Tolerable and curable treatment in HIV/HCV co-infected patients using anti-HCV direct antiviral agents: a real-world observation in China

Objective No brand direct-acting antiviral agents (DAAs) are available for treatment of HIV-1/HCV co-infected patients in China. This study aimed to observe the therapeutic efficacy and safety of generic DAAs for affected Chinese patients. Design Real-world setting to elucidate whether DAAs were tol...

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Veröffentlicht in:Hepatology international 2018-09, Vol.12 (5), p.465-473
Hauptverfasser: Li, Yuanyuan, Li, Linghua, Liu, Jun, Zhang, Da-Wei, Zhao, Fang, Wang, Li, Mahemure, Aizezi, Xie, Ronghui, Lei, Suyun, Cai, Weiping, Wang, Xicheng, Shu, Zhanjun, Chen, Xiejie, Wang, Hui, Wang, Fu-Sheng
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container_end_page 473
container_issue 5
container_start_page 465
container_title Hepatology international
container_volume 12
creator Li, Yuanyuan
Li, Linghua
Liu, Jun
Zhang, Da-Wei
Zhao, Fang
Wang, Li
Mahemure, Aizezi
Xie, Ronghui
Lei, Suyun
Cai, Weiping
Wang, Xicheng
Shu, Zhanjun
Chen, Xiejie
Wang, Hui
Wang, Fu-Sheng
description Objective No brand direct-acting antiviral agents (DAAs) are available for treatment of HIV-1/HCV co-infected patients in China. This study aimed to observe the therapeutic efficacy and safety of generic DAAs for affected Chinese patients. Design Real-world setting to elucidate whether DAAs were tolerated and effective in HIV-1/HCV co-infected patients. Methods 176 HIV-1/HCV co-infected patients received anti-HCV DAA treatment together with ART regimens for HIV infection. Among the 176 patients, 99 patients were treated with SOF + DCV ± RBV, 60 patients were treated with SOF + LDV ± RBV, and 17 patients received SOF + RBV ± Peg-IFN regimens, for 12 or 24 weeks, respectively. The primary endpoint was undetectable HCV RNA 12 weeks after therapy was completed (SVR12). Data pertaining to safety and adverse events were analyzed. Results 151/176 HIV-1/HCV co-infected patients finished the treatment and 12-week follow-up. SVR12 for the patients treated with regimens of SOF + DCV, SOF + DCV+RBV, SOF + Peg-IFN+RBV, SOF + RBV, SOF + LDV, and SOF + LDV+RBV for 12 or 24 weeks was 100% (75/75), 100% (11/11), 100% (14/14), 100% (2/2), 95.2% (40/42), and 100% (7/7), respectively. HIV-1/HCV co-infected patients with liver cirrhosis achieved well SRV12. Notably, there was no significant difference in adverse effects among patients with different baseline CD4 + T-cell count in those who received DAA regimens with or without Peg-IFN and RBV. Conclusion We showed generic SOF + DCV and SOF + LDV regimens were well tolerated and with high efficiency. Patient’s baseline CD4 + T-cell count did not exhibit significant difference in adverse effects.
doi_str_mv 10.1007/s12072-018-9891-9
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This study aimed to observe the therapeutic efficacy and safety of generic DAAs for affected Chinese patients. Design Real-world setting to elucidate whether DAAs were tolerated and effective in HIV-1/HCV co-infected patients. Methods 176 HIV-1/HCV co-infected patients received anti-HCV DAA treatment together with ART regimens for HIV infection. Among the 176 patients, 99 patients were treated with SOF + DCV ± RBV, 60 patients were treated with SOF + LDV ± RBV, and 17 patients received SOF + RBV ± Peg-IFN regimens, for 12 or 24 weeks, respectively. The primary endpoint was undetectable HCV RNA 12 weeks after therapy was completed (SVR12). Data pertaining to safety and adverse events were analyzed. Results 151/176 HIV-1/HCV co-infected patients finished the treatment and 12-week follow-up. SVR12 for the patients treated with regimens of SOF + DCV, SOF + DCV+RBV, SOF + Peg-IFN+RBV, SOF + RBV, SOF + LDV, and SOF + LDV+RBV for 12 or 24 weeks was 100% (75/75), 100% (11/11), 100% (14/14), 100% (2/2), 95.2% (40/42), and 100% (7/7), respectively. HIV-1/HCV co-infected patients with liver cirrhosis achieved well SRV12. Notably, there was no significant difference in adverse effects among patients with different baseline CD4 + T-cell count in those who received DAA regimens with or without Peg-IFN and RBV. Conclusion We showed generic SOF + DCV and SOF + LDV regimens were well tolerated and with high efficiency. Patient’s baseline CD4 + T-cell count did not exhibit significant difference in adverse effects.