Sofosbuvir/Velpatasvir for Hepatitis C

(MINMON-J Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Lifespan

Must be taking: Sofosbuvir/Velpatasvir

Disqualifiers: Cirrhosis, Hepatitis B, Pregnancy, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a simple treatment plan can help people with hepatitis C in jail start and complete their treatment. Participants will receive a 12-week course of the medication sofosbuvir/velpatasvir (a combination antiviral drug), even if released before completion. Community Health Workers (CHWs) will support participants during and after incarceration to ensure treatment continuation. The trial seeks adults in jail with active hepatitis C who have used injection drugs and are awaiting trial. The goal is to assess if this approach can be applied in other jails to help stop the spread of hepatitis C. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand its benefits for more patients.

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 healthcare provider.

What is the safety track record for sofosbuvir/velpatasvir?

Research has shown that the medication sofosbuvir/velpatasvir, also known as Epclusa, is generally well-tolerated. One study found that this 12-week treatment for hepatitis C was effective for most patients. Common side effects included fatigue and headaches, but these were not severe for most individuals.

The FDA has already approved the medication for treating hepatitis C, suggesting its safety. During trials, most participants did not experience serious issues, indicating that the treatment is safe for many, although individual experiences may vary.

For those considering joining this trial, it is reassuring that sofosbuvir/velpatasvir has a strong safety record. However, discussing health concerns with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about sofosbuvir/velpatasvir for treating Hepatitis C because it offers a potent combination therapy that targets the virus at multiple stages. Unlike older treatments that often require interferons, which can have severe side effects, this combination directly blocks the virus's ability to replicate. Additionally, sofosbuvir/velpatasvir is an oral medication, making it more convenient and potentially improving patient adherence compared to injectable therapies. This dual-action approach not only simplifies the treatment regimen but also increases the likelihood of achieving a sustained virologic response, effectively curing the infection.

What is the effectiveness track record for sofosbuvir/velpatasvir in treating hepatitis C?

Research has shown that the medication sofosbuvir/velpatasvir, which participants in this trial will receive, effectively treats hepatitis C. Studies have found that it often makes the virus undetectable in the blood, indicating recovery. This success has been observed across various virus types, specifically genotypes 1 through 6. In everyday use, this medication consistently delivers strong results in combating the virus. Overall, it effectively helps many people with hepatitis C improve. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults with active hepatitis C virus (HCV) who are currently incarcerated at the Rhode Island Department of Corrections and awaiting trial. The study aims to see if a simplified treatment program can help them start and complete HCV treatment more easily.

Inclusion Criteria

Incarcerated individual at RIDOC

English speaking

Self-report of injection drug use

Exclusion Criteria

I have cirrhosis confirmed by a recent test or clinical signs.

Positive for Hepatitis B surface antigen

Actively pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

12 weeks

In-facility visits as needed, with community follow-up if released

Follow-up

Participants are monitored for HCV cure and adherence post-treatment, including support from Community Health Workers

12 weeks

Community follow-up visits

Long-term follow-up

Participants are assessed for maintenance of HCV cure and engagement in care 6 months post-treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Sofosbuvir / Velpatasvir

Trial Overview The intervention being tested is a 12-week course of sofosbuvir/velpatasvir (Epclusa) combined with support from Community Health Workers. The study will evaluate if this low-barrier approach helps participants finish treatment, get cured, and could be implemented in other jail settings.

How Is the Trial Designed?

Group I: MINMON-J Experimental Treatment 2 Interventions

Individuals in this arm will be provided the full-course treatment of sofosbuvir / velpatasvir for treatment of hepatitis C virus. They will also receive support from a Community Health Worker (CHW) to assist with community re-entry, medication adherence, and lab follow-up.

Who Is Running the Clinical Trial?

Lifespan

Lead Sponsor

Trials

43

Recruited

41,100+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

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]

In a study of 1880 patients with chronic hepatitis C in Taiwan, the treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks resulted in a high sustained virologic response (SVR12) rate of 95.6%, indicating its effectiveness in clearing the virus.

The treatment was well-tolerated, with only 0.2% of patients discontinuing due to adverse events, and serious adverse events were not related to the medication, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sofosbuvir/velpatasvir for patients with chronic hepatitis C virus infection and compensated liver disease: real-world data in Taiwan. Liu, CH., Chen, PY., Chen, JJ., et al.[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 study of 1701 patients with hepatitis C, treatment with sofosbuvir and velpatasvir, with or without ribavirin, led to significant improvements in patient-reported outcomes (PROs), especially in those with decompensated cirrhosis, indicating effective symptom relief and quality of life enhancement during and after treatment.

Patients with decompensated cirrhosis experienced greater increases in PRO scores compared to those with compensated cirrhosis, suggesting that this treatment regimen is particularly beneficial for those with more severe liver disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis. Younossi, ZM., Stepanova, M., Feld, J., et al.[2022]

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 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]

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 ... In conclusion, SOF+VEL ± RBV, GLE+PIB, and SOF+VEL+VOX had good antiviral effectiveness for chronic HCV-GT3 infection in real-world settings.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2055664024000335

Real-life study on the effectiveness and safety of sofosbuvir ... The primary outcome for the effectiveness of the SOF/VEL regimen was the rate of SVR defined as HCV RNA <15 IU/mL at 12 weeks after the end of treatment in ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1512610

Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5 ... Once-daily sofosbuvir–velpatasvir for 12 weeks provided high rates of sustained virologic response among both previously treated and untreated patients.

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. 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 ...

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

For HCP's | Epclusa® (sofosbuvir/velpatasvir) Use in GT 3 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% among patients with GT ...

9. 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 ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT05140941

Study Details | NCT05140941 | Sofosbuvir/Velpatasvir ... This is a phase 4, multicenter study, single arm study of Sofosbuvir/Velpatasvir (SOF/VEL) for treatment of chronic hepatitis C infection during pregnancy.