A minimal monitoring approach for the treatment of hepatitis C virus infection (ACTG A5360 [MINMON]): a phase 4, open-label, single-arm trial

Solomon, Sunil S.; Wagner-Cardoso, Sandra; Smeaton, Laura; Sowah, Leonard A; Wimbish, Chanelle; Robbins, Gregory K.; Brates, Irena; Scello, Christine; Son, Annie; Avihingsanon, Anchalee; Linas, Benjamin P.; Anthony, Donald D.; Nunes, Estêvão Portela; Kliemann, Dimas Alexandre; Supparatpinyo, Khuanchai; Kityo, Cissy; Tebas, Pablo; Bennet, J; Santana‐Bagur, Jorge; Benson, Constance A.; Schalkwyk, Marije Van; Cheinquer, Nelson; Naggie, Susanna; Wyles, David L.; Sulkowski, Mark S.

doi:10.1016/s2468-1253(21)00397-6

Cited by 52 publications

(57 citation statements)

References 29 publications

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“…No side effects or drug interactions were reported, despite 22.9% of patients were taking psychotropic medications. This finding confirms the high tolerability and the safety of SOF/VEL regimen, as already demonstrated in MINMON study, in which it was observed that a minimal monitoring approach (only clinical baseline assessment and SVR laboratory testing) may be safe and effective as the standard monitoring approach [ 25 ].…”

Section: Discussionsupporting

confidence: 85%

Telemedicine Improves HCV Elimination among Italian People Who Use Drugs: An Innovative Therapeutic Model to Increase the Adherence to Treatment into Addiction Care Centers Evaluated before and during the COVID-19 Pandemic

Rosato¹,

Nevola²,

Conturso³

et al. 2022

Biology

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People who use drugs (PWUDs) are generally considered “hard-to-treat” patients, due to adherence to HCV antiviral therapy or re-infection concerns. Linkage-to-care still remains a significant gap for HCV elimination, worsened by the COVID-19 pandemic. To reduce time-to-treat and improve treatment adherence, we have developed a patient-tailored model-of-care, decentralized within the addiction center and supervised remotely by hepatologists. From January 2017 to December 2020, patients were enrolled in one addiction care center in Southern Italy, where a complete hepatologic assessment, including blood chemistry, ultrasound, and transient elastography examination, was provided. DAAs treatment has been adapted on clinical features, also performing a daily administration during an outpatient visit, and monitored remotely by specialists via telemedicine interactions. Adherence was evaluated on the accomplishment of therapy or on the percentage of attended visits. From a total of 690 PWUDs, 135 had an active HCV infection and were enrolled in the study. All patients started the treatment within 3 weeks after HCV diagnosis. Six drop-outs were recorded, obtaining a sustained virological response at week 12 (SVR12) in 98.5% of PWUDs. There were only two cases of treatment failure, one of which is re-infection. No differences were found between the SVR12 rates before and during the COVID-19 pandemic. We obtained a high SVR12 rate, providing a comprehensive assessment within the addiction care center, tailoring the drug administration with a hepatologic remote stewardship. Our therapeutic model should improve the time-to-treat and treatment adherence in PWUDs.

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Section: Discussionsupporting

confidence: 85%

Telemedicine Improves HCV Elimination among Italian People Who Use Drugs: An Innovative Therapeutic Model to Increase the Adherence to Treatment into Addiction Care Centers Evaluated before and during the COVID-19 Pandemic

Rosato¹,

Nevola²,

Conturso³

et al. 2022

Biology

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“…No serious adverse events related to treatment were reported. 35 Further work assessing the safety and effectiveness of this model for diverse patient groups may be required, for example, only 14% of the patient group reported current substance use; however, these results suggest no issues with cure rates using this minimal monitoring method. 35 …”

Section: Discussionmentioning

confidence: 94%

“…The recent minimal monitoring (MINMON) approach trial tested having the entire 12-week course dispensed at the treatment initiation visit, no scheduled visits or laboratory monitoring, and only two points of remote contact scheduled to check adherence at week 4 and then to schedule SVR12 assessment appointment. 35 Throughout, patients were able to attend for unplanned visits whenever they required assistance. The SVR rates were excellent, at 95% (379/399) for all those initiated treatment.…”

