This document provides information about Dr. Alexandre Naime Barbosa, an infectious disease physician in Brazil. It lists his affiliations, research funding sources, speaking engagements, and publications. It then summarizes global and Brazilian data on hepatitis C prevalence and incidence. Finally, it presents treatment response concepts and flowcharts outlining response patterns over time for hepatitis C patients treated with pegylated interferon and ribavirin combination therapy.
This document provides a summary of Grifols' line of immunohematology products, including reagents, instrumentation, and hemovigilance tools. The reagents section describes Grifols' DG Gel system, an 8-column gel card for blood typing and antibody screening/identification. Key features include Clear Card Technology for consistent clarity, and monoclonal antibodies for antigens in the ABO, Rh, and other blood groups. The system includes cards for general typing, confirmation, and other specialized applications. Instrumentation includes both automated and manual/semiautomated devices. The hemovigilance section describes software tools for monitoring transfusion safety.
Microbial S.L. is a biotechnological company devoted to the design and production of products for the rapid detection of pathogen microorganisms in environmental and food samples.
A Cabopec é uma empresa com mais de 30 anos de experiência no fornecimento de cabos de aço e peças para elevação de cargas. A empresa possui um laboratório próprio com equipamentos avançados para testes de resistência e qualidade. Seu objetivo é oferecer produtos e serviços de alta qualidade para atender as necessidades dos clientes de forma personalizada e eficiente.
The document appears to be a slide presentation on hepatitis C. It discusses epidemiology and transmission routes of hepatitis C virus globally and in Brazil. It provides treatment guidelines for hepatitis C, including protocols for protease inhibitor-based regimens with boceprevir or telaprevir in addition to pegylated interferon and ribavirin. It summarizes clinical trial results showing improved sustained virologic response rates with protease inhibitor regimens compared to pegylated interferon and ribavirin alone. It also notes ongoing challenges in treating hepatitis C.
This document summarizes key aspects of hepatitis C virus (HCV) management and treatment in 2011, with a focus on HIV/HCV co-infection. It discusses the natural history of HCV infection and the goals of HCV therapy. New protease inhibitor drugs boceprevir and telaprevir are described that significantly improve sustained virologic response rates compared to pegylated interferon and ribavirin alone. Toxicities, treatment monitoring, and considerations for HIV/HCV co-infected patients are also covered.
This document discusses new frontiers in viral hepatitis, specifically considerations for patients with HIV/HCV co-infection. It provides information on historical and current treatment approaches for hepatitis C, including cure rates of different treatment regimens. It also addresses factors to consider when making treatment decisions, such as genotype, duration of infection, and comorbidities. Upcoming interferon-free treatment options and drug-drug interactions with antiretrovirals are briefly touched upon.
The document discusses three key points:
1) Hepatitis C and B viruses and HIV have a large global prevalence, infecting hundreds of millions of people worldwide.
2) Coinfection of HIV and hepatitis viruses can accelerate liver disease. A study of over 23,000 HIV-positive individuals found that liver-related causes accounted for 14.5% of deaths.
3) Acute hepatitis C infection among HIV-positive men who have sex with men is an emerging issue, with hundreds of reported cases in the United States, Europe, and Australia. Monitoring HCV RNA levels can help determine if antiviral therapy is needed.
The document summarizes research on hepatitis C virus (HCV) resistance to treatments. It discusses three key points:
1. HCV can develop resistance to interferon-alpha and ribavirin treatment, as well as direct-acting antivirals (DAAs). Resistance is caused by genetic mutations in the virus.
2. Certain genetic variants of the host, particularly near the IL28B gene, influence treatment response by affecting interferon signaling and HCV kinetics.
