DBS TaT for Hepatitis C
Recruiting in Palo Alto (17 mi)
Overseen byHunter Spencer, DO
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Oregon Health and Science University
Disqualifiers: Pregnancy
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to compare the rate of treatment initiation achieved by peer-assisted telemedicine contingent on phlebotomy (usual care) versus that achieved with a new protocol, called Dried Blood Spot Test and Treat (DBS TaT). DBS TaT includes DBS testing to diagnose hepatitis C (HCV), utilizes a novel clinical decision aid that identifies patients who are low risk for hepatic (liver) fibrosis, and directs those patients to HCV treatment initiation prior to routine hepatic fibrosis assessment.
The investigators hypothesize that DBS TaT will increase the rate of HCV treatment initiation compared to peer-assisted telemedicine contingent on phlebotomy (usual care).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment DBS TaT for Hepatitis C?
Direct-acting antivirals (DAAs), which are a type of treatment for Hepatitis C, have shown high effectiveness with sustained virologic response rates of 93-100% in various studies. This suggests that treatments involving DAAs, like DBS TaT, could be effective for Hepatitis C.
12345Is DBS TaT safe for humans?
The safety of direct-acting antivirals (DAAs) for hepatitis C, which may be similar to DBS TaT, has been studied. These treatments are generally well-tolerated, but some people experience side effects like tiredness, headaches, nausea, and trouble sleeping. More serious side effects affecting the skin, metabolism, lungs, liver, and kidneys have been reported, so ongoing safety monitoring is important.
678910How is the DBS TaT treatment for Hepatitis C different from other treatments?
DBS TaT for Hepatitis C is unique because it uses dried blood spots (DBS) for testing, which is a minimally invasive method that can be done in non-traditional settings, making it easier to reach people who inject drugs and other hard-to-reach populations. This approach helps increase access to testing and treatment, which is crucial for managing and eliminating Hepatitis C.
1112131415Eligibility Criteria
This trial is for individuals willing to engage with the PATHS program and who have an active hepatitis C infection. It's designed to see if a new protocol can help patients start treatment faster compared to the usual care which requires standard blood testing.Inclusion Criteria
I have an active hepatitis C infection.
I am willing to participate in the PATHS program for my care.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person or virtual)
Diagnosis and Risk Assessment
Participants undergo dried blood spot testing to diagnose HCV and assess risk for hepatic fibrosis using a questionnaire
2 weeks
1 visit (virtual)
Treatment Initiation
Participants with low risk for hepatic fibrosis start HCV treatment; those at high risk undergo confirmatory blood draw before treatment
12 weeks
Telemedicine visits as needed
Follow-up
Participants are monitored for safety and effectiveness after treatment initiation, including transient elastography
24 weeks
2 visits (in-person or virtual)
Participant Groups
The study compares two approaches: 'Dried Blood Spot Test and Treat' (DBS TaT), which uses DBS testing for HCV diagnosis and a clinical decision aid for quick treatment initiation, against peer-assisted telemedicine that depends on traditional phlebotomy.
2Treatment groups
Experimental Treatment
Active Control
Group I: DBS TaTExperimental Treatment1 Intervention
At DBS TaT sites, peers administer dried blood spot tests to all those interested in HCV screening or treatment. When HCV is diagnosed, peers coordinate a telemedicine visit with a PATHS provider and peer. At the time of the telemedicine visit, a questionnaire, Decompensated Cirrhosis in Hepatitis C Evaluation Questionnaire (DCHEQ), is used to determine risk level of liver fibrosis (liver scaring that is sometimes caused by hepatitis C). Those at low risk for liver fibrosis can start HCV treatment before completing the usual tests for liver fibrosis. Those at high risk for liver fibrosis will be directed to receive a confirmatory blood draw at a local laboratory prior to treatment initiation. Participants will complete transient elastography after treatment initiation.
Group II: Usual CareActive Control1 Intervention
At usual care sites, participants either self-report a known history of untreated HCV or undergo peer-performed point-of-care HCV antibody testing or DBS for HCV testing. Peers take those with positive results to local laboratories for a confirmatory blood draw prior to treatment initiation, the results of which are received and managed by PATHS providers. When active HCV is diagnosed, PATHS staff coordinate on-demand telemedicine visits with peers and participants, during which PATHS clinicians recommend treatment. Participants will complete transient elastography after treatment initiation.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Oregon Health & Science UniversityPortland, OR
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Who Is Running the Clinical Trial?
