DBS TaT for Hepatitis C

Overseen By Tonhi Gailey

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

141 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{11 12 13 14 15}

Research Team

Hunter Spencer, DO

Principal Investigator

Oregon Health and Science University

Eligibility 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.

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)

Treatment Details

Interventions

• DBS TaT

Trial Overview 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.

Participant Groups

Group I: DBS TaT Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Oregon Clinical and Translational Research Institute

Collaborator

Trials

17

Recruited

800+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Collins Medical Trust

Collaborator

Trials

6

Recruited

410+

Findings from Research

In a study of 7747 chronic hepatitis C patients in Germany, those on opioid substitution therapy (OST) achieved a sustained virological response (SVR) rate of 85%, which is comparable to 86% in former/current drug users and 92% in patients with no drug use history, indicating that DAAs are effective across different patient groups.

However, patients on OST had a higher rate of being lost to follow-up (10.2%) compared to non-OST patients (8.5% for former/current drug users and 3.2% for those with no drug use), suggesting that while treatment is effective, additional support may be needed for OST patients to ensure they complete their therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct-acting antiviral treatment of chronic HCV-infected patients on opioid substitution therapy: Still a concern in clinical practice? Christensen, S., Buggisch, P., Mauss, S., et al.[2022]

In a study of 1256 hepatitis C patients treated with direct-acting antivirals (DAAs), those with low positive viral loads (VL) at the end of treatment (EOT) still achieved high sustained virologic response (SVR) rates of 100% at 12 and 24 weeks.

The presence of low positive EOT VLs does not indicate treatment failure, suggesting that patients can still successfully clear the virus despite these low levels, which is important for managing expectations in DAA therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Low Positive End of Treatment Viral Load with Direct-Acting Antiviral Therapy on Sustained Virologic Response. Pal, V., Ancha, N., Mann, J., et al.[2021]

Interferon alfa treatment for Hepatitis C shows a 50% response rate but also a 50% relapse rate, leading to an overall response rate of only 25%, indicating that while it can be effective, many patients may not achieve lasting results.

Combining interferon with ribavirin has shown promising results, leading to increased sustained and complete responses in patients, suggesting that combination therapy may enhance treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiviral therapy for chronic hepatitis C viral infection. Sherlock, S.[2013]

In a study of 2,798 patients with chronic hepatitis C virus type 1, achieving undetectable viremia at 28 days of antiviral therapy was a strong predictor of a sustained virological response (SVR), especially when combined with the CC genotype of the IL-28B gene.

Patients receiving short-term triple antiviral therapy with a protease inhibitor showed a 100% recovery rate when both predictive factors were present, suggesting that treatment duration could potentially be reduced for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Predictors of the efficiency of short-term interferon-containing therapy using direct-acting antiviral drugs in patients with chronic hepatitis C virus genotype 1]. Kokina, KY., Bueverov, AO., Bogomolov, PO., et al.[2019]

In a study of 15,720 veterans treated with direct-acting antivirals (DAAs) for chronic hepatitis C, the overall sustained virologic response (SVR) rate was 92%, indicating high effectiveness in real-world settings.

Certain subgroups, such as African Americans, patients with genotype 3, and those with cirrhosis, showed lower SVR rates, highlighting the need for targeted strategies to improve treatment outcomes in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world experiences with direct-acting antiviral agents for chronic hepatitis C treatment. Daniel, KE., Saeian, K., Rizvi, S.[2021]

In a study analyzing 2925 adverse drug reaction reports for direct-acting antivirals (DAAs) in Egypt, 38.6% were classified as serious, with the most common reactions being anemia (21.3%), HCV relapse (14.5%), and headache (14%).

The SOF/RBV regimen was associated with the highest severity of adverse events, while the OBV/PTV/r regimen showed significant associations with renal impairment and anemia, despite being more effective overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Safety Profile of Direct-Acting Antivirals on Patients with Hepatitis C Virus: A Pharmacovigilance Study. El-Marakby, MG., Solayman, MH., Sabri, NA.[2023]

New direct-acting antivirals (DAAs) for hepatitis C virus (HCV) infection have significantly improved treatment management, showing a good tolerability profile in pivotal studies with common side effects like headache and nausea.

Despite their overall safety, real-world data from post-marketing studies indicate that second-generation DAAs can lead to various adverse events, necessitating further observational studies to fully understand their safety in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New era in treatment options of chronic hepatitis C: focus on safety of new direct-acting antivirals (DAAs). Scavone, C., Sportiello, L., Rafaniello, C., et al.[2022]

In a study of 33,808 adults with hepatitis C, exposure to direct-acting antivirals (DAAs) was linked to significantly lower rates of serious adverse events, including death and multiple organ failure, compared to those not treated with DAAs.

The analysis indicated that DAAs do not increase the risk of serious complications related to liver, kidney, or cardiovascular health, contradicting previous safety concerns raised by earlier reports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Safety of Direct-Acting Antiviral Agents for Hepatitis C. McGlynn, EA., Adams, JL., Kramer, J., et al.[2020]

The combination of sofosbuvir and velpatasvir is highly effective in treating chronic hepatitis C, achieving a sustained virologic response (SVR12) rate of 98.3% in non-cirrhotic patients and 89.7% in cirrhotic patients, based on a study of 116 patients over 12 weeks.

