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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Epclusa, which combines sofosbuvir and velpatasvir to treat hepatitis C. The goal is to determine if easier access to this treatment can improve health in a rural area of Kentucky affected by both hepatitis C and opioid use. Residents of Perry County, Kentucky, with hepatitis C can join this trial by providing proof of residency. Participants will take the medication for 12 weeks, and researchers will compare their health outcomes to those in a nearby county where the treatment isn't provided. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand its benefits for more patients, offering a chance to contribute to valuable research.

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 is the safety track record for Sofosbuvir/velpatasvir (Epclusa®)?

Research shows that Epclusa, a combination of sofosbuvir and velpatasvir, is generally safe and effective for treating hepatitis C. It has proven effective for both adults and children aged 3 and older. The most common side effects, headache and tiredness, are usually mild. Importantly, the FDA has already approved Epclusa for treating hepatitis C, indicating thorough safety testing. This information can reassure those considering joining a clinical trial about the treatment's safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Epclusa® for treating Hepatitis C because it combines two powerful antiviral agents, sofosbuvir and velpatasvir, into a single treatment. Unlike other treatments that might require multiple drugs or longer durations, Epclusa® offers a simplified, all-oral regimen that lasts just 12 weeks. This combination targets all six major strains of the Hepatitis C virus, providing a broad-spectrum solution that increases the likelihood of success across diverse patient populations. This streamlined approach, paired with its high cure rates, makes Epclusa® a promising option for effectively managing and potentially eradicating the disease.

What is the effectiveness track record for Epclusa in treating hepatitis C?

Research shows that Epclusa, a combination of sofosbuvir and velpatasvir, effectively treats hepatitis C. Studies have found that a 12-week course of this medication can eliminate the virus in most patients. In everyday use, it has performed well across different hepatitis C virus types, with particularly strong results for most genotypes. Notably, the treatment often clears the virus in over 95% of cases, making it undetectable in the blood after treatment. This success makes Epclusa a proven and reliable choice for people with chronic hepatitis C. Participants in this trial will receive a standard 12-week course of Epclusa to further evaluate its effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Jennifer Havens, PhD

Principal Investigator

University of Kentucky Ctr on Drug & Alcohol Rsrch

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9592351/

Safety and efficacy of sofosbuvir-velpatasvir: A meta-analysis In conclusion, the 12-week regimen of sofosbuvir-velpatasvir was highly effective in HCV patients. Except for genotype-3, adding ribavirin was ...

2. hcp.epclusa.com hcp.epclusa.com/efficacy-and-adherence

Efficacy & Adherence Learn about efficacy and adherence data with EPCLUSA® (sofosbuvir/velpatasvir) for adults with chronic hepatitis C virus (HCV) genotypes 1-6.

3. frontiersin.org frontiersin.org/journals/gastroenterology/articles/10.3389/fgstr.2025.1511150/full

Real-world effectiveness of sofosbuvir/velpatasvir ... Conclusion: SOF+VEL ± RBV, GLE+PIB, and SOF+VEL+VOX had good antiviral effectiveness for chronic HCV-GT3 infection in real-world settings.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36281168/

Safety and efficacy of sofosbuvir-velpatasvir: A meta-analysis In conclusion, the 12-week regimen of sofosbuvir-velpatasvir was highly effective in HCV patients. Except for genotype-3, adding ribavirin ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589555922002221

Sofosbuvir plus velpatasvir for 8 weeks in patients with ... The efficacy of 8 weeks of GLE/PIB should be >95% based on data in individuals with chronic hepatitis C and a study reported high SVR rates of 96% even with 6 ...

6. hcp.epclusa.com hcp.epclusa.com/safety

Safety | EPCLUSA® (sofosbuvir/velpatasvir) Official HCP ... See the safety profile for EPCLUSA® (sofosbuvir/velpatasvir), including drug-drug interaction information and adverse reactions.

7. gilead.com gilead.com/-/media/files/pdfs/medicines/liver-disease/epclusa/epclusa_pi.pdf

EPCLUSA® (sofosbuvir and velpatasvir) tablets, for oral ... EPCLUSA is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or ...

8. natap.org natap.org/2021/AASLD/AASLD_12.htm

A Case Series of Safety and Efficacy of Crushed Sofosbuvir ... There is limited safety and efficacy data using crushed Sofosbuvir/Velpatasvir (SOF/VEL). to treat HCV. There are multiple instances where a ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/208341s019lbl.pdf

EPCLUSA® (sofosbuvir and velpatasvir) tablets, for oral use ... EPCLUSA is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or ...

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39688397/

Sofosbuvir/Velpatasvir Pharmacokinetics, Safety, and Efficacy ... All 10 participants who completed treatment had undetectable HCV RNA at delivery. Two participants were lost to follow-up after delivery, but 1 ...