Interferon-free DAA Research Articles

Alcohol consumption upon direct-acting antiviral therapy for hepatitis C among persons with human immunodeficiency virus in the United States

BackgroundDirect-acting antivirals (DAA) are highly effective against hepatitis C virus (HCV) infection among persons with human immunodeficiency virus (PWH). However, alcohol use post-DAA treatment poses a continued threat to the liver. Whether the focus on liver health alone during HCV treatment can impact alcohol consumption is unclear. Therefore, we examined the change in alcohol use among HCV-coinfected PWH who received DAA therapy by non-addiction medical providers. MethodsIn our longitudinal clinical cohort study, we identified HCV-coinfected PWH who received interferon-free DAA therapy between January 2014 and June 2019 in the Centers for AIDS Research Network of Integrated Clinical Systems. The Alcohol Use Disorders Identification Test—Consumption (AUDIT-C) was the alcohol screening instrument. We used mixed-effects logistic regression models to estimate the longitudinal change in alcohol use upon DAA therapy. ResultsAmong 738 HCV-coinfected PWH, 339 (46 %) reported any alcohol use at the end of HCV treatment, including 113 (15 %) with high-risk use (i.e., AUDIT-C ≥3 for women, ≥4 for men). Concurrently, 280 (38 %) PWH noted active drug use, and 357 (48 %) were currently smoking. We observed no changes in the odds of any alcohol or high-risk alcohol use over time with DAA therapy. Findings were similar in the PWH subgroup with a history of alcohol use before DAA treatment. ConclusionsFor PWH with HCV, alcohol use did not change following interferon-free DAA treatment by non-addiction medical providers. Thus, clinicians should consider integrating targeted alcohol use interventions into HCV care to motivate reduced alcohol consumption and safeguard future liver health.

Uptake of interferon-free DAA therapy among HCV-infected decompensated cirrhosis patients and evidence for decreased mortality.

Interferon-free DAA therapies have recently been licensed for patients infected with hepatitis C virus (HCV) who have decompensated cirrhosis (DC). Our aim was to describe factors associated with uptake of IFN-free DAAs in DC patients and to compare mortality risk and hospital admission rates between pre-DAA and DAA eras. This observational study used record-linkage between Scotland's HCV Clinical Database and national inpatient hospitalization and mortality registers. For the DAA uptake analysis, the study population (n=297) was restricted to patients alive on 1November 2014, and Cox regression was used to estimate uptake associated with various covariates. For the Cox regression of mortality comparing pre-DAA and DAA eras, the study population (n=624) comprised those diagnosed with DC in 2005-2018; follow-up was censored at two years. DAA uptake was 63% overall and was significantly higher for treatment-experienced patients (adjusted hazard ratio (aHR)=1.64, 95% CI:1.14-2.34), genotype 1 vs. other genotypes (aHR=1.55. 95% CI:1.15-2.10) and lower for persons diagnosed with DC pre-2014 (0.47, 95% CI:0.33-0.68) and in Greater Glasgow (0.64, 95% CI:0.47-0.88). The intention-to-treat SVR rate was 89% (95% CI:83-93%). All-cause and liver-related mortality risk were significantly reduced among patients diagnosed with DC in the DAA era (November 2014-December 2018) compared with the pre-DAA era (2005-October 2014) (aHRs of 0.68, 95% CI:0.49-0.93; 0.69, 95% CI:0.50-0.95, respectively); in contrast, hospital admission rates were higher in the DAA era (aRR=1.14, 95% CI:1.04-1.26). The majority of HCV-infected DC patients engaged with specialist services can be treated with IFN-free DAAs. Improved survival among patients diagnosed with DC in the DAA era supports the beneficial impact of IFN-free therapies among those with advanced liver disease.