Oregon Health and Science UniversityLead Sponsor
Oregon Clinical and Translational Research InstituteCollaborator
National Center for Advancing Translational Sciences (NCATS)Collaborator
Collins Medical TrustCollaborator
References
Direct-acting antiviral treatment of chronic HCV-infected patients on opioid substitution therapy: Still a concern in clinical practice? [2022]There is limited real-world information on the effectiveness of antiviral treatment of chronic hepatitis C virus (HCV) infection with direct-acting antivirals (DAA) in people on opioid substitution therapy (OST). This study compared sustained virological response (SVR) rates and proportion of lost to follow-up (LTFU) between OST and non-OST patients in the German Hepatitis C-Registry (DHC-R).
Effect of Low Positive End of Treatment Viral Load with Direct-Acting Antiviral Therapy on Sustained Virologic Response. [2021]Direct-acting antivirals (DAAs) are highly effective treatments against hepatitis C virus (HCV), with sustained virologic response (SVR) rates of 93-100% against all genotypes. In most patients, viral load (VL) becomes undetectable four weeks into treatment, but rarely a low positive VL may be observed at the end of treatment (EOT). This study was conducted to determine the effect of low positive EOT VLs with DAA therapies on SVR at 12 and 24 weeks.
Antiviral therapy for chronic hepatitis C viral infection. [2013]Hepatitis C affects at least 200 million people worldwide. It can be followed by chronic hepatitis, cirrhosis, and primary liver cancer. Outcome assessments in controlled trials of antiviral therapy are based on serum transaminase values, serum HCV-RNA determinations, and liver biopsy scores. Patients most likely to respond to antiviral treatment are relatively young, have low serum HCV-RNA and transaminase levels, and do not have cirrhosis. Patients whose disease is caused by genotype 1b HCV isolates are unlikely to respond. Interferon alfa (3 million units [MU] three times a week for 6 months) is associated with a 50% response rate and a 50% relapse rate--an overall response rate of 25%. Increasing the duration of therapy may increase the sustained response rate. Ribavirin, given orally, may be used for patients who fail to respond to or relapse after interferon therapy. Its side effects are few. Treatment results in a fall in transaminase levels and some decrease in hepatic inflammation, but serum HCV RNA (viral titer) is unaltered. Combinations of interferon with ribavirin are giving promising results with increased sustained, complete responses.
[Predictors of the efficiency of short-term interferon-containing therapy using direct-acting antiviral drugs in patients with chronic hepatitis C virus genotype 1]. [2019]To identify predictors for the high efficiency of short-term interferon-containing antiviral therapy (AVT) using direct-acting antivirals (DAAs) in patients with chronic hepatitis C (CHC) virus (HCV) type 1 (CHC-1).
Real-world experiences with direct-acting antiviral agents for chronic hepatitis C treatment. [2021]As direct-acting antiviral (DAA) agents become more readily available for the treatment of chronic hepatitis C, it is important to understand real-world treatment experiences. In order to assess the effectiveness of DAA regimens and factors that influence sustained virologic response (SVR) rates in the Veterans Affairs healthcare system, we retrospectively identified veterans with chronic hepatitis C who were treated with DAAs from January 2014 to June 2015. We determined SVR rates and collected data on demographics, genotype (GT), previous interferon-based treatment, antiviral regimens, and co-morbidities (HIV, prior solid organ transplant, haemodialysis) for analysis. Of 15 720 veterans, the majority were infected with genotype 1a (GT1a, 60.5%). Excluding the special populations, the overall cohort SVR rate was 92%. Compared to treatment-experienced patients, treatment-naïve patients had significantly higher SVR rates (90% vs 92%, P = .006). Subgroups associated with lower likelihood of achieving SVR-included African Americans (OR 0.79, 95% CI 0.69-0.91), GT3 (OR 0.65, CI 0.50-0.86), and cirrhosis (OR 0.91, CI 0.84-0.99) or decompensated cirrhosis (ascites: OR 0.78, CI 0.67-0.91, variceal bleed: OR 0.75, CI 0.57-0.99). The only treatment regimen independently associated with lower SVR rates was SOF+RBV+IFN (OR 0.65, CI 0.50-0.84). Special populations achieved high SVR rates: HIV 92%, haemodialysis 93%, liver transplant 96% and renal transplant 94%. In conclusion, overall SVR rates were comparable to those reported in clinical trials and carried over to historically more difficult-to-treat patients. Several patient- and treatment-related factors were identified as independent predictors of treatment failure and suggest subgroups to target for efforts to improve therapeutic strategies.