3. New DAAs target various stages of the HCV life cycle including the NS3/4A protease, NS5B polymerase, and NS5A protein. While some DAAs have a low barrier to resistance,
This document provides a summary of Grifols' line of immunohematology products, including reagents, instrumentation, and hemovigilance tools. The reagents section describes Grifols' DG Gel system, an 8-column gel card for blood typing and antibody screening/identification. Key features include Clear Card Technology for consistent clarity, and monoclonal antibodies for antigens in the ABO, Rh, and other blood groups. The system includes cards for general typing, confirmation, and other specialized applications. Instrumentation includes both automated and manual/semiautomated devices. The hemovigilance section describes software tools for monitoring transfusion safety.
Microbial S.L. is a biotechnological company devoted to the design and production of products for the rapid detection of pathogen microorganisms in environmental and food samples.
A Cabopec é uma empresa com mais de 30 anos de experiência no fornecimento de cabos de aço e peças para elevação de cargas. A empresa possui um laboratório próprio com equipamentos avançados para testes de resistência e qualidade. Seu objetivo é oferecer produtos e serviços de alta qualidade para atender as necessidades dos clientes de forma personalizada e eficiente.
The document appears to be a slide presentation on hepatitis C. It discusses epidemiology and transmission routes of hepatitis C virus globally and in Brazil. It provides treatment guidelines for hepatitis C, including protocols for protease inhibitor-based regimens with boceprevir or telaprevir in addition to pegylated interferon and ribavirin. It summarizes clinical trial results showing improved sustained virologic response rates with protease inhibitor regimens compared to pegylated interferon and ribavirin alone. It also notes ongoing challenges in treating hepatitis C.
This document summarizes key aspects of hepatitis C virus (HCV) management and treatment in 2011, with a focus on HIV/HCV co-infection. It discusses the natural history of HCV infection and the goals of HCV therapy. New protease inhibitor drugs boceprevir and telaprevir are described that significantly improve sustained virologic response rates compared to pegylated interferon and ribavirin alone. Toxicities, treatment monitoring, and considerations for HIV/HCV co-infected patients are also covered.
This document discusses new frontiers in viral hepatitis, specifically considerations for patients with HIV/HCV co-infection. It provides information on historical and current treatment approaches for hepatitis C, including cure rates of different treatment regimens. It also addresses factors to consider when making treatment decisions, such as genotype, duration of infection, and comorbidities. Upcoming interferon-free treatment options and drug-drug interactions with antiretrovirals are briefly touched upon.
The document discusses three key points:
1) Hepatitis C and B viruses and HIV have a large global prevalence, infecting hundreds of millions of people worldwide.
2) Coinfection of HIV and hepatitis viruses can accelerate liver disease. A study of over 23,000 HIV-positive individuals found that liver-related causes accounted for 14.5% of deaths.
3) Acute hepatitis C infection among HIV-positive men who have sex with men is an emerging issue, with hundreds of reported cases in the United States, Europe, and Australia. Monitoring HCV RNA levels can help determine if antiviral therapy is needed.
The document summarizes research on hepatitis C virus (HCV) resistance to treatments. It discusses three key points:
1. HCV can develop resistance to interferon-alpha and ribavirin treatment, as well as direct-acting antivirals (DAAs). Resistance is caused by genetic mutations in the virus.
2. Certain genetic variants of the host, particularly near the IL28B gene, influence treatment response by affecting interferon signaling and HCV kinetics.
3. New DAAs target various stages of the HCV life cycle including the NS3/4A protease, NS5B polymerase, and NS5A protein. While some DAAs have a low barrier to resistance,
This document discusses Harvoni and its role in treating Hepatitis C. It provides an overview of Hepatitis C, including epidemiology and clinical presentation. It describes the mechanism of action and pharmacokinetics of the two drugs in Harvoni - Ledipasvir and Sofosbuvir. It summarizes several clinical trials that evaluated Harvoni's efficacy and safety in treating genotype 1 Hepatitis C in treatment-naive and experienced patients, with and without cirrhosis, finding high sustained virologic response rates with 12 weeks of Harvoni treatment.
