May some HCV genotype 1 patients still benefit from dual therapy? The role of very early HCV kinetics.
When treating HCV patients with conventional dual therapy in the current context of rapidly evolving HCV therapy, outcome prediction is crucial and HCV kinetics, as early as 48 hours after the start of treatment, may play a major role. We aimed at clarifying the role of HCV very early kinetics. We consecutively enrolled mono-infected HCV patients at 7 treatment sites in Central Italy and evaluated the predictive value of logarithmic decay of HCV RNA 48 hours after the start of dual therapy (Delta48). Among the 171 enrolled patients, 144 were evaluable for early and sustained virological response (EVR, SVR) prediction; 108 (75.0%) reached EVR and 84 (58.3%) reached SVR. Mean Delta 48 was 1.68 ± 1.22 log10 IU/ml, being higher in patients with SVR and EVR. Those genotype-1 patients experiencing a Delta 48 >2 logs showed a very high chance of success (100% positive predictive value), even in the absence of rapid virological response (RVR). Evaluation of very early HCV kinetics helped identify a small but significant proportion of genotype-1 patients (close to 10%) in addition to those identified with RVR, who could be treated with dual therapy in spite of not reaching RVR. In the current European context, whereby sustainability of HCV therapy is a crucial issue, conventional dual therapy may still play a reasonable role in patients with good tolerance and early prediction of success.
Infectious Disease Unit, Pescara General Hospital, Pescara, Italy;|Clinic of Infectious Diseases, Department of Medicine and Science of Aging, University "G. d'Annunzio" Chieti-Pescara, Chieti, Italy.
Monica
M
Tontodonati
Virology Unit, Department of Experimental Medicine and Surgery, "Tor Vergata" University of Rome, Rome, Italy.
Valeria
V
Cento
Microbiology and Virology Unit, Pescara General Hospital, Pescara, Italy.
Ennio
E
Polilli
Infectious Disease Unit, Pescara General Hospital, Pescara, Italy.
Cecilia
C
Colabattista
Department of Biomedicine and Prevention, School of Medicine, University of Rome "Tor Vergata", Rome, Italy.
Raffaella
R
Cascella
Infectious Disease Unit, Vasto General Hospital, Vasto (CH), Italy.
Mariapina
M
Sciotti
Infectious Disease Unit, "G. Mazzini" Teramo General Hospital, Teramo, Italy.
Dante
D
Di Giammartino
Infectious Disease Unit, Pescara General Hospital, Pescara, Italy.
Francesca
F
Trave
Virology Unit, Department of Experimental Medicine and Surgery, "Tor Vergata" University of Rome, Rome, Italy.
Velia Chiara
VC
Di Maio
Infectious Disease Unit, Belcolle General Hospital, Viterbo, Italy.
Roberto
R
Monarca
Clinic of Infectious Diseases, "Santa Maria della Misericordia" Hospital, Perugia, Italy.
Francesco
F
Di Candilo
Infectious Disease Unit, IRCCS San Martino Hospital-IST, Genoa, Italy.
Roberta
R
Prinapori
Infectious Disease Unit, Belcolle General Hospital, Viterbo, Italy.
Elena
E
Rastrelli
Clinic of Infectious Diseases, Department of Medicine and Science of Aging, University "G. d'Annunzio" Chieti-Pescara, Chieti, Italy.
Jacopo
J
Vecchiet
Virology Unit, Department of Experimental Medicine and Surgery, "Tor Vergata" University of Rome, Rome, Italy.
Francesca
F
Ceccherini-Silberstein
Section of Hygiene, Epidemiology, Pharmacology and Legal Medicine, University of Chieti- Pescara, Chieti, Italy.
Lamberto
L
Manzoli
Department of Biomedicine and Prevention, School of Medicine, University of Rome "Tor Vergata", Rome, Italy.|Molecular Genetics Laboratory UILDM, Santa Lucia Foundation, Rome, Italy.
Emiliano
E
Giardina
Virology Unit, Department of Experimental Medicine and Surgery, "Tor Vergata" University of Rome, Rome, Italy.
Carlo Federico
CF
Perno
Infectious Disease Unit, Pescara General Hospital, Pescara, Italy.
Giustino
G
Parruti
D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000145:classification / Q000187:drug effects* / Q000235:genetics* / Q000302:isolation & purification; D006526:Hepatitis C / Q000188:drug therapy* / Q000235:genetics / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage*; D007372:Interferons; D007378:Interleukins / Q000235:genetics; D007558:Italy; D007700:Kinetics; D008297:Male; D008875:Middle Aged; D020641:Polymorphism, Single Nucleotide; D012254:Ribavirin / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult; D000095022:Interferon Lambda
D000998:Antiviral Agents; D016898:Interferon-alpha; D007372:Interferons; D007378:Interleukins; D012254:Ribavirin; C000624353:interferon-lambda, human; D000095022:Interferon Lambda
EVR; Early viral kinetics; HCV dual therapy; HCV therapy optimization; RVR