The purpose of this investigational study is for scientists to evaluate the effectiveness, safety and tolerability of Glecaprevir/Pibrentasvir - Mavyret® in participants who have acute HCV.

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• Effective for all HCV genotypes

• Dosed once daily

• Avoids ribavirin  (RBV)

• Associated with minimal side effects

• Extremely high barrier to development of resistance

• 8 weeks of therapy with G/P is highly effective across a wide variety of populations with chronic HCV infection

• ~95-100%, for all genotypes and regardless of baseline HCV RNA

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This study will include people who have acute hepatitis C virus (HCV) without cirrhosis, regardless of their HIV status or HCV genotype.

 

If the participant is HIV positive, they can either be on antiretroviral therapy (ART) or not on ART.

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Step 1  (4 weeks)

All participants will receive Glecaprevir (300 mg)/pibrentasvir (120 mg) fixed dose combination tablets orally, once daily, for 4 weeks.

 

Participants will continue to be followed until 24 weeks after treatment completion.

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Step 2 (16 weeks)

Participants for whom the G/P is not effective after 4 weeks will be offered 16 additional weeks of G/P plus weight-based ribavirin.

 

These participants will also be followed 24 weeks after stopping the additional therapy.

 

Modifications to the re-treatment regimen are allowed.

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​Length of Study: up to 60 weeks

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Schedule of Study Appointments:

• Screening

• Entry

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Medications administered during study: Glecaprevir 100 mg/pibrentasvir 40 mg tablets to be taken as 3 tablets orally once daily with food for 4 weeks. An additional 16 weeks of G/P with weight based RBV may be indicated.

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Study Procedures: 

• Blood tests at clinic visits

• Urine sampling

• Hair Sampling

• Adherence monitoring

• Questionnaire asking whether you use street drugs

 

Reimbursement: Participants will receive $20 for all visits,

starting with the screening visit.

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TO ENTER THIS STUDY

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• Be 18 years old or older.

• You have acute HCV infection (confirmed within 6 months prior to entry), regardless of genotype.

• If you are HIV-positive and if you are on ART, CD4 must be greater than 200 and your viral load undetectable.

• If you are HIV positive and are not on ART, you must have no plans to start ART during study treatment.

• If you are a woman, you must agree to contraception/birth control methods or provide documentation of sterilization and/or menopause.

• Be willing to sign the consent after discussion with the research staff.

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• Cannot have known preexisting cirrhosis.

• Cannot have chronic liver disease caused by something other than HCV.

• Cannot be positive for the presence of Hepatitis A Virus or Hepatitis B Virus.

• Cannot have a history of solid organ transplant.

• Cannot have acute HIV infection.

• Cannot be currently receiving ritonavir-boosted atazanavir, atazanavir (even if unboosted), rifampin, efavirenz, etravirine, didanosine, stavudine, ethinyl estradiol-containing medications, carbamazepine, oxcarbazepine, St. John’s wort.

• Cannot have had any previous attempt at HCV treatment during this acute HCV infection episode, (within 24 weeks prior to entry).

• Cannot be breastfeeding or pregnant.

• Cannot have a known allergy/sensitivity or any hypersensitivity to components of study drug(s).

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Talk to our study staff for a complete list of requirements. 

 

CALL or TEXT

ACTU Staff  (206) 773-7129