Evaluation of the Safety Profile of Direct-Acting Antivirals on Patients with Hepatitis C Virus: A Pharmacovigilance Study. [2023]Hepatitis C virus (HCV) is the primary contributor to chronic hepatic diseases. A rapid change in the situation took place with the advent of oral direct-acting antivirals (DAAs). However, a comprehensive review of the adverse event (AE) profile of the DAAs is lacking. This cross-sectional study aimed to analyze the reported Adverse Drug Reactions (ADRs) with DAA treatment using data from VigiBase, the WHO Individual Case Safety Report (ICSR) database.
New era in treatment options of chronic hepatitis C: focus on safety of new direct-acting antivirals (DAAs). [2022]New direct-acting antivirals have changed hepatitis C virus infection management extremely. Areas covered: The pharmacological management of HCV infection and the main characteristics of new DAA therapies have been discussed. In order to analyse safety data regarding DAA therapies, a narrative review was performed searching for safety results of main second generation DAAs pivotal and post-marketing studies. Data on main DAAs drug-drug interactions have also been discussed. Results of main DAAs pivotal studies revealed that these drugs were frequently associated to adverse events such as asthenia, headache, nausea, and insomnia. Although some of post-marketing studies confirmed the good tolerability profile already detected in the pre-marketing phase, real-world safety data showed that second generation DAAs can be associated to cutaneous, metabolic, pulmonary, hepatic, and renal adverse events. Expert opinion: Safety results of pivotal and post-marketing studies indicated that the most recently approved DAAs are well tolerated. However, considering the recent marketing approval of new DAAs, further observational studies and post-marketing surveillance activities will be necessary in order to improve the knowledge of their safety.
Assessing the Safety of Direct-Acting Antiviral Agents for Hepatitis C. [2020]Recent reports based on the US Food and Drug Administration's voluntary Adverse Events Reporting System raised questions about the safety of direct-acting antivirals (DAAs) for treatment of the hepatitis C virus (HCV).
Efficacy and Safety of Sofosbuvir and Velpatasvir Combination for the Treatment of Chronic Hepatitis C in Patients With or Without Cirrhosis. [2021]Background and aim For years, interferon-based treatment has been offered to patients with chronic hepatitis C virus (HCV) infection; however, the complexity of the treatment, efficacy, and adverse effects were the primary concerns. All these concerns were addressed with the introduction of directly acting antivirals (DAAs) to treat chronic HCV. Sofosbuvir and velpatasvir are second-generation DAAs used in combination for the treatment of chronic HCV infection. The aim of our study was to determine and compare the efficacy and safety profile of the sofosbuvir and velpatasvir combination in treating patients with chronic hepatitis C with or without cirrhosis. Materials and methods This descriptive study was conducted at the Department of Medicine, Khyber Teaching Hospital, Peshawar, from March 15th to September 15th, 2021 after approval from the Institution Research and Ethical Review Board (IREB). Diagnosis of HCV was based on the detection of hepatitis C ribonucleic acid (RNA) fragments by reverse transcription-polymerase chain reaction (RT-PCR). Liver status was assessed with liver function tests and imaging. Sofosbuvir (400 mg) and velpatasvir (100 mg) were administered once daily for 12 weeks, followed by polymerase chain reaction (PCR) for HCV RNA after 12 weeks of completion of treatment for determination of sustained virologic response at 12 weeks (SVR12). Patients with cirrhosis also received weight-based ribavirin. Adverse events experienced by the study participants during the course of treatment were recorded. Data were collected regarding patients' demographics, laboratory parameters, SVR12, and adverse events, and were then analyzed using SPSS, version 22 (IBM SPSS Statistics, Armonk, NY). Results A total of 58 patients with cirrhosis and 58 patients without cirrhosis with chronic HCV were enrolled. The rate of SVR12 in patients with cirrhosis was 89.7% (52 patients achieved SVR12), compared to 98.3% in patients without cirrhosis (57 patients achieved SVR12). Subgroup analysis of patients with cirrhosis revealed that patients who have failed to achieve SVR12 were mostly males, had prolonged disease duration, and low hemoglobin at baseline; however, the association of these factors with SVR12 was not significant. The incidence of adverse events among all study participants was 46.5%. Among the cirrhotic cohort, 37 (63.8%) patients experienced adverse events, while only 17 (29.3%) patients among the non-cirrhotic cohort had adverse events. A total of 24 patients with cirrhosis (41.37%) reported mild complaints. The most commonly reported adverse event was gastrointestinal (GI) upsets (46.2%), followed by fatigue (33.9%), while 19.9% developed miscellaneous adverse events such as headaches, rash, and insomnia. Conclusion The combination of sofosbuvir and velpatasvir is highly effective and safe in patients with HCV with or without cirrhosis. However, this combination's efficacy was slightly higher in non-cirrhotic patients (98.3%) than in cirrhotic patients (89.7%).
