Impact of resistance-associated variant dominancy on treatment in patients with HCV genotype 1b receiving daclatasvir/asunaprevir

Journal of Medical Virology

Volumn 89, Issue 1, 2017, Pages 99-105

  Ikeda, Hiroki ^a   Watanabe, Tsunamasa ^a   Okuse, Chiaki ^a,b   Matsumoto, Nobuyuki ^a   Ishii, Toshiya ^c   Yamada, Norie ^d   Shigefuku, Ryuta ^a   Hattori, Nobuhiro ^a   Matsunaga, Kotaro ^a   Nakano, Hiroyasu ^a   Hiraishi, Tetsuya ^b   Kobayashi, Minoru ^a,d   Yasuda, Kiyomi ^d   Yamamoto, Hiroyuki ^a   Yasuda, Hiroshi ^a   Kurosaki, Masayuki ^e   Izumi, Namiki ^e   Yotsuyanagi, Hiroshi ^f   Suzuki, Michihiro ^a,b   Itoh, Fumio ^a  

^a ST MARIANNA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b KAWASAKI MUNICIPAL TAMA HOSPITAL   (Japan)

^c ST MARIANNA UNIVERSITY   (Japan)

^d Kiyokawa Hospital   (Japan)

^e MUSASHINO RED CROSS HOSPITAL   (Japan)

^f UNIVERSITY OF TOKYO   (Japan)

Author keywords

asunaprevir; daclatasvir; HCV; resistance associated variant; sustained virological response

Indexed keywords

ASUNAPREVIR; ASUNAPREVIR PLUS DACLATASVIR; DACLATASVIR; NONSTRUCTURAL PROTEIN 3; NONSTRUCTURAL PROTEIN 5A; UNCLASSIFIED DRUG; ANTIVIRUS AGENT; BMS-790052; IMIDAZOLE DERIVATIVE; ISOQUINOLINE DERIVATIVE; NS-5 PROTEIN, HEPATITIS C VIRUS; SULFONAMIDE; VIRAL PROTEIN;

ADULT; AGED; ANTIVIRAL RESISTANCE; ARTICLE; FEMALE; HEPATITIS C VIRUS GENOTYPE 1; HEPATITIS C VIRUS GENOTYPE 1B; HUMAN; MAJOR CLINICAL STUDY; MALE; POLYMERASE CHAIN REACTION; PROSPECTIVE STUDY; QUANTITATIVE ANALYSIS; RESISTANCE ASSOCIATED VARIANT; SINGLE NUCLEOTIDE POLYMORPHISM; TREATMENT DURATION; TREATMENT OUTCOME; VERY ELDERLY; VIRAL PHENOMENA AND FUNCTIONS; CLASSIFICATION; GENETICS; GENOTYPE; GENOTYPING TECHNIQUE; HEPACIVIRUS; HEPATITIS C, CHRONIC; ISOLATION AND PURIFICATION; MIDDLE AGED; MISSENSE MUTATION; SUSTAINED VIROLOGIC RESPONSE; VIROLOGY;

ADULT; AGED; AGED, 80 AND OVER; ANTIVIRAL AGENTS; DRUG RESISTANCE, VIRAL; FEMALE; GENOTYPE; GENOTYPING TECHNIQUES; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; IMIDAZOLES; ISOQUINOLINES; MALE; MIDDLE AGED; MUTATION, MISSENSE; POLYMERASE CHAIN REACTION; PROSPECTIVE STUDIES; SULFONAMIDES; SUSTAINED VIROLOGIC RESPONSE; TREATMENT OUTCOME; VIRAL NONSTRUCTURAL PROTEINS;

EID: 84993996060     PISSN: 01466615     EISSN: 10969071     Source Type: Journal    
DOI: 10.1002/jmv.24608     Document Type: Article

References (22)

