scholarly journals Clinical and Patient-Reported Outcomes of Direct-Acting Antivirals for the Treatment of Chronic Hepatitis C Among Patients on Opioid Agonist Treatment: A Real-world Prospective Cohort Study

2020 ◽  
Vol 7 (8) ◽  
Author(s):  
Bernd Schulte ◽  
Christiane S Schmidt ◽  
Jakob Manthey ◽  
Lisa Strada ◽  
Stefan Christensen ◽  
...  
Keyword(s):  
Cohort Study ◽  
Hepatitis C ◽  
Real World ◽  
Patient Reported Outcomes ◽  
Direct Acting Antivirals ◽  
Hcv Treatment ◽  
Opioid Agonist ◽  
Patient Reported ◽  
Direct Acting ◽  
Over Time

Abstract Background Patient-reported outcomes (PROs) can help to reduce uncertainties about hepatitis C virus (HCV) treatment with direct-acting antivirals (DAAs) among people who inject drugs and increase treatment uptake in this high-risk group. Besides clinical data, this study analyzed for the first time PROs in a real-world sample of patients on opioid agonist treatment (OAT) and HCV treatment with DAAs. Methods HCV treatment data including virological response, adherence, safety, and PROs of 328 German patients on OAT were analyzed in a pragmatic prospective cohort study conducted from 2016 to 2018. Clinical effectiveness was defined as sustained virological response (SVR) at week 12 after end of treatment and calculated in per-protocol (PP) and intention-to-treat (ITT) analyses. Changes over time in PROs on health-related quality of life, physical and mental health, functioning, medication tolerability, fatigue, concentration, and memory were analyzed by repeated-measures analyses of variances (ANOVAs). Results We found high adherence and treatment completion rates, a low number of mainly mild adverse events, and high SVR rates (PP: 97.5% [n = 285]; ITT: 84.5% [n = 328]). Missing SVR data in the ITT sample were mainly caused by patients lost to follow-up after treatment completion. Most PROs showed statistically significant but modest improvements over time, with more pronounced improvements in highly impaired patients. Conclusions This real-world study confirms that DAA treatment among OAT patients is feasible, safe, and effective. PROs show that all patients, but particularly those with higher somatic, mental, and social burden, benefit from DAA treatment.

scholarly journals The Impact of Hepatitis C Virus Direct-Acting Antivirals on Patient-Reported Outcomes: A Dutch Prospective Cohort Study

2018 ◽  
Vol 7 (3) ◽  
pp. 373-385 ◽  
Author(s):  
Patricia A. M. Kracht ◽  
Faydra I. Lieveld ◽  
Linde M. Amelung ◽  
Carina J. R. Verstraete ◽  
Eveline P. Mauser-Bunschoten ◽  
...  
Keyword(s):  
Cohort Study ◽  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Patient Reported Outcomes ◽  
Direct Acting Antivirals ◽  
Patient Reported ◽  
Direct Acting ◽  
The Impact

Real-world study of hepatitis C treatment with direct-acting antivirals in patients with drug abuse and opioid agonist therapy

2019 ◽  
Vol 54 (5) ◽  
pp. 646-655 ◽  
Author(s):  
Vijay Gayam ◽  
Benjamin Tiongson ◽  
Amrendra Kumar Mandal ◽  
Pavani Garlapati ◽  
Calvin Pan ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Drug Abuse ◽  
Real World ◽  
Direct Acting Antivirals ◽  
Agonist Therapy ◽  
Opioid Agonist ◽  
Hepatitis C Treatment ◽  
Opioid Agonist Therapy ◽  
Direct Acting

scholarly journals Real-world efficacy and safety of pangenotypic direct-acting antivirals against hepatitis C virus infection in Taiwan

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Kao-Chi Chang ◽  
Shui-Yi Tung ◽  
Kuo-Liang Wei ◽  
Chen-Heng Shen ◽  
Yung-Yu Hsieh ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Real World ◽  
Population Analysis ◽  
Virologic Response ◽  
Efficacy And Safety ◽  
Hepatitis C Virus Infection ◽  
Direct Acting Antivirals ◽  
Evaluable Population ◽  
Direct Acting