Section: Discussionmentioning

confidence: 99%

Feasibility of decentralised, task-shifted hepatitis C testing and treatment services in urban Myanmar: implications for scale-up

Draper

Yee²,

Shilton

et al. 2022

BMJ Open

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ObjectivesTo assess the feasibility considerations for a decentralised, one-stop-shop model of care implemented in Yangon, Myanmar.SettingTwo primary care level clinics in urban Yangon, Myanmar.DesignThis is a feasibility study of a highly effective care model. Using Intervention Complexity Framework by Gericke et al, we collated and analysed programmatic data and evaluation data to outline key project implementation requirements and experiences.ParticipantsProgrammatic data were collected from clinical records, GeneXpert device test and maintenance reports, national guidelines, product and device instructions and site monitoring visit reports. Healthcare providers involved in delivering care model contributed interview data.ResultsThe main feasibility considerations are appropriate storage for test kits and treatments (in response to temperature and humidity requirements), installation of a continuous stable electricity supply for the GeneXpert device, air-conditioning for the laboratory room hosting GeneXpert, access to a laboratory for pretreatment assessments and clear referral pathways for specialist consultation when required. Lessons from our project implementation experiences included the extensive time requirements for patient education, the importance of regular error monitoring and stock storage reviews and that flexible appointment scheduling and robust reminder system likely contributed to high retention in care.ConclusionsDetailed documentation and dissemination of feasibility requirements and implementation considerations is vital to assist others to successfully implement a similar model of care elsewhere. We provide 10 recommendations for successful implementation.Trial registration numberThe trial was registered at ClinicalTrials.gov NCT03939013 on May 6, 2019. This manuscript presents post-results data on feasibility.

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“…To do this, they require no pretreatment genotyping, provided patients all of the necessary medication up front, and do not schedule any clinic or lab visits while patients were undergoing treatment but did remotely contact patients at 4 and 22 wk. Promising results for this study were presented at the American Association for the Study of Liver Diseases Liver Meeting in 2020 and showed that sustained virologic response (SVR) was near 95%[ 99 ]. If adopted on a broader scale, this approach has the potential to further simplify HCV treatment and remove some of the treatment burden.…”

Section: Hepatitis Cmentioning

confidence: 99%

Viral hepatitis: Past, present, and future

Odenwald¹,

Paul²

2022

WJG

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Each hepatitis virus—Hepatitis A, B, C, D, E, and G—poses a distinct scenario to the patient and clinician alike. Since the discovery of each virus, extensive knowledge regarding epidemiology, virologic properties, and the natural clinical and immunologic history of acute and chronic infections has been generated. Basic discoveries about host immunologic responses to acute and chronic viral infections, combined with virologic data, has led to vaccines to prevent Hepatitis A, B, and E and highly efficacious antivirals for Hepatitis B and C. These therapeutic breakthroughs are transforming the fields of hepatology, transplant medicine in general, and public and global health. Most notably, there is even an ambitious global effort to eliminate chronic viral hepatitis within the next decade. While attainable, there are many barriers to this goal that are being actively investigated in basic and clinical labs on the local, national, and international scales. Herein, we discuss pertinent clinical information and recent organizational guidelines for each of the individual hepatitis viruses while also synthesizing this information with the latest research to focus on exciting future directions for each virus.

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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

Cited by 52 publications

References 29 publications

Telemedicine Improves HCV Elimination among Italian People Who Use Drugs: An Innovative Therapeutic Model to Increase the Adherence to Treatment into Addiction Care Centers Evaluated before and during the COVID-19 Pandemic

Telemedicine Improves HCV Elimination among Italian People Who Use Drugs: An Innovative Therapeutic Model to Increase the Adherence to Treatment into Addiction Care Centers Evaluated before and during the COVID-19 Pandemic

Feasibility of decentralised, task-shifted hepatitis C testing and treatment services in urban Myanmar: implications for scale-up

Viral hepatitis: Past, present, and future

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