Hepatitis C core antigen: a simple predictive marker for treatment response to the new direct-acting antiviral drugs in chronic HCV Egyptian patients

BackgroundSuccessful eradication of hepatitis C virus (HCV) has great impact on the prognosis of HCV-related complications and the associated mortality. The development of the new direct-acting antiviral drugs (DAAs) has revolutionized the treatment of HCV infection. HCV core antigen (HCVcAg) is a recently developed marker that displayed a good correlation with HCV RNA assays. Our main objectives were to correlate between serum levels of HCVcAg and HCV RNA loads in chronic HCV patients as well as to explore the potential value of HCVcAg assay in predicting treatment response to the new DAAs. The study enrolled a total of 280 chronic HCV-infected patients scheduled to start the new regimen for treatment of chronic HCV by all-oral, interferon-free DAAs. According to the viral load, the studied individuals were arranged into three groups corresponding to mild, moderate, and sever viremia. Serum level of HCVcAg was determined by ELISA technique and HCV RNA viral loads were quantified using the real-time PCR system. The assays were performed three times for all participants: prior to initiation of treatment, at the end of treatment (week 12), and 3 months post-treatment cessation (week 24).ResultsA statistically significant difference between HCV RNA and HCVcAg baseline levels among different viremia groups was detected (P < 0.001). There was a significant positive correlation between HCV RNA and HCVcAg baseline values among all the studied cases (P < 0.05) with a correlation coefficient of 0.752, 0.976, and 1.00 respectively for mild, moderate, and severe viremia groups. 92.9% (260/280) of the studied patients achieved sustained virologic response, 3.6% (10/280) were non-responders, and 3.6% (10/280) had recurrent viremia/relapse as regards RT-PCR results.ConclusionHCVcAg is a promising alternative to HCV RNA assay. The ELISAs for HCVcAg proved excellent correlations with HCV RNA levels. Moreover, HCVcAg can be introduced as a simple and highly specific tool for monitoring the new DAA regimens particularly in low-resource settings.

Chronic hepatitis C treatment in HIV co-infection in Portugal: Results from a cohort OF 2133 patients presented by GEPCOI (Portuguese Coinfection Study Group).

Direct‐acting antiviral drugs (DAAs) have recently changed the paradigm of hepatitis C therapy, significantly improving treatment response rates, patient life expectancy and quality of life. In Portugal, sofosbuvir (SOF) and SOF/ledipasvir (SOF/LDV) were fully reimbursed by the National Health System since early 2015 and generalized use of interferon‐free DAA based regimens became current practice. During 2016, the remaining DAAs were sequentially added and covered by the same health access policy. The Portuguese Study Group of Hepatitis and HIV Co‐infection (GEPCOI) collected data from 15 clinical centres in Portugal, pertaining to the HCV treatment experience with DAA regimens. A cohort of 2133 patients was analysed, representing one of the largest DAA treated HCV/HIV co‐infected individuals. The global sustained virologic response (SVR) achieved was 95% in this real‐life cohort setting. Linear regression analysis showed significant differences in treatment response rates when using SOF plus ribavirin (RBV) combination in genotype 2 or 3 infected individuals (P < .002) and in those with liver cirrhosis (P < .002). These findings corroborate that early treatment is mandatory in HIV/HCV co‐infected patients, as response rates may be negatively influenced by higher fibrosis stages and suboptimal DAA regimens. The current national Portuguese health policy should continue to promote wider treatment access and individualized therapy strategies, aiming at the elimination of HCV infection in this high‐risk co‐infected population.

Авиремическая низкоуровневая репликация RNA HCV в иммунных клетках крови PBMC/WBC (вторичная оккультная HCV-инфекция) как один из результатов первичной безинтерфероновой DAA-терапии в реальной клинической практике у ПВТ-наивных пациентов с хронической виремией RNA HCV (описание серии случаев)

Авиремическая низкоуровневая репликация RNA HCV в иммунных клетках крови PBMC/WBC (вторичная оккультная HCV-инфекция) как один из результатов первичной безинтерфероновой DAA-терапии в реальной клинической практике у ПВТ-наивных пациентов с хронической виремией RNA HCV (описание серии случаев)

The impact of a successful treatment of hepatitis C virus on glyco-metabolic control in diabetic patients: a systematic review and meta-analysis.

