Hepatitis CPhase 4MINMONNCT03512210
Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection
A Phase 4 study testing Sofosbuvir/Velpatasvir (SOF/VEL) and Minimal Monitoring (MINMON) Strategy in people with Hepatitis C and HIV-1-infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 38 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, HIV-1-infection, Liver Diseases
- What is being tested?
- Sofosbuvir/Velpatasvir (SOF/VEL) and Minimal Monitoring (MINMON) Strategy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 38 sitesin 6 countries
- Study dates
- 22 Oct 2018to 28 Feb 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 <3.25) or compensated cirrhotic (FIB-4 Score ≥3.25 and Child-Turcotte-Pugh (CTP) ≤Score 6) within 35 days prior to study entry
- HIV-1 negative, or HIV-1 positive with either a) Non-efavirenz containing antiretroviral therapy (ART) started at least 14 days prior to study entry with plasma HIV-1 RNA <400 copies/mL within 90 days prior to study entry or b) not taking ART and CD4+ cell count >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
Show all 20Show fewer
- 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) <10 times the upper limit of the normal range (ULN)
- Alanine transaminase (ALT) <10 times the ULN
- Total bilirubin <1.5 times the ULN for participants not on atazanavir (ATV); <3 times the ULN for participants on ATV
- International normalized ratio (INR) <1.5 times the ULN
- For females of reproductive potential, a negative serum or urine pregnancy test within 48 hours prior to study entry
- All participants of reproductive potential must have agreed not to participate in conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) while on study treatment and for 6 weeks after stopping study treatment
- If participating in sexual activity that could lead to pregnancy, the all participants of reproductive potential had to agree to use at least one reliable methods of contraception while on study treatment and for 6 weeks after stopping study treatment
- Participants who were not of reproductive potential were eligible without requiring the use of contraceptives.
- Life expectancy >12 months
- Ability and willingness to be contacted remotely
- Ability and willingness of participant to provide informed consent.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
38 sites in 6 countries.
38 sites in 6 countries
United States30 sites
The Ponce de Leon Center CRS (5802)
Atlanta, Georgia, 30308
University of Colorado Hospital CRS (6101)
Aurora, Colorado, 80045
Johns Hopkins University CRS (201)
Baltimore, Maryland, 21205
Alabama CRS (31788)
Birmingham, Alabama, 35294
Massachusetts General Hospital (MGH) CRS (101)
Boston, Massachusetts, 02114
Brigham and Women's Hosp. ACTG CRS (107)
Boston, Massachusetts, 02115
Unc Aids Crs (3201)
Chapel Hill, North Carolina, 27514
Northwestern University CRS (2701)
Chicago, Illinois, 60611
Rush Univ. Med. Ctr. ACTG CRS (2702)
Chicago, Illinois, 60612
Univ. of Cincinnati CRS (2401)
Cincinnati, Ohio, 45267
Case CRS (2501)
Cleveland, Ohio, 44106
The Ohio State Univ. AIDS CRS (2301)
Columbus, Ohio, 43210
Trinity Health and Wellness Center CRS (31443)
Dallas, Texas, 75208
Greensboro CRS (3203)
Greensboro, North Carolina, 27401
Houston AIDS Research Team CRS (31473)
Houston, Texas, 77030
University of Southern California (1201)
Los Angeles, California, 90033-1079
UCLA CARE Center CRS (601)
Los Angeles, California, 90095
Vanderbilt Therapeutics (VT) CRS (3652)
Nashville, Tennessee, 37204
Weill Cornell Chelsea CRS (7804)
New York, New York, 10010
Columbia Physicians and Surgeons CRS (30329)
New York, New York, 10032
Weill Cornell Upton CRS (7803)
New York, New York, 10065
New Jersey Medical School Clinical Research Center CRS (31786)
Newark, New Jersey, 07103
Hosp. of the Univ. of Pennsylvania CRS (6201)
Philadelphia, Pennsylvania, 19104
Pittsburgh CRS (1001)
Pittsburgh, Pennsylvania, 15213
The Miriam Hospital ACTG CRS (2951)
Providence, Rhode Island, 02906
University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787)
Rochester, New York, 14642
Ucsd, Avrc Crs (701)
San Diego, California, 92103
Ucsf Aids Crs (801)
San Francisco, California, 94110
Washington U CRS (2101)
St Louis, Missouri, 63110
Whitman Walker Health CRS (31791)
Washington D.C., District of Columbia, 20009
Brazil2 sites
Hospital Nossa Senhora da Conceicao CRS (12201)
Porto Alegre, Rio Grande do Sul, 9043010
Instituto de Pesquisa Clinica Evandro Chagas (12101)
Rio de Janeiro, 21045
South Africa2 sites
Family Clinical Research Unit (FAM-CUR) CRS (8950)
Cape Town, West Cape, 7505
University of the Witwatersrand Helen Joseph (WITS HJH) CRS (11101)
Johannesburg, Gauteng, 2193
Thailand2 sites
Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (31802)
Bangkok, Patumwan, 10330
Chiang Mai University HIV Treatment CRS (31784)
Chiang Mai, 50200
About this study
Official title: A Single-arm Study to Evaluate the Feasibility and Efficacy of a Minimal Monitoring Strategy to Deliver Pan-genotypic Ribavirin-free HCV Therapy to HCV Infected Populations Who Are HCV Treatment Naïve With Evidence of Active HCV Infection: The MINMON Study
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.
