Week 4 response predicts sustained virological response to all-oral direct-acting antiviral-based therapy in cirrhotic patients with hepatitis C virus genotype 3 infection

Pineda, Juan A.; Amado, Luis Enrique Morano; Granados, Rafael; Macı́as, Juan; Téllez, Francisco; García-Deltoro, Miguel; Rios, María; Collado, Antonio; Delgado-Fernández, Marcial; Suárez-Santamaría, Marta; Serrano, Miriam; Miralles-Álvarez, C.; Neukam, Karin; Alados-Arboledas, Juan Carlos; Albendín, Helena; Alemán, Marı́a Remedios; Alonso, M.M.; Asensi, Vı́ctor; Blanco, Maria-Jose; Borrallo, J.; Cabo, Rafael de; Camacho, Ángela; Casas, Mario Frias; Castro, Ángeles; Cucurull, J.; Cuéllar, S Óscar; Cuenca, F.; Santos-Gil, Ignacio de los; Dueñas, Cristina Saldaña; Fernández, Elisa; Galera, Carlos; Gálvez, Mont; Geijo-Martínez, Paloma; Gomez, Alexandra; Gómez, Jordi; Gutiérrez, Félix; Hernández, J. M.; Llenas-García, Jara; Mancebo, M.J.; Márquez, M.; Martin, Jeff; Martinez, L García; Martínez‐Álvarez, Roberto; Madrid, O Martínez; Masía, Mar; Merchante, Nicolás; Merino, Dolores; Monje, P.; Núñez, Rafael; Omar, Mohamed; Ortega, Enrique; Padilla, Sergio; Robledano, Catalina; Pelazas, Ricardo; Pérez, Elisabet; Pérez-Camacho, Inés; Pérez-Pérez, Montserrat; Pernas, Berta; Portu, J.J.; Raffo, Miguel; Real, Luis Miguel; Reina, G.; Rivero, A.; Rivero‐Juárez, Antonio; Romero-Palacios, Alberto; Portilla, Joaquín; Rubio, P.; Ryan, Pablo; Hoya, Pablo Saíz de la; Santos, Jesús; Toyas, C.; Vera-Méndez, Francisco Jesús; Vergara, Antonio; Hernández, M.V.; García, Daniel

doi:10.1016/j.cmi.2016.12.034

Cited by 8 publications

(5 citation statements)

References 11 publications

(13 reference statements)

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“…But it signifies nothing more than the fact that the observed sample is too small to detect a population effect [63]. Hepatitis C patients can achieve SVR12 at week 4 of treatment with the oral DAA-based therapy [64]. BLC has shown a decline in the HCV-RNA after 12 weeks of treatment in hepatitis C patients [48].…”

Section: Discussionmentioning

confidence: 99%

Enhanced Efficacy of Direct-Acting Antivirals in Hepatitis C Patients by Coadministration of Black Cumin and Ascorbate as Antioxidant Adjuvants

Ahmed

Zahoor

Ibrahim

et al. 2020

Oxidative Medicine and Cellular Longevity

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The widespread adaptation of a new generation of direct-acting antiviral agents (DAAs) unveils a superlative effect in the eradication of the hepatitis C virus (HCV). However, this therapy has been reported to exhibit vigorous side effects that pose a risk in fleet recovery. This study was conducted to investigate the efficacy of DAAs: sofosbuvir (SOF) and ribavirin (RBV), along with black cumin (BLC) and ascorbate (ASC), as adjuvants on hematological parameters; oxidative stress markers such as total antioxidant status (TAS), superoxide dismutase (SOD), reduced (GSH) and oxidized (GSSG) glutathione (GSH), gamma-glutamyl transferase (GGT), and malondialdehyde (MDA); liver function markers such as aspartate transaminase (AST), alanine aminotransferase (ALT), bilirubin, and alkaline phosphatase (ALP); and viral load with determined genotypes. HCV-infected patients (n=30) were randomly divided into two equal groups: control group (n=15) and treatment group (n=15). The control group was subjected only to SOF and RBV (400 mg each/day). Synergistically, the treatment group was administered with adjuvant therapy of BLC (250 mg/day) and ASC (1000 mg/day) along with DAAs (400 mg each/day) for 8 weeks. All selected patients were subjected to sampling at pre- and posttreatment stages for the assessment of defined parameters. The data revealed that the BLC/ASC adjuvant therapy boosted the efficacy of DAAs by reducing the elevated levels of liver markers such as AST, ALT, ALP, and bilirubin in the treatment group compared with those in the control group (P>0.05). The adjuvant therapy synchronously showed an ameliorating effect on hematological parameters. The SOF/RBV with adjuvant therapy also demonstrated an increasing effect in the activity of SOD, TAS, and GSH and a decreasing effect for GSSG, GGT, and malondialdehyde (MDA; P>0.05) followed by curtailing a RT-PCR-quantified viral load. Our findings provide evidence that systemic administration of BLC/ASC efficiently alleviates hematological, serological, and antioxidant markers as well as the viral load in hepatitis C patients. This highlights a potentially novel role of BLC and ASC in palliating hepatitis C.

