Subgroup differences in response to 8 weeks of ledipasvir/sofosbuvir for chronic hepatitis C

doi:10.1093/ofid/ofu110

. 2014 Dec 13;1(3):ofu110.

doi: 10.1093/ofid/ofu110. eCollection 2014 Dec.

Subgroup differences in response to 8 weeks of ledipasvir/sofosbuvir for chronic hepatitis C

Thomas R O'Brien¹, Krystle A Lang Kuhs¹, Ruth M Pfeiffer²

Affiliations

¹ Infections and Immunoepidemiology Branch .
² Biostatistics Branch, Division of Cancer Epidemiology and Genetics , National Cancer Institute , Bethesda, Maryland.

PMID: 25734178
PMCID: PMC4324232
DOI: 10.1093/ofid/ofu110

Subgroup differences in response to 8 weeks of ledipasvir/sofosbuvir for chronic hepatitis C

Thomas R O'Brien et al. Open Forum Infect Dis. 2014.

. 2014 Dec 13;1(3):ofu110.

doi: 10.1093/ofid/ofu110. eCollection 2014 Dec.

Authors

Thomas R O'Brien¹, Krystle A Lang Kuhs¹, Ruth M Pfeiffer²

Affiliations

¹ Infections and Immunoepidemiology Branch .
² Biostatistics Branch, Division of Cancer Epidemiology and Genetics , National Cancer Institute , Bethesda, Maryland.

PMID: 25734178
PMCID: PMC4324232
DOI: 10.1093/ofid/ofu110

Abstract

Treatment of hepatitis C virus (HCV) infection with ledipasvir/sofosbuvir promises tremendous benefits, but high cost may impede implementation of this regimen. Subgroups with excellent response to 8 weeks of treatment might respond to a shorter course. In ION-3, 423 previously untreated HCV genotype 1-infected patients without cirrhosis had outcome data after receiving ledipasvir/sofosbuvir for 8 weeks. After reanalyzing published ION-3 data, we found that sustained virologic response (SVR) rates varied significantly by gender (P = .002) and rs12979860 genotype (P trend = .03), exceeding 98% in women and rs12979860-CC individuals. The very high SVR rates in these subgroups suggest that these factors might be considered in selecting patients to receive 8 weeks of ledipasvir/sofosbuvir and support shorter trials of this regimen in selected patients.

Keywords: IFNL4; clinical trial; cost-effectiveness; direct-acting antiviral agents; gender; hepatitis C virus.

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References

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[1] Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370:1879–88. - PubMed

[2] Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370:1879–88. - PubMed

[3] Hoofnagle JH, Sherker AH. Therapy for hepatitis C—the costs of success. N Engl J Med. 2014;370:1552–3. - PubMed

[4] Hoofnagle JH, Sherker AH. Therapy for hepatitis C—the costs of success. N Engl J Med. 2014;370:1552–3. - PubMed

[5] Alshurafa M, Briel M, Akl EA, et al. Inconsistent definitions for intention-to-treat in relation to missing outcome data: systematic review of the methods literature. PLoS One. 2012;7:e49163. - PMC - PubMed

[6] Alshurafa M, Briel M, Akl EA, et al. Inconsistent definitions for intention-to-treat in relation to missing outcome data: systematic review of the methods literature. PLoS One. 2012;7:e49163. - PMC - PubMed

[7] White IR, Horton NJ, Carpenter J, et al. Strategy for intention to treat analysis in randomised trials with missing outcome data. BMJ. 2011;342:d40. - PMC - PubMed

[8] White IR, Horton NJ, Carpenter J, et al. Strategy for intention to treat analysis in randomised trials with missing outcome data. BMJ. 2011;342:d40. - PMC - PubMed

[9] Zeuzem S, Soriano V, Asselah T, et al. Faldaprevir and deleobuvir for HCV genotype 1 infection. N Engl J Med. 2013;369:630–9. - PubMed

[10] Zeuzem S, Soriano V, Asselah T, et al. Faldaprevir and deleobuvir for HCV genotype 1 infection. N Engl J Med. 2013;369:630–9. - PubMed

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Subgroup differences in response to 8 weeks of ledipasvir/sofosbuvir for chronic hepatitis C

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Subgroup differences in response to 8 weeks of ledipasvir/sofosbuvir for chronic hepatitis C

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