1. Abe H, Ochi H, Maekawa T, Hayes CN, Tsuge M, Miki D, Mitsui F, Hiraga N, Imamura M, Takahashi S, Ohishi W, Arihiro K, Kubo M, Nakamura Y, Chayama K. 2010. Common variation of IL28 affects gamma-GTP levels and inflammation of the liver in chronically infected hepatitis C virus patients. J Hepatol 53:439–443.
2. Drafting Committee for Hepatitis Management Guidelines tJSoH. 2014. JSH guidelines for the management of hepatitis C virus infection: A 2014 update for genotype 1. Hepatol Res 44:59–70.
3. Fridell RA, Qiu D, Wang C, Valera L, Gao M. 2010. Resistance analysis of the hepatitis C virus NS5A inhibitor BMS-790052 in an in vitro replicon system. Antimicrob Agents Chemother 54:3641–3650.
4. Itakura J, Kurosaki M, Takada H, Nakakuki N, Matsuda S, Gondou K, Asano Y, Hattori N, Itakura Y, Tamaki N, Yasui Y, Suzuki S, Hosokawa T, Tsuchiya K, Nakanishi H, Takahashi Y, Maekawa S, Enomoto N, Izumi N. 2015. Naturally occurring, resistance-associated hepatitis C virus NS5A variants are linked to interleukin-28 B genotype and are sensitive to interferon-based therapy. Hepatol Res 45:E115–E121.
5. Kan T, Hashimoto S, Kawabe N, Murao M, Nakano T, Shimazaki H, Nakaoka K, Ohki M, Takagawa Y, Kurashita T, Takamura T, Yoshioka K. 2016. The clinical features of patients with a Y93H variant of hepatitis C virus detected by a PCR invader assay. J Gastroenterol 51:63–70.
6. Karino Y, Toyota J, Ikeda K, Suzuki F, Chayama K, Kawakami Y, Ishikawa H, Watanabe H, Hernandez D, Yu F, McPhee F, Kumada H. 2013. Characterization of virologic escape in hepatitis C virus genotype 1b patients treated with the direct-acting antivirals daclatasvir and asunaprevir. J Hepatol 58:646–654.
7. Kinugasa H, Ikeda F, Takaguchi K, Mori C, Matsubara T, Shiraha H, Takaki A, Iwasaki Y, Toyooka S, Yamamoto K. 2016. Low frequency of drug-resistant virus did not affect the therapeutic efficacy in daclatasvir plus asunaprevir therapy in patients with chronic HCV genotype-1 infection. Antivir Ther 21:37–44.
8. Kumada H, Suzuki Y, Ikeda K, Toyota J, Karino Y, Chayama K, Kawakami Y, Ido A, Yamamoto K, Takaguchi K, Izumi N, Koike K, Takehara T, Kawada N, Sata M, Miyagoshi H, Eley T, McPhee F, Damokosh A, Ishikawa H, Hughes E. 2014. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology 59:2083–2091.
9. Lenz O, Verbinnen T, Fevery B, Tambuyzer L, Vijgen L, Peeters M, Buelens A, Ceulemans H, Beumont M, Picchio G, De Meyer S. 2015. Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies. J Hepatol 62:1008–1014.
10. Marcellin P, Asselah T, Boyer N. 2002. Fibrosis and disease progression in hepatitis C. Hepatology 36:S47–S56.
11. Martell M, Esteban JI, Quer J, Genesca J, Weiner A, Esteban R, Guardia J, Gomez J. 1992. Hepatitis C virus (HCV) circulates as a population of different but closely related genomes: Quasispecies nature of HCV genome distribution. J Virol 66:3225–3229.
12. McPhee F, Friborg J, Levine S, Chen C, Falk P, Yu F, Hernandez D, Lee MS, Chaniewski S, Sheaffer AK, Pasquinelli C. 2012. Resistance analysis of the hepatitis C virus NS3 protease inhibitor asunaprevir. Antimicrob Agents Chemother 56:3670–3681.
13. McPhee F, Suzuki Y, Toyota J, Karino Y, Chayama K, Kawakami Y, Yu ML, Ahn SH, Ishikawa H, Bhore R, Zhou N, Hernandez D, Mendez P, Kumada H. 2015. High sustained virologic response to daclatasvir plus asunaprevir in elderly and cirrhotic patients with hepatitis C virus genotype 1b without baseline NS5A polymorphisms. Adv Ther 32:637–649.
14. Miura M, Maekawa S, Sato M, Komatsu N, Tatsumi A, Takano S, Amemiya F, Nakayama Y, Inoue T, Sakamoto M, Enomoto N. 2014. Deep sequencing analysis of variants resistant to the non-structural 5A inhibitor daclatasvir in patients with genotype 1b hepatitis C virus infection. Hepatol Res 44:E360–E367.
15. Shepard CW, Finelli L, Alter MJ. 2005. Global epidemiology of hepatitis C virus infection. Lancet Infect Dise 5:558–567.
16. Suzuki F, Sezaki H, Akuta N, Suzuki Y, Seko Y, Kawamura Y, Hosaka T, Kobayashi M, Saito S, Arase Y, Ikeda K, Kobayashi M, Mineta R, Watahiki S, Miyakawa Y, Kumada H. 2012. Prevalence of hepatitis C virus variants resistant to NS3 protease inhibitors or the NS5A inhibitor (BMS-790052) in hepatitis patients with genotype 1b. J Clin Virol 54:352–354.
17. Tadokoro K, Kobayashi M, Suzuki F, Tanaka C, Yamaguchi T, Nagano M, Egashira T, Kumada H. 2013. Comparative quantitative analysis of hepatitis C mutations at amino acids 70 and 91 in the core region by the Q-Invader assay. J Virol Methods 189:221–227.
18. Tadokoro K, Suzuki F, Kobayashi M, Kawakami Y, Sezaki H, Hosaka T, Akuta N, Kobayashi M, Suzuki Y, Saitoh S, Arase Y, Ikeda K, Kumada H. 2014. Rapid and high sensitive detection of Y93H amino acid substitution in HCV NS5A region using the PCR-Invader assay. Kanzo 55:720–722.
19. Tadokoro K, Suzuki F, Kobayashi M, Yamaguchi T, Nagano M, Egashira T, Kumada H. 2011. Rapid detection of drug-resistant mutations in hepatitis B virus by the PCR-Invader assay. J Virol Methods 171:67–73.
20. Uchida Y, Kouyama J, Naiki K, Mochida S. 2014. A novel simple assay system to quantify the percent HCV-RNA levels of NS5A Y93 H mutant strains and Y93 wild-type strains relative to the total HCV-RNA levels to determine the indication for antiviral therapy with NS5A inhibitors. PLoS ONE 9:e112647.
21. Vallet-Pichard A, Mallet V, Nalpas B, Verkarre V, Nalpas A, Dhalluin-Venier V, Fontaine H, Pol S. 2007. FIB-4: An inexpensive and accurate marker of fibrosis in HCV infection. comparison with liver biopsy and fibrotest. Hepatology 46:32–36.
22. Yoshimi S, Ochi H, Murakami E, Uchida T, Kan H, Akamatsu S, Hayes CN, Abe H, Miki D, Hiraga N, Imamura M, Aikata H, Chayama K. 2015. Rapid, sensitive, and accurate evaluation of drug resistant mutant (NS5A-Y93H) strain frequency in genotype 1b HCV by invader assay. PLoS ONE 10:e0130022.