</description><identifier>ISSN: 1936-0533</identifier><identifier>EISSN: 1936-0541</identifier><identifier>DOI: 10.1007/s12072-018-9891-9</identifier><identifier>PMID: 30203381</identifier><language>eng</language><publisher>New Delhi: Springer India</publisher><subject>Adult ; Antiretroviral therapy ; Antiviral agents ; Antiviral Agents - therapeutic use ; Antiviral drugs ; CD4 antigen ; China ; Cirrhosis ; Coinfection - drug therapy ; Colorectal Surgery ; Drug Therapy, Combination ; Drugs, Generic - therapeutic use ; Female ; Follow-Up Studies ; Hepatitis C, Chronic - drug therapy ; Hepatology ; HIV ; HIV Infections - drug therapy ; HIV-1 ; Human immunodeficiency virus ; Humans ; Interferon ; Liver ; Liver cirrhosis ; Lymphocytes T ; Male ; Medicine ; Medicine &amp; Public Health ; Middle Aged ; Original Article ; Patients ; Retrospective Studies ; Ribonucleic acid ; RNA ; Safety ; Side effects ; Surgery ; Treatment Outcome</subject><ispartof>Hepatology international, 2018-09, Vol.12 (5), p.465-473</ispartof><rights>Asian Pacific Association for the Study of the Liver 2018</rights><rights>Hepatology International is a copyright of Springer, (2018). All Rights Reserved.</rights><rights>Asian Pacific Association for the Study of the Liver 2018.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c400t-67412f2fb9d155e61add1668cf60ceb44cd31941cdb4385700a4817b4e5989e03</citedby><cites>FETCH-LOGICAL-c400t-67412f2fb9d155e61add1668cf60ceb44cd31941cdb4385700a4817b4e5989e03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s12072-018-9891-9$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12072-018-9891-9$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30203381$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Li, Yuanyuan</creatorcontrib><creatorcontrib>Li, Linghua</creatorcontrib><creatorcontrib>Liu, Jun</creatorcontrib><creatorcontrib>Zhang, Da-Wei</creatorcontrib><creatorcontrib>Zhao, Fang</creatorcontrib><creatorcontrib>Wang, Li</creatorcontrib><creatorcontrib>Mahemure, Aizezi</creatorcontrib><creatorcontrib>Xie, Ronghui</creatorcontrib><creatorcontrib>Lei, Suyun</creatorcontrib><creatorcontrib>Cai, Weiping</creatorcontrib><creatorcontrib>Wang, Xicheng</creatorcontrib><creatorcontrib>Shu, Zhanjun</creatorcontrib><creatorcontrib>Chen, Xiejie</creatorcontrib><creatorcontrib>Wang, Hui</creatorcontrib><creatorcontrib>Wang, Fu-Sheng</creatorcontrib><title>Tolerable and curable treatment in HIV/HCV co-infected patients using anti-HCV direct antiviral agents: a real-world observation in China</title><title>Hepatology international</title><addtitle>Hepatol Int</addtitle><addtitle>Hepatol Int</addtitle><description>Objective No brand direct-acting antiviral agents (DAAs) are available for treatment of HIV-1/HCV co-infected patients in China. This study aimed to observe the therapeutic efficacy and safety of generic DAAs for affected Chinese patients. Design Real-world setting to elucidate whether DAAs were tolerated and effective in HIV-1/HCV co-infected patients. Methods 176 HIV-1/HCV co-infected patients received anti-HCV DAA treatment together with ART regimens for HIV infection. Among the 176 patients, 99 patients were treated with SOF + DCV ± RBV, 60 patients were treated with SOF + LDV ± RBV, and 17 patients received SOF + RBV ± Peg-IFN regimens, for 12 or 24 weeks, respectively. The primary endpoint was undetectable HCV RNA 12 weeks after therapy was completed (SVR12). Data pertaining to safety and adverse events were analyzed. Results 151/176 HIV-1/HCV co-infected patients finished the treatment and 12-week follow-up. SVR12 for the patients treated with regimens of SOF + DCV, SOF + DCV+RBV, SOF + Peg-IFN+RBV, SOF + RBV, SOF + LDV, and SOF + LDV+RBV for 12 or 24 weeks was 100% (75/75), 100% (11/11), 100% (14/14), 100% (2/2), 95.2% (40/42), and 100% (7/7), respectively. HIV-1/HCV co-infected patients with liver cirrhosis achieved well SRV12. Notably, there was no significant difference in adverse effects among patients with different baseline CD4 + T-cell count in those who received DAA regimens with or without Peg-IFN and RBV. Conclusion We showed generic SOF + DCV and SOF + LDV regimens were well tolerated and with high efficiency. Patient’s baseline CD4 + T-cell count did not exhibit significant difference in adverse effects.