Read the detailed description
This study evaluated the feasibility, safety, and efficacy of a minimal monitoring (MINMON) strategy of delivering interferon- and ribavirin (RBV)-free, pan-genotypic direct-acting antiviral (DAA) therapy to treat active hepatitis C virus (HCV) in HCV treatment naïve participants, with or without HIV-1 co-infection, and with no evidence of decompensated cirrhosis.
The MINMON intervention included four components: 1) No pre-treatment HCV genotyping; 2) Entire 12-week treatment course (84 tablets) dispensed to participants at study entry; 3) No scheduled on-treatment laboratory monitoring or clinic visits prior to SVR evaluation scheduled 24 weeks following entry; 4) Remote contact with participants at week 4 for adherence counseling and locator update, and week 22 for scheduling of SVR visit and locator update.
At study entry, all participants received a single-tablet, fixed-dose combination (FDC) of sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks.
The trial was designed to accrue 400 adult participants who may be co-infected with HIV-1 (limited to no more than 200 participants), and whose liver disease state is either no cirrhosis (defined by Fibrosis-4 score) or compensated cirrhosis (defined by Fibrosis-4 and Child-Turcotte-Pugh (CTP) scores, and limited to no more than 80 participants). Accrual from research sites in the United States was limited to no more than 132 participants.
The study proceeded in two steps: Step 1: MINMON intervention and Step 2: post-MINMON follow up.
During Step 1 (MINMON intervention), participants were contacted remotely at week 4 to inquire about study medication adherence and confirm locator information, and again at week 22 to schedule the sustained virologic response (SVR) evaluation and confirm locator information. Unplanned in-person clinic visits before week 22 were permissible to address common treatment toxicities that could not be managed remotely. The primary efficacy outcome measure, sustained virologic response (SVR), was evaluated starting at the week 24 study visit. Early discontinuation of treatment did not alter the timing of the SVR evaluation. If the week 24 visit was missed, SVR could be evaluated at any time up to 76 weeks following study entry.
Following SVR evaluation, participants entered Step 2 for two additional post-SVR evaluation study visits at weeks 48 and 72. Participants were contacted remotely at weeks 42 and 68 to schedule such visits. The schedule of additional post-MINMON evaluation visits were dependent on the week of Step 2 entry.
In version 1 of the study, total study duration was up to 76 weeks. Due to the COVID-19 Pandemic, the window of the week 72 visit was extended for participants who completed SVR evaluations and registered to Step 2 to October 31, 2020 for US sites and to February 28, 2021 for non-US sites. This extension did not alter the window for SVR evaluation.
All scheduled in-clinic study visits included a physical exam, blood collection, and collection of plasma samples. For participants able to become pregnant, pregnancy testing was conducted at screening, entry, and at any in-clinic visit during Step 1 if pregnancy was suspected. Liver Elastography was an optional evaluation.
- Conditions
- Hepatitis C, HIV-1-infection, Liver Diseases
- Being tested
- Sofosbuvir/Velpatasvir (SOF/VEL), Minimal Monitoring (MINMON) Strategy
- Medical subject headings
- Hepatitis C, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir/Velpatasvir (SOF/VEL)Drug
Also called Epclusa
400/100 mg fixed-dose combination (FDC) tablet administered orally once daily with or without food.