The effect of HCV eradication following the use of direct-acting antiviral drugs (DAAs) on the glyco-metabolic control is unknown. Through a meta-analysis of available clinical studies, we investigated whether eradication of HCV infection with interferon-free DAAs is associated with improved glyco-metabolic control in diabetic patients. We searched the PubMed, MEDLINE and Embase, up to 08th June 2018, for all studies evaluating whether eradication of HCV infection with DAAs is associated with changes in glycated haemoglobin (HbA1c) and fasting plasma glucose (FPG) levels from baseline in human subjects, without restrictions for study type and language. Data were independently extracted by two researchers using pre-specified forms. Random effects meta-analyses were conducted on HbA1c and FPG levels before/after HCV eradication. We found a significant mean reduction in HbA1c levels of - 0.45% (95% CI - 0.60 to - 0.30%; P < 0.001) and in FPG levels of - 22.03mg/dL (95% CI - 41.61 to - 2.44mg/dL; P = 0.03), with high heterogeneity between studies (χ2 = 20.4, P < 0.001, I2 = 80% and χ2 = 35.8, P = 0.001, I2 = 94%, respectively). The number of available manuscripts did not allow conducting a meta-regression to elucidate the role of sustained virological response and other confounders in determining the effect of direct-acting antiviral agents on HbA1c reduction. We found a significant improvement in glyco-metabolic control after HCV eradication (in terms of glycated haemoglobin and fasting plasma glucose levels reduction) following direct-acting antiviral treatment in patients with established diabetes, including a consequent positive impact on anti-diabetic therapies.

Editorial: interferon‐free DAAs are a great boon for patients with hepatitis C and cryoglobulinaemia

Linked ContentThis article is linked to Gragnani et al and Zignego et al papers. To view these articles visit https://doi.org/10.1111/apt.14845 and https://doi.org/10.1111/apt.14936.

FRI-406 - Changes in liver steatosis and lipid metabolism accompanied by successful interferon-free DAAs therapy in HCV infected patients; a comprehensive analysis

FRI-406 - Changes in liver steatosis and lipid metabolism accompanied by successful interferon-free DAAs therapy in HCV infected patients; a comprehensive analysis

Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe

All-oral direct-acting antiviral drugs (DAAs) for hepatitis C virus, which have response rates of 95% or more, represent a major clinical advance. However, the high list price of DAAs has led many governments to restrict their reimbursement. We reviewed the availability of, and national criteria for, interferon-free DAA reimbursement among countries in the European Union and European Economic Area, and Switzerland. Reimbursement documentation was reviewed between Nov 18, 2016, and Aug 1, 2017. Primary outcomes were fibrosis stage, drug or alcohol use, prescriber type, and HIV co-infection restrictions. Among the 35 European countries and jurisdictions included, the most commonly reimbursed DAA was ombitasvir, paritaprevir, and ritonavir, with dasabuvir, and with or without ribavirin (33 [94%] countries and jurisdictions). 16 (46%) countries and jurisdictions required patients to have fibrosis at stage F2 or higher, 29 (83%) had no listed restrictions based on drug or alcohol use, 33 (94%) required a specialist prescriber, and 34 (97%) had no additional restrictions for people co-infected with HIV and hepatitis C virus. These findings have implications for meeting WHO targets, with evidence of some countries not following the 2016 hepatitis C virus treatment guidelines by the European Association for the Study of Liver.

