| Abstract | Cilj: Prevalencija HCV infekcije u Hrvatskoj iznosi 0.9%. Od 2014. godine u Hrvatskoj su dostupni direktno djelujući antivirusni lijekovi (DAA) za liječenje kronične infekcije hepatitis C virusom. Cilj ovog istraživanja je prikazati učinkovitost direktno djelujućih antivirusnih lijekova u liječenju 170 bolesnika s kroničnim hepatitisom C u Splitsko-dalmatinskoj županiji.
Ispitanici i metode: Od 1. kolovoza 2015. godine do 28. veljače 2019. godine ukupno je liječeno 170 bolesnika s kroničnom infekcijom hepatitis C virusom u Splitsko-dalmatinskoj županiji. Podatci su prikupljeni iz arhiva bolesnika s kroničnim hepatitisom C liječenih u Kliničkom bolničkom centru (KBC) Split. Podatci korišteni u statističkoj analizi su genotip hepatitis C virusa, stupanj fibroze jetre, prethodno liječenje hepatitisa C, nuspojave terapije i terapijski protokol. Za određivanje stupnja fibroze jetre korišten je FibroScan® uređaj.
Rezultati: Od ukupnog broja bolesnika, njih je 83 (48.82%) bilo prethodno liječeno, a 87 (51.18%) bolesnika bilo je ''naivno''. Genotip 1 imalo je 60.59% bolesnika, genotip 3 35.89% bolesnika, genotip 4 2.35% bolesnika i genotip 2 1.17% bolesnika. Koristeći FibroScan®, u svih je bolesnika postupkom elastografije utvrđen stupanj fibroze (raspon 7.1-70.6 kPa). Stupanj F4 (cirozu) imalo je 76.47% bolesnika, stupanj F3 imalo je 16.47% bolesnika, stupanj F2 6.47%, a stupanj F1 0.59%. Od 170 bolesnika, 50 (29.41%) je liječeno kombinacijom ombitasvir/paritaprevir/ritonavir plus dasabuvir +/- ribavirin (OBV/PTV/r+DSV+/-RBV) te je jednak broj bolesnika liječen kombinacijom glekaprevir/pibrentasvir (GLE/PIB). Kombinacijom sofosbuvir/velpatasvir +/- ribavirin (SOF/VEL+/-RBV) liječeno je 29 (17.06%) bolesnika. 19 (11.18%) bolesnika dobilo je kombinaciju elbasvir/grazoprevir sa ili bez ribavirina (ELB/GRA+/-RBV), 16 (9.41%) bolesnika dobilo je kombinaciju sofosbuvir/ledipasvir +/- ribavirin (SOF/LED+/-RBV), a njih 6 (3.53%) liječeno je kombinacijom sofosbuvir+ribavirin (SOF+RBV). Trajni virološki odgovor (SVR) ispitan je 12 tjedana nakon završetka terapije. SVR postiglo je 167 (98.24%) bolesnika, dok kod preostala 3 (1.76%) bolesnika nije postignuta trajna eliminacija infekcije hepatitis C virusom. Svi su bolesnici dobro podnijeli liječenje. Ni u jednog bolesnika nisu zabilježene značajne nuspojave niti je došlo do prekida terapije.
Zaključak: Prikazani su rezultati liječenja kroničnog hepatitisa C DAA terapijom u Splitsko-dalmatinskoj županiji od uvođenja terapije u kolovozu 2015. godine do kraja veljače 2019. godine, odnosno u rasponu od 3 godine i 7 mjeseci. Rezultat ovog istraživanja je trajni virološki odgovor (SVR-sustained virological response) postignut u 98.24% bolesnika, što je usporedivo s drugim objavljenim istraživanjima. U budućnosti se očekuje ranije započinjanje terapije kod bolesnika s nižim stadijem fibroze i povećanje godišnjeg broja liječenih bolesnika. |
| Abstract (english) | Objectives: Prevalence of HCV infection in Croatia is 0.1%. Treatment of chronic hepatitis C with direct-acting antiviral agents in Croatia began in 2014. The aim of this study is to demonstrate the efficacy of DAA therapy in 170 patients with chronic hepatitis C infection treated in Split-Dalmatia County.
Patients and Methods: From August 1st of 2015 to February 28th of 2019, 170 patients were treated with DAAs in Split-Dalmatia County. The data was collected from chronic hepatitis C patients' archives in Clinical Hospital Center of Split. Data used in statistical analysis was hepatitis C genotype, stage of liver fibrosis, previous treatment of hepatitis C, side effects of therapy and treatment protocol. FibroScan® was used to determine stage of liver fibrosis.
Results Out od 170 patients, 83 (48.82%) wew treatment-experienced and 87 (51.18%) were treatment-naive. Considering genotype distribution, most of the patients had genotype 1 HCV (60.59%), followed by genotype 3 HCV (35.89%), genotype 4 HCV (2.35%) and genotype 2 (1.17%). Fibrosis stage was determined in all patients using FibroScan® (range 7.1-70.6 kPa). Among 170 patients, 76.47% had cirrhosis (F4 stage), 16.47% had F3 stage, 6.47% had F2 stage, and 0.59% had F1 stage of liver fibrosis. Out of 170 patients, 50 were treated with ombitasvir/paritaprevir/ritonavir + dasabuvir +/- ribavirin (OBV/PTV/r+DSV+/-RBV). The same number was treated with glecaprevir/pibrentasvir (GLE/PIB). Sofosbuvir/velpatasvir +/- ribavirin (SOF/VEL+/-RBV) combination was given to 29 (17.06%) patients. 19 (11.18%) patients were treated with elbasvir/grazoprevir with or without ribavirin (ELB/GRA+/-RBV), 16 (9.41%) with sofosbuvir/ledipasvir +/- ribavirin (SOF/LED+/-RBV), and finally, 6 (3.53%) patients were treated with sofosbuvir+ribavirin (SOF+RBV). Sustained virological response (SVR) was tested 12 weeks after completion of therapy in all patients. Among 170 patients, 167 (98.24%) achieved SVR and 3 (1.76%) did not achieve SVR. All patients tolerated the treatment well. None of the 170 patients had any significant side effects and there was no discontinuation of treatment.
Conclusion: This thesis presents results of chronic hepatitis C treatment with DAA therapy in Split-Dalmatia County from its start in August 2015 to the end of February in 2019, covering the period of 3 years and 7 months. Result of this research is sustained virological response (SVR) in 98.24% patients, which is comparable to other published studies. In the future, earlier onset of treatment in patients with lower fibrosis stages and increase in nuber of treated patients annually is expected. |