Minimal Monitoring (MINMON) StrategyOther
MINMON Strategy:
- No pre-treatment HCV genotyping
- Entire treatment course (84) tablets of SOF/VEL administered to participants at study entry
- No scheduled on-treatment laboratory monitoring or clinic visits
- Remote contact with participants at week 4 and week 22
| Study group | Role | What they receive |
|---|---|---|
| MINMON 24 weeks with SOF/VEL 12 Weeks | Experimental | Participants received Sofosbuvir/Velpatasvir (SOF/VEL [Tradename: Epclusa®]) tablet for 12 weeks with a minimal monitoring (MINMON) strategy for 24 weeks Receives: Drug: Sofosbuvir/Velpatasvir (SOF/VEL); Other: Minimal Monitoring (MINMON) Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Sustained Virologic Response 12 (SVR12)
SVR12 was defined as plasma HCV RNA less than the lower limit of quantification (LLOQ) from the earliest sample drawn at least 22 weeks following study treatment initiation (i.e. at a visit scheduled at least 10 weeks after scheduled end of study treatment). Participants without any HCV RNA result at least 22 weeks after treatment initiation will be considered as having HCV RNA greater than the LLOQ.
LLOQ was defined as <15 IU/mL for results tested at USA centralized testing laboratory Quest using the "Roche COBAS® HCV Quantitative nucleic acid test for use on the COBAS® 6800/8800" assays for quantitation (and detection) of HCV, and <12 IU/mL for results tested at regional international labs using "Abbott RealTime HCV" assay for quantitation (and detection) of HCV.
A two-sided 95%, confidence interval was calculated for this percentage using the Wilson (score) method.
Measured: From at least 22 weeks and up to 76 weeks from treatment initiation
Percentage of Participants With an Occurrence of Serious Adverse Events According to International Council for Harmonization (ICH) Criteria
Serious adverse events (SAEs) as defined by ICH guidelines.
A two-sided, 95% confidence interval was calculated for the percentage using the Wilson (score) method.
Measured: From treatment initiation to 28 weeks
Secondary outcomes (3)
Percentage of Participants With at Least One Unplanned Clinic Visit Prior to SVR12 Evaluation
According to the study minimal monitoring intervention, there were no planned clinic visits prior to study week 24, when SVR12 was scheduled to be evaluated. An unplanned clinic visit was defined as an in-clinic visit occurring from treatment initiation to up to week 22.
A two-sided, 95% confidence interval was calculated for the percentage using the Wilson (score) method.
Measured: From treatment initiation to 22 weeks
Percentage of Participants With an Occurrence of One or More Non-serious, Grade >= 3 Adverse Event (AE), or Treatment Limiting AE.
AEs included all primary diagnoses, primary signs/symptoms, and primary laboratory abnormalities that either had severity grade ≥ 3 or led to a change in study medication. Serious Adverse Events (SAE) by International Council for Harmonization (ICH) criteria were excluded as they contributed to the primary safety outcome measure.
Severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1.
A two-sided, 95% confidence interval was calculated for the percentage using the Wilson (score) method.
Measured: From treatment initiation to 28 weeks
Percentage of Participants Who Prematurely Discontinued HCV Study Medications
Since there were no planned clinic visits during the 12 week study medication period, the last dose of study treatment was self-reported by participants, and recorded at the SVR evaluation visit at 24 weeks. Premature treatment discontinuation was defined when the self-reported final dose date was <11 weeks (<77 days) after the date of initial dose (accounting for any reported treatment holds). Participants discontinuing study follow up without information about completion of HCV study medications were counted as having prematurely discontinued medications.
A two-sided, 95% confidence interval was calculated for the percentage using the Wilson (score) method.
Measured: From at least 22 weeks and up to 76 weeks from treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start22 Oct 2018
- Primary completion30 Jul 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Sunil Solomon, MBBS, PhD, MPH, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512210
- Sponsor's protocol ID
- ACTG A5360
- Other IDs
- UM1AI068636
- Acronym
- MINMON
- Status last verified
- Jan 2022
- First submitted
- 19 Apr 2018
- Last updated
- 4 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Han WM, Solomon S, Wagner-Cardoso S, Li J, Parvangada A, Sulkowski M, Naggie S, Martin R, Mo H, Maiorova E, Wyles D; ACTG A5360 study team. Rare and Novel Hepatitis C Virus Genotype Subtypes and Response to Sofosbuvir/Velpatasvir in A5360 (MINMON) Clinical Trial. J Viral Hepat. 2026 Nov;33(11):e70251. doi: 10.1111/jvh.70251.