Reactivation of occult HBV infection in an HIV/HCV Co-infected patient successfully treated with sofosbuvir/ledipasvir: a case report and review of the literature

BackgroundReactivation of occult or inactive Hepatitis B virus (HBV) infection during immunosuppressant treatments is well known and widely described in literature. The same observation has been made in Hepatitis C (HCV)-infected patients previously exposed to HBV and treated with interferon-free DAA treatments. Because of common transmission routes, persons may have been exposed to HCV, HBV and HIV, but few cases have been reported in this scenario to date. Frequency of HBV reactivation in HIV/HCV co-infected patients previously exposed to HBV and treated with DAA remains unclear. Herein, we report an episode of HBV reactivation in an HIV/HCV co-infected patient prescribed with sofosbuvir/ledipasvir for HCV.Case presentationThe patient is a Caucasian 54-years old female, with HIV/HCV co-infection (genotype 4), and a previous exposure to HBV, documented by negativity of HBsAg and positivity of HBsAb and HBcAb. Her medical history included: myocardial infarct, chronic kidney disease stage 3, chronic obstructive pulmonary disease, and mild pulmonary hypertension. HCV had not been treated with interferon (IFN)-based regimens and liver stiffness was 10.5 KPa (Metavir stage F3) at hepatic elastography. Because of CKD, she was prescribed with a nucleoside reverse transcriptase (NRTI)-sparing regimen including darunavir/ritonavir plus etravirine, and thereafter with sofosbuvir/ledipasvir for 12 weeks. Four weeks after DAA termination, the patient was hospitalized with symptoms of acute hepatitis. Blood tests showed HCV RNA <12 IU/ml, but positivity of HBAg, HBeAg, and of anti-core antibodies (IgM and IgG), while anti-HBs and anti-HBe antibodies were negative. HBV DNA was 6.06 Log10 IU/ml. Entecavir was started obtaining resolution of symptoms, normalization of liver enzymes, as well as reduction of HBV DNA and of quantitative HBV surface antigen.ConclusionsThis case-report highlights the risk of HBV reactivation with interferon-free DAA treatment in HIV/HCV co-infected patients previously exposed to HBV and who have contraindications for treatment with nucleoside/nucleotide reverse transcriptase Inhibitors because of comorbid conditions. In the setting of HIV infection, clinicians prescribing DAA should be aware of this risk, and HBV assessment at treatment start as well as virological monitoring during DAA treatment is recommended. Large epidemiological and virological studies are needed to investigate reactivation of occult HBV infection more in depth.

FRI-260 - Efficacy of therapy against chronic hepatitis C virus genotype 1 infection in HIV-coinfected patients with several interferon-free DAA combinations: real life data from the HEPAVIR-DAA Cohort

FRI-260 - Efficacy of therapy against chronic hepatitis C virus genotype 1 infection in HIV-coinfected patients with several interferon-free DAA combinations: real life data from the HEPAVIR-DAA Cohort

Safety and efficacy of IFN/RBV-free DAA-based regimens in HCV-recurrence after Orthotopic Liver Transplantation

Background & Aim: Interferon-free DAA combinations allow an effective treatment of HCV recurrence after orthotopic liver transplantation (OLT), but the role of ribavirin (RBV) in the post transplant setting is still under debate. So far published data gained from IFN/RBV-free DAA-based regimens are sparse. We thus aimed to analyze safety and efficacy of IFN/RBV-free DAA-based regimens in HCV-recurrence after OLT.

Long-term impact of achieving sustained virologic response(SVR)by IFN-free DAA treatment in patients with advanced liver disease.

Background and aims: IFN-free antiviral treatment with DAAs improves liver function in many patients with cirrhosis already at the end of therapy, however, results of long-term follow-up are not yet known. The aim of this study was to evaluate patients' virological and clinical outcomes at follow-up week 48 after interferon-free DAA therapy.

Comparison of sleep disorders in chronic hepatitis C patients treated with interferon-based therapy and direct acting antivirals using actigraphy.

