Türkiye'de kronik Hepatit C Genotip 1 hastalarında direkt-etkili oral antiviral tedavinin gerçek yaşamda etkinliği ve güvenliği

Amaç: Bu çalışmanın amacı, Türkiye'de ve dünyada kronik hepatit C virüsünün (HCV) en yaygın şekli olan genotip 1 hastalarında kullanılan paritaprevir / ritonavir, ombitasvir, dasabuvir (PrOD) ± ribavirin (RBV) ve ledipasvir / sofosbuvir (LDV / SOF) ± RBV kombinasyon rejimlerinin gerçek yaşamda etkinliğini ve güvenirliğini araştırmakdı. Yöntem: Haziran 2016 ile Ekim 2017 yılları arasında, PrOD ± RBV veya LDV / SOF ± RBV tedavi rejimleri alan toplam 81 HCV genotipi 1 hasta dahil edildi. Hastalar demografik, klinik ve virolojik verileri, kalıcı virolojik yanıt (KVY) ve ayrıntılı yan etkiler değerlendirildi. Bulgular: 81 HCV hastası, 35 (% 43.2) erkek, 46 (% 56.8) kadın olup ortalama yaş 62 idi. Hastalar Türkiye'de en sık görülen genotip olan genotip 1 ve alt genotipler % 12.3 genotip 1a ve % 87.7 genotip 1b idi. Kronik HCV genotip 1 hastalarının KVY oranı 79 (% 96.4), PrOD ± RBV hastalarında % 98.2 ve SOF / LDV ± RBV'de % 96 idi. Ayrıntılı yan etki 46 (% 56.8) hastada bildirildi. Hastalarda en sık görülen yan etkiler; 18 (% 22.2) kaşıntı, 17 yorgunluk (% 21) ve 16 (% 19.8) baş ağrısı idi. Sonuç: Bu çalışmada bölgemizdeki tek bir merkezden elde edilen gerçek yaşam verilerine göre, kronik HCV genotip 1 hastalarında direkt etkili oral viral tedavi rejimleri ile yüksek KVY 12 yanıtı elde edildi ve mükemmel tolere edildiği görüldü.

The real-world efficacy and safety of direct-acting oral antiviral treatment in chronic Hepatitis C Genotype 1 patients in Turkey

Objective: The aim of this study was to investigate the real-world efficacy and safety in Turkey of the paritaprevir/ritonavir, ombitasvir, dasabuvir (PrOD) ± ribavirin (RBV) and ledipasvir/sofosbuvir (LDV/SOF) ± RBV combination regimens used for chronic hepatits C virus (HCV) genotype 1 patients, which is the most common form of this disease seen both in Turkey and worldwide. Method: The study included a total of 81 HCV genotype 1 patients receiving PrOD ± RBV or LDV/SOF ± RBV treatment regimens between June 2016 and October 2017. The patients were evaluated in respect of demographic, clinical and virological data, sustained virologic response (SVR) and detailed adverse events (AE). Results: The 81 HCV patients comprised 35 (43.2%) males and 46 (56.8%) females with a mean age of 62 years. All the patients were genotype 1, which is the most commonly seen genotype in Turkey, and the sub-genotypes were HCV genotype 1a in 12.3% and genotype 1b in 87.7%. The SVR12 rate of all the chronic HCV genotype 1 patients was 79 (96.4%), 98.2% in the PrOD ± RBV patients and 96% in SOF/LDV ± RBV. AEs were reported in 46 (56.8%) of the total patient group. The most common AEs were pruritus in 18 (22.2%) patients, fatigue in 17 (21%) and headache in 16 (19.8%). Conclusions: According to the real-world data obtained in this study from a single centre in our region, a high rate of SVR12 response was obtained direct-acting oral viral treatment regimens in patients with chronic HCV genotype 1 and there was seen to be excellent tolerability.

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