ^f   Rabinovitz, Mordechai ^g   Ravendhran, Natarajan ^h   Sheikh, Aasim M ⁱ   Siddique, Asma ^j   Bhore, Rafia ^k   Noviello, Stephanie ^k   Rana, Khurram ^l  

^a SWEDISH MEDICAL CENTER   (United States)

^b UNIVERSITY OF FLORIDA   (United States)

^c Quest Clinical Research   (United States)

^d Clinical Research Centers of America   (United States)

^e Atlanta Gastroenterology Associates   (United States)

^f Digestive Health Specialists   (United States)

^g UNIVERSITY OF PITTSBURGH   (United States)

^h Digestive Disease Associates   (United States)

ⁱ Gastrointestinal Specialists of Georgia   (United States)

^j VIRGINIA MASON MEDICAL CENTER   (United States)

^k BRISTOL MYERS SQUIBB RESEARCH AND DEVELOPMENT   (United States)

^l BRISTOL MYERS SQUIBB   (United States)

more..

Author keywords

direct acting antiviral; HCV therapy; NS5A inhibitor; NS5B inhibitor; response guided therapy

Indexed keywords

DACLATASVIR; INTERFERON; SOFOSBUVIR; VIRUS RNA; ANTIVIRUS AGENT; BMS-790052; IMIDAZOLE DERIVATIVE;

ADULT; AGED; ANTIVIRAL THERAPY; ARTICLE; CHRONOPHARMACOLOGY; COHORT ANALYSIS; CONTROLLED STUDY; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; FEMALE; HEPATITIS C; HEPATITIS C VIRUS GENOTYPE 3; HUMAN; LIMIT OF QUANTITATION; LIVER CIRRHOSIS; MAJOR CLINICAL STUDY; MALE; PHASE 3 CLINICAL TRIAL (TOPIC); PREDICTIVE VALUE; PREGNANCY; PROGNOSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); SIDE EFFECT; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE; VIRUS LOAD; BLOOD; CLINICAL TRIAL; COMBINATION DRUG THERAPY; COMPLICATION; DRUG EFFECTS; GENETICS; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; MIDDLE AGED; PHASE 3 CLINICAL TRIAL; SUSTAINED VIROLOGIC RESPONSE; TIME FACTOR; UNITED STATES; YOUNG ADULT;

ADULT; AGED; ANTIVIRAL AGENTS; DRUG THERAPY, COMBINATION; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; IMIDAZOLES; LIVER CIRRHOSIS; MALE; MIDDLE AGED; RNA, VIRAL; SOFOSBUVIR; SUSTAINED VIROLOGIC RESPONSE; TIME FACTORS; UNITED STATES; VIRAL LOAD; YOUNG ADULT;

EID: 84977070927     PISSN: 14783223     EISSN: 14783231     Source Type: Journal    
DOI: 10.1111/liv.13165     Document Type: Article

References (20)

1. Pol S, Vallet-Pichard A, Corouge M. Treatment of hepatitis C virus genotype 3-infection. Liver Int 2014; 34: 18–23.
2. Negro F, Alberti A. The global health burden of hepatitis C virus infection. Liver Int 2011; 31: 1–3.
3. Nkontchou G, Ziol M, Aout M, et al. HCV genotype 3 is associated with a higher hepatocellular carcinoma incidence in patients with ongoing viral C cirrhosis. J Viral Hepat 2011; 18: e516–22.
4. Bochud PY, Cai T, Overbeck K, et al. Genotype 3 is associated with accelerated fibrosis progression in chronic hepatitis C. J Hepatol 2009; 51: 655–66.
5. Asselah T, Rubbia-Brandt L, Marcellin P, Negro F. Steatosis in chronic hepatitis C: why does it really matter? Gut 2006; 55: 123–30.
6. Zeuzem S, Dusheiko GM, Salupere R, et al. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med 2014; 370: 1993–2001.
7. Nelson DR, Cooper JN, Lalezari JP, et al. 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.
8. Lawitz EJ, Membreno FE. Response-guided therapy in patients with genotype 1 hepatitis C virus: current status and future prospects. J Gastroenterol Hepatol 2014; 29: 1574–81.
9. Shiffman ML, Suter F, Bacon BR, et al. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med 2007; 357: 124–34.
10. European Association for Study of Liver. EASL recommendations on treatment of hepatitis C 2015. J Hepatol 2015; 63: 199–236.
11. Leroy V, Angus P, Bronowicki JP, et al. Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: a randomized phase III study (ALLY-3+). Hepatology 2016; 63: 1430–41.
12. Mangia A, Santoro R, Minerva N, et al. Peginterferon alfa-2b and ribavirin for 12 vs. 24 weeks in HCV genotype 2 or 3. N Engl J Med 2005; 352: 2609–17.
13. Sherman KE, Flamm SL, Afdhal NH, et al. Response-guided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med 2011; 365: 1014–24.
14. Poordad F, McCone J Jr, Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011; 364: 1195–206.
15. Steinebrunner N, Sprinzl MF, Zimmermann T, et al. Early virological response may predict treatment response in sofosbuvir-based combination therapy of chronic hepatitis c in a multi-center “real-life” cohort. BMC Gastroenterol 2015; 15: 97.
16. Lawitz E, Lalezari JP, Hassanein T, et al. Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C infection: a randomised, double-blind, phase 2 trial. Lancet Infect Dis 2013; 13: 401–8.
17. Sidharthan S, Kohli A, Sims Z, et al. Utility of hepatitis C viral load monitoring on direct-acting antiviral therapy. Clin Infect Dis 2015; 60: 1743–51.
18. Maasoumy B, Vermehren J, Welker MW, et al. Clinical value of on-treatment HCV RNA levels during different approved sofosbuvir-based antiviral regimens. J Hepatol 2016; 65: 473–82.
19. Sarrazin C, Wedemeyer H, Cloherty G, et al. Importance of very early HCV RNA kinetics for prediction of treatment outcome of highly effective all oral direct acting antiviral combination therapy. J Virol Methods 2015; 214: 29–32.
20. Lau GK, Benhamou Y, Chen G, et al. Complete cure after three weeks of all-oral triple-direct acting antiviral regimens in non-cirrhotic chronic hepatitis C genotpye 1b chinese subjects (SODAPI study). Hepatology 2015; 62: 1394A.