Effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in patients with chronic hepatitis C previously treated with DAAs

Llaneras, Jordi; Riveiro‐Barciela, Mar; Lens, Sabela; Diago, M.; Cachero, Alba; García-Samaniego, Javier; Conde, Isabel; Arencibía, Ana; Arenas, Juan; Gea, Francisco; Torras, Xavier; Calleja, José Luís; Carrión, J.A.; Fernández, Inmaculada; Morillas, Rosa María; Rosales, José Miguel; Carmona, Isabel; Fernández-Rodrı́guez, Conrado; Hernández‐Guerra, Manuel; Llerena, Susana; Bernal, Vanesa; Turnés, Juan; González-Santiago, Jesús M.; Montoliu, Silvia; Figueruela, Blanca; Badía, Ester; Delgado, Manuel; Fernandez–Bermejo, Miguel; Iñarrairaegui, Mercedes; Pascasio, J.M.; Esteban, Rafael; Mariñó, Zoe; Buti, María

doi:10.1016/j.jhep.2019.06.002

Cited by 80 publications

(92 citation statements)

References 30 publications

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“…The safety data of sofosbuvir, velpatasvir and voxilaprevir was based on data from phase II and III clinical trials and real-world studies. [35][36][37][38][39] Headache, diarrhoea and nausea were the most commonly reported adverse events. The incidence of gastrointestinal side effects was greater than with the combination of sofosbuvir and velpatasvir alone.…”

Section: Evidence Quality Notes Gradingmentioning

confidence: 99%

EASL recommendations on treatment of hepatitis C: Final update of the series☆

Pawlotsky¹,

Negro²,

Aghemo³

et al. 2020

Journal of Hepatology

857

632

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Hepatitis C virus (HCV) infection is a major cause of chronic liver disease, with approximately 71 million chronically infected individuals worldwide. Clinical care for patients with HCV-related liver disease has advanced considerably thanks to an enhanced understanding of the pathophysiology of the disease, as well as developments in diagnostic procedures and improvements in therapy and prevention. These therapies make it possible to eliminate hepatitis C as a major public health threat, as per the World Health Organization target, although the timeline and feasibility vary from region to region. These European Association for the Study of the Liver recommendations on treatment of hepatitis C describe the optimal management of patients with recently acquired and chronic HCV infections in 2020 and onwards.

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Section: Evidence Quality Notes Gradingmentioning

confidence: 99%

EASL recommendations on treatment of hepatitis C: Final update of the series☆

Pawlotsky¹,

Negro²,

Aghemo³

et al. 2020

Journal of Hepatology

857

632

View full text Add to dashboard Cite

show abstract

“…Real world cohorts have confirmed SVR12 > 90% with this regimen, mainly for genotypes 1-4, following unsuccessful therapy with first generation NS5A inhibitors (65)(66)(67)(68) or unspecified NS5A inhibitors (69,70). However, a lower SVR12 (9/13, 69%) was reported for genotype 3 infected patients (subtypes not presented) with cirrhosis (71) . Regarding second generation NS5A inhibitor exposed individuals, lower SVR12 rates (83-86%) were reported in individuals with genotypes 1-3 previously exposed to sofosbuvir-velpatasvir, (72), but with no impact of this prior combination in other studies (SVR 94-100%) (73),(74) emphasising the need for further retreatment outcome datasets in sofosbuvir-velpatasvir exposed patients, including resistance data.…”

Section: Sofosbuvir-velpatasvir-voxilaprevirmentioning

confidence: 85%

Consensus recommendations for resistance testing in the management of chronic hepatitis C virus infection: Public Health England HCV Resistance Group

Bradshaw

Mbisa

Geretti

et al. 2019

Journal of Infection

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“…Thus, no general conclusions on risk factors for failure to SOF/VEL/VOX can be made. Two larger real-world cohorts from Italy and Spain reported a higher frequency of virologic treatment failure to SOF/VEL/VOX as rescue treatment for DAA failures in patients infected with HCV genotype 3a or liver cirrhosis [13,14].…”

Section: Discussionmentioning

confidence: 99%

Sofosbuvir, velpatasvir, and voxilaprevir for patients with failure of previous direct-acting antiviral therapy for chronic hepatitis C: Results from the German Hepatitis C-Registry (DHC-R)

et al. 2020

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Despite the high effectiveness of direct-acting antivirals for the treatment of hepatitis C, a small proportion of patients do not respond to approved regimens. The combination regimen of SOF/VEL/VOX was recently approved for patients with failure to prior NS5A-based treatment. In this German real-world cohort including patients with cirrhosis (27.3 %) and previous decompensation events, 12 weeks of SOF/VEL/VOX resulted in high virologic response rates irrespective of disease severity and prior DAA regimen. Adverse events were mostly mild or moderate and comparable to those seen in the approval studies.

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Effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in patients with chronic hepatitis C previously treated with DAAs

Cited by 80 publications

References 30 publications

EASL recommendations on treatment of hepatitis C: Final update of the series☆

EASL recommendations on treatment of hepatitis C: Final update of the series☆

Consensus recommendations for resistance testing in the management of chronic hepatitis C virus infection: Public Health England HCV Resistance Group

Sofosbuvir, velpatasvir, and voxilaprevir for patients with failure of previous direct-acting antiviral therapy for chronic hepatitis C: Results from the German Hepatitis C-Registry (DHC-R)

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