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    Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey
    (Elsevier Science Inc, 2021) Tanriover, Mine Durusu; Doganay, Hamdi Levent; Akova, Murat; Guner, Hatice Rahmet; Azap, Alpay; Akhan, Sila; Kose, Sukran
    Background CoronaVac, an inactivated whole-virion SARS-CoV-2 vaccine, has been shown to be well tolerated with a good safety profile in individuals aged 18 years and older in phase 1/2 trials, and provided a good humoral response against SARS-CoV-2. We present the interim efficacy and safety results of a phase 3 clinical trial of CoronaVac in Turkey. Methods This was a double-blind, randomised, placebo-controlled phase 3 trial. Volunteers aged 18-59 years with no history of COVID-19 and with negative PCR and antibody test results for SARS-CoV-2 were enrolled at 24 centres in Turkey. Exclusion criteria included (but were not limited to) immunosuppressive therapy (including steroids) within the past 6 months, bleeding disorders, asplenia, and receipt of any blood products or immunoglobulins within the past 3 months. The K1 cohort consisted of health-care workers (randomised in a 1:1 ratio), and individuals other than health-care workers were also recruited into the K2 cohort (randomised in a 2:1 ratio) using an interactive web response system. The study vaccine was 3 mu g inactivated SARS-CoV-2 virion adsorbed to aluminium hydroxide in a 0.5 mL aqueous suspension. Participants received either vaccine or placebo (consisting of all vaccine components except inactivated virus) intramuscularly on days 0 and 14. The primary efficacy outcome was the prevention of PCR-confirmed symptomatic COVID-19 at least 14 days after the second dose in the per protocol population. Safety analyses were done in the intention-to-treat population. This study is registered with ClinicalTrials.gov (NCT04582344) and is active but no longer recruiting. Findings Among 11 303 volunteers screened between Sept 14, 2020, and Jan 5, 2021, 10 218 were randomly allocated. After exclusion of four participants from the vaccine group because of protocol deviations, the intention-to-treat group consisted of 10 214 participants (6646 [65.1%] in the vaccine group and 3568 [34.9%] in the placebo group) and the per protocol group consisted of 10 029 participants (6559 [65.4%] and 3470 [34.6%]) who received two doses of vaccine or placebo. During a median follow-up period of 43 days (IQR 36-48), nine cases of PCR-confirmed symptomatic COVID-19 were reported in the vaccine group (31.7 cases [14.6-59.3] per 1000 person-years) and 32 cases were reported in the placebo group (192.3 cases [135.7-261.1] per 1000 person-years) 14 days or more after the second dose, yielding a vaccine efficacy of 83.5% (95% CI 65.4-92.1; p<0.0001). The frequencies of any adverse events were 1259 (18.9%) in the vaccine group and 603 (16.9%) in the placebo group (p=0.0108) with no fatalities or grade 4 adverse events. The most common systemic adverse event was fatigue (546 [8.2%] participants in the vaccine group and 248 [7.0%] the placebo group, p=0.0228). Injection-site pain was the most frequent local adverse event (157 [2.4%] in the vaccine group and 40 [1.1%] in the placebo group, p<0.0001). Interpretation CoronaVac has high efficacy against PCR-confirmed symptomatic COVID-19 with a good safety and tolerability profile. Copyright (C) 2021 Elsevier Ltd. All rights reserved.