Twelve weeks of ombitasvir/paritaprevir/r and dasabuvir without ribavirin is effective and safe in the treatment of patients with HCV genotype 1b infection and compensated cirrhosis: results from a real-world cohort study. [2021]To explore the effectiveness and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir (OBV/PTV/r+DSV) for 12 weeks without ribavirin in adults with chronic HCV genotype 1b infection and compensated cirrhosis.
Comparison of Hepatitis C Virus RNA and antibody detection in dried blood spots and plasma specimens. [2023]Current diagnostic tests for Hepatitis C Virus (HCV) involve phlebotomy and serologic testing for HCV antibodies (anti-HCV) and RNA, which are not always feasible. Dried blood spots (DBS) present a minimally invasive sampling method and are suitable for sample collection, storage and testing.
Investigating utilising the Alinity m platform to detect hepatitis C virus RNA in dried blood spot samples. [2021]Elimination of Hepatitis C virus (HCV) relies on increasing HCV diagnostic rates in hard to reach populations. Dried blood spot (DBS) samples are a convenient sample type for HCV testing, as they can be collected in non-traditional settings such as drug services and prison settings, increasing access to HCV testing.
Usefulness of dried blood spot samples for monitoring hepatitis C treatment outcome and reinfection among people who inject drugs in a test-and-treat program. [2023]Dried blood spots (DBS) are a reliable tool to diagnose viremic hepatitis C virus (HCV) infection. We evaluated the clinical performance of a DBS-based molecular assay for the assessment of cure and reinfection after on-site treatment at a harm reduction center (HRC). Genotyping from DBS samples was also assessed to discriminate reinfection from treatment failure. People who inject drugs (PWID) from an ongoing test-and-treat pilot at the largest HRC in Barcelona were included in the study. HCV-RNA detection from DBS collected after treatment (with follow-up at 12, 36, and 60 weeks) was compared with a molecular point-of-care test using finger-stick blood (GeneXpert). Baseline and follow-up DBS samples were genotyped by NS5B sequencing or commercial real-time PCR. Among treated patients, 193 follow-up DBS samples were tested. The DBS-based assay showed 100% specificity (129/129), and sensitivity ranged from 84.4% to 96.1% according to different viral load cut-offs (from detectable to 3000 IU/mL). Sensitivity as test of cure (follow-up 12) ranged from 85.1% to 97.4%. Among the 64 patients with recurrent viremia, 10.9% had low viral loads (≤1000 IU/mL); HCV genotyping allowed us to classify 73.5% of viremic cases either as reinfection or as treatment failure. DBS samples are useful to assess cure and differentiate reinfection from relapse after HCV antiviral treatment in the real world, facilitating decentralization of treatment and posttreatment follow-up in PWID. However, a fraction of patients presented with low viral loads, limiting viremia detection and genotyping in DBS and, therefore, repeat testing is recommended.
Uptake of hepatitis C specialist services and treatment following diagnosis by dried blood spot in Scotland. [2018]Dried blood spot (DBS) testing for hepatitis C (HCV) was introduced to Scotland in 2009. This minimally invasive specimen provides an alternative to venipuncture and can overcome barriers to testing in people who inject drugs (PWID).
Evaluation of the Abbott m2000 system for dried blood spot detection of hepatitis C virus RNA. [2020]Hepatitis C virus RNA testing using dried blood spots (DBS) offers a method for detecting ongoing HCV infection in "hard to reach" populations. Abbott Molecular have developed a quantitative HCV RNA DBS protocol (currently for research use only) for extraction and real-time PCR amplification using them2000sp and m2000rt system.