Clinical trials of second generation direct-acting antivirals in HCV show high cure rates. But do those rates reflect real life?
What are HCV cure rates with second-generation direct-acting antivirals in difficult to treat populations in real world settings? Most clinical trials of the efficacy of direct-acting antivirals exclude people with HIV, so results may not extend to this population.
Aspinall and colleagues conducted a retospective database study in 4 university and community centers of 351 patients who started direct-acting antivirals for HCV in 2014-2016. They evaluaed sustained viral rate at 18 months in these difficult to treat patients, who included those with a liver transplate and those coninfected with HIV.
The overall sustained viral rate was 92.9%. There were no significant differences in attaining SVR by HIV coinfection, liver transplant, cirrhosis, or liver cancer.
Older age, male sex, and past liver cancer were independent predictors of failure to attain SVR.
Aspinall AI, Shaheen AA, Kochaksaraei GS, et al. Real-world treatment of hepatitis C with second-generation direct-acting antivirals: initial results from a multicentre Canadian retrospective cohort of diverse patients. CMAJ Open. 2018 Jan 5;6(1):E12-E18. doi: 10.9778/cmajo.20170059.
Results highlight how studies in real world settings can identify factors associated with worse outcomes not found in clinical trials
What are HCV cure rates with second-generation direct-acting antivirals in difficult-to-treat populations, such as those with liver transplant or HIV coinfection?
References:
1. Afdhal N, Zeuzem S, Kwo P, et al.; ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. NEJM. 2014;370:1889-1898.2.Kowdley KV, Gordon SC, Reddy KR, et al.; ION-3 Investigators. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. NEJM. 2014;370:1879-88.3. Afdhal N, Reddy KR, Nelson DR, et al.; ION-2 Investigators. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. NEJM. 2014;370:1483-1493.4. Ferenci P, Bernstein D, Lalezari J, et al. PEARL-III Study; PEARL-IV Study. ABT-450/rombitasvir and dasabuvir with or without ribavirin for HCV. NEJM. 2014;370:1983-19895. Aspinall AI, Shaheen AA, Kochaksaraei GS, et al. Real-world treatment of hepatitis C with second-generation direct-acting antivirals: initial results from a multicentre Canadian retrospective cohort of diverse patients. CMAJ Open. 2018 Jan 5;6(1):E12-E18. doi: 10.9778/cmajo.20170059.