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    Hepatitis B Virus and Hepatitis C Virus Co-infection: An Evaluation of Eighty-Two Patients
    (Galenos Yayincilik, 2017) Aygen, Bilgehan; Gunal, Ozgur; Yildiz, Orhan; Celen, Mustafa Kemal; Akhan, Sila; Barut, Sener; Ayaz, Celal
    Objective: In this study, we aimed to investigate the characteristics and treatment results of 82 co-infected patients with hepatitis B virus (HBV)/hepatitis C virus (HCV). Materials and Methods: Four university hospitals evaluated HBV/HCV co-infection cases retrospectively. We analyzed the epidemiological, virological, clinical, and histopathological data and the results of treatment in patients co-infected with HBV and HCV. Pegylated interferon (peg IFN) plus ribavirin treatment was given to patients with HCV dominance. The results of patients receiving different treatment for HBV were evaluated. Results: The mean age of the patients was 44.3 +/- 14.7 years and 52.4% were female. The major risk factors were dental therapy, any surgical procedure, hemodialysis, and blood transfusion. The average HCV RNA level and HBV DNA level were found to be 1.36x10(6)+/- 3.06x10(6) IU/mL, and 1.55x10(7)+/- 4.83x10(7) IU/mL, respectively. On histopathology, the mean grade of necroinflammation was found to be 4.9 +/- 2.6 while the mean stage of fibrosis was 1.7 +/- 1.5 in 39 patients. 8.5% of patients were positive for both HCV-RNA and HBV-DNA positive and in 85.7% of cases, HCV infection was found to be dominant. The rate of sustained virologic response was 70.8% in 24 patients receiving peg IFN plus ribavirin therapy. Reactivation of HBV was found in 33.3% of cases. HBV DNA was negative in all patients who received oral antiviral therapy. Conclusion: In cases where both HCV RNA and HBV DNA were positive, HCV was predominant. This is especially noticeable in hemodialysis patients
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    Inhaled Aviptadil is a new hope for recovery of lung damage due to COVID-19
    (European Respiratory Soc Journals Ltd, 2024) Esendagli, Dorina Rama; Sari, Nuran; Akhan, Sila; Arslan, Sonay; Yilmaz, Guerdal; Aksoy, Firdevs; Unlu, Esra Canpolat
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    Liver Histology of Patients with Hepatitis C Virus Infection and Normal Alanine Aminotransferase Levels
    (Aves, 2012) Aygen, Bilgehan; Deniz, Kemal; Akhan, Sila; Celen, Mustafa Kemal; Yildiz, Orhan; Ayaz, Celal; Dogan, Suat Ali
    Objective: In this study, our objective is to evaluate histological changes in livers of hepatitis C virus (HCV)-infected patients with normal alanine aminotransferase (ALT) levels. Methods: 72 patients over 16 years old, with chronic hepatitis C (CHC) and normal ALT levels were evaluated in this multicenter retrospective study. Persistently normal ALT level was defined as 2 or 3 normal ALT levels at intervals of at least 1 month during 6 months. Demographic data, year of diagnosis, at least 2 ALT values within 6 months, hepatitis markers, results of HCV RNA and the liver biopsy were all evaluated. Serological markers have been tested with different kits. HCV RNA has been studied by RT-PCR with dynamic range and sensitivity of different kits. All biopsies were evaluated again by the same pathologist. Results: The mean age was 44 +/- 13 years and 61.1% were female. HCV RNA levels were between 1.53x10(2)-1.13x10(8) IU/ml. The mean ALT levels were 30.3 +/- 9.6 IU/lt. The mean grade of necro-inflammation was 4.67 +/- 1.96 and mean staging of fibrosis was 1.03 +/- 1.13. The ratios of minimal, mild and moderate activity in the liver biopsies were 48.6%, 45.3% and, 2.8%, respectively. Rate of portal-periportal fibrosis, bridging fibrosis and incomplete cirrhosis were 51.4%, 6.9%, and 1.4%, respectively. Conclusions: ALT level is a poor indicator of liver disease activity in patients with CHC. Patients with indication for treatment should be evaluated for liver biopsy.
