Sofosbuvir and Velpatasvir combination is safe and effective in treating chronic hepatitis C in end‐stage renal disease on maintenance haemodialysis
Background & Aims There is emerging data on the use of Sofosbuvir‐based directly acting antiviral (DAA) drug regimens in chronic hepatitis C (CHC) patients with end‐stage renal disease (ESRD) on maintenance haemodialysis (MHD). We evaluated the safety and efficacy of Sofosbuvir plus Velpatasvir...
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| Veröffentlicht in: | Liver international 2021-04, Vol.41 (4), p.705-709 |
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| creator | Taneja, Sunil Duseja, Ajay Mehta, Manu De, Arka Verma, Nipun Premkumar, Madhumita Dhiman, Radha K. Singh, Virendra Singh, Mini P. Ratho, Radha K. Ramachandran, Raja Kumar, Vivek Kohli, Harbir S. |
| description | Background & Aims
There is emerging data on the use of Sofosbuvir‐based directly acting antiviral (DAA) drug regimens in chronic hepatitis C (CHC) patients with end‐stage renal disease (ESRD) on maintenance haemodialysis (MHD). We evaluated the safety and efficacy of Sofosbuvir plus Velpatasvir fixed‐dose combination in CHC patients with ESRD on MHD.
Methods
Fifty‐one CHC patients with ESRD on MHD were included in a real‐life prospective study. All patients irrespective of genotype; presence of cirrhosis; treatment naive or experienced status were treated with full‐dose Sofosbuvir (400 mg) plus Velpatasvir (100 mg) fixed‐dosed combination given daily for 12 weeks. The efficacy was assessed by the sustained virological response (SVR12) with negative HCV RNA 12 weeks after the end of treatment (ETR). Side effects if any were recorded in all patients.
Results
The median HCV RNA level in 51 CHC patients [Males 41 (80.4%), mean age 42.8 ± 14.6 years] was 2.0 × 106 IU/mL. HCV genotype was available in 19 patients with predominant genotype 1 in 15 (79%) patients. Ten (19.6%) patients had evidence of cirrhosis (defined as LSM ≥ 12.5 kPa on Transient Elastography), and 8 (15.6%) patients were treatment experienced. Testing for ETR was done in 36 patients and all 36 (100%) patients achieved ETR, and 49 patients (96%) achieved SVR 12. All 51 patients tolerated the Sofosbuvir + Velpatasvir combination, with none of the patients reporting any serious adverse event.
Conclusion
Sofosbuvir plus Velpatasvir fixed‐dose combination is safe and effective in treating CHC in patients with ESRD on MHD. |
| doi_str_mv | 10.1111/liv.14685 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2449180383</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2449180383</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4195-d00028101a8bd96be4e912233329553794fe66cc73d2d3dc44d6f8572579e1e73</originalsourceid><addsrcrecordid>eNp10btuFDEUBmALgUgIFLwAskQDxSa-zoxLtIIQaSUKIO3IY5_JOpqxF5-ZjbbLI6TiAfMkeLMhBRJufPv8S9ZPyFvOTnkZZ0PYnnJVNfoZOeaqbhZSSP78aS3kEXmFeM0YN0bzl-RISiZ08cfk9_fUJ-zmbcjURk8vYdjYyeJ-79LYhWinkCINSNH28GCg78FNYQs0RDplKCJeUbfOKQZH11ACwlQeLPf3EP397R1O9gpohmgH6gOCRaAldbQhTuUwOqBrC2PywQ47DPiavOjtgPDmcT4hP798_rH8ulh9O79YflotnOJGLzxjTDSccdt03lQdKDC8_FdKYbSWtVE9VJVztfTCS--U8lXf6Fro2gCHWp6QD4fcTU6_ZsCpHQM6GAYbIc3YCqUMb5hsZKHv_6HXac7lQ0VpJoSoTa2K-nhQLifEDH27yWG0eddy1u7LaktZ7UNZxb57TJy7EfyT_NtOAWcHcBMG2P0_qV1dXB4i_wD8s6B7</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2502227974</pqid></control><display><type>article</type><title>Sofosbuvir and Velpatasvir combination is safe and effective in treating chronic hepatitis C in end‐stage renal disease on maintenance haemodialysis</title><source>Wiley Online Library Journals【Remote access available】</source><creator>Taneja, Sunil ; Duseja, Ajay ; Mehta, Manu ; De, Arka ; Verma, Nipun ; Premkumar, Madhumita ; Dhiman, Radha K. ; Singh, Virendra ; Singh, Mini P. ; Ratho, Radha K. ; Ramachandran, Raja ; Kumar, Vivek ; Kohli, Harbir S.</creator><creatorcontrib>Taneja, Sunil ; Duseja, Ajay ; Mehta, Manu ; De, Arka ; Verma, Nipun ; Premkumar, Madhumita ; Dhiman, Radha K. ; Singh, Virendra ; Singh, Mini P. ; Ratho, Radha K. ; Ramachandran, Raja ; Kumar, Vivek ; Kohli, Harbir S.</creatorcontrib><description>Background & Aims
There is emerging data on the use of Sofosbuvir‐based directly acting antiviral (DAA) drug regimens in chronic hepatitis C (CHC) patients with end‐stage renal disease (ESRD) on maintenance haemodialysis (MHD). We evaluated the safety and efficacy of Sofosbuvir plus Velpatasvir fixed‐dose combination in CHC patients with ESRD on MHD.
