Summary Background Virologic and safety outcomes of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin (OBV/PTV/r ± DSV ± RBV) therapy have shown high sustained virologic response (SVR) rates and good tolerability in most patient populations in pre‐registration studies. Aim To confirm these clinical trial findings in the treatment of genotype 1 and 4 hepatitis C under real‐world conditions. Methods Patients enrolled for treatment with OBV/PTV/r ± DSV ± RBV based on therapeutic guidelines were included, and the regimen was administered according to product characteristics. Clinical and laboratory data, including virologic response, were collected at baseline, end of treatment (EOT) and 12 weeks after EOT. Results A total of 209 patients with chronic hepatitis C were enrolled, most were genotype 1b‐infected (84.2%) and 119 (56.9%) had liver cirrhosis. Among these, 150 (71.7%) had failed previous anti‐viral therapies and 84 (40.2%) were null‐responders. At 12 weeks after EOT, SVR was achieved by 207 (99.0%) patients, ranging from 96.4% to 100.0% across subgroups. All Child–Pugh B and post‐orthotopic liver transplantation patients achieved SVR. Adverse events occurred in 151 (72.2%) patients and were mostly mild and associated with the use of RBV. Serious adverse events, including hepatic decompensation, renal insufficiency, anaemia, hepatotoxicity and diarrhoea, were reported in eight (3.8%) patients. In five (2.4%) patients, adverse events led to treatment discontinuation. On‐treatment decompensation was experienced by seven (3.3%) patients. Conclusions The results of our study confirm previous findings. They demonstrate excellent effectiveness and a good safety profile of OBV/PTV/r± DSV±RBV in HCV genotype 1‐infected patients treated in the real‐world setting.

A b s t r a c tBackground: Metabolic syndrome (MS) is usually diagnosed based on the presence of abdominal obesity, elevated blood pressure (BP), elevated fasting plasma glucose, high serum triglycerides (TG), and low high-density lipoprotein (HDL) cholesterol levels. Whether HIV is associated with a higher prevalence of MS than in the general population remains unclear. Aim:The aim of the study was to determine the incidence of MS in the population of HIV-infected adults and its association with clinical, virological, and biochemical features. Methods:Two hundred and seventy HIV-infected Caucasian adult patients were enrolled in the study and evaluated based on clinical records in the years 2013-2015.Results: Metabolic syndrome was diagnosed in 60 of 270 (22%) patients, 47 (24%) males and 13 (17%) females, mostly (72%) aged above 40 years. The percentage of patients with diagnosed MS in specific age groups in comparison to the general Polish population for females aged < 40 years was 7% vs. 4%, and males in the same age -18% vs. 9%, for females aged 40-59 years -47% vs. 24.4%, and males -33% vs. 28.3%. Particular components of MS in the MS population were found as follows: body mass index > 30 kg/m 2 in 29%, waist circumference exceeding 94 cm in men and 80 cm in woman -87.5%, TG ≥ 150 mg/dL -82%, HDL cholesterol < 40/50 mg/dL (males/females) -42%, systolic/diastolic BP ≥ 130 mmHg/≥ 85 mmHg -83%, and fasting glucose > 100 mg/dL -42%. In stepwise multivariate logistic regression analysis, age (odds ratio [OR] 1.052, 95% confidence interval [CI] 1.018-1.088, p = 0.003) and nadir CD4 < 350 cells/mm 3 (OR 3.576, 95% CI 1.035-12.355, p = 0.04) were associated with MS. Patients with MS compared with those without this disorder had low, intermediate, high, and very high cardiovascular risk in 10% vs. 23%, 73% vs. 70%, 7% vs. 5%, and 10% vs. 2%, respectively (p = 0.006). Conclusions:Prevalence of MS in the HIV-infected population is higher than in the general Polish population. Age and low nadir CD4 were found to be associated with MS.

OBV/PTV/r±DSV±RBV provided an opportunity to cure almost all patients including cirrhotics and non-responders to previous therapy. This treatment is currently recommended as a first line regimen. However, there is still a need for real-world data. In coming years this medication will probably be replaced with the next DAA generation with improved characteristics such as a shorter treatment duration, improved safety and resistance profile.

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