Efficacy and tolerability of interferon‑free regimen for patients with genotype‑1 HCV infection

Takeda,Kosuke; Noguchi,Ryuichi; Namisaki,Tadashi; Moriya,Kei; Akahane,Takemi; Kitade,Mitsuteru; Kawaratani,Hideto; Shimozato,Naotaka; Kaji,Kosuke; Takaya,Hiroaki; Sawada,Yasuhiko; Seki,Kenichiro; Fujinaga,Yukihisa; Tsuji,Yuki; Kubo,Takuya; Sato,Shinya; Saikawa,Soichiro; Nakanishi,Keisuke; Furukawa,Masanori; Kitagawa,Koh; Ozutsumi,Takahiro; Kaya,Daisuke; Mitoro,Akira; Mashitani,Tsuyoshi; Okura,Yasushi; Yamao,Junichi; Yoshiji,Hitoshi

doi:10.3892/etm.2018.6481

Efficacy and tolerability of interferon‑free regimen for patients with genotype‑1 HCV infection

Authors:
- Kosuke Takeda
- Ryuichi Noguchi
- Tadashi Namisaki
- Kei Moriya
- Takemi Akahane
- Mitsuteru Kitade
- Hideto Kawaratani
- Naotaka Shimozato
- Kosuke Kaji
- Hiroaki Takaya
- Yasuhiko Sawada
- Kenichiro Seki
- Yukihisa Fujinaga
- Yuki Tsuji
- Takuya Kubo
- Shinya Sato
- Soichiro Saikawa
- Keisuke Nakanishi
- Masanori Furukawa
- Koh Kitagawa
- Takahiro Ozutsumi
- Daisuke Kaya
- Akira Mitoro
- Tsuyoshi Mashitani
- Yasushi Okura
- Junichi Yamao
- Hitoshi Yoshiji
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Affiliations: Third Department of Internal Medicine, Nara Medical University, Kashihara, Nara 634‑8522, Japan, Department of Endoscopy, Nara Medical University, Kashihara, Nara 634‑8522, Japan
Published online on: July 19, 2018 https://doi.org/10.3892/etm.2018.6481
Pages: 2743-2750

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Abstract

Depression is a major reason for interferon (IFN) therapy cessation. IFN‑free direct‑acting antiviral (DAA) therapy for depression is not well‑documented. Thus, four different IFN‑free regimens were assessed in genotype‑1 hepatitis C virus (HCV) patients with depression. Overall, 287 HCV genotype‑1 patients who received combination therapies with IFN‑free DAAs of daclatasvir/asunaprevir (DCV/ASV) (n=84), sofosbuvir/ledipasvir (SOF/LDV) (n=95), ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) (n=74), and elbasvir/grazoprevir (EBR/GZR) (n=34) were included. Treatment‑induced depression as a complication of HCV therapy in IFN‑free DAA regimens was assessed. The severity of depression was evaluated using the Beck Depression Inventory‑II (BDI‑II) questionnaire. It was demonstrated that all four DAA regimens achieved similar high efficacy in Japanese patients with HCV genotype‑1 infection. Moreover, in seven patients with depression who received the 24‑week DCV/ASV treatment regimen, the BDI‑II scores significantly increased at week 4 as compared with pretreatment values; furthermore, they decreased below baseline at week 12 despite the rapid decline of serum HCV levels after the initiation of DCV/ASV therapy. The BDI‑II scores gradually decreased during therapy in the remaining 77 DCV/ASV‑treated patients without depression. The BDI‑II scores showed a significant decrease from baseline to the end of treatment with 12‑week regimens, including SOF/LDV and EBR/GZR. The 12‑week DAA regimen of SOF/LDV and EBR/GZR can be safely used with high efficacy in patients with genotype‑1 HCV infection, including those with depression.