Methods
Fifty‐one CHC patients with ESRD on MHD were included in a real‐life prospective study. All patients irrespective of genotype; presence of cirrhosis; treatment naive or experienced status were treated with full‐dose Sofosbuvir (400 mg) plus Velpatasvir (100 mg) fixed‐dosed combination given daily for 12 weeks. The efficacy was assessed by the sustained virological response (SVR12) with negative HCV RNA 12 weeks after the end of treatment (ETR). Side effects if any were recorded in all patients.
Results
The median HCV RNA level in 51 CHC patients [Males 41 (80.4%), mean age 42.8 ± 14.6 years] was 2.0 × 106 IU/mL. HCV genotype was available in 19 patients with predominant genotype 1 in 15 (79%) patients. Ten (19.6%) patients had evidence of cirrhosis (defined as LSM ≥ 12.5 kPa on Transient Elastography), and 8 (15.6%) patients were treatment experienced. Testing for ETR was done in 36 patients and all 36 (100%) patients achieved ETR, and 49 patients (96%) achieved SVR 12. All 51 patients tolerated the Sofosbuvir + Velpatasvir combination, with none of the patients reporting any serious adverse event.
Conclusion
Sofosbuvir plus Velpatasvir fixed‐dose combination is safe and effective in treating CHC in patients with ESRD on MHD.</description><identifier>ISSN: 1478-3223</identifier><identifier>EISSN: 1478-3231</identifier><identifier>DOI: 10.1111/liv.14685</identifier><identifier>PMID: 33025685</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Adverse events ; chronic kidney disease ; Cirrhosis ; directly acting antivirals ; Dosage ; Genotype & phenotype ; Genotypes ; Hemodialysis ; Hepatitis ; Hepatitis C ; hepatitis C virus ; Interferon ; Kidney diseases ; Liver cirrhosis ; Maintenance ; renal failure ; Side effects</subject><ispartof>Liver international, 2021-04, Vol.41 (4), p.705-709</ispartof><rights>2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd</rights><rights>2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.</rights><rights>2021 John Wiley & Sons A/S</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4195-d00028101a8bd96be4e912233329553794fe66cc73d2d3dc44d6f8572579e1e73</citedby><cites>FETCH-LOGICAL-c4195-d00028101a8bd96be4e912233329553794fe66cc73d2d3dc44d6f8572579e1e73</cites><orcidid>0000-0002-9113-5167 ; 0000-0003-3901-6969 ; 0000-0003-3590-2664 ; 0000-0003-4328-0914</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fliv.14685$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fliv.14685$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1416,27922,27923,45572,45573</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33025685$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Taneja, Sunil</creatorcontrib><creatorcontrib>Duseja, Ajay</creatorcontrib><creatorcontrib>Mehta, Manu</creatorcontrib><creatorcontrib>De, Arka</creatorcontrib><creatorcontrib>Verma, Nipun</creatorcontrib><creatorcontrib>Premkumar, Madhumita</creatorcontrib><creatorcontrib>Dhiman, Radha K.</creatorcontrib><creatorcontrib>Singh, Virendra</creatorcontrib><creatorcontrib>Singh, Mini P.</creatorcontrib><creatorcontrib>Ratho, Radha K.</creatorcontrib><creatorcontrib>Ramachandran, Raja</creatorcontrib><creatorcontrib>Kumar, Vivek</creatorcontrib><creatorcontrib>Kohli, Harbir S.</creatorcontrib><title>Sofosbuvir and Velpatasvir combination is safe and effective in treating chronic hepatitis C in end‐stage renal disease on maintenance haemodialysis</title><title>Liver international</title><addtitle>Liver Int</addtitle><description>Background & Aims
There is emerging data on the use of Sofosbuvir‐based directly acting antiviral (DAA) drug regimens in chronic hepatitis C (CHC) patients with end‐stage renal disease (ESRD) on maintenance haemodialysis (MHD). We evaluated the safety and efficacy of Sofosbuvir plus Velpatasvir fixed‐dose combination in CHC patients with ESRD on MHD.
