Real-World Evidence of Sofosbuvir/Velpatasvir as an Effective and Simple Hepatitis C Virus Treatment and Elimination Tool in Homeless Populations

Conway, Brian; Rodríguez‐Tajes, Sergio; García–Retortillo, Montserrat; Pérez-Hernandez, Paco; Teti, Elisabetta; Ryan, Pablo; Fraser, Chris; Macedo, Guilherme; Amado, Luis Enrique Morano; Lédinghen, Victor de; Fenech, Mary; Martins, Alexandra; Guerra-Veloz, María Fernanda; Ντάλλα, Ιωάννα; Ramroth, Heribert; Vanstraelen, Kim; Hernández, Cándido Márquez; Mertens, Michael; O’Loan, Joss

doi:10.2217/fvl-2021-0266

Cited by 3 publications

(3 citation statements)

References 38 publications

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“…Individuals infected with HCV genotype 1-6, with or without compensated cirrhosis, who initiated treatment with a 12week SOF/VEL 400/100 mg regimen (without ribavirin) as part of routine clinical practice, were eligible for inclusion. The full study methodology is available in previously published retrospective analyses of the effectiveness of SOF/VEL in other special populations (homeless and prison populations) [26,27]. Patients were managed and treated according to local guidelines and standards of care.…”

Section: Methodsmentioning

confidence: 99%

Global Real-World Evidence of Sofosbuvir/Velpatasvir as a Highly Effective Treatment and Elimination Tool in People with Hepatitis C Infection Experiencing Mental Health Disorders

Wedemeyer

Marco

García–Retortillo

et al. 2022

Viruses

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Hepatitis C virus (HCV) is prevalent in people with mental health disorders, a priority population to diagnose and cure in order to achieve HCV elimination. This integrated analysis pooled data from 20 cohorts in seven countries to evaluate the real-world effectiveness of the pangenotypic direct-acting antiviral (DAA) sofosbuvir/velpatasvir (SOF/VEL) in people with mental health disorders. HCV-infected patients diagnosed with mental health disorders who were treated with SOF/VEL for 12 weeks without ribavirin as part of routine clinical practice were included. The primary outcome was sustained virological response (SVR) in the effectiveness population (EP), defined as patients with an available SVR assessment. Secondary outcomes were reasons for not achieving SVR, characteristics of patients with non-virological failures, adherence, and time from HCV RNA diagnosis to SOF/VEL treatment initiation. A total of 1209 patients were included; 142 did not achieve an SVR for non-virological reasons (n = 112; 83 lost to follow-up, 20 early treatment discontinuations) or unknown reasons (n = 30). Of the 1067 patients in the EP, 97.4% achieved SVR. SVR rates in the EP were ≥95% when stratified by type of mental health disorder and other complicating baseline characteristics, including active injection drug use and antipsychotic drug use. Of 461 patients with data available in the EP, only 2% had an adherence level < 90% and 1% had an adherence level < 80%; all achieved SVR. Patients with mental health disorders can be cured of HCV using a well-tolerated, pangenotypic, protease inhibitor-free SOF/VEL regimen. This DAA allows the implementation of a simple treatment algorithm, with minimal monitoring requirements and fewer interactions with central nervous system drugs compared with protease-inhibitor DAA regimens.

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Section: Methodsmentioning

confidence: 99%

Global Real-World Evidence of Sofosbuvir/Velpatasvir as a Highly Effective Treatment and Elimination Tool in People with Hepatitis C Infection Experiencing Mental Health Disorders

Wedemeyer

Marco

García–Retortillo

et al. 2022

Viruses

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“…For some treatment regimens, adherence was measured in clinical studies as completion of ≥80% of the treatment, while other studies have applied a threshold of ≥90%. [13][14][15][16] However, a real-world evidence (RWE) study showed that with DAA treatment, those who achieved at least 50% adherence had an overall SVR rate of 99%, demonstrating that suboptimal adherence to DAA treatment may still lead to HCV cure. [17] Different methods have been used to assess patients' adherence to treatment regimens, and this can affect reported adherence rates.…”

Section: Considerations In Evaluating Hcv Therapy Adherencementioning

confidence: 99%

“…A retrospective RWE study analyzed pooled data from 15 clinical cohorts of HCVinfected people experiencing homelessness treated with a once-daily SOF/VEL regimen. [14] Among 153 patients treated with SOF/VEL without ribavirin (RBV), SVR was 100% in the effectiveness population (EP; n = 122) irrespective of various baseline factors, such as active injection drug use and mental health disorders. Treatment adherence data were available for 98 of 122 patients (80.3%) in the EP.…”

Section: Accepted Manuscriptmentioning

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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Real-world Effectiveness of sofosbuvir/velpatasvir for the Treatment of Hepatitis C Virus in Prison Settings

et al. 2022

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Background: People in prison are at high risk of hepatitis C virus (HCV) infection and often have a history of injection drug use and mental health disorders. Simple test-and-treat regimens which require minimal monitoring are critical. Methods: This integrated real-world analysis evaluated the effectiveness of once daily sofosbuvir/velpatasvir (SOF/VEL) in 20 prison cohorts across Europe and Canada. The primary outcome was sustained virological response (SVR) in the effectiveness population (EP), defined as patients with a valid SVR status. Secondary outcomes were reasons for not achieving SVR, adherence and time between HCV RNA diagnosis and SOF/VEL treatment. Results: Overall, 526 people in prison were included with 98.9% SVR achieved in the EP (n = 442). Cure rates were not compromised by drug use or existence of mental health disorders. Conclusion: SOF/VEL for 12 weeks is highly successful in prison settings and enables the implementation of a simple treatment algorithm in line with guideline recommendations and test-and-treat strategies.

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Real-World Evidence of Sofosbuvir/Velpatasvir as an Effective and Simple Hepatitis C Virus Treatment and Elimination Tool in Homeless Populations

Cited by 3 publications

References 38 publications

Global Real-World Evidence of Sofosbuvir/Velpatasvir as a Highly Effective Treatment and Elimination Tool in People with Hepatitis C Infection Experiencing Mental Health Disorders

Global Real-World Evidence of Sofosbuvir/Velpatasvir as a Highly Effective Treatment and Elimination Tool in People with Hepatitis C Infection Experiencing Mental Health Disorders

Adherence in Hepatitis C Virus Treatment: What We Know

Real-world Effectiveness of sofosbuvir/velpatasvir for the Treatment of Hepatitis C Virus in Prison Settings

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