TY - JOUR
T1 - Effectiveness of Direct-Acting Antiviral Therapy in Patients with Human Immunodeficiency Virus-Hepatitis C Virus Coinfection in Routine Clinical Care
T2 - A Multicenter Study
AU - Kim, H. Nina
AU - Nance, Robin M.
AU - Williams-Nguyen, Jessica S.
AU - Chris Delaney, J. A.
AU - Crane, Heidi M.
AU - Cachay, Edward R.
AU - Martin, Jeffrey
AU - Mathews, W. Christopher
AU - Chander, Geetanjali
AU - Franco, Ricardo
AU - Hurt, Christopher B.
AU - Geng, Elvin H.
AU - Rodriguez, Benigno
AU - Moore, Richard D.
AU - Saag, Michael S.
AU - Kitahata, Mari M.
N1 - Funding Information:
Financial support. This work was supported by the National Institute of Allergy and Infectious Diseases (grantsR24 AI067039 and P30 AI027757) and the National Institute on Alcohol Abuse and Alcoholism (grant U01 AA020793), National Institutes of Health. Potential conflicts of interest. H. M. C. has received grant support from ViiV. E. R. C. has received grant support from Merck and Gilead Sciences and has served on the speaker’s bureau for Gilead Sciences. R. F. has received grant support from Gilead Sciences, Merck, and Janssen; he has also received consulting fees from Gilead Sciences and Bristol-Myers Squibb. C. B. H. has received research funding from AbbVie. B. R. has received personal fees from Gilead and ViiV. R. D. M. has received personal fees from Medscape. M. S. S. has received grant support as well as fees for service as a consultant/scientific advisor for Bristol-Myers Squibb, Merck, and ViiV. All other authors report no potential conflicts. All authors have submitted ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
Publisher Copyright:
© The Author(s) 2019. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
PY - 2019/3/23
Y1 - 2019/3/23
N2 - Background Direct-acting antiviral (DAA) therapy have been shown to be highly successful in clinical trials and observational studies, but less is known about treatment success in patients with a high burden of comorbid conditions, including mental health and substance use disorders. We evaluated DAA effectiveness across a broad spectrum of patients with human immunodeficiency virus (HIV)-hepatitis C virus (HCV) coinfection in routine clinical care, including those with psychosocial comorbid conditions. Methods The primary end point was sustained virologic response (SVR), defined as HCV RNA not detected or <25 IU/mL ≥10 weeks after treatment. We calculated SVR rates and 95% confidence intervals (CIs) in a modified intent-to-treat analysis. We repeated this analysis after multiply imputing missing SVR values. Results Among 642 DAA-treated patients, 536 had SVR assessments. The median age was 55 years; 79% were men, 59% black, and 32% white. Cirrhosis (fibrosis-4 index>3.25) was present in 24%, and 17% were interferon treatment experienced; 96% had genotype 1 infection and 432 (81%) had received ledipasvir-sofosbuvir. SVR occurred in 96.5% (95% CI, 94.5%-97.9%). Patients who were black, treatment experienced, or cirrhotic all had SVR rates >95%. Patients with depression and/or anxiety, psychotic disorder, illicit drug use, or alcohol use disorder also had high SVR rates, ranging from 95.4% to 96.8%. The only factor associated with lower SVR rate was early discontinuation (77.8%; 95% CI, 52.4%-93.6%). Similar results were seen in multiply imputed data sets. Conclusions Our study represents a large multicenter examination of DAA therapy in HIV/HCV-coinfected patients. The broad treatment success we observed across this diverse group of patients with significant comorbid conditions is highly affirming and argues for widespread implementation of DAA therapy.
AB - Background Direct-acting antiviral (DAA) therapy have been shown to be highly successful in clinical trials and observational studies, but less is known about treatment success in patients with a high burden of comorbid conditions, including mental health and substance use disorders. We evaluated DAA effectiveness across a broad spectrum of patients with human immunodeficiency virus (HIV)-hepatitis C virus (HCV) coinfection in routine clinical care, including those with psychosocial comorbid conditions. Methods The primary end point was sustained virologic response (SVR), defined as HCV RNA not detected or <25 IU/mL ≥10 weeks after treatment. We calculated SVR rates and 95% confidence intervals (CIs) in a modified intent-to-treat analysis. We repeated this analysis after multiply imputing missing SVR values. Results Among 642 DAA-treated patients, 536 had SVR assessments. The median age was 55 years; 79% were men, 59% black, and 32% white. Cirrhosis (fibrosis-4 index>3.25) was present in 24%, and 17% were interferon treatment experienced; 96% had genotype 1 infection and 432 (81%) had received ledipasvir-sofosbuvir. SVR occurred in 96.5% (95% CI, 94.5%-97.9%). Patients who were black, treatment experienced, or cirrhotic all had SVR rates >95%. Patients with depression and/or anxiety, psychotic disorder, illicit drug use, or alcohol use disorder also had high SVR rates, ranging from 95.4% to 96.8%. The only factor associated with lower SVR rate was early discontinuation (77.8%; 95% CI, 52.4%-93.6%). Similar results were seen in multiply imputed data sets. Conclusions Our study represents a large multicenter examination of DAA therapy in HIV/HCV-coinfected patients. The broad treatment success we observed across this diverse group of patients with significant comorbid conditions is highly affirming and argues for widespread implementation of DAA therapy.
KW - HIV
KW - direct-acting antiviral
KW - hepatitis C virus
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U2 - 10.1093/ofid/ofz100
DO - 10.1093/ofid/ofz100
M3 - Article
C2 - 30949539
AN - SCOPUS:85064139075
SN - 2328-8957
VL - 6
JO - Open Forum Infectious Diseases
JF - Open Forum Infectious Diseases
IS - 4
ER -