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1.
Cureus ; 14(7): e27379, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-36046318

RESUMO

Introduction The global struggle against the impact of severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) on physical and mental health and on economic and social aspects of human life continues even after two and a half years have passed since the emergence of this virus. The development of vaccines was a milestone. By June 2022, billions of people have been vaccinated against the deadly virus. However, like any other vaccine, the various vaccines against coronavirus disease 2019 (COVID-19) also cause a variety of adverse effects. Therefore this study aimed to determine the different acute side effects experienced after receiving the vaccines and correlating them with some socio-demographic and biomedical factors.  Methodology This cross-sectional study has a sample size of 467. Study participants were recruited after fulfilling inclusion and exclusion criteria. After gaining approval from the Ethical Review Board (ERB) of CMH Lahore Medical College and Institute of Dentistry, Lahore, Pakistan, an online questionnaire was distributed via social media. The survey questionnaire had a series of questions regarding the socio-demographic and biomedical characteristics of the participants, as well as the type of vaccine they got, followed by questions about the development of adverse effects after each dose (first and second). Data were statistically analyzed using IBM SPSS Statistics for Windows, Version 25.0 (Released 2017; IBM Corp., Armonk, New York, United States). The analysis was carried out in a confidence range of 95%, and a p-value<0.05 was considered statistically significant.  Results Sinopharm (76.0%) was the most frequently received vaccine. Adverse events were reported more after the first dose (79.7%) than in the second (67.2%) (p value 0.001). The reported adverse events after either dose were of mild intensity (p<0.05). None of the individuals reported serious adverse events or hospitalization after getting the shots. Females, younger age groups, and individuals with BMI in the underweight category were more prone to developing symptoms and experiencing difficulty doing routine work after getting the doses. The associations were statistically significant (p<0.05). Blood group (A,B,0,AB), past COVID-19 history, and smoking status were not positively associated with the appearance of symptoms after either dose or with inconvenience doing daily work post-vaccination. Conclusion The vaccines developed against COVID-19 offer benefits that outweigh the few mild adverse effects experienced. None of these symptoms is severe enough to stop an individual from doing routine work or result in morbidity or mortality. Therefore, people should avoid any hesitancy towards getting vaccinated to get past this pandemic.

2.
PLoS One ; 11(10): e0164563, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27749900

RESUMO

BACKGROUND: A randomized, double-blind, multinational, phase 3 study was conducted comparing the efficacy and safety of peginterferon lambda-1a (Lambda)/ribavirin (RBV)/telaprevir (TVR) vs. peginterferon alfa-2a (Alfa)/RBV/TVR in patients with chronic hepatitis C virus (HCV) genotype-1 (GT-1) infection. METHODS: Patients (treatment-naïve or relapsers on prior Alfa/RBV treatment) were randomly assigned in a 2:1 ratio to receive Lambda/RBV/TVR or Alfa/RBV/TVR. Total duration of treatment was either 24 or 48 weeks (response-guided treatment), with TVR administered for the first 12 weeks. The primary endpoint was the proportion of patients who achieved a sustained virologic response at post treatment week 12 (SVR12), which was tested for noninferiority of Lambda/RBV/TVR. RESULTS: A total of 838 patients were enrolled, and 617 were treated; 411 and 206 patients received Lambda/RBV/TVR and Alfa/RBV/TVR, respectively. The majority of patients were treatment-naïve, with HCV GT-1b and a high baseline viral load (≥800,000 IU/mL). Less than 10% of patients had cirrhosis (Lambda, 7.5%; Alfa, 6.8%). Lambda/RBV/TVR did not meet the criterion for noninferiority (lower bound of the treatment difference interval was -12.3%); the SVR12 in all patients (modified intent-to-treat) was 76.2% in the Lambda arm and 82.0% in the Alfa arm. Overall, the frequency of adverse events in each arm was comparable (Lambda, 91.7%; Alfa, 97.1%). As expected based on the safety profile of the 2 interferons, there were more hepatobiliary events observed in the Lambda arm and more hematologic events in the Alfa arm. CONCLUSIONS: In this comparison of Lambda/RBV/TVR and Alfa/RBV/TVR in patients who were treatment-naïve or had relapsed on prior Alfa/RBV treatment, Lambda failed to demonstrate noninferiority based on SVR12 results. Treatment with Lambda/RBV/TVR was associated with a higher incidence of relapse. More patients discontinued Lambda/RBV/TVR treatment during the first 4 weeks of study treatment, mainly due to hepatobiliary-related events, and more Lambda patients were lost to follow-up.


Assuntos
Antivirais/uso terapêutico , Hepatite C Crônica/tratamento farmacológico , Interferon-alfa/uso terapêutico , Interleucinas/uso terapêutico , Oligopeptídeos/uso terapêutico , Polietilenoglicóis/uso terapêutico , Ribavirina/uso terapêutico , Adulto , Idoso , Antivirais/efeitos adversos , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Genótipo , Doenças Hematológicas/etiologia , Hepacivirus/genética , Hepacivirus/isolamento & purificação , Hepatite C Crônica/virologia , Humanos , Interferon-alfa/efeitos adversos , Interferons , Interleucinas/efeitos adversos , Interleucinas/genética , Masculino , Pessoa de Meia-Idade , Polietilenoglicóis/efeitos adversos , RNA Viral/sangue , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/uso terapêutico , Resultado do Tratamento , Carga Viral , Adulto Jovem
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