</description><subject>Adult</subject><subject>Antiretroviral therapy</subject><subject>Antiviral agents</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Antiviral drugs</subject><subject>CD4 antigen</subject><subject>China</subject><subject>Cirrhosis</subject><subject>Coinfection - drug therapy</subject><subject>Colorectal Surgery</subject><subject>Drug Therapy, Combination</subject><subject>Drugs, Generic - therapeutic use</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Hepatitis C, Chronic - drug therapy</subject><subject>Hepatology</subject><subject>HIV</subject><subject>HIV Infections - drug therapy</subject><subject>HIV-1</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Interferon</subject><subject>Liver</subject><subject>Liver cirrhosis</subject><subject>Lymphocytes T</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Middle Aged</subject><subject>Original Article</subject><subject>Patients</subject><subject>Retrospective Studies</subject><subject>Ribonucleic acid</subject><subject>RNA</subject><subject>Safety</subject><subject>Side effects</subject><subject>Surgery</subject><subject>Treatment Outcome</subject><issn>1936-0533</issn><issn>1936-0541</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kc9u1DAQxiMEomXhAbggS1y4mM74XxJuaEXZSpW4lF4tx3YWV1lnsZNWPAJvXYeUIiHByWPN7_tmNF9VvUZ4jwD1WUYGNaOADW2bFmn7pDrFlisKUuDTx5rzk-pFzjcAUipUz6sTDgw4b_C0-nk1Dj6ZbvDEREfsvNZT8mY6-DiREMnu4vpst70mdqQh9t5O3pGjmUJpZzLnEPdFOwW6MC6kAvz634ZkBmL2C_aBGFIsB3o3psGRscs-3RaLMS4Dtt9CNC-rZ70Zsn_18G6qr-efrrY7evnl88X24yW1AmCiqhbIetZ3rUMpvULjHCrV2F6B9Z0Q1nFsBVrXCd7IGsCIButOeFlu5IFvqner7zGN32efJ30I2fphMNGPc9YMgXEGbTnepnr7F3ozzimW7TRTrZQgGs7-SyGgqmXNFy9cKZvGnJPv9TGFg0k_NIJe0tRrmrqkqZc09aJ58-A8dwfvHhW_4ysAW4FcWnHv05_R_3a9B6S5qNQ</recordid><startdate>20180901</startdate><enddate>20180901</enddate><creator>Li, Yuanyuan</creator><creator>Li, Linghua</creator><creator>Liu, Jun</creator><creator>Zhang, Da-Wei</creator><creator>Zhao, Fang</creator><creator>Wang, Li</creator><creator>Mahemure, Aizezi</creator><creator>Xie, Ronghui</creator><creator>Lei, Suyun</creator><creator>Cai, Weiping</creator><creator>Wang, Xicheng</creator><creator>Shu, Zhanjun</creator><creator>Chen, Xiejie</creator><creator>Wang, Hui</creator><creator>Wang, Fu-Sheng</creator><general>Springer India</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7U7</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope></search><sort><creationdate>20180901</creationdate><title>Tolerable and curable treatment in HIV/HCV co-infected patients using anti-HCV direct antiviral agents: a real-world observation in China</title><author>Li, Yuanyuan ; Li, Linghua ; Liu, Jun ; Zhang, Da-Wei ; Zhao, Fang ; Wang, Li ; Mahemure, Aizezi ; Xie, Ronghui ; Lei, Suyun ; Cai, Weiping ; Wang, Xicheng ; Shu, Zhanjun ; Chen, Xiejie ; Wang, Hui ; Wang, Fu-Sheng</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c400t-67412f2fb9d155e61add1668cf60ceb44cd31941cdb4385700a4817b4e5989e03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Adult</topic><topic>Antiretroviral therapy</topic><topic>Antiviral agents</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Antiviral drugs</topic><topic>CD4 antigen</topic><topic>China</topic><topic>Cirrhosis</topic><topic>Coinfection - drug therapy</topic><topic>Colorectal Surgery</topic><topic>Drug Therapy, Combination</topic><topic>Drugs, Generic - therapeutic use</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Hepatitis C, Chronic - drug therapy</topic><topic>Hepatology</topic><topic>HIV</topic><topic>HIV Infections - drug therapy</topic><topic>HIV-1</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Interferon</topic><topic>Liver</topic><topic>Liver cirrhosis</topic><topic>Lymphocytes T</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Middle Aged</topic><topic>Original Article</topic><topic>Patients</topic><topic>Retrospective Studies</topic><topic>Ribonucleic acid</topic><topic>RNA</topic><topic>Safety</topic><topic>Side