Back to Search
Start Over
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
- Source :
- International journal of antimicrobial agents. 49(3)
- Publication Year :
- 2016
-
Abstract
- 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/mm3 was 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.
- Subjects :
- 0301 basic medicine
Microbiology (medical)
Simeprevir
Male
medicine.medical_specialty
Sofosbuvir
Drug-Related Side Effects and Adverse Reactions
Sustained Virologic Response
Hepatitis C virus
HIV Infections
medicine.disease_cause
Antiviral Agents
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Internal medicine
Ribavirin
medicine
Humans
Pharmacology (medical)
Protease Inhibitors
Adverse effect
Aged
Retrospective Studies
Aged, 80 and over
business.industry
virus diseases
Retrospective cohort study
General Medicine
Hepatitis C, Chronic
Middle Aged
digestive system diseases
Regimen
030104 developmental biology
Infectious Diseases
Treatment Outcome
chemistry
Italy
Immunology
Cohort
030211 gastroenterology & hepatology
Female
business
medicine.drug
Subjects
Details
- ISSN :
- 18727913
- Volume :
- 49
- Issue :
- 3
- Database :
- OpenAIRE
- Journal :
- International journal of antimicrobial agents
- Accession number :
- edsair.doi.dedup.....45bfd80465ec4b24fd116d9791a57dd7