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1	Toshikuni N, Arisawa T and Tsutsumi M: Hepatitis C-related liver cirrhosis-strategies for the prevention of hepatic decompensation, hepatocarcinogenesis and mortality. World J Gastroenterol. 20:2876–2887. 2014. View Article : Google Scholar : PubMed/NCBI
2	Sievert W, Altraif I, Razavi HA, Abdo A, Ahmed EA, Alomair A, Amarapurkar D, Chen CH, Dou X, El Khayat H, et al: A systematic review of hepatitis C virus epidemiology in Asia, Australia and Egypt. Liver Int. 31 Suppl 2:S61–S80. 2011. View Article : Google Scholar
3	Alazawi W, Cunningham M, Dearden J and Foster GR: Systematic review: Outcome of compensated cirrhosis due to chronic hepatitis C infection. Aliment Pharmacol Ther. 32:344–355. 2010. View Article : Google Scholar : PubMed/NCBI
4	Younossi Z and Henry L: Systematic review: Patient-reported outcomes in chronic hepatitis C-the impact of liver disease and new treatment regimens. Aliment Pharmacol Ther. 41:497–520. 2015. View Article : Google Scholar : PubMed/NCBI
5	Younossi ZM, Stepanova M, Henry L, Nader F and Hunt S: An in-depth analysis of patient-reported outcomes in patients with chronic hepatitis c treated with different anti-viral regimens. Am J Gastroenterol. 111:808–816. 2016. View Article : Google Scholar : PubMed/NCBI
6	Younossi ZM, Stepanova M, Nader F, Lam B and Hunt S: The patient's journey with chronic hepatitis C from interferon plus ribavirin to interferon- and ribavirin-free regimens: A study of health-related quality of life. Aliment Pharmacol Ther. 42:286–295. 2015. View Article : Google Scholar : PubMed/NCBI
7	Younossi Z, Stepanova M, Omata M, Mizokami M, Walters M and Hunt S: Health utilities using SF-6D scores in Japanese patients with chronic hepatitis C treated with sofosbuvir-based regimens in clinical trials. Health Qual Life Outcomes. 15:252017. View Article : Google Scholar : PubMed/NCBI
8	Spengler U: Direct antiviral agents (DAAs)-A new age in the treatment of hepatitis C virus infection. Pharmacol Ther. 183:118–126. 2018. View Article : Google Scholar : PubMed/NCBI
9	Patterson AL, Morasco BJ, Fuller BE, Indest DW, Loftis JM and Hauser P: Screening for depression in patients with hepatitis C using the Beck Depression Inventory-II: Do somatic symptoms compromise validity? Gen Hosp Psychiatry. 33:354–362. 2011. View Article : Google Scholar : PubMed/NCBI
10	Huang SL, Hsieh CL, Wu RM and Lu WS: Test-retest reliability and minimal detectable change of the Beck Depression Inventory and the Taiwan geriatric depression scale in patients with parkinson's disease. PLoS One. 12:e01848232017. View Article : Google Scholar : PubMed/NCBI
11	Pawlotsky JM: Hepatitis C virus resistance to direct-acting antiviral drugs in interferon-free regimens. Gastroenterology. 151:70–86. 2016. View Article : Google Scholar : PubMed/NCBI
12	Zeuzem S, Mizokami M, Pianko S, Mangia A, Han KH, Martin R, Svarovskaia E, Dvory-Sobol H, Doehle B, Hedskog C, et al: NS5A resistance-associated substitutions in patients with genotype 1 hepatitis C virus: Prevalence and effect on treatment outcome. J Hepatol. 66:910–918. 2017. View Article : Google Scholar : PubMed/NCBI
13	Uchida Y, Kouyama J, Naiki K and Mochida S: A novel simple assay system to quantify the percent HCV-RNA levels of NS5A Y93H 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:e1126472014. View Article : Google Scholar : PubMed/NCBI