PubMed 42922282Torres TS, Saha PT, Smeaton L, Wimbish C, Kliemann DA, Avihingsanon A, Kityo C, Bennet JA, Van Schalkwyk M, Linas B, Nunes EP, Robbins GK, Wyles D, Naggie S, Sulkowski M, Cardoso SW, Solomon S. Impact of a minimal monitoring HCV treatment approach on Health-Related Quality of Life. Qual Life Res. 2025 Jun;34(6):1683-1694. doi: 10.1007/s11136-025-03922-1. Epub 2025 Feb 28.
PubMed 40019678Han WM, Solomon SS, Smeaton L, Avihingsanon A, Wagner Cardoso S, Li J, Parvangada A, Sulkowski M, Naggie S, Martin R, Mo H, Maiorova E, Wyles D. Reinfection and Resistance Associated Substitutions Following a Minimal Monitoring Approach for Hepatitis C Virus Treatment in MINMON Trial. Clin Infect Dis. 2025 Jul 18;80(6):1293-1301. doi: 10.1093/cid/ciae627.
PubMed 39702964Sowah LA, Smeaton L, Brates I, Bhattacharya D, Linas B, Kreter B, Wagner-Cardoso S, Solomon S, Sulkowski M, Robbins GK. Perspectives on Adherence From the ACTG 5360 MINMON Trial: A Minimum Monitoring Approach With 12 Weeks of Sofosbuvir/Velpatasvir in Chronic Hepatitis C Treatment. Clin Infect Dis. 2023 Jun 8;76(11):1959-1968. doi: 10.1093/cid/ciad034.
PubMed 36694361Solomon SS, Wagner-Cardoso S, Smeaton L, Sowah LA, Wimbish C, Robbins G, Brates I, Scello C, Son A, Avihingsanon A, Linas B, Anthony D, Nunes EP, Kliemann DA, Supparatpinyo K, Kityo C, Tebas P, Bennet JA, Santana-Bagur J, Benson CA, Van Schalkwyk M, Cheinquer N, Naggie S, Wyles D, Sulkowski M. A minimal monitoring approach for the treatment of hepatitis C virus infection (ACTG A5360 [MINMON]): a phase 4, open-label, single-arm trial. Lancet Gastroenterol Hepatol. 2022 Apr;7(4):307-317. doi: 10.1016/S2468-1253(21)00397-6. Epub 2022 Jan 10.
PubMed 35026142
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Study to Evaluate the Feasibility and Efficacy of a Minimal Monitoring Strategy to Deliver Pan-genotypic Ribavirin-free HCV Therapy to HCV Infected Populations Who Are HCV Treatment Naïve With Evidence of Active HCV Infection: The MINMON Study
- ClinicalTrials.gov ID
- NCT03512210
- Acronym / sponsor ID
- MINMON / ACTG A5360
- Conditions
- Hepatitis C, HIV-1-infection, Liver Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 30 Apr 2018 (actual)
- Results
- Posted 16 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study evaluated the feasibility, safety, and efficacy of a minimal monitoring (MINMON) strategy of delivering interferon- and ribavirin (RBV)-free, pan-genotypic direct-acting antiviral (DAA) therapy to treat active hepatitis C virus (HCV) in HCV treatment naïve participants, with or without HIV-1 co-infection, and with no evidence of decompensated cirrhosis.
The MINMON intervention included four components: 1) No pre-treatment HCV genotyping; 2) Entire 12-week treatment course (84 tablets) dispensed to participants at study entry; 3) No scheduled on-treatment laboratory monitoring or clinic visits prior to SVR evaluation scheduled 24 weeks following entry; 4) Remote contact with participants at week 4 for adherence counseling and locator update, and week 22 for scheduling of SVR visit and locator update.
At study entry, all participants received a single-tablet, fixed-dose combination (FDC) of sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks.
The trial was designed to accrue 400 adult participants who may be co-infected with HIV-1 (limited to no more than 200 participants), and whose liver disease state is either no cirrhosis (defined by Fibrosis-4 score) or compensated cirrhosis (defined by Fibrosis-4 and Child-Turcotte-Pugh (CTP) scores, and limited to no more than 80 participants). Accrual from research sites in the United States was limited to no more than 132 participants.