While the treatment is generally safe, 46.5% of participants experienced adverse events, with a higher incidence in cirrhotic patients (63.8%) compared to non-cirrhotic patients (29.3%), primarily involving gastrointestinal issues and fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Sofosbuvir and Velpatasvir Combination for the Treatment of Chronic Hepatitis C in Patients With or Without Cirrhosis. Shah, I., Ahmad, W., Qadir, A., et al.[2021]

In a study of 78 adults with chronic HCV genotype 1b and compensated cirrhosis, a 12-week treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir (OBV/PTV/r+DSV) achieved a high sustained virological response rate of 96.1%, indicating strong efficacy without the need for ribavirin.

While 78% of patients experienced adverse events, 97.7% were mild (grade 1/2), and there were no serious adverse reactions related to drug-drug interactions, suggesting that the treatment is safe for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Chamorro-de-Vega, E., Gimenez-Manzorro, A., Rodriguez-Gonzalez, CG., et al.[2021]

Dried blood spots (DBS) demonstrated a sensitivity of 90% and specificity of 100% for detecting HCV RNA, making them a reliable alternative to traditional plasma testing methods.

For anti-HCV detection, DBS showed a sensitivity of 70% and a perfect specificity of 100%, indicating that while they are effective, they may be less sensitive than plasma tests, but still provide a minimally invasive option for HCV diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Hepatitis C Virus RNA and antibody detection in dried blood spots and plasma specimens. Dokubo, EK., Evans, J., Winkelman, V., et al.[2023]

The Abbott Alinity m platform shows improved analytical sensitivity for HCV detection using dried blood spot (DBS) samples, being one log more sensitive than the previous DBS assay, which could enhance HCV testing in hard-to-reach populations.

The clinical evaluation of the Alinity m DBS assay demonstrated a high clinical sensitivity of 94% and perfect specificity of 100%, indicating its reliability for HCV testing, although it may miss some low viral load samples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating utilising the Alinity m platform to detect hepatitis C virus RNA in dried blood spot samples. Goldstein, EJ., Shepherd, SJ., Gunson, RN.[2021]

The dried blood spots (DBS) assay demonstrated 100% specificity and high sensitivity (ranging from 84.4% to 96.1%) for detecting hepatitis C virus (HCV) after treatment, making it a reliable tool for assessing cure and reinfection in people who inject drugs (PWID).

DBS genotyping successfully classified 73.5% of cases with recurrent viremia as either reinfection or treatment failure, although some patients had low viral loads that limited detection, suggesting the need for repeat testing to ensure accurate results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Not, A., Saludes, V., Gálvez, M., et al.[2023]

In the first two years of dried blood spot (DBS) testing for hepatitis C in Scotland, 1322 individuals were tested, with 476 found to have active infections, highlighting the effectiveness of DBS in identifying HCV cases.

Only 32% of those diagnosed attended a specialist clinic within a year, and 18% initiated antiviral treatment within 18 months, indicating a need for improved support to encourage treatment among younger individuals and those with unknown risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uptake of hepatitis C specialist services and treatment following diagnosis by dried blood spot in Scotland. McAllister, G., Innes, H., Mcleod, A., et al.[2018]

The Abbott Molecular quantitative HCV RNA DBS protocol demonstrated high sensitivity (86%) for detecting Hepatitis C virus in dried blood spots, particularly excelling with viral loads greater than 1000 IU/ml, where sensitivity reached 100%.

The Abbott system showed comparable performance to an in-house real-time PCR method, with a specificity of 100%, indicating it is a reliable option for detecting HCV in hard-to-reach populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Abbott m2000 system for dried blood spot detection of hepatitis C virus RNA. Shepherd, SJ., Baxter, RE., Gunson, RN.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Direct-acting antiviral treatment of chronic HCV-infected patients on opioid substitution therapy: Still a concern in clinical practice? [2022]

2. Egypt pubmed.ncbi.nlm.nih.gov

Effect of Low Positive End of Treatment Viral Load with Direct-Acting Antiviral Therapy on Sustained Virologic Response. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Antiviral therapy for chronic hepatitis C viral infection. [2013]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[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]

5. England pubmed.ncbi.nlm.nih.gov

Real-world experiences with direct-acting antiviral agents for chronic hepatitis C treatment. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of the Safety Profile of Direct-Acting Antivirals on Patients with Hepatitis C Virus: A Pharmacovigilance Study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

New era in treatment options of chronic hepatitis C: focus on safety of new direct-acting antivirals (DAAs). [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Assessing the Safety of Direct-Acting Antiviral Agents for Hepatitis C. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Sofosbuvir and Velpatasvir Combination for the Treatment of Chronic Hepatitis C in Patients With or Without Cirrhosis. [2021]

10. England pubmed.ncbi.nlm.nih.gov

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]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of Hepatitis C Virus RNA and antibody detection in dried blood spots and plasma specimens. [2023]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Investigating utilising the Alinity m platform to detect hepatitis C virus RNA in dried blood spot samples. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

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]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Uptake of hepatitis C specialist services and treatment following diagnosis by dried blood spot in Scotland. [2018]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of the Abbott m2000 system for dried blood spot detection of hepatitis C virus RNA. [2020]