Phase 4
Completed N=400
Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection
Source: ClinicalTrials.gov NCT03512210 ↗Enrolled (actual)
400
Serious AEs
7.8%
Results posted
Jul 2021
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 (SVR12) — 95.0 percentage of participants
◆ Published Evidence
Highly cited
111citations · ~28 / year
A minimal monitoring approach for the treatment of hepatitis C virus infection (ACTG A5360 [MINMON]): a phase 4, open-label, single-arm trial.
Summary
To achieve global hepatitis C virus (HCV) elimination by 2030, 80% of the ~71 million people with chronic HCV infection will need to be treated, necessitating simplification of treatment delivery and associated laboratory monitoring without compromising efficacy or safety. The COVID-19 pandemic has further highlighted the need for innovative models of health care delivery that minimize face-to-face patient-provider contact. The purpose of this study was to evaluate the feasibility, safety, and efficacy of a minimal monitoring (MINMON) strategy to deliver interferon- and RBV-free, pan-genotypic DAA therapy to treat active HCV in HCV treatment naïve participants.
Linked Publications (4)
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A minimal monitoring approach for the treatment of hepatitis C virus infection (ACTG A5360 [MINMON]): a phase 4, open-label, single-arm trial.
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Perspectives on Adherence From the ACTG 5360 MINMON Trial: A Minimum Monitoring Approach With 12 Weeks of Sofosbuvir/Velpatasvir in Chronic Hepatitis C Treatment.
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Impact of a minimal monitoring HCV treatment approach on Health-Related Quality of Life.
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Reinfection and Resistance Associated Substitutions Following a Minimal Monitoring Approach for Hepatitis C Virus Treatment in MINMON Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 (SVR12) |
95.0 | — |
| PRIMARY Percentage of Participants With an Occurrence of Serious Adverse Events According to International Council for Harmonization (ICH) Criteria |
3.5 | — |
| SECONDARY Percentage of Participants With at Least One Unplanned Clinic Visit Prior to SVR12 Evaluation |
3.8 | — |
| SECONDARY Percentage of Participants With an Occurrence of One or More Non-serious, Grade >= 3 Adverse Event (AE), or Treatment Limiting AE. |
5.8 | — |
| SECONDARY Percentage of Participants Who Prematurely Discontinued HCV Study Medications |
1.0 | — |
Eligibility Criteria
Inclusion Criteria
- Active Hepatitis C (HCV) infection, defined by HCV RNA >1000 international units (IU/mL) within 35 days prior to study entry
- HCV treatment naïve
- Liver disease staged as either non-cirrhotic (Fibrosis-4 (FIB-4) Score 350 cells/uL within 90 days prior to study entry
- The following laboratory values obtained within 35 days prior to study entry:
- Albumin >3.0 g/L
- Hemoglobin >8.0 g/dL for women; >9.0 g/dL for men
- Platelet count >50,000/mm^3
- Calculated creatinine clearance (CrCl) >30 mL/min
- Aspartate aminotransferase (AST) 12 months
- Ability and willingness to be contacted remotely
- Ability and willingness of participant to provide informed consent.
Exclusion Criteria
- Positive for hepatitis B virus (HBV) surface antigen
- For cirrhotic participants, CTP score >6 corresponding to Class B or C
- Breastfeeding or pregnancy
- Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation
- Active drug or alcohol use or dependence and other conditions that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Acute or serious illness requiring systemic treatment and/or hospitalization within 35 days prior to study entry
- For HIV positive participants, presence of active or acute AIDS-defining opportunistic infections within 35 days prior to study entry
- Any history of hepatic decompensation including ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatorenal syndrome, and/or bleeding esophageal varices
- Use of prohibited medications within the past 14 days prior to study entry
Data sourced from ClinicalTrials.gov (NCT03512210) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.