The study proceeded in two steps: Step 1: MINMON intervention and Step 2: post-MINMON follow up.
During Step 1 (MINMON intervention), participants were contacted remotely at week 4 to inquire about study medication adherence and confirm locator information, and again at week 22 to schedule the sustained virologic response (SVR) evaluation and confirm locator information. Unplanned in-person clinic visits before week 22 were permissible to address common treatment toxicities that could not be managed remotely. The primary efficacy outcome measure, sustained virologic response (SVR), was evaluated starting at the week 24 study visit. Early discontinuation of treatment did not alter the timing of the SVR evaluation. If the week 24 visit was missed, SVR could be evaluated at any time up to 76 weeks following study entry.
Following SVR evaluation, participants entered Step 2 for two additional post-SVR evaluation study visits at weeks 48 and 72. Participants were contacted remotely at weeks 42 and 68 to schedule such visits. The schedule of additional post-MINMON evaluation visits were dependent on the week of Step 2 entry.
In version 1 of the study, total study duration was up to 76 weeks. Due to the COVID-19 Pandemic, the window of the week 72 visit was extended for participants who completed SVR evaluations and registered to Step 2 to October 31, 2020 for US sites and to February 28, 2021 for non-US sites. This extension did not alter the window for SVR evaluation.
All scheduled in-clinic study visits included a physical exam, blood collection, and collection of plasma samples. For participants able to become pregnant, pregnancy testing was conducted at screening, entry, and at any in-clinic visit during Step 1 if pregnancy was suspected. Liver Elastography was an optional evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MINMON 24 weeks with SOF/VEL 12 Weeks | Experimental | Drug: Sofosbuvir/Velpatasvir (SOF/VEL), Other: Minimal Monitoring (MINMON) StrategyParticipants received Sofosbuvir/Velpatasvir (SOF/VEL [Tradename: Epclusa®]) tablet for 12 weeks with a minimal monitoring (MINMON) strategy for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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 <3.25) or compensated cirrhotic (FIB-4 Score ≥3.25 and Child-Turcotte-Pugh (CTP) ≤Score 6) within 35 days prior to study entry
- HIV-1 negative, or HIV-1 positive with either a) Non-efavirenz containing antiretroviral therapy (ART) started at least 14 days prior to study entry with plasma HIV-1 RNA <400 copies/mL within 90 days prior to study entry or b) not taking ART and CD4+ cell count >350 cells/uL within 90 days prior to study entry
- The following laboratory values obtained within 35 days prior to study entry:
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sofosbuvir/Velpatasvir (SOF/VEL)Also: Epclusa400/100 mg fixed-dose combination (FDC) tablet administered orally once daily with or without food. | Drug | MINMON 24 weeks with SOF/VEL 12 Weeks |
| Minimal Monitoring (MINMON) StrategyMINMON Strategy: 1. No pre-treatment HCV genotyping 2. Entire treatment course (84) tablets of SOF/VEL administered to participants at study entry 3. No scheduled on-treatment laboratory monitoring or clinic visits 4. Remote contact with participants at week 4 and week 22 | Other | MINMON 24 weeks with SOF/VEL 12 Weeks |
Primary outcome
Percentage of Participants With Sustained Virologic Response 12 (SVR12)
Time frame: From at least 22 weeks and up to 76 weeks from treatment initiation
SVR12 was defined as plasma HCV RNA less than the lower limit of quantification (LLOQ) from the earliest sample drawn at least 22 weeks following study treatment initiation (i.e. at a visit scheduled at least 10 weeks after scheduled end of study treatment). Participants without any HCV RNA result at least 22 weeks after treatment initiation will be considered as having HCV RNA greater than the LLOQ. LLOQ was defined as <15 IU/mL for results tested at USA centralized testing laboratory Quest using the "Roche COBAS® HCV Quantitative nucleic acid test for use on the COBAS® 6800/8800" assays for quantitation (and detection) of HCV, and <12 IU/mL for results tested at regional international labs using "Abbott RealTime HCV" assay for quantitation (and detection) of HCV. A two-sided 95%, confidence interval was calculated for this percentage using the Wilson (score) method.
