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Blizard Researcher Prof Graham Foster makes major breakthrough in treatment of Chronic Hepatitis C

Congratulations are due to Professor Graham Foster and his team in the Centre for Immunobiology for the below publication. Hepatitis C is a global problem and this treatment will go a long way to reducing the global burden of this disease. The impact of this work cannot be underestimated.  

5 January 2016

N Engl J Med. 2015 Dec 31;373(27):2608-17. doi: 10.1056/NEJMoa1512612. Epub 2015 Nov 17.

Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.

Foster GRAfdhal NRoberts SKBräu NGane EJPianko SLawitz EThompson AShiffman MLCooper CTowner WJConway BRuane PBourlière M,Asselah TBerg TZeuzem SRosenberg WAgarwal KStedman CAMo HDvory-Sobol HHan LWang JMcNally JOsinusi ABrainard DMMcHutchison JG,Mazzotta FTran TTGordon SCPatel KReau NMangia ASulkowski MASTRAL-2 InvestigatorsASTRAL-3 Investigators.

Collaborators (127)

Abstract

BACKGROUND:

In phase 2 trials, treatment with the combination of the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir resulted in high rates of sustained virologic response in patients chronically infected with hepatitis C virus (HCV) genotype 2 or 3.

METHODS:

We conducted two randomized, phase 3, open-label studies involving patients who had received previous treatment for HCV genotype 2 or 3 and those who had not received such treatment, including patients with compensated cirrhosis. In one trial, patients with HCV genotype 2 were randomly assigned in a 1:1 ratio to receive sofosbuvir-velpatasvir, in a once-daily, fixed-dose combination tablet (134 patients), or sofosbuvir plus weight-based ribavirin (132 patients) for 12 weeks. In a second trial, patients with HCV genotype 3 were randomly assigned in a 1:1 ratio to receive sofosbuvir-velpatasvir for 12 weeks (277 patients) or sofosbuvir-ribavirin for 24 weeks (275 patients). The primary end point for the two trials was a sustained virologic response at 12 weeks after the end of therapy.

RESULTS:

Among patients with HCV genotype 2, the rate of sustained virologic response in the sofosbuvir-velpatasvir group was 99% (95% confidence interval [CI], 96 to 100), which was superior to the rate of 94% (95% CI, 88 to 97) in the sofosbuvir-ribavirin group (P=0.02). Among patients with HCV genotype 3, the rate of sustained virologic response in the sofosbuvir-velpatasvir group was 95% (95% CI, 92 to 98), which was superior to the rate of 80% (95% CI, 75 to 85) in the sofosbuvir-ribavirin group (P<0.001). The most common adverse events in the two studies were fatigue, headache, nausea, and insomnia.

CONCLUSIONS:

Among patients with HCV genotype 2 or 3 with or without previous treatment, including those with compensated cirrhosis, 12 weeks of treatment with sofosbuvir-velpatasvir resulted in rates of sustained virologic response that were superior to those with standard treatment with sofosbuvir-ribavirin. (Funded by Gilead Sciences; ASTRAL-2 ClinicalTrials.gov number, NCT02220998; and ASTRAL-3, NCT02201953.).

Comment in

Simple, Effective, but Out of Reach? Public Health Implications of HCV Drugs. [N Engl J Med. 2015]

 

 

 

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