Epclusa for Hepatitis C

(KeY Treat Trial)

Overseen By Madelyn McDonald, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Jennifer Havens

Disqualifiers: Under 18, Unable to consent, Pregnant

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

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 9

Duration: 12 weeks

374 Participants Needed

Trial Summary

What is the purpose of this trial?

The overarching goal of the Kentucky Viral Hepatitis Treatment Project (KeY Treat) is to increase hepatitis C virus (HCV) treatment access and delivery in a rural Appalachian community, which is in the midst of the opioid/hepatitis C (HCV) syndemic. KeY Treat is a clinical research study seeking to determine whether removing barriers (cost, insurance, specialist, abstinence) associated with accessing direct-acting antivirals (DAAs) for the treatment of HCV will impact health in Perry County, Kentucky.

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 study staff or your doctor.

What data supports the effectiveness of the drug Epclusa for treating Hepatitis C?

Research shows that Epclusa, a combination of sofosbuvir and velpatasvir, is highly effective in treating various types of Hepatitis C, achieving high rates of virus clearance in patients, including those with liver issues or co-infections. It is well-tolerated with few side effects, making it a valuable option for many patients. ^{1 2 3 4 5}

Is Epclusa (sofosbuvir-velpatasvir) safe for humans?

Epclusa (sofosbuvir-velpatasvir) is generally safe for humans, with common side effects being headache, fatigue, and nausea. Serious side effects were rare and not considered related to the treatment. ^{2 5 6 7 8}

How is the drug Epclusa unique for treating Hepatitis C?

Epclusa is unique because it is a once-daily, single-tablet regimen that works for all genotypes of Hepatitis C, making it a versatile option for many patients. It combines two drugs, sofosbuvir and velpatasvir, which target different parts of the virus, and is effective even in patients with cirrhosis or those who have had a liver transplant. ^{2 3 4 5 7}

Research Team

Jennifer Havens, PhD

Principal Investigator

University of Kentucky Ctr on Drug & Alcohol Rsrch

Eligibility Criteria

This trial is for adults over 18 living in Perry County, Kentucky who have tested RNA positive for Hepatitis C. It's not open to those under 18, pregnant women during pregnancy, or anyone unable to give informed consent.

Inclusion Criteria

Perry County residency (verified via ID card showing local address, lease, utility bill, etc.)

I have tested positive for hepatitis C.

Exclusion Criteria

Pregnant women (unable to participate during duration of pregnancy, but encouraged to return following delivery)

I am able to understand and give consent for the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a 12-week course of sofosbuvir/velpatasvir (Epclusa®) for HCV treatment

12 weeks

5 visits (in-person)

Follow-up

Participants are monitored for sustained virologic response (SVR) and re-infection

90 weeks

3 visits (in-person)

Treatment Details

Interventions

• Sofosbuvir/velpatasvir (Epclusa®)

Trial Overview The study tests the impact of providing easy access to a hepatitis C treatment called Sofosbuvir/velpatasvir (Epclusa®) without barriers like cost and insurance issues in a rural community affected by opioid use.

Participant Groups

Group I: HCV Positive Study Participants Experimental Treatment 1 Intervention

Study participants will be administered a standard 12-week course of sofosbuvir/velpatasvir (Epclusa®).

Group II: Control (Pike County) Active Control 1 Intervention

After completion of the study, we will compare HCV incidence and prevalence rates in Perry County (intervention) and Pike County (control). This will be measured through data provided by the local health departments of each county. Confidential Hepatitis C screening will be conducted in some cases, and resources will be provided to those testing positive but they will not receive treatment as part of this study.

Who Is Running the Clinical Trial?

Jennifer Havens

Lead Sponsor

Trials

1

Recruited

370+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+

University of Bristol

Collaborator

Trials

114

Recruited

25,030,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Findings from Research

The sofosbuvir-velpatasvir regimen achieved a high sustained virological response (SVR12) rate of 94.2% in 1277 patients with chronic hepatitis C virus (HCV) infection, indicating its strong efficacy.

Adding ribavirin did not significantly improve SVR12 rates for HCV genotypes 1 and 2, but it did enhance the response for genotype 3 patients, suggesting that ribavirin may be beneficial for specific HCV genotypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of sofosbuvir-velpatasvir: A meta-analysis. Ren, XD., Fu, X., He, YQ., et al.[2022]

The combination of sofosbuvir and velpatasvir (Epclusa®) is a once-daily, single-tablet treatment that has shown very high rates of sustained virological response (SVR12) in adults with chronic hepatitis C virus (HCV) genotypes 1-6, including those with cirrhosis or HIV-1 co-infection, based on phase III ASTRAL trials.

Sofosbuvir/velpatasvir is generally well tolerated with low rates of adverse events, making it a safe and effective treatment option for a wide range of patients with chronic HCV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sofosbuvir/Velpatasvir: A Review in Chronic Hepatitis C. Greig, SL.[2022]

Sofosbuvir/velpatasvir/voxilaprevir is highly effective for treating hepatitis C virus (HCV) in patients with genotypes 1 through 6 who have previously been treated with an NS5A inhibitor, as shown in the POLARIS-1 study with a 12-week treatment duration.

The treatment is generally safe, with common side effects including headache, fatigue, diarrhea, and nausea, making it a viable option for patients with chronic HCV, especially those with prior exposure to direct-acting antivirals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sofosbuvir/Velpatasvir/Voxilaprevir: A Pan-Genotypic Direct-Acting Antiviral Combination for Hepatitis C. Chahine, EB., Kelley, D., Childs-Kean, LM.[2021]

In a phase 3 study of 111 patients with chronic hepatitis C, 97% achieved a sustained virologic response (SVR12) after 12 weeks of treatment with sofosbuvir-velpatasvir, demonstrating its high efficacy across various HCV genotypes.

The treatment was well tolerated, with a safety profile similar to placebo, and only one patient discontinued due to an adverse event not related to the drug, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection. Asselah, T., Shafran, SD., Bourgeois, S., et al.[2020]

In a phase 2 trial involving 161 patients with hepatitis C, an 8-week treatment regimen of sofosbuvir, velpatasvir, and GS-9857 achieved a sustained virologic response (SVR12) in 100% of treatment-naïve patients with HCV genotype 1 and 3, including those with compensated cirrhosis.

The combination therapy was generally well-tolerated, with common side effects including headache, nausea, and fatigue, indicating a favorable safety profile alongside its high efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naïve or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections. Gane, EJ., Schwabe, C., Hyland, RH., et al.[2021]

References

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

Patient-reported outcomes in patients co-infected with hepatitis C virus and human immunodeficiency virus treated with sofosbuvir and velpatasvir: The ASTRAL-5 study. [2022]

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

Safety and efficacy of sofosbuvir-velpatasvir: A meta-analysis. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Sofosbuvir/Velpatasvir: A Review in Chronic Hepatitis C. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Sofosbuvir/velpatasvir for 12 weeks in genotype 1-4 HCV-infected liver transplant recipients. [2022]

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

Sofosbuvir/Velpatasvir/Voxilaprevir: A Pan-Genotypic Direct-Acting Antiviral Combination for Hepatitis C. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection. [2020]

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

Sofosbuvir/Velpatasvir: The First Pangenotypic Direct-Acting Antiviral Combination for Hepatitis C. [2018]

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

Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naïve or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections. [2021]