Percentage of Participants With an Occurrence of Serious Adverse Events According to International Council for Harmonization (ICH) Criteria
Time frame: From treatment initiation to 28 weeks
Serious adverse events (SAEs) as defined by ICH guidelines. A two-sided, 95% confidence interval was calculated for the percentage using the Wilson (score) method.
3 secondary outcomes
Percentage of Participants With at Least One Unplanned Clinic Visit Prior to SVR12 Evaluation
Time frame: From treatment initiation to 22 weeks
Percentage of Participants With an Occurrence of One or More Non-serious, Grade >= 3 Adverse Event (AE), or Treatment Limiting AE.
Time frame: From treatment initiation to 28 weeks
Percentage of Participants Who Prematurely Discontinued HCV Study Medications
Time frame: From at least 22 weeks and up to 76 weeks from treatment initiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42922282Han WM, Solomon S, Wagner-Cardoso S, Li J, Parvangada A, Sulkowski M, Naggie S, Martin R, Mo H, Maiorova E, Wyles D; ACTG A5360 study team. Rare and Novel Hepatitis C Virus Genotype Subtypes and Response to Sofosbuvir/Velpatasvir in A5360 (MINMON) Clinical Trial. J Viral Hepat. 2026 Nov;33(11):e70251. doi: 10.1111/jvh.70251.
- Derived from this study: PubMed 40019678Torres TS, Saha PT, Smeaton L, Wimbish C, Kliemann DA, Avihingsanon A, Kityo C, Bennet JA, Van Schalkwyk M, Linas B, Nunes EP, Robbins GK, Wyles D, Naggie S, Sulkowski M, Cardoso SW, Solomon S. Impact of a minimal monitoring HCV treatment approach on Health-Related Quality of Life. Qual Life Res. 2025 Jun;34(6):1683-1694. doi: 10.1007/s11136-025-03922-1. Epub 2025 Feb 28.
- Derived from this study: PubMed 39702964Han WM, Solomon SS, Smeaton L, Avihingsanon A, Wagner Cardoso S, Li J, Parvangada A, Sulkowski M, Naggie S, Martin R, Mo H, Maiorova E, Wyles D. Reinfection and Resistance Associated Substitutions Following a Minimal Monitoring Approach for Hepatitis C Virus Treatment in MINMON Trial. Clin Infect Dis. 2025 Jul 18;80(6):1293-1301. doi: 10.1093/cid/ciae627.
- Derived from this study: PubMed 36694361Sowah LA, Smeaton L, Brates I, Bhattacharya D, Linas B, Kreter B, Wagner-Cardoso S, Solomon S, Sulkowski M, Robbins GK. Perspectives on Adherence From the ACTG 5360 MINMON Trial: A Minimum Monitoring Approach With 12 Weeks of Sofosbuvir/Velpatasvir in Chronic Hepatitis C Treatment. Clin Infect Dis. 2023 Jun 8;76(11):1959-1968. doi: 10.1093/cid/ciad034.
- Derived from this study: PubMed 35026142Solomon SS, Wagner-Cardoso S, Smeaton L, Sowah LA, Wimbish C, Robbins G, Brates I, Scello C, Son A, Avihingsanon A, Linas B, Anthony D, Nunes EP, Kliemann DA, Supparatpinyo K, Kityo C, Tebas P, Bennet JA, Santana-Bagur J, Benson CA, Van Schalkwyk M, Cheinquer N, Naggie S, Wyles D, Sulkowski M. A minimal monitoring approach for the treatment of hepatitis C virus infection (ACTG A5360 [MINMON]): a phase 4, open-label, single-arm trial. Lancet Gastroenterol Hepatol. 2022 Apr;7(4):307-317. doi: 10.1016/S2468-1253(21)00397-6. Epub 2022 Jan 10.
- DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1Link provided by the sponsor.
- Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010Link provided by the sponsor.
- NIH. BLAST® Basic Local Alignment Search Tool. US National Library of Medicine, National Center for Biotechnology Information, NIH; 2021Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunil Solomon, MBBS, PhD, MPH study chair
Johns Hopkins University
38 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sofosbuvir/Velpatasvir (SOF/VEL) and Minimal Monitoring (MINMON) Strategy in people with Hepatitis C and HIV-1-infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 38 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Brazil, South Africa, Thailand, Puerto Rico and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Sustained Virologic Response 12 (SVR12) (time frame: From at least 22 weeks and up to 76 weeks from treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03512210, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.