Our study included 31 patients in group A (Peg-IFN/RBV/SMV combination therapy) and 41 patients in the group B (IFN-free DAA therapy). We prospectively compared the effect of each antiviral treatment regimen on sleep conditions between the two groups adding actigraphy data. Five parameters detected by actigraphy (objective assessment) and scores of the Pittsburgh Sleep Quality Index (subjective assessment, n = 30 [group A] and 35 [group B]) were estimated. The causal effect of each therapy on sleep disturbances was evaluated at baseline and at 4weeks after commencement of therapy. In terms of baseline characteristics, no significant differences between groups were found, except for hepatitis C virus genotype. In group A, sustained virological response 12 rate was 83.9% (26/31), whereas in group B it was 95.1% (39/41). In group A, each score of waking after sleep onset, activity index, wake episodes, and Pittsburgh Sleep Quality Index at 4weeks significantly increased compared to those evaluated at baseline. In group B, scores of all variables except for sleep episodes at 4weeks did not significantly change compared to those at baseline. Interferon-based triple therapy in patients with CHC may cause significant sleep disturbances. Interferon-free DAA therapy is less likely to deteriorate sleep conditions in patients with CHC.

FRI-190 - Interferon-Free Daa Regimens Decrease Portal Pressure and Halt Histological Necroinflammation in HIV/HCV coinfected Patients

FRI-190 - Interferon-Free Daa Regimens Decrease Portal Pressure and Halt Histological Necroinflammation in HIV/HCV coinfected Patients

Dual treatment of acute HCV infection in HIV co-infection: influence of HCV genotype upon treatment outcome

With DAAs still only being licensed for chronic HCV infection, the ongoing epidemic of acute hepatitis C (AHC) infection among MSM highlights the need to identify factors allowing for optimal HCV treatment outcome. 303 HIV-infected patients from 4 European countries with diagnosed acute HCV infection were treated early with pegylated interferon (pegIFN) and ribavirin (RBV) (n = 273) or pegylated interferon alone (n = 30). All patients were male, median age was 39 years. Main routes of transmission were MSM (95%) and IVDU (3%). 69% of patients were infected with HCV GT 1, 4.3% with GT 2, 10.6% with GT 3, 16.1% with GT 4. Overall SVR rate was 69.3% (210/303). RVR (p ≤ 0.001), 48-w treatment duration (p ≤ 0.001) and GT 2/3 (p = 0.024) were significantly associated with SVR. SVR rates were significantly higher in HCV GT 2/3 receiving pegIFN and RBV (33/35) when compared with pegIFN mono-therapy (6/10) (94% vs. 60 % respectively; p = 0.016). In multivariate analysis, pegIFN/RBV combination therapy (p = 0.017) and rapid virological response (RVR) (p = 0.022) were significantly associated with SVR in HCV GT 2/3. In HCV GT 1/4, RVR (p ≤ 0.001) and 48-w treatment duration (p ≤ 0.001) were significantly associated with SVR. Treatment of AHC GT 2 and 3 infections with pegIFN/RBV is associated with higher SVR rates suggesting different cure rates depending on HCV genotype similar to the genotype effects seen previously in chronic HCV under pegIFN/RBV. With pegIFN/RBV still being the gold standard of AHC treatment and in light of cost issues around DAAs and very limited licensed interferon-free DAA treatment options for chronic HCV GT 3 infection AHC GT 3 patients might benefit most from early interferon-containing treatment.

Su1061 Pearl-IV: a 12-Week Regimen of ABT-450/r/ABT-267 and ABT-333, With or Without Ribavirin Achieves Svr12 Rates≥90% in Treatment-Naïve Adults Infected With Hepatitis C Virus Genotype 1A

