Sofosbuvir/velpatasvir for 12 vs. 6 weeks for the treatment of recently acquired hepatitis C infection

Matthews, Gail V.; Valk, Marc van der; Rockstroh, Juergen; Feld, Jordan J.; Rauch, Andri; Thurnheer, Christine; Bruneau, Julie; Kim, Arthur; Hellard, Margaret; Shaw, David R.; Gane, Ed; Nelson, Mark; Ingiliz, Patrick; Applegate, Tanya; Grebely, Jason; Marks, Pip; Martinello, Marianne; Petoumenos, Kathy; Dore, Gregory J.; Investigators, Site Principal

doi:10.1016/j.jhep.2021.04.056

Cited by 34 publications

(41 citation statements)

References 30 publications

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“…Despite the low overall cure rate for four weeks of treatment, we observed a 93% SVR12 among patients with a baseline HCV RNA < 2,000,000 IU/mL. Several other studies support that viral load is an important factor in reducing the treatment duration [ 14 , 18 , 23 , 24 , 25 ]. The reason why viral load was not included in this study design is that we wanted a simple and replicable design that easily could be transferred to clinical practice and especially in resource limited areas where preclinical baseline variables can be difficult to obtain.…”

Section: Discussioncontrasting

confidence: 50%

Four Weeks Treatment with Glecaprevir/Pibrentasvir + Ribavirin—A Randomized Controlled Clinical Trial

Madsen

Christensen

Hansen

et al. 2022

Viruses

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Enhancing treatment uptake for hepatitis C to achieve the elimination goals set by the World Health Organization could be achieved by reducing the treatment duration. The aim of this study was to compare the sustained virological response at week 12 (SVR12) after four weeks of glecaprevir/pibrentasvir (GLE/PIB) + ribavirin compared to eight weeks of GLE/PIB and to estimate predictors for SVR12 with four weeks of treatment through a multicenter open label randomized controlled trial. Patients were randomized 2:1 (4 weeks:8 weeks) and stratified by genotype 3 and were treatment naïve of all genotypes and without significant liver fibrosis. A total of 27 patients were analyzed for predictors for SVR12, including 15 from the first pilot phase of the study. In the ‘modified intention to treat’ group, 100% (7/7) achieved cure after eight weeks and for patients treated for four weeks the SVR12 was 58.3% (7/12). However, patients with a baseline viral load <2 mill IU/mL had 93% SVR12. The study closed prematurely due to the low number of included patients due to the COVID-19 pandemic. Our results suggest that viral load should be taken into account when considering trials of short course treatment.

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Section: Discussioncontrasting

confidence: 50%

Four Weeks Treatment with Glecaprevir/Pibrentasvir + Ribavirin—A Randomized Controlled Clinical Trial

Madsen

Christensen

Hansen

et al. 2022

Viruses

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show abstract

Section: Methodsmentioning

confidence: 99%

“…Peripheral blood mononuclear cells (PBMCs) were acquired throughout the course of treatment from participants enrolled in five clinical trials of acute/recent or chronic HCV infection. [24][25][26][27][28] Only patients who achieved SVR were eligible for inclusion. Samples from people with spontaneous clearance were acquired from patients at the Toronto Centre for Liver Disease at University Health Network in Toronto.…”

Section: Patient Cohortsmentioning

confidence: 99%

Hepatitis C virus‐specific immune responses following direct‐acting antivirals administered during recent hepatitis C virus infection

Casey

Dore

Grebely

et al. 2022

Journal of Viral Hepatitis

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Individuals who spontaneously clear hepatitis C virus (HCV) infection have demonstrated evidence of partial protective immunity, whereas treatment-induced clearance provides little or no protection against reinfection. We aimed to investigate whether treatment of acute HCV infection with direct-acting antivirals (DAA) prevents establishment of, or reverses, T-cell exhaustion, leading to a virus-specific T-cell immune profile more similar to that seen in spontaneous clearance. The magnitude and breadth of HCV-specific T-cell responses before and after DAA or interferonbased therapy in acute or chronic HCV were compared to those of participants with spontaneous clearance of infection, using Enzyme-linked Immunospot (ELISPOT).PBMCs were available for 55 patients comprising 4 groups: spontaneous clearance (n = 17), acute interferon (n = 14), acute DAA (n = 13) and chronic DAA (n = 11). After controlling for sex, the magnitude of post-treatment HCV-specific responses after acute DAA treatment was greater than after chronic DAA or acute IFN treatment and similar to those found in spontaneous clearers. However, spontaneous clearers responded to more HCV peptide pools indicating greater breadth of response. In conclusion, early treatment with DAAs may prevent or reverse some degree of immune exhaustion and result in stronger HCV-specific responses post-treatment. However, individuals with spontaneous clearance had broader HCV-specific responses.

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“…89 These patients on the other hand may and will infect others with HCV. 90 However, DAA therapy is extremely effective and safe in this setting [91][92][93] and an unrestricted DAA availability among HIV-positive men who have sex with men (MSM) has shown to reduce acute infections by 51%. 94 Thus, EASL recommends the treatment of acute hepatitis C, 38 but pharmaceutical companies are encouraged to take all measures to ensure that DAAs are officially approved for the treatment of acute hepatitis C as well.…”

Section: Threat To Hcv Therapy and Hcv Elimination Effortsmentioning

confidence: 99%

The curing regimens of HCV: A SWOT analysis

Cornberg

Manns

2022

Antiviral Therapy

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The development of direct-acting antivirals (DAA) has revolutionized the treatment of chronic hepatitis C, enabling cure of hepatitis C virus (HCV) infection in more than 95% of cases. There are essentially no contraindications, so almost any patient can now be successfully treated. The result is the prevention or amelioration of cirrhosis, hepatocellular carcinoma (HCC), and extrahepatic manifestations. Consequently, the 2020 Nobel Prize in Medicine and Physiology was awarded for the discovery of HCV. Due to the high efficacy of therapy, even global HCV elimination is conceivable even without a vaccine. Here, we would like to venture a SWOT analysis of current HCV therapies aimed at HCV elimination.

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Sofosbuvir/velpatasvir for 12 vs. 6 weeks for the treatment of recently acquired hepatitis C infection

Cited by 34 publications

References 30 publications

Four Weeks Treatment with Glecaprevir/Pibrentasvir + Ribavirin—A Randomized Controlled Clinical Trial

Four Weeks Treatment with Glecaprevir/Pibrentasvir + Ribavirin—A Randomized Controlled Clinical Trial

Hepatitis C virus‐specific immune responses following direct‐acting antivirals administered during recent hepatitis C virus infection

The curing regimens of HCV: A SWOT analysis

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