Methods
Fifty‐one CHC patients with ESRD on MHD were included in a real‐life prospective study. All patients irrespective of genotype; presence of cirrhosis; treatment naive or experienced status were treated with full‐dose Sofosbuvir (400 mg) plus Velpatasvir (100 mg) fixed‐dosed combination given daily for 12 weeks. The efficacy was assessed by the sustained virological response (SVR12) with negative HCV RNA 12 weeks after the end of treatment (ETR). Side effects if any were recorded in all patients.
Results
The median HCV RNA level in 51 CHC patients [Males 41 (80.4%), mean age 42.8 ± 14.6 years] was 2.0 × 106 IU/mL. HCV genotype was available in 19 patients with predominant genotype 1 in 15 (79%) patients. Ten (19.6%) patients had evidence of cirrhosis (defined as LSM ≥ 12.5 kPa on Transient Elastography), and 8 (15.6%) patients were treatment experienced. Testing for ETR was done in 36 patients and all 36 (100%) patients achieved ETR, and 49 patients (96%) achieved SVR 12. All 51 patients tolerated the Sofosbuvir + Velpatasvir combination, with none of the patients reporting any serious adverse event.
Conclusion
Sofosbuvir plus Velpatasvir fixed‐dose combination is safe and effective in treating CHC in patients with ESRD on MHD.</description><subject>Adverse events</subject><subject>chronic kidney disease</subject><subject>Cirrhosis</subject><subject>directly acting antivirals</subject><subject>Dosage</subject><subject>Genotype & phenotype</subject><subject>Genotypes</subject><subject>Hemodialysis</subject><subject>Hepatitis</subject><subject>Hepatitis C</subject><subject>hepatitis C virus</subject><subject>Interferon</subject><subject>Kidney diseases</subject><subject>Liver cirrhosis</subject><subject>Maintenance</subject><subject>renal failure</subject><subject>Side effects</subject><issn>1478-3223</issn><issn>1478-3231</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp10btuFDEUBmALgUgIFLwAskQDxSa-zoxLtIIQaSUKIO3IY5_JOpqxF5-ZjbbLI6TiAfMkeLMhBRJufPv8S9ZPyFvOTnkZZ0PYnnJVNfoZOeaqbhZSSP78aS3kEXmFeM0YN0bzl-RISiZ08cfk9_fUJ-zmbcjURk8vYdjYyeJ-79LYhWinkCINSNH28GCg78FNYQs0RDplKCJeUbfOKQZH11ACwlQeLPf3EP397R1O9gpohmgH6gOCRaAldbQhTuUwOqBrC2PywQ47DPiavOjtgPDmcT4hP798_rH8ulh9O79YflotnOJGLzxjTDSccdt03lQdKDC8_FdKYbSWtVE9VJVztfTCS--U8lXf6Fro2gCHWp6QD4fcTU6_ZsCpHQM6GAYbIc3YCqUMb5hsZKHv_6HXac7lQ0VpJoSoTa2K-nhQLifEDH27yWG0eddy1u7LaktZ7UNZxb57TJy7EfyT_NtOAWcHcBMG2P0_qV1dXB4i_wD8s6B7</recordid><startdate>202104</startdate><enddate>202104</enddate><creator>Taneja, Sunil</creator><creator>Duseja, Ajay</creator><creator>Mehta, Manu</creator><creator>De, Arka</creator><creator>Verma, Nipun</creator><creator>Premkumar, Madhumita</creator><creator>Dhiman, Radha K.</creator><creator>Singh, Virendra</creator><creator>Singh, Mini P.</creator><creator>Ratho, Radha K.</creator><creator>Ramachandran, Raja</creator><creator>Kumar, Vivek</creator><creator>Kohli, Harbir S.</creator><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QO</scope><scope>7T5</scope><scope>7U9</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-9113-5167</orcidid><orcidid>https://orcid.org/0000-0003-3901-6969</orcidid><orcidid>https://orcid.org/0000-0003-3590-2664</orcidid><orcidid>https://orcid.org/0000-0003-4328-0914</orcidid></search><sort><creationdate>202104</creationdate><title>Sofosbuvir and Velpatasvir combination is safe and effective in treating chronic hepatitis C in end‐stage renal disease on maintenance haemodialysis</title><author>Taneja, Sunil ; Duseja, Ajay ; Mehta, Manu ; De, Arka ; Verma, Nipun ; Premkumar, Madhumita ; Dhiman, Radha K. ; Singh, Virendra ; Singh, Mini P. ; Ratho, Radha K. ; Ramachandran, Raja ; Kumar, Vivek ; Kohli, Harbir S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4195-d00028101a8bd96be4e912233329553794fe66cc73d2d3dc44d6f8572579e1e73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adverse events</topic><topic>chronic kidney disease</topic><topic>Cirrhosis</topic><topic>directly acting antivirals</topic><topic>Dosage</topic><topic>Genotype & phenotype</topic><topic>Genotypes</topic><topic>Hemodialysis</topic><topic>Hepatitis</topic><topic>Hepatitis C</topic><topic>hepatitis C virus</topic><topic>Interferon</topic><topic>Kidney diseases</topic><topic>Liver cirrhosis</topic><topic>Maintenance</topic><topic>renal failure</topic><topic>Side effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Taneja, Sunil</creatorcontrib><creatorcontrib>Duseja, Ajay</creatorcontrib><creatorcontrib>Mehta, Manu</creatorcontrib><creatorcontrib>De, Arka</creatorcontrib><creatorcontrib>Verma, Nipun</creatorcontrib><creatorcontrib>Premkumar, Madhumita</creatorcontrib><creatorcontrib>Dhiman, Radha K.