Palestra Novos Conceitos na Terapia com Inibidores de Protease - Dr. Jordan FeldFabiane Martins
Protease inhibitors like boceprevir provide improved cure rates for hepatitis C, but require careful use to minimize resistance and side effects. Response-guided therapy allows shortening treatment for many patients by stopping the protease inhibitor early if they achieve an early viral load reduction. While resistance to protease inhibitors preexists, multiple factors work together to limit the growth and persistence of resistant viral strains. Careful patient selection and monitoring can maximize benefits while reducing risks of protease inhibitor treatment.
This randomized controlled trial evaluated the efficacy and safety of REGEN-COV (casirivimab and imdevimab) in reducing COVID-19 related hospitalizations or death in non-hospitalized high-risk adults with confirmed COVID-19. Over 800 patients received either 1.2g or 2.4g of REGEN-COV or placebo. The trial found that REGEN-COV reduced the risk of hospitalization or death compared to placebo, mainly by reducing hospitalizations. REGEN-COV also reduced the time to resolution of COVID-19 symptoms. The study demonstrates that REGEN-COV can help reduce adverse outcomes for high-risk patients with COVID-19.
Virología virus de las hepatitis (parte 2.2) hepatitis b ¿sabes cómo evolucio...119WilliamMezarinaCa
1. The document discusses the evolution of hepatitis B infection and its diagnosis based on serological markers.
2. There are several stages of infection: susceptible, acute infection, past infection/cure, and chronic infection. Different serological markers are present or absent depending on the stage.
3. The accurate diagnosis of hepatitis B requires determining the presence or absence of specific viral antigens and antibodies through serological tests. The results of these tests vary according to the phase of infection.
This document discusses advances in treatment for hepatitis C virus (HCV) infection. It provides information on:
- The primary goals of HCV treatment as viral eradication and prevention of liver disease progression.
- Definitions of sustained virological response (SVR) and response rates achieved with pegylated interferon and ribavirin treatment.
- New direct-acting antiviral drugs in development that target specific steps in the HCV lifecycle, including protease, polymerase, and NS5A inhibitors.
The study analyzed 139 fecal samples from 15 age groups of pigs on a farm experiencing acute diarrhea to determine prevalence and viral load of porcine epidemic diarrhea virus (PEDV), transmissible gastroenteritis virus (TGE), porcine deltacoronavirus (PDCoV), and rotavirus (RVA, RVB, RVC). PEDV was present in all samples and age groups but with significantly higher viral loads in post-weaned pigs. TGE and PDCoV were rarely detected. Rotaviruses were detected exclusively in post-weaned pigs. The results suggest PEDV incidence and load may depend on age and some viruses were co-infecting pigs.
This document discusses several methods for diagnosing infections based on detecting DNA and RNA, including polymerase chain reaction (PCR) and real-time PCR. It provides details on PCR, describing how it exponentially amplifies DNA or RNA sequences. It also explains that real-time PCR can detect results more rapidly and sensitively than conventional PCR. The document outlines several applications of these molecular diagnostic techniques for specific infections.
__Lecture 11 Hepatitis B &D viruses Part-2.pptxssuser3ef762
This document provides information about Hepatitis B virus (HBV) including its definition, structure, pathogenesis, laboratory diagnosis, and prevention/treatment. It defines HBV as a hepatotropic DNA virus that causes both acute and chronic liver infection. The key points covered are:
I. HBV is a partially double-stranded DNA virus that attacks the liver and can cause acute or chronic infection.
II. HBV infection is diagnosed through serological markers including HBsAg, HBeAg, Anti-HBc IgM/IgG, and Anti-HBs.
III. HBV can be prevented through vaccination and immunoglobulin treatment for those exposed to the virus. Chronic infection can
Eugm 2012 unknown - incivex drug development process overview road to findi...Cytel USA
1) The document discusses the development of the drug Incivek for the treatment of hepatitis C virus (HCV) genotype 1.
2) It describes two phase 3 clinical trials called ADVANCE and ILLUMINATE that evaluated the efficacy and safety of Incivek in combination with pegylated interferon and ribavirin.
3) The trials found high sustained viral response rates, particularly in patients who achieved an early viral response, supporting the approval of