What is the mechanism of action of this treatment?

The most common treatments for Chronic Hepatitis C, such as Sofosbuvir and Velpatasvir, are direct-acting antivirals (DAAs) that inhibit the replication of HCV RNA and the processing of viral polyproteins. Sofosbuvir is a nucleotide analog that inhibits the HCV RNA polymerase, preventing viral RNA synthesis. Velpatasvir inhibits the NS5A protein, which is essential for viral replication and assembly. These mechanisms are important for patients because they directly target and disrupt the virus's ability to reproduce, leading to higher rates of sustained virologic response (SVR) and improved long-term health outcomes.

What side effects are associated with this type of intervention?

Common treatments for Chronic Hepatitis C, such as Sofosbuvir/Velpatasvir, are generally well-tolerated. The most frequently reported side effects include headache, fatigue, and nausea. Serious adverse events are rare but can include anemia and elevated bilirubin levels, particularly when ribavirin is part of the regimen. Other potential side effects, though less common, may include insomnia and mild gastrointestinal disturbances. Patients with advanced liver disease or those on complex medication regimens should be monitored closely for drug interactions and liver function.

What prior FDA approvals exist?

Several direct-acting antiviral (DAA) agents have been FDA approved for the treatment of Chronic Hepatitis C, focusing on inhibiting HCV RNA replication and polyprotein processing. Sofosbuvir, often combined with other agents like Ledipasvir or Velpatasvir, is a nucleotide polymerase inhibitor that has shown high efficacy. Ledipasvir/Sofosbuvir and Sofosbuvir/Velpatasvir combinations are approved for various HCV genotypes and have demonstrated high sustained virologic response (SVR) rates. Other notable combinations include Glecaprevir/Pibrentasvir and Elbasvir/Grazoprevir, which are also effective across multiple HCV genotypes. These treatments have transformed HCV management by providing effective, well-tolerated, all-oral regimens.

What other types of research exist?

Promising alternatives to Sofosbuvir/Velpatasvir for Chronic Hepatitis C patients include Glecaprevir/Pibrentasvir and Elbasvir/Grazoprevir. Glecaprevir/Pibrentasvir is effective across all HCV genotypes and is well-tolerated, with common side effects being mild, such as headache and fatigue. Elbasvir/Grazoprevir has shown efficacy in preventing chronic HCV infection in transplant recipients and is also well-tolerated. Both regimens offer high SVR rates and are suitable for a broad range of patients, including those with renal impairment.

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Antiviral

Sofosbuvir/Velpatasvir for Hepatitis C in Pregnancy (STORC Trial)

Phase 4

Recruiting

Led By Catherine Chappell, MD, MSc

Research Sponsored by Catherine Chappell

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HCV antibody seropositivity with detectable HCV RNA viral load at screening

If taking acid-suppressant medication(s), willing and able to either discontinue administration during the 12-week period of study treatment or to follow specific dosing instructions for concomitant use with SOF/VEL

Must not have

Participant report of previous DAA treatment for HCV without documentation of SVR12

Plans to relocate away from the study site area in the next 16 months and unable/unwilling to return for study visits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately six months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests a combination pill called Sofosbuvir/Velpatasvir (SOF/VEL) for treating hepatitis C in pregnant people. The treatment aims to stop the virus from multiplying and clear the infection. The study will check if this treatment is effective and safe during pregnancy. Sofosbuvir/Velpatasvir (SOF/VEL) has been demonstrated to be safe and effective in treating almost all types of hepatitis C infected individuals.

Who is the study for?

This trial is for pregnant individuals aged 18-45 with chronic hepatitis C, between 20-30 weeks of gestation, and no major pregnancy complications. They must not have plans to relocate and should agree not to join other drug/device trials during the study. Exclusions include certain medication use, severe liver abnormalities, low blood counts, or uncontrolled health conditions.

What is being tested?

The trial tests Sofosbuvir/Velpatasvir (SOF/VEL) in treating chronic hepatitis C during pregnancy. About 100 participants will take one tablet daily for 12 weeks starting in their second or third trimester. The main goals are to see if the virus stays undetectable after treatment and how it affects delivery timing.

What are the potential side effects?

Potential side effects may include headache, fatigue, nausea, insomnia, itching skin rashes or irritations. Since this is a study involving pregnant individuals, close monitoring will ensure any side effects are managed promptly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have hepatitis C with a detectable virus level.

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I can stop or follow special instructions for my acid-suppressant meds during the study.

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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was treated for hepatitis C but don't have proof of being virus-free after 12 weeks.

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I plan to stay near the study site for the next 16 months and can attend all visits.

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I have a documented history of cirrhosis.

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I am not taking any medications that can't be used with EPCLUSA®.

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My unborn baby has a confirmed genetic abnormality.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of maternal participants that deliver prior to 37 weeks' gestation

Number of maternal participants with sustained virologic response after completion of SOF/VEL treatment (SVR12)

Secondary study objectives

Head circumference of infant participant at 12 months

Head circumference of infant participant at 6 months

Head circumference of infant participant at 8 weeks

+28 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sofosbuvir/VelpatasvirExperimental Treatment1 Intervention

Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet, one tablet taken once daily for 84 days

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Hepatitis C, such as Sofosbuvir and Velpatasvir, are direct-acting antivirals (DAAs) that inhibit the replication of HCV RNA and the processing of viral polyproteins. Sofosbuvir is a nucleotide analog that inhibits the HCV RNA polymerase, preventing viral RNA synthesis. Velpatasvir inhibits the NS5A protein, which is essential for viral replication and assembly. These mechanisms are important for patients because they directly target and disrupt the virus's ability to reproduce, leading to higher rates of sustained virologic response (SVR) and improved long-term health outcomes.

Specifically targeted antiviral therapy for hepatitis C virus.