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Section: Discussionmentioning

confidence: 99%

Enhanced Efficacy of Direct-Acting Antivirals in Hepatitis C Patients by Coadministration of Black Cumin and Ascorbate as Antioxidant Adjuvants

Ahmed

Zahoor

Ibrahim

et al. 2020

Oxidative Medicine and Cellular Longevity

View full text Add to dashboard Cite

show abstract

“…In this study, SVR12 rates were not impacted by time to first undetectable HCV RNA . In contrast, a recent Spanish multicohort study suggested that the response at treatment week 4 is predictive of SVR in HCV genotype 3‐infected patients. The population of this study was however different from that in our study, as patients were receiving different DAA combinations with ribavirin (SOF+DCV+RBV; SOF/LDV+RBV or SOF+RBV).…”

Section: Discussionmentioning

confidence: 99%

Viral kinetics analysis and virological characterization of treatment failures in patients with chronic hepatitis C treated with sofosbuvir and an NS5A inhibitor

Fourati

Guedj

Chevaliez

et al. 2017

Aliment Pharmacol Ther

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“…19,20 Additional evidence has suggested that viral response at week 4 is still predictive of SVR12 with interferon-free DAA regimens, particularly in more difficult-to-treat populations such as genotype 3 patients with cirrhosis. [21][22][23] A study of 21,095 veterans on interferon-free regimens showed a significant association between detectable week 4 HCV RNA and lower SVR rates, which decreased with increasing baseline viral load. 24 The American Association for the Study of Liver Diseases and Infectious Diseases Society of America (AASLD-IDSA) hepatitis C guidance recommends measuring HCV RNA at week 4 of treatment for all patients on DAA therapy.…”

mentioning

confidence: 99%

Standard Versus Extended Duration Direct-Acting Antiviral Therapy in Hepatitis C Patients With Slow Response to Treatment

et al. 2020

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Background: Response-guided hepatitis C therapy was standard with interferon-based regimens but is not used for direct-acting antivirals (DAAs). Week 4 viral kinetics may predict sustained virological response (SVR) with DAAs, but it is unclear whether extending therapy in slow responders affects outcomes. Objectives: The primary objective was to compare SVR rates between traditional and extended duration groups. Secondary objectives were to compare SVR rates among subgroups and to determine factors associated with SVR. Methods: This institutional review board–approved, retrospective, single-center study identified patients with chronic hepatitis C virus (HCV) infection with detectable week 4 HCV RNA who were treated with DAAs. Patients were excluded for early discontinuation, treatment regimen not recommended first-line, or missing HCV RNA labs. Patients were stratified into traditional and extended duration groups. The primary end point was SVR. Secondary end points included factors associated with SVR and rationale for extension of therapy duration. Results: A total of 363 patients were included; 58 (16%) received extended therapy. Patients were primarily genotype 1a (70%) and treatment naïve (80%). More than half had advanced fibrosis or cirrhosis. SVR12 rates were 100% in the extended duration group and 96.7% in the traditional duration group ( P = 0.37). There were no associations with SVR and prespecified patient-specific factors. Sample size was limited. Conclusion and Relevance: Based on these findings, a recommendation for extension of therapy cannot be made for patients with detectable HCV RNA at week 4 of treatment at this time. Cost analyses may help guide recommendations to re-treat rare failures versus extend therapy in all slow responders.

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Week 4 response predicts sustained virological response to all-oral direct-acting antiviral-based therapy in cirrhotic patients with hepatitis C virus genotype 3 infection

Abstract: TW4-response indicates the probability of achieving SVR to currently used DAA-based therapy in HCV genotype 3-infected individuals with cirrhosis. This finding may be useful to tailor treatment strategy in this setting.

Cited by 8 publications

References 11 publications

Enhanced Efficacy of Direct-Acting Antivirals in Hepatitis C Patients by Coadministration of Black Cumin and Ascorbate as Antioxidant Adjuvants

Enhanced Efficacy of Direct-Acting Antivirals in Hepatitis C Patients by Coadministration of Black Cumin and Ascorbate as Antioxidant Adjuvants

Viral kinetics analysis and virological characterization of treatment failures in patients with chronic hepatitis C treated with sofosbuvir and an NS5A inhibitor

Standard Versus Extended Duration Direct-Acting Antiviral Therapy in Hepatitis C Patients With Slow Response to Treatment

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