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1.
researchsquare; 2022.
Preprint in English | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-2235121.v1

ABSTRACT

Background: COVID-19 has hindered HCV and HIV screening, particularly in marginalised groups, who have some of the highest rates of these conditions and lowest rates of COVID-19 vaccination. We assessed the acceptability of combining HCV testing with COVID-19 vaccination in a centre for addiction services (CAS) in Barcelona and a mobile testing unit (MTU) in Madrid, Spain. Methods: From 28/09/2021-30/06/2022, 187 adults from marginalised populations were offered HCV antibody (Ab) testing along with COVID-19 vaccination. If HCV Ab+, they were tested for HCV-RNA. MTU participants were screened for HIV, per the standard of care. HCV-RNA+ and HIV+ participants not on ART were offered treatment. Results: Findings show how of the 86 CAS participants: 93% had been previously vaccinated for COVID-19, of whom 90% had the full first round schedule; none had a COVID-19 vaccine booster and all received a COVID-19 vaccine; 62.8% were tested for HCV Ab, of whom 31.5% were positive, of whom all were tested for HCV-RNA and none were positive. Of the 101 MTU participants: none had been vaccinated for COVID-19 and all received a COVID-19 vaccine; all were tested for HCV Ab and HIV and 14.9% and 8.9% were positive, respectively; of those HCV Ab+, nine (60%) were HCV-RNA+, of whom eight (88.9%) have started treatment; five (55.6%) of those HIV+ had abandoned ART, of whom three (60%) have re-started it. Conclusions: The intervention had an acceptability rate of 62.8% at the CAS and 100% at the MTU and can be used in marginalised communities.


Subject(s)
COVID-19 , HIV Infections , Hepatitis C
2.
ssrn; 2021.
Preprint in English | PREPRINT-SSRN | ID: ppzbmed-10.2139.ssrn.3719080

ABSTRACT

Background: There are currently no effective treatments for outpatients with coronavirus disease. 2019 (COVID-19). Interferon-lambda-1 is a Type III interferon involved in the innate antiviral response with activity against respiratory pathogens.Methods: In this double-blind, placebo-controlled trial, outpatients with laboratory-confirmed COVID-19 were randomized to a single subcutaneous injection of peginterferon-lambda 180μg or placebo within 7 days of symptom onset or first positive swab if asymptomatic. The primary endpoint was proportion negative for SARS-CoV-2 RNA on Day 7 post-injection.Results: There were 30 patients per arm, with median baseline SARS-CoV-2 viral load of 6.71 (IQR 1.3-8.0) log copies/mL. The decline in SARS-CoV-2 RNA was greater in those treated with peginterferon-lambda than placebo (p=0.04). On Day 7, 24 participants (80%) in the peginterferon-lambda group had an undetectable viral load compared to 19 (63%) in the placebo arm (p=0.15). After controlling for baseline viral load, peginterferon-lambda treatment resulted in a 4.12-fold (95CI 1.15-16.7, p=0.029) higher likelihood of viral clearance by Day 7. Of those with baseline viral load above 10E6 copies/mL, 15/19 (79%) in the peginterferon-lambda group were undetectable on Day 7 compared to 6/16 (38%) in the placebo group (p=0.012). Adverse events were similar between groups with only mild reversible transaminase elevations more frequently observed in the peginterferon-lambda group.Conclusion: Peginterferon-lambda accelerated viral decline in outpatients with COVID-19 resulting in a greater proportion with viral clearance by Day 7, particularly in those with high baseline viral load. Peginterferon-lambda may have potential to prevent clinical deterioration and shorten duration of viral shedding.Trial Registration: NCT04354259Funding Statement: This study was supported by the Toronto COVID-19 Action Initiative, University of Toronto and the Ontario First COVID-19 Rapid Research Fund. Medication was supplied by Eiger BioPharma. Declaration of Interests: JJF reports research support unrelated to this work from Eiger BioPharmaceuticals. BC has received research support unrelated to this work from Nubiyota LLC and Sanofi. IC and CH are employees of Eiger BioPharmaceuticals. JSG is a board member and founder of Eiger BioPharmaceuticals, Inc., in which he has an equity interest, and is an inventor on a patent application for the use of interferon lambda to treat coronavirus infections. All other authors have nothing to declare. Ethics Approval Statement: The Research Ethics Boards of all participating institutions approved the study, which was conducted under a Clinical Trial Application approved by Health Canada.


Subject(s)
COVID-19 , Coronavirus Infections
3.
ClinicalTrials.gov; 01/10/2020; TrialID: NCT04620226
Clinical Trial Register | ICTRP | ID: ictrp-NCT04620226

ABSTRACT

Condition:

Hepatitis C;Hepatitis B

Intervention:

Other: Quality Improvement

Primary outcome:

Number of HCV RNA positive participants who achieve a Sustained Virological Response at 12 weeks (SVR12) after treatment completion.;Number of HCV antibody positive participants who complete an HCV RNA PCR.;Number of HCV RNA positive participants who attend their first hepatology appointment.

Criteria:


Inclusion Criteria:

- Adults aged 18 years or older at time of consent

- Patients admitted to GIMIUs at TGH or TWH

Exclusion Criteria:

- Patients whose end of life is expected to be less than 6 months

- Patients who are unable or decline to provide informed consent

- Patients with confirmed, active COVID-19 infections

- Patients with immediate life-threatening conditions where screening for chronic HCV
and HBV infection may delay urgent care


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