Safety and effectiveness of a 12-week course of sofosbuvir and simeprevir ± ribavirin in HCV-infected patients with or without HIV infection: a multicentre observational study.
The combination of sofosbuvir and simeprevir ± ribavirin (SOF + SMV ± RBV) for hepatitis C virus (HCV) treatment has been associated with high rates of sustained virological response (SVR). Few data are available regarding this regimen in HIV/HCV co-infected patients. This study evaluated the effectiveness and safety of a 12-week course of SOF + SMV ± RBV in a cohort of HCV monoinfected and HIV/HCV co-infected individuals. HCV-infected patients, with or without HIV infection, receiving a 12-week course of SOF + SMV ± RBV in four Italian centres from February to October 2015, were included in this retrospective observational study. Clinical and biochemical data were retrieved for all patients. A total of 88 individuals were evaluated: 29 (33.0%) HIV/HCV co-infected and 59 (67.0%) monoinfected. Most patients were males with HCV genotype 1b (62.5%) and 1a (25%) infection. RBV was used in 41 HCV monoinfected and 6 HIV/HCV co-infected patients. Cirrhosis was found in 67 patients (76.1%). The most common adverse events (AEs) were rash and/or pruritus (23.9%), fatigue (13.6%) and anaemia (9.1%). Serious AEs occurred in three patients (3.4%). No treatment discontinuations were observed. RBV use was associated with multiple AEs (P = 0.02). An overall SVR12 of 93.2% was achieved; 96.6% in HCV monoinfected and 86.2% in HIV/HCV co-infected individuals, without significance both in univariate (P = 0.09) and multivariate analyses (P = 0.12). A baseline platelet count ≥90 000/mm3was associated with higher rates of SVR (P = 0.005). A 12-week course of SOF + SMV ± RBV was associated with good safety and high SVR12 rate both in HCV monoinfected and HIV-HCV co-infected individuals.
Clinic of Infectious Diseases, University of Bari, Piazza G. Cesare 11, 70124 Bari, Italy. Electronic address: giusbruno85@gmail.com.
Giuseppe
G
Bruno
Clinic of Infectious Diseases, University of Bari, Piazza G. Cesare 11, 70124 Bari, Italy.
Annalisa
A
Saracino
Clinic of Infectious Diseases, University of Bari, Piazza G. Cesare 11, 70124 Bari, Italy.
Claudia
C
Fabrizio
Scientific Direction, Clinical Epidemiology Unit, IRCCS San Matteo Foundation, Pavia, Italy.
Luigia
L
Scudeller
Clinic of Infectious Diseases, University of Bari, Piazza G. Cesare 11, 70124 Bari, Italy.
Eugenio
E
Milano
Clinic of Infectious Diseases, University of Bari, Piazza G. Cesare 11, 70124 Bari, Italy.
Raffaele
R
Dell'Acqua
Clinic of Infectious Diseases, University of Bari, Piazza G. Cesare 11, 70124 Bari, Italy.
Nicoletta
N
Ladisa
Clinic of Infectious Diseases, University of Foggia, Foggia, Italy.
Massimo
M
Fasano
Infectious Diseases Unit, 'A. Perrino' Hospital, ASL Brindisi, Brindisi, Italy.
Salvatore
S
Minniti
Oncohaematologic Department, Infectious Diseases, 'San G. Moscati' Hospital, ASL Taranto, Taranto, Italy.
Giovanni
G
Buccoliero
Clinic of Infectious Diseases, University of Foggia, Foggia, Italy.
Alessandra
A
Tartaglia
Clinic of Infectious Diseases, University of Foggia, Foggia, Italy.
Adele
A
Giammario
Clinic of Infectious Diseases, University of Bari, Piazza G. Cesare 11, 70124 Bari, Italy.
Michele
M
Milella
Clinic of Infectious Diseases, University of Bari, Piazza G. Cesare 11, 70124 Bari, Italy.
Gioacchino
G
Angarano
D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D015658:HIV Infections / Q000150:complications; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D011480:Protease Inhibitors; D012189:Retrospective Studies; D012254:Ribavirin / Q000008:administration & dosage / Q000009:adverse effects; D000069616:Simeprevir / Q000008:administration & dosage* / Q000009:adverse effects*; D000069474:Sofosbuvir / Q000008:administration & dosage* / Q000009:adverse effects*; D000072230:Sustained Virologic Response; D016896:Treatment Outcome
D000998:Antiviral Agents; D011480:Protease Inhibitors; D012254:Ribavirin; D000069616:Simeprevir; D000069474:Sofosbuvir
HIV/HCV co-infection; SVR; Simeprevir; Sofosbuvir; Sustained virological response