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    Protease Inhibitors Drug Resistance Mutations in Turkish Patients with Chronic Hepatitis C
    (Elsevier Sci Ltd, 2016) Altunok, Elif Sargin; Sayan, Murat; Akhan, Sila; Aygen, Bilgehan; Yildiz, Orhan; Koruk, Suda Tekin; Mistik, Resit
    Background: Drug resistance development is an expected problem during treatment with protease inhibitors (PIs), this is largely due to the fact that Pls are low-genetic barrier drugs. Resistance-associated variants (RAVs) however may also occur naturally, and prior to treatment with Pls, the clinical impact of this basal resistance remains unknown. In Turkey, there is yet to be an investigation into the hepatitis C (HCV) drug associated resistance to oral antivirals. Materials and methods: 178 antiviral-naive patients infected with HCV genotype 1 were selected from 27 clinical centers of various geographical regions in Turkey and included in the current study. The basal NS3 Pls resistance mutations of these patients were analyzed. Results: In 33 (18.5%) of the patients included in the study, at least one mutation pattern that can cause drug resistance was identified. The most frequently detected mutation pattern was T54S while R109K was the second most frequently detected. Following a more general examination of the patients studied, telaprevir (TVR) resistance in 27 patients (15.2%), boceprevir (BOC) resistance in 26 (14.6%) patients, simeprevir (SMV) resistance in 11 (6.2%) patients and faldaprevir resistance in 13 (7.3%) patients were detected. Our investigation also revealed that rebound developed in the presence of a Q80K mutation and amongst two V55A mutations following treatment with TVR, while no response to treatment was detected in a patient with a R55K mutation. Conclusion: We are of the opinion that drug resistance analyses can be beneficial and necessary in revealing which variants are responsible for pre-treatment natural resistance and which mutations are responsible for the viral breakthrough that may develop during the treatment. (C) 2016 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases.
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    Retreatment of Chronic Hepatitis C Infection with Telaprevir: Preliminary Results in Turkey
    (Galenos Publ House, 2015) Aygen, Bilgehan; Yildiz, Orhan; Akhan, Sila; Celen, Mustafa Kemal; Ural, Onur; Koruk, Suda Tekin; Kose, Sukran
    Background: The use of pegylated interferon alpha and ribavirin (PegIFN/RBV) for the retreatment of chronic hepatitis C virus (HCV) infection without a sustained virological response (SVR) prior to PegIFN/RBV treatment has resulted in low success rates. Aims: To investigate the efficacy and safety of telaprevir (TVR) in combination with PegIFN/RBV in patients infected with HCV genotypes 1 and 4 who were previously treated with PegIFN/RBV and failed to achieve SVR. Study Design: Multi-center, retrospective, cross-sectional study. Methods: The study included 111 patients: 80 prior relapsers, 25 prior null responders, and six prior partial responders to PegIFN/RBV treatment. The patients were given TVR/PegIFN/RBV for 12 weeks, followed by a 12-week PegIFN/RBV treatment; virological response results were assessed at weeks 4, 12, and 24. Treatment was discontinued in patients with HCV RNA >1000 IU/mL at week 4 or with negative RNA results at week 4 but >1000 IU/mL at week 12. Rapid virological response (RVR), early virological response (EVR), extended rapid virological response (eRVR), and virological response at 24th week of treatment were evaluated. The side effects of combination therapy and the rates of treatment discontinuation were investigated. Results: The mean age of the patients was 56.02 +/- 9.96 years and 45.9% were male. Ninety-one percent of the patients were infected with viral genotype 1, 69.6% with the interleukin (IL) 28B genotype CT and 20.2% were cirrhotic. The RVR rate was 86.3% in prior relapsers, 56% in prior null responders, and 50% in prior partial responders (p=0.002). EVR rates in those groups were 91.3%, 56%, and 83.3%, respectively (p<0.001). eRVR rates were 83.8% in prior relapsers, 48% in prior null responders, and 50% in prior partial responders (<0.001). The virological response at the 24th week of treatment was found to be the highest in prior relapsers (88.8%); it was 56% in prior null responders and 66.7% in prior partial responders (p<0.001). Common side effects were fatigue, headache, anorexia, malaise, anemia, pruritus, dry skin, rash, dyspepsia, nausea, pyrexia, stomachache, and anorectal discomfort. All treatments were discontinued due to side effects in 9.9% of patients. Conclusion: High virological response rates were obtained with TVR/PegIFN/RBV treatment. Although side effects were frequently observed, the discontinuation rate of combination therapy was low.