AbstractClinical trials showed pangenotypic direct-acting antivirals’ (DAAs) excellent efficacy and safety when treating hepatitis C virus (HCV). Two pangenotypic regimens were examined, glecaprevir/pibrentasvir (GLE/PIB) and sofosbuvir/velpatasvir (SOF/VEL), in a real-world Taiwanese setting, including all HCV patients treated with GLE/PIB or SOF/VEL from August 2018 to April 2020. The primary endpoint was sustained virologic response 12 weeks after treatment cessation (SVR12), including adverse events (AEs). A total of 1,356 HCV patients received pangenotypic DAA treatment during the study: 742 and 614 received GLE/PIB and SOF/VEL, respectively. The rates of SVR12 for GLE/PIB and SOF/VEL were 710/718 (98.9%) and 581/584 (99.5%), respectively, by per-protocol analysis, and 710/742 (95.7%) and 581/614 (94.6%), respectively, by evaluable population analysis. Eleven (GLE/PIB: 8, SOF/VEL: 3) did not achieve SVR12. The most common AEs for GLE/PIB and SOF/VEL were pruritus (17.4% vs. 2.9%), abdominal discomfort (5.8% vs. 4.4%), dizziness (4.2% vs. 2%), and malaise (3.1% vs. 2.9%). Laboratory abnormalities were uncommon; only < 1% exhibited elevated total bilirubin or aminotransferase levels with both regimens. Five drug discontinuations occurred due to AEs (bilirubin elevation: 3; dermatological issues: 2). Pangenotypic DAAs GLE/PIB and SOF/VEL are effective and well tolerated, achieving high SVR12 rates for patients with all HCV genotypes.

scholarly journals Declines in Depressive Symptoms Among People who Inject Drugs Treated With Direct-Acting Antivirals While on Opioid Agonist Therapy

2020 ◽  
Vol 7 (10) ◽  
Author(s):  
Irene Pericot-Valverde ◽  
Moonseong Heo ◽  
Jiajing Niu ◽  
Brianna L Norton ◽  
Matthew J Akiyama ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Illicit Drugs ◽  
People Who Inject Drugs ◽  
Sustained Viral Response ◽  
Addiction Severity Index ◽  
Psychiatric Diagnoses ◽  
Direct Acting Antivirals ◽  
Hcv Treatment ◽  
Opioid Agonist ◽  
Direct Acting

Abstract Background Hepatitis C virus (HCV) frequently co-occurs with symptoms of depression, which are aggravated on interferon-based regimens. However, it is unknown whether HCV treatment with direct-acting antivirals (DAAs) has effects on depressive symptoms among people who inject drugs (PWID). In this study, we examined changes in depressive symptoms during and after HCV treatment among PWID on opioid agonist therapies (OATs). Methods Participants were 141 PWID who achieved sustained viral response after on-site HCV treatment at 3 OAT programs. Depressive symptoms were assessed using the Beck Depression Inventory–II (BDI-II) at baseline, every 4 weeks during treatment, and 12 and 24 weeks after treatment completion. Current diagnosis of depression or other psychiatric diagnoses were obtained through chart review. Use of illicit drugs was measured by urine toxicology screening. Alcohol use was measured using the Addiction Severity Index–Lite. Results Of the 141 PWID infected with HCV, 24.1% had severe, 9.9% had moderate, 15.6% had mild, and 50.4% had minimal levels of depression as per BDI-II scores at baseline. HCV treatment was significantly associated with reductions in depressive symptoms that persisted long term, regardless of symptom severity (P &lt; .001) or presence of depression (P ≤ .01) or other psychiatric diagnoses (P ≤ .01) at baseline. Concurrent drug use (P ≤ .001) or hazardous alcohol drinking (P ≤ .001) did not interfere with reductions in depressive symptoms. Conclusions Depressive symptoms are highly prevalent among HCV-infected PWID. HCV treatment was associated with sustained reductions in depressive symptoms. HCV therapy with DAAs may have important implications for PWID that go beyond HCV cure.

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