14	Steer RA, Ball R, Ranieri WF and Beck AT: Dimensions of the Beck Depression Inventory-II in clinically depressed outpatients. J Clin Psychol. 55:117–128. 1999. View Article : Google Scholar : PubMed/NCBI
15	Hayden MJ, Dixon JB, Dixon ME and O'Brien PE: Confirmatory factor analysis of the Beck Depression Inventory in obese individuals seeking surgery. Obes Surg. 20:432–439. 2010. View Article : Google Scholar : PubMed/NCBI
16	Beck AT, Ward CH, Mendelson M, Mock J and Erbaugh J: An inventory for measuring depression. Arch Gen Psychiatry. 4:561–571. 1961. View Article : Google Scholar : PubMed/NCBI
17	Dbouk N, Arguedas MR and Sheikh A: Assessment of the PHQ-9 as a screening tool for depression in patients with chronic hepatitis C. Dig Dis Sci. 53:1100–1106. 2008. View Article : Google Scholar : PubMed/NCBI
18	Armstrong AR, Herrmann SE, Chassany O, Lalanne C, Da Silva MH, Galano E, Carrieri PM, Estellon V, Sogni P and Duracinsky M: The International development of PROQOL-HCV: An instrument to assess the health-related quality of life of patients treated for Hepatitis C virus. BMC Infect Dis. 16:4432016. View Article : Google Scholar : PubMed/NCBI
19	Younossi Z, Park H, Henry L, Adeyemi A and Stepanova M: Extrahepatic manifestations of hepatitis C: A meta-analysis of prevalence, quality of life and economic burden. Gastroenterology. 150:1599–1608. 2016. View Article : Google Scholar : PubMed/NCBI
20	Sockalingam S, Blank D, Banga CA, Mason K, Dodd Z and Powis J: A novel program for treating patients with trimorbidity: Hepatitis C, serious mental illness and active substance use. Eur J Gastroenterol Hepatol. 25:1377–1384. 2013. View Article : Google Scholar : PubMed/NCBI
21	Younossi ZM, Stepanova M, Afdhal N, Kowdley KV, Zeuzem S, Henry L, Hunt SL and Marcellin P: Improvement of health-related quality of life and work productivity in chronic hepatitis C patients with early and advanced fibrosis treated with ledipasvir and sofosbuvir. J Hepatol. 63:337–345. 2015. View Article : Google Scholar : PubMed/NCBI
22	Younossi ZM, Stepanova M, Omata M, Mizokami M, Walters M and Hunt S: Quality of life of Japanese patients with chronic hepatitis C treated with ledipasvir and sofosbuvir. Medicine (Baltimore). 95:e42432016. View Article : Google Scholar : PubMed/NCBI
23	Younossi ZM, Stepanova M, Chan HL, Lee MH, Yu Ml, Dan YY, Choi MS and Henry L: Patient-reported outcomes in asian patients with chronic hepatitis C treated with ledipasvir and sofosbuvir. Medicine (Baltimore). 95:e27022016. View Article : Google Scholar : PubMed/NCBI
24	Tang LS, Masur J, Sims Z, Nelson A, Osinusi A, Kohli A, Kattakuzhy S, Polis M and Kottilil S: Safe and effective sofosbuvir-based therapy in patients with mental health disease on hepatitis C virus treatment. World J Hepatol. 8:1318–1326. 2016. View Article : Google Scholar : PubMed/NCBI
25	Ichikawa T, Miyaaki H, Miuma S, Taura N, Motoyoshi Y, Akahoshi H, Nakamura S, Nakamura J, Takahashi Y, Honda T, et al: Hepatitis C virus-related symptoms, but not quality of life, were improved by treatment with direct-acting antivirals. Hepatol Res. 48:E232–E239. 2018. View Article : Google Scholar : PubMed/NCBI
26	Kawakubo M, Eguchi Y, Okada M, Iwane S, Oeda S, Otsuka T, Nakashita S, Araki N and Koga A: Chronic hepatitis c treatment with daclatasvir plus asunaprevir does not lead to a decreased quality of life. Intern Med. 2018.doi: 10.2169/internalmedicine.0091-17. View Article : Google Scholar