</creatorcontrib><creatorcontrib>Singh, Virendra</creatorcontrib><creatorcontrib>Singh, Mini P.</creatorcontrib><creatorcontrib>Ratho, Radha K.</creatorcontrib><creatorcontrib>Ramachandran, Raja</creatorcontrib><creatorcontrib>Kumar, Vivek</creatorcontrib><creatorcontrib>Kohli, Harbir S.</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Biotechnology Research Abstracts</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Liver international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Taneja, Sunil</au><au>Duseja, Ajay</au><au>Mehta, Manu</au><au>De, Arka</au><au>Verma, Nipun</au><au>Premkumar, Madhumita</au><au>Dhiman, Radha K.</au><au>Singh, Virendra</au><au>Singh, Mini P.</au><au>Ratho, Radha K.</au><au>Ramachandran, Raja</au><au>Kumar, Vivek</au><au>Kohli, Harbir S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Sofosbuvir and Velpatasvir combination is safe and effective in treating chronic hepatitis C in end‐stage renal disease on maintenance haemodialysis</atitle><jtitle>Liver international</jtitle><addtitle>Liver Int</addtitle><date>2021-04</date><risdate>2021</risdate><volume>41</volume><issue>4</issue><spage>705</spage><epage>709</epage><pages>705-709</pages><issn>1478-3223</issn><eissn>1478-3231</eissn><abstract>Background & Aims
There is emerging data on the use of Sofosbuvir‐based directly acting antiviral (DAA) drug regimens in chronic hepatitis C (CHC) patients with end‐stage renal disease (ESRD) on maintenance haemodialysis (MHD). We evaluated the safety and efficacy of Sofosbuvir plus Velpatasvir fixed‐dose combination in CHC patients with ESRD on MHD.
Methods
Fifty‐one CHC patients with ESRD on MHD were included in a real‐life prospective study. All patients irrespective of genotype; presence of cirrhosis; treatment naive or experienced status were treated with full‐dose Sofosbuvir (400 mg) plus Velpatasvir (100 mg) fixed‐dosed combination given daily for 12 weeks. The efficacy was assessed by the sustained virological response (SVR12) with negative HCV RNA 12 weeks after the end of treatment (ETR). Side effects if any were recorded in all patients.
Results
The median HCV RNA level in 51 CHC patients [Males 41 (80.4%), mean age 42.8 ± 14.6 years] was 2.0 × 106 IU/mL. HCV genotype was available in 19 patients with predominant genotype 1 in 15 (79%) patients. Ten (19.6%) patients had evidence of cirrhosis (defined as LSM ≥ 12.5 kPa on Transient Elastography), and 8 (15.6%) patients were treatment experienced. Testing for ETR was done in 36 patients and all 36 (100%) patients achieved ETR, and 49 patients (96%) achieved SVR 12. All 51 patients tolerated the Sofosbuvir + Velpatasvir combination, with none of the patients reporting any serious adverse event.
Conclusion
Sofosbuvir plus Velpatasvir fixed‐dose combination is safe and effective in treating CHC in patients with ESRD on MHD.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>33025685</pmid><doi>10.1111/liv.14685</doi><tpages>5</tpages><orcidid>https://orcid.org/0000-0002-9113-5167</orcidid><orcidid>https://orcid.org/0000-0003-3901-6969</orcidid><orcidid>https://orcid.org/0000-0003-3590-2664</orcidid><orcidid>https://orcid.org/0000-0003-4328-0914</orcidid></addata></record> |
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| ispartof | Liver international, 2021-04, Vol.41 (4), p.705-709 |
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| source | Wiley Online Library Journals【Remote access available】 |
| subjects | Adverse events chronic kidney disease Cirrhosis directly acting antivirals Dosage Genotype & phenotype Genotypes Hemodialysis Hepatitis Hepatitis C hepatitis C virus Interferon Kidney diseases Liver cirrhosis Maintenance renal failure Side effects |
| title | Sofosbuvir and Velpatasvir combination is safe and effective in treating chronic hepatitis C in end‐stage renal disease on maintenance haemodialysis |
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