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    Real-world efficacy and safety of Ledipasvir plus Sofosbuvir and Ombitasvir/Paritaprevir/Ritonavir +/- Dasabuvir combination therapies for chronic hepatitis C: A Turkish experience
    (2020) Gokturk, Huseyin Savas; 33626001
    Background/Aims: This study aimed to evaluate the real-life efficacy and tolerability of direct-acting antiviral treatments for patients with chronic hepatitis C (CHC) with/without cirrhosis in the Turkish population. Material and Methods: A total of 4,352 patients with CHC from 36 different institutions in Turkey were enrolled. They received ledipasvir (LDV) and sofosbuvir (SOF)+/- ribavirin (RBV) ombitasvir/paritaprevir/ritonavir +/- dasabuvir (PrOD)+/- RBV for 12 or 24 weeks. Sustained virologic response (SVR) rates, factors affecting SVR, safety profile, and hepatocellular cancer (HCC) occurrence were analyzed. Results: SVR12 was achieved in 92.8% of the patients (4,040/4,352) according to intention-to-treat and in 98.3% of the patients (4,040/4,108) according to per-protocol analysis. The SVR12 rates were similar between the treatment regimens (97.2%-100%) and genotypes (95.6%-100%). Patients achieving SVR showed a significant decrease in the mean serum alanine transaminase (ALT) levels (50.90 +/- 54.60 U/L to 17.00 +/- 14.50 U/L) and model for end-stage liver disease (MELD) scores (7.51 +/- 4.54 to 7.32 +/- 3.40) (p<0.05). Of the patients, 2 were diagnosed with HCC during the treatment and 14 were diagnosed with HCC 37.0 +/- 16.0 weeks post-treatment. Higher initial MELD score (odds ratio [OR]: 1.92, 95% confidence interval [CI]: 1.22-2.38; p=0.023]), higher hepatitis C virus (HCV) RNA levels (OR: 1.44, 95% CI: 1.31-2.28; p=0.038), and higher serum ALT levels (OR: 1.38, 95% CI: 1.21-1.83; p=0.042) were associated with poor SVR12. The most common adverse events were fatigue (12.6%), pruritis (7.3%), increased serum ALT (4.7%) and bilirubin (3.8%) levels, and anemia (3.1%). Conclusion: LDV/SOF or PrOD +/- RBV were effective and tolerable treatments for patients with CHC and with or without advanced liver disease before and after liver transplantation. Although HCV eradication improves the liver function, there is a risk of developing HCC.
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    HBsAg, Anti-HBs and Anti-HCV Seropositivity Rates among Pregnant Women Attending a University Hospital in Zonguldak
    (2015) Aynioglu, Aynur; Aynioglu, Oner; Akar, Tarik; Aydin, Mehtap; Altunok, Elif Sargin
    Objective: To explore the HBV and HCV seroprevalence rates among pregnant women attending the Obstetric Outpatient Unit at the Medical Faculty of Zonguldak Bulent Ecevit University and to provide contributory data to the already existing data from the other geographical regions of Turkey. Materials and Methods: HBsAg, anti-HBs and anti-HCV seropositivity rates were retrospectively investigated among a total of 1084 pregnant women attending the Obstetric Outpatient Unit at the Medical Faculty of Zonguldak Bulent Ecevit University between January 2012 and January 2014 Serum assays were performed using a chemiluminescence immunoassay method according the manufacturer's instructions (Cobas e 411 Analyzer, Roche Diagnostics, Mannheim, Germany). Statistical analyses of the study data were performed using SPSS 18.0 software package (SPSS Inc., Chicago IL, USA). Results: The mean age of the 1084 pregnant participants was 29.12 +/- 5.48 years (min: 17, max: 46 y) and the average gestational age was 10.7 +/- 4.64 weeks. HBsAg, anti-HBs, and anti-HCV detection rates were 4% (n= 43), 7.3% (n= 79), and 0.6% (n= 7), respectively. With regard to age groups, HBsAg was positive in 3.1%, 3.7%, 4.4%, and 5.9% of the women who were below 20 years of age, between 21 and 30 years of age, between 31 and 40 years of age, and over 40 years of age, respectively. Conclusion: While similar rates of seroprevalence for HBsAg and anti-HCV were found as compared to the previous reports from Turkey, anti-HBs positivity rates were lower than that in most of the previous reports.