Epclusa for Chronic Hepatitis C

Overseen By Alaina Magnani

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Must be taking: Hepatitis C drugs

Must not be taking: Acid reducers, Antiarrhythmics, Anticancer, others

Disqualifiers: Pregnancy, HIV, Solid organ transplant, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 32

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how liver disease progresses or causes complications even after curing hepatitis C. The study will use Epclusa, a medication combining two hepatitis C drugs, to treat participants and monitor their liver health over time. It targets individuals with chronic hepatitis C, regardless of previous treatment or cure status. Participants will undergo various tests and procedures to track changes in liver health. This research could help uncover why some people continue to experience liver issues post-cure. As a Phase 4 trial, this study uses an FDA-approved treatment to explore its potential benefits for more patients.

Do I need to stop my current medications to join the trial?

You may need to stop certain medications before joining the trial. Specifically, you cannot use medications that are contraindicated with sofosbuvir/velpatasvir within 21 days before starting the trial, except for proton pump inhibitors, which can be taken up to 7 days before. Please consult with the trial team for specific guidance on your medications.

What is the safety track record for Epclusa?

Research has shown that Epclusa, a combination of sofosbuvir and velpatasvir, is generally safe and well-tolerated for treating chronic hepatitis C. Most people taking Epclusa experience only mild side effects, with headache and tiredness being the most common.

The FDA has approved Epclusa for treating hepatitis C, confirming its safety record. Many patients have used it successfully, providing strong evidence of its safety. Studies indicate that serious side effects are rare. However, discussing any concerns or current medications with a healthcare provider is important, as Epclusa can interact with other drugs. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Epclusa for chronic hepatitis C because it offers a pan-genotypic treatment option, meaning it can treat all major genotypes of the hepatitis C virus. Unlike some other treatments that may be limited to specific genotypes, Epclusa combines sofosbuvir and velpatasvir to target a broader range of the virus. This treatment is also notable for its relatively short treatment duration of 12 weeks, with a high rate of sustained virologic response (SVR), which means it has the potential to effectively clear the virus from the body in most cases. This broad efficacy and streamlined treatment course make Epclusa a promising option for simplifying and improving hepatitis C care.

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

Research has shown that Epclusa, a combination of sofosbuvir and velpatasvir, effectively treats chronic hepatitis C. Studies indicate it cures about 98% of patients after 12 weeks of treatment, including those with various virus genotypes. The treatment stops the virus from multiplying, aiding the body in eliminating the infection. With such high cure rates, Epclusa serves as a trusted option for many with this condition. ^{5 6 7 8 9}

Who Is on the Research Team?

Marc G Ghany, M.D.

Principal Investigator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Are You a Good Fit for This Trial?

Adults over 18 with chronic hepatitis C, either untreated or previously treated but not cured. They must have a liver biopsy showing chronic hepatitis and meet specific health criteria like normal bilirubin levels and platelet counts. Pregnant women, those unable to use contraception, people with other significant diseases or conditions that could interfere with the study drug's absorption are excluded.

Inclusion Criteria

I had successful hepatitis treatment with medication and a liver biopsy before treatment.

I have either never been treated or have not responded to previous hepatitis treatments.

I have had chronic hepatitis C confirmed by a test more than 6 months ago.

Exclusion Criteria

I do not have major health issues that could affect my participation in the study.

I have previously been treated with an NS5a agent.

I am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Phase 1 Treatment

Participants receive 12 weeks of therapy with sofosbuvir/velapatasvir (Epclusa) and undergo various tests including liver biopsy

12 weeks

3 visits (in-person) during treatment

Phase 1 Follow-up

Participants are monitored for sustained virological response (SVR) with additional blood tests

24 weeks

4 visits (in-person)

Phase 2 Long-term Follow-up

Participants are followed every 24 weeks for 10 years to monitor liver-related outcomes and complications

480 weeks

Visits every 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Epclusa

Trial Overview The trial is testing Epclusa in individuals who've achieved sustained virological response after direct-acting antiviral agents for hepatitis C. It includes initial hospital admission for tests, daily medication for 12 weeks followed by blood tests, then biannual visits for up to 10 years including various screenings and procedures.

How Is the Trial Designed?

Group I: Phase I Experimental Treatment 1 Intervention

Phase I treatment

Group II: Phase II after Phase I Active Control 1 Intervention

Participants who achieved SVR12 in Phase I

Group III: Phase II without Phase I Active Control 1 Intervention

Participants who achieved SVR 24 previously

Epclusa is already approved in European Union, United States for the following indications:

Approved in European Union as Epclusa for:

• Chronic hepatitis C

Approved in United States as Epclusa for:

• Chronic hepatitis C

Who Is Running the Clinical Trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Lead Sponsor

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

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]

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 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]

Citations

1. 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.

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

Safety and efficacy of sofosbuvir-velpatasvir: A meta-analysis This meta-analysis study suggests that the single-tablet regimen of sofosbuvir- velpatasvir (Epclusa) is highly effective in chronic HCV (GT–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. gastrojournal.org gastrojournal.org/article/s0016-5085(17)35399-4/fulltext

Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and ... Eight weeks of sofosbuvir-velpatasvir-voxilaprevir (95% cured) was not statistically equivalent to 12 weeks of sofosbuvir-velpatasvir (98%), but both regimens ...

5. askgileadmedical.com askgileadmedical.com/docs/epclusa/epclusa-use-in-gt-3

For HCP's | Epclusa® (sofosbuvir/velpatasvir) Use in GT 3 Efficacy and safety ... The SVR12 rates were 99% and 94% among patients with GT 2 who were treated with SOF/VEL and SOF/VEL + RBV, respectively, and 99% and 95% ...

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. epclusa.com epclusa.com/

EPCLUSA® (sofosbuvir/velpatasvir) A Hep C Treatment ... Discover EPCLUSA® (sofosbuvir/velpatasvir), a prescription medicine used to treat chronic Hep C. See Important Safety Information including Important Warning.

8. 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 ...

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

EPCLUSA® (sofosbuvir and velpatasvir) tablets, for oral ... The safety and effectiveness of EPCLUSA for treatment of HCV genotype 5 in pediatric patients 3 years of age and older without cirrhosis or with compensated ...