Consequences of inaccurate hepatitis C virus genotyping on the costs of prescription of direct antiviral agents in an Italian district.
Available commercial assays may yield inaccurate hepatitis C virus (HCV) genotype assignment in up to 10% of cases. We investigated the cost-effectiveness of re-evaluating HCV genotype by population sequencing, prior to choosing a direct acting antiviral (DAA) regimen. Between March and September 2015, HCV sequence analysis was performed in order to confirm commercial LiPA-HCV genotype (Versant®HCV Genotype 2.0) in patients eligible for treatment with DAAs. Out of 134 consecutive patients enrolled, sequencing yielded 21 (15.7%) cases of discordant results. For three cases of wrong genotype assignment, the putative reduction in efficacy was gauged between 15% and 40%. Among the eight cases for whom G1b was assigned by commercial assays instead of G1a, potentially suboptimal treatments would have been prescribed. Finally, for five patients with G1 and indeterminate subtype, the choice of regimens would have targeted the worst option, with a remarkable increase in costs, as in the case of the four mixed HCV infections for whom pan-genotypic regimens would have been mandatory. Precise assignment of HCV genotype and subtype by sequencing may, therefore, be more beneficial than expected, until more potent pan-genotypic regimens are available for all patients.
Infectious Diseases Unit, Pescara General Hospital, Pescara.
Ennio
E
Polilli
Department of Experimental Medicine and Surgery, University of Rome "Tor Vergata", Rome.
Valeria
V
Cento
CREMS - Centre for Research on Health Economics, Social and Health Care Management, Carlo Cattaneo - LIUC University, Castellanza, Italy; School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Umberto
U
Restelli
Department of Experimental Medicine and Surgery, University of Rome "Tor Vergata", Rome.
Francesca
F
Ceccherini-Silberstein
Department of Experimental Medicine and Surgery, University of Rome "Tor Vergata", Rome.
Marianna
M
Aragri
Department of Experimental Medicine and Surgery, University of Rome "Tor Vergata", Rome.
Velia Chiara
VC
Di Maio
Infectious Diseases Unit, Pescara General Hospital, Pescara.
Antonina
A
Sciacca
Hospital Pharmacy, Pescara General Hospital.
Fiorenzo
F
Santoleri
Microbiology and Virology Unit, Pescara General Hospital, Pescara, Italy.
Paolo
P
Fazii
Hospital Pharmacy, Pescara General Hospital.
Alberto
A
Costantini
Department of Experimental Medicine and Surgery, University of Rome "Tor Vergata", Rome.
Carlo Federico
CF
Perno
Infectious Diseases Unit, Pescara General Hospital, Pescara.
Giustino
G
Parruti
HCV; HCV genotype; HCV sequence analysis; direct acting antiviral; treatment costs
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