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

Trial Summary

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 data supports the effectiveness of the drug Sofosbuvir/Velpatasvir for treating Hepatitis C?

The drug Sofosbuvir/Velpatasvir has been shown to be effective in treating Hepatitis C, achieving high cure rates across all 6 genotypes of the virus. It is effective for patients with and without liver cirrhosis, and even for those who have failed previous treatments, with common side effects being mild, such as headache and fatigue. ^{1 2 3 4 5}

Is Sofosbuvir/Velpatasvir safe for humans?

Sofosbuvir/Velpatasvir is generally safe for humans, with common side effects including headaches, fatigue, and nausea. In studies, some patients experienced mild gastrointestinal issues and fatigue, but serious side effects were rare and not considered related to the treatment. ^{1 3 6 7 8}

How is the drug Sofosbuvir/Velpatasvir unique for treating Hepatitis C?

Sofosbuvir/Velpatasvir is unique because it is a once-daily, single-tablet regimen that works for all major types of Hepatitis C, making it a versatile option for patients with different genotypes. It is effective even in patients with cirrhosis (liver scarring) or those who have HIV-1 co-infection, and it generally has low rates of side effects. ^{1 2 7 9 10}

What is the purpose of this trial?

The goal of this clinical trial is to learn whether a low-barrier treatment program can help people with hepatitis C virus (HCV) who are in jail start and complete treatment more easily. This study focuses on adults at the Rhode Island Department of Corrections who have active HCV and are awaiting trial. The study asks: * Can a simplified, low-barrier HCV treatment program work in a jail setting? * Do participants finish treatment and get cured using this approach? All participants will receive a 12-week course of the HCV medication sofosbuvir/velpatasvir (Epclusa). If they are released before completing treatment, they will take the remaining doses with them. Community Health Workers (CHWs) will help support participants after release, including reminding them to take medications and helping them get follow-up lab work. Researchers will measure: * Whether participants are cured of HCV * Whether the treatment approach is easy to use (feasible), acceptable, and followed correctly (fidelity) * Whether the program could be used in other jails or expanded in the future This study may help bring HCV treatment to more people in jail, reduce community spread of the virus, and support national goals to eliminate HCV.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

References

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

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

2. United States 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. [2022]

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

Sofosbuvir/velpatasvir for patients with chronic hepatitis C virus infection and compensated liver disease: real-world data in Taiwan. [2021]

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

Real-world efficacy and safety of 12-week sofosbuvir/velpatasvir treatment for patients with decompensated liver cirrhosis caused by hepatitis C virus infection. [2021]

5. Spain pubmed.ncbi.nlm.nih.gov

Sofosbuvir/velpatasvir fixed-dose combination for the treatment of chronic hepatitis C virus infection. [2022]

6. 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]

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

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

8. 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]

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

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

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

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