Harborview Medical Center

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2nd Floor West Clinic

Seattle, WA 98104

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The Acute Hepatitis C Study

The UW AIDS Clinical Trials Unit is looking for men and women with a new diagnosis of hepatitis C (HCV)--with OR without HIV--to volunteer for an investigational research study to evaluate if 4 weeks (instead of 8 to 12 weeks) of the drug glecaprevir/pibrentasvir (brand name Mavyret®) will cure HCV when given during acute infection.

HCV infection affects more than 4 million persons and causes at least 20,000 deaths annually in the United States.

 

Recently, incidence of acute HCV has been rising.

 

The Centers for Disease Control and Prevention (CDC) estimate that there are

about 30,000 new cases of acute HCV per year.

 

Those with recent infection, if unaware of their status, are at high-risk for

transmission to others.

 

Early identification of acute HCV infection is essential to provide preventive counseling and, if necessary, curative treatment to clear virus and prevent onward transmission.

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.

  • 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

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.

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.

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.

Length of Study: up to 60 weeks

Schedule of Study Appointments:

  • Screening

  • Entry

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.

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 at Entry.

TO ENTER THIS STUDY

  • 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.

  • 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).

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

 

CALL or TEXT

Eric Helgeson, RN
(206) 773-7129