Perspectives on Adherence From the ACTG 5360 MINMON Trial: A Minimum Monitoring Approach With 12 Weeks of Sofosbuvir/Velpatasvir in Chronic Hepatitis C Treatment

Sowah, Leonard A; Smeaton, Laura; Brates, Irena; Bhattacharya, Debika; Linas, Benjamin P.; Kreter, Bruce; Wagner-Cardoso, Sandra; Solomon, Sunil S.; Sulkowski, Mark S.; Robbins, Gregory

doi:10.1093/cid/ciad034

Cited by 3 publications

(1 citation statement)

References 26 publications

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“…32 The MINMON single-arm, open-label, international trial evaluated the efficacy and safety of a 12-week SOF/VEL regimen with minimal in-person visits and laboratory monitoring. 33 Patients with HCV were aged !18 years and were treatment-naïve without decompensated cirrhosis. Adherence was self-reported and was categorized as "timely" (defined as taking 84 AE 7 days to complete therapy) versus "not timely" and "good" (defined as a week 4 questionnaire response of "all" and "timely" adherence at week 24).…”

Section: Available Evidence Of Daa Adherence On Hcv Cure By Treatment...mentioning

confidence: 99%

Adherence in Hepatitis C Virus Treatment: What We Know

Flamm,

Mangia

2024

Semin Liver Dis

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Although therapy with direct-acting antiviral (DAA) agents achieves high HCV cure rates and is forgiving of missed doses, certain patient populations, such as people who inject drugs (PWID), are often denied therapy because of a perceived high risk of nonadherence. However, a relationship between adherence to DAAs for various patient populations and efficacy has not been well defined. The lack of a standardized method for evaluating adherence complicates making comparisons between studies, making it difficult to develop and implement novel measures that may improve adherent behavior. Traditional methods for assessing adherence may overestimate medication adherence, while newer, technology-based methods may assist with accurately assessing and maintaining patient adherence to therapy. Data demonstrate that special populations of patients with HCV, such as PWID, can be successfully treated, with relatively high rates of sustained virologic response (SVR) despite less-than-optimal adherence. While rates of adherence, and subsequently SVR, can be improved, antiviral therapy should not be withheld because of fear of nonadherence. This paper addresses medication adherence and forgiveness of DAA regimens, such as sofosbuvir/velpatasvir and glecaprevir/pibrentasvir, in different patient populations with HCV. Considerations in evaluating adherence in HCV therapy and available methods for assessing adherence are detailed.

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Section: Available Evidence Of Daa Adherence On Hcv Cure By Treatment...mentioning

confidence: 99%

Adherence in Hepatitis C Virus Treatment: What We Know

Flamm,

Mangia

2024

Semin Liver Dis

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Self-reported and measured adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs: The HERO study

Lopes,

Pericot-Valverde,

Arnsten

et al. 2024

International Journal of Drug Policy

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An novel effective and safe model for the diagnosis of nonalcoholic fatty liver disease in China: gene excavations, clinical validations, and mechanism elucidation

Wang,

Jia,

Miao

et al. 2024

J Transl Med

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Background Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases. NAFLD leads to liver fibrosis and hepatocellular carcinoma, and it also has systemic effects associated with metabolic diseases, cardiovascular diseases, chronic kidney disease, and malignant tumors. Therefore, it is important to diagnose NAFLD early to prevent these adverse effects. Methods The GSE89632 dataset was downloaded from the Gene Expression Omnibus database, and then the optimal genes were screened from the data cohort using lasso and Support Vector Machine Recursive Feature Elimination (SVM-RFE). The ROC values of the optimal genes for the diagnosis of NAFLD were calculated. The relationship between optimal genes and immune cells was determined using the DECONVOLUTION algorithm CIBERSORT. Finally, the specificity and sensitivity of the diagnostic genes were verified by detecting the expression of the diagnostic genes in blood samples from 320 NAFLD patients and liver samples from 12 mice. Results Through machine learning we identified FOSB, GPAT3, RGCC and RNF43 were the key diagnostic genes for NAFLD, and they were further demonstrated by a receiver operating characteristic curve analysis. We found that the combined diagnosis of the four genes identified NAFLD samples well from normal samples (AUC = 0.997). FOSB, GPAT3, RGCC and RNF43 were strongly associated with immune cell infiltration. We also experimentally examined the expression of these genes in NAFLD patients and NAFLD mice, and the results showed that these genes are highly specific and sensitive. Conclusions Data from both clinical and animal studies demonstrate the high sensitivity, specificity and safety of FOSB, GPAT3, RGCC and RNF43 for the diagnosis of NAFLD. The relationship between diagnostic key genes and immune cell infiltration may help to understand the development of NAFLD. The study was reviewed and approved by Ethics Committee of Tianjin Second People’s Hospital in 2021 (ChiCTR1900024415).

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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

Cited by 3 publications

References 26 publications

Adherence in Hepatitis C Virus Treatment: What We Know

Adherence in Hepatitis C Virus Treatment: What We Know

Self-reported and measured adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs: The HERO study

An novel effective and safe model for the diagnosis of nonalcoholic fatty liver disease in China: gene excavations, clinical validations, and mechanism elucidation

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