effects</topic><topic>Surgery</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Li, Yuanyuan</creatorcontrib><creatorcontrib>Li, Linghua</creatorcontrib><creatorcontrib>Liu, Jun</creatorcontrib><creatorcontrib>Zhang, Da-Wei</creatorcontrib><creatorcontrib>Zhao, Fang</creatorcontrib><creatorcontrib>Wang, Li</creatorcontrib><creatorcontrib>Mahemure, Aizezi</creatorcontrib><creatorcontrib>Xie, Ronghui</creatorcontrib><creatorcontrib>Lei, Suyun</creatorcontrib><creatorcontrib>Cai, Weiping</creatorcontrib><creatorcontrib>Wang, Xicheng</creatorcontrib><creatorcontrib>Shu, Zhanjun</creatorcontrib><creatorcontrib>Chen, Xiejie</creatorcontrib><creatorcontrib>Wang, Hui</creatorcontrib><creatorcontrib>Wang, Fu-Sheng</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing &amp; 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Allied Health Database (Alumni Edition)</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><jtitle>Hepatology international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Li, Yuanyuan</au><au>Li, Linghua</au><au>Liu, Jun</au><au>Zhang, Da-Wei</au><au>Zhao, Fang</au><au>Wang, Li</au><au>Mahemure, Aizezi</au><au>Xie, Ronghui</au><au>Lei, Suyun</au><au>Cai, Weiping</au><au>Wang, Xicheng</au><au>Shu, Zhanjun</au><au>Chen, Xiejie</au><au>Wang, Hui</au><au>Wang, Fu-Sheng</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Tolerable and curable treatment in HIV/HCV co-infected patients using anti-HCV direct antiviral agents: a real-world observation in China</atitle><jtitle>Hepatology international</jtitle><stitle>Hepatol Int</stitle><addtitle>Hepatol Int</addtitle><date>2018-09-01</date><risdate>2018</risdate><volume>12</volume><issue>5</issue><spage>465</spage><epage>473</epage><pages>465-473</pages><issn>1936-0533</issn><eissn>1936-0541</eissn><abstract>Objective No brand direct-acting antiviral agents (DAAs) are available for treatment of HIV-1/HCV co-infected patients in China. This study aimed to observe the therapeutic efficacy and safety of generic DAAs for affected Chinese patients. Design Real-world setting to elucidate whether DAAs were tolerated and effective in HIV-1/HCV co-infected patients. Methods 176 HIV-1/HCV co-infected patients received anti-HCV DAA treatment together with ART regimens for HIV infection. Among the 176 patients, 99 patients were treated with SOF + DCV ± RBV, 60 patients were treated with SOF + LDV ± RBV, and 17 patients received SOF + RBV ± Peg-IFN regimens, for 12 or 24 weeks, respectively. The primary endpoint was undetectable HCV RNA 12 weeks after therapy was completed (SVR12). Data pertaining to safety and adverse events were analyzed. Results 151/176 HIV-1/HCV co-infected patients finished the treatment and 12-week follow-up. SVR12 for the patients treated with regimens of SOF + DCV, SOF + DCV+RBV, SOF + Peg-IFN+RBV, SOF + RBV, SOF + LDV, and SOF + LDV+RBV for 12 or 24 weeks was 100% (75/75), 100% (11/11), 100% (14/14), 100% (2/2), 95.2% (40/42), and 100% (7/7), respectively. HIV-1/HCV co-infected patients with liver cirrhosis achieved well SRV12. Notably, there was no significant difference in adverse effects among patients with different baseline CD4 + T-cell count in those who received DAA regimens with or without Peg-IFN and RBV. Conclusion We showed generic SOF + DCV and SOF + LDV regimens were well tolerated and with high efficiency. Patient’s baseline CD4 + T-cell count did not exhibit significant difference in adverse effects.</abstract><cop>New Delhi</cop><pub>Springer India</pub><pmid>30203381</pmid><doi>10.1007/s12072-018-9891-9</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record>
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subjects Adult
Antiretroviral therapy
Antiviral agents
Antiviral Agents - therapeutic use
Antiviral drugs
CD4 antigen
China
Cirrhosis
Coinfection - drug therapy
Colorectal Surgery
Drug Therapy, Combination
Drugs, Generic - therapeutic use
Female
Follow-Up Studies
Hepatitis C, Chronic - drug therapy
Hepatology
HIV
HIV Infections - drug therapy
HIV-1
Human immunodeficiency virus
Humans
Interferon
Liver
Liver cirrhosis
Lymphocytes T
Male
Medicine
Medicine & Public Health
Middle Aged
Original Article
Patients
Retrospective Studies
Ribonucleic acid
RNA
Safety
Side effects
Surgery
Treatment Outcome
title Tolerable and curable treatment in HIV/HCV co-infected patients using anti-HCV direct antiviral agents: a real-world observation in China
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