Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Efficacy of Glecaprevir-Pibrentasvir in HCV
N Engl J Med; 2018 Jan 25; Zeuzem, et al
Among patients with hepatitis C virus (HCV) genotype 1 or 3 infection who did not have cirrhosis, once-daily treatment with glecaprevir-pibrentasvir for either 8 weeks or 12 weeks achieved high rates of sustained virologic response. In a pair of phase 3, randomized, open-label trials, 1,208 patients with genotype 1 infection were randomly assigned 1:1 to receive once-daily glecaprevir-pibrentasvir for either 8 or 12 weeks. Patients with genotype 3 infection were randomly assisted 2:1 to receive 12 weeks of treatment with either glecaprevir-pibrentasvir or sofosbuvir-daclatasvir. Additional patients with genotype 3 infection were subsequently enrolled and nonrandomly assigned to receive 8 weeks of treatment with glecaprevir-pibrentasvir. The primary end point was the rate of sustained virologic response 12 weeks after the end of treatment. Researchers found:
- The rate of sustained virologic response at 12 weeks among genotype 1-infected patients was 99.1% in the 8-week group and 99.7% in the 12-week group.
- Genotype 3-infected patients who were treated for 12 weeks had a rate of sustained virologic response at 12 weeks of 95% with glecaprevir-pibrentasvir and 97% with sofosbuvir-daclatasvir; 8 weeks of treatment with glecaprevir-pibrentasvir had a rate of 95%.
- Adverse events were low in all treatment groups.
Zeuzem A, Foster GR, Wang S, et al. Glecaprevir-pibrentasvir for 8 or 12 weeks in HCV genotype 1 or 3 infection. N Engl J Med. 2018:378:354-369. doi:10.1056/NEJMoa1702417.
This Week's Must Reads
Must Reads in Hepatitis
Glecaprevir/Pibrentasvir Efficacy & Safety Assessed, J Hepatol; ePub 2018 Nov 23; D’Ambrosio, et al
HCV Infection Among Children & Young Persons, J Hepatol; ePub 2018 Nov 26; Modin, et al
HCV Patients with Limited Access to Antiviral Therapy, Dig Liver Dis; ePub 2018 Nov 29; Lens, et al
Progression in the Elimination of HCV Infection, PLoS One; ePub 2018 Dec 4; Juanbeltz, et al
Increased HCV Screening in Veteran Populations, Jt Comm J Qual Patient Saf; ePub 2018 Sep 25; Wray, et al