Background: The HCV-PRO is a validated disease-specific patient reported outcome (PRO) instrument. This analysis reports on HCV-infected patient response in a trial of oral DAA therapy and assesses psychometric properties of the French-translated HCV-PRO. Method: French Genotype 1 patients in the multinational AVIATOR trial of interferon-free DAA therapy responded to theHCV-PRO, SF-36v.2, and EQ-5D 5L+VAS. HCV-PROwas translated under Harmonization standards. Approved French-language SF-36 and EQ-5Dwere included for psychometric comparison. Analyses of response were performed at Baseline, week 8 (Wk8), End of Treatment (EOT), and 24 week follow-up (PTW24), and included change from baseline. Internal consistency/reliability of HCV-PRO items and total score were evaluated using Cronbach's alpha. Convergent validity was assessed through Pearson's correlation (0.5-0.9=moderate-strong) to SF-36 MCS/PCS and EQ-5D VAS. Discriminant validity was assessed by dichotomizing HCV-PRO score on EQ-5D Anxiety/Depression and Pain/Discomfort dimensions (none versus some). Results: Demographics (N=58): 48% female, 88% white, 45% ≥50 years of age, 45% Genotype 1a, 86% IL28B non-CC. Clinical response (SVR24) was 93.1%. All PRO scores were minimally changed during treatment (Wk8, EOT). Mean HCV-PRO score at PTW24 was improved (p<0.03) over baseline. Cronbach's alpha for HCV-PRO items and total scores were 0.44-0.95. HCV-PRO total score exhibited moderateto-high correlation with SF-36 MCS/PCS and EQ-5D VAS total scores (r=0.54-0.87). HCVPRO scores were lower in patients with anxiety/depression or pain/discomfort (p<0.01). Conclusion: The French-translated HCV-PRO is a valid, responsive, disease-specific instrument. HCV-PRO score changed minimally during oral DAA treatment and improved over baseline after therapy.

Su1059 Treatment Satisfaction in Clinical Trial (Aviator) Patients Treated With Interferon-Free, Oral DAA Regimens: External Validation of the Hepatitis C Virus (HCV) Treatment Satisfaction (HCVTSAT) Instrument

Background: The HCV-PRO is a validated disease-specific patient reported outcome (PRO) instrument. This analysis reports on HCV-infected patient response in a trial of oral DAA therapy and assesses psychometric properties of the French-translated HCV-PRO. Method: French Genotype 1 patients in the multinational AVIATOR trial of interferon-free DAA therapy responded to theHCV-PRO, SF-36v.2, and EQ-5D 5L+VAS. HCV-PROwas translated under Harmonization standards. Approved French-language SF-36 and EQ-5Dwere included for psychometric comparison. Analyses of response were performed at Baseline, week 8 (Wk8), End of Treatment (EOT), and 24 week follow-up (PTW24), and included change from baseline. Internal consistency/reliability of HCV-PRO items and total score were evaluated using Cronbach's alpha. Convergent validity was assessed through Pearson's correlation (0.5-0.9=moderate-strong) to SF-36 MCS/PCS and EQ-5D VAS. Discriminant validity was assessed by dichotomizing HCV-PRO score on EQ-5D Anxiety/Depression and Pain/Discomfort dimensions (none versus some). Results: Demographics (N=58): 48% female, 88% white, 45% ≥50 years of age, 45% Genotype 1a, 86% IL28B non-CC. Clinical response (SVR24) was 93.1%. All PRO scores were minimally changed during treatment (Wk8, EOT). Mean HCV-PRO score at PTW24 was improved (p<0.03) over baseline. Cronbach's alpha for HCV-PRO items and total scores were 0.44-0.95. HCV-PRO total score exhibited moderateto-high correlation with SF-36 MCS/PCS and EQ-5D VAS total scores (r=0.54-0.87). HCVPRO scores were lower in patients with anxiety/depression or pain/discomfort (p<0.01). Conclusion: The French-translated HCV-PRO is a valid, responsive, disease-specific instrument. HCV-PRO score changed minimally during oral DAA treatment and improved over baseline after therapy.

