What is the clinical evidence from this study?

Study design: RCT. Population: Genotype 1 Hepatitis C Virus Infection (n=197). Intervention: Sofosbuvir, velpatasvir, and GS-9857. Primary outcome: sustained virologic response 12 weeks after treatment (SVR12).

What does this research mean for the field?

Sofosbuvir-velpatasvir plus GS-9857 is safe and achieves high sustained virologic response rates, achieving 100% SVR12 after 8 weeks in treatment-naive patients without cirrhosis and after 12 weeks in DAA-experienced patients with genotype 1 HCV. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

July 31, 2016GastroenterologyOpen Access

Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Genotype 1 Hepatitis C Virus Infection in an Open-Label, Phase 2 Trial

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Key result

Sofosbuvir-velpatasvir plus GS-9857 achieves 100% SVR12 in treatment-naive and DAA-experienced patients.

n=197

Why the study?

Does sofosbuvir-velpatasvir plus GS-9857 improve sustained virologic response in patients with genotype 1 hepatitis C virus infection?

Population

197 patients with genotype 1 hepatitis C virus infection, with or without compensated cirrhosis, who were…

Design

Other, open-label

Follow-up

12 weeks after treatment

Authors

ELEric LawitzThe University of Texas Health Science Center at San Antonio NRNancy ReauGoethe University Frankfurt FHFederico HinestrosaUniversity of Central Florida

Discussion

Member takes

Implication

May support 8-week retreatment in naive genotype 1 HCV; leaves open phase 3 confirmation for DAA-experienced patients.

Study Design

Type

RCT (n=197)

Blinding

Open-label

Multicenter

Yes

Structured PICO

Does sofosbuvir-velpatasvir plus GS-9857 improve sustained virologic response in patients with genotype 1 hepatitis C virus infection?

Population

197 patients with genotype 1 hepatitis C virus infection, with or without compensated cirrhosis, who were treatment-naive or previously treated with a DAA, treated for 6-12 weeks.

Intervention

Sofosbuvir-velpatasvir (400 mg/100 mg fixed-dose combination) plus GS-9857 (100 mg) once daily for 6-12 weeks, plus ribavirin for 1 treatment group consisting of treatment-naive patients with cirrhosis.

Outcome

Sustained virologic response 12 weeks after treatment (SVR12)surrogate

8 to 12 weeks of sofosbuvir-velpatasvir plus GS-9857 is safe and highly effective for achieving sustained virologic response in patients with genotype 1 hepatitis C virus infection, regardless of prior DAA treatment or compensated cirrhosis.

Cite This Study

Lawitz et al. (2016) conducted an RCT in Genotype 1 Hepatitis C Virus Infection (n=197). Sofosbuvir, velpatasvir, and GS-9857 was evaluated on sustained virologic response 12 weeks after treatment (SVR12). Sofosbuvir-velpatasvir plus GS-9857 achieved 100% SVR12 after 8 weeks in treatment-naive patients without cirrhosis, and 100% SVR12 after 12 weeks in DAA-experienced patients.

synapsesocial.com/papers/6aa7696f4f7f2f0fe173faad https://doi.org/10.1053/j.gastro.2016.07.039

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Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Genotype 1 Hepatitis C Virus Infection in an Open-Label, Phase 2 Trial

Discussion

Member takes

Implication

Study Design

Structured PICO

Cite This Study

Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Genotype 1 Hepatitis C Virus Infection in an Open-Label, Phase 2 Trial

Discussion

Member takes

Implication

Study Design

Structured PICO

Cite This Study

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