Su1058 Early Stopping Rules for Faldaprevir Plus Pegylated Interferon α-2A and Ribavirin in Treatment-Naïve Patients: Exploratory Study of Pooled Data From Phase III Trials

Background: The HCV-PRO is a validated disease-specific patient reported outcome (PRO) instrument. This analysis reports on HCV-infected patient response in a trial of oral DAA therapy and assesses psychometric properties of the French-translated HCV-PRO. Method: French Genotype 1 patients in the multinational AVIATOR trial of interferon-free DAA therapy responded to theHCV-PRO, SF-36v.2, and EQ-5D 5L+VAS. HCV-PROwas translated under Harmonization standards. Approved French-language SF-36 and EQ-5Dwere included for psychometric comparison. Analyses of response were performed at Baseline, week 8 (Wk8), End of Treatment (EOT), and 24 week follow-up (PTW24), and included change from baseline. Internal consistency/reliability of HCV-PRO items and total score were evaluated using Cronbach's alpha. Convergent validity was assessed through Pearson's correlation (0.5-0.9=moderate-strong) to SF-36 MCS/PCS and EQ-5D VAS. Discriminant validity was assessed by dichotomizing HCV-PRO score on EQ-5D Anxiety/Depression and Pain/Discomfort dimensions (none versus some). Results: Demographics (N=58): 48% female, 88% white, 45% ≥50 years of age, 45% Genotype 1a, 86% IL28B non-CC. Clinical response (SVR24) was 93.1%. All PRO scores were minimally changed during treatment (Wk8, EOT). Mean HCV-PRO score at PTW24 was improved (p<0.03) over baseline. Cronbach's alpha for HCV-PRO items and total scores were 0.44-0.95. HCV-PRO total score exhibited moderateto-high correlation with SF-36 MCS/PCS and EQ-5D VAS total scores (r=0.54-0.87). HCVPRO scores were lower in patients with anxiety/depression or pain/discomfort (p<0.01). Conclusion: The French-translated HCV-PRO is a valid, responsive, disease-specific instrument. HCV-PRO score changed minimally during oral DAA treatment and improved over baseline after therapy.

P723 FALDAPREVIR PLUS PEGYLATED INTERFERON/RIBAVIRIN DID NOT INCREASE ANAEMIA COMPARED WITH PEGYLATED INTERFERON/RIBAVIRIN IN HCV GENOTYPE-1, TREATMENT-NAIVE PATIENTS: POOLED ANALYSIS OF PHASE III STUDIES

Background: The HCV-PRO is a validated disease-specific patient reported outcome (PRO) instrument. This analysis reports on HCV-infected patient response in a trial of oral DAA therapy and assesses psychometric properties of the French-translated HCV-PRO. Method: French Genotype 1 patients in the multinational AVIATOR trial of interferon-free DAA therapy responded to theHCV-PRO, SF-36v.2, and EQ-5D 5L+VAS. HCV-PROwas translated under Harmonization standards. Approved French-language SF-36 and EQ-5Dwere included for psychometric comparison. Analyses of response were performed at Baseline, week 8 (Wk8), End of Treatment (EOT), and 24 week follow-up (PTW24), and included change from baseline. Internal consistency/reliability of HCV-PRO items and total score were evaluated using Cronbach's alpha. Convergent validity was assessed through Pearson's correlation (0.5-0.9=moderate-strong) to SF-36 MCS/PCS and EQ-5D VAS. Discriminant validity was assessed by dichotomizing HCV-PRO score on EQ-5D Anxiety/Depression and Pain/Discomfort dimensions (none versus some). Results: Demographics (N=58): 48% female, 88% white, 45% ≥50 years of age, 45% Genotype 1a, 86% IL28B non-CC. Clinical response (SVR24) was 93.1%. All PRO scores were minimally changed during treatment (Wk8, EOT). Mean HCV-PRO score at PTW24 was improved (p<0.03) over baseline. Cronbach's alpha for HCV-PRO items and total scores were 0.44-0.95. HCV-PRO total score exhibited moderateto-high correlation with SF-36 MCS/PCS and EQ-5D VAS total scores (r=0.54-0.87). HCVPRO scores were lower in patients with anxiety/depression or pain/discomfort (p<0.01). Conclusion: The French-translated HCV-PRO is a valid, responsive, disease-specific instrument. HCV-PRO score changed minimally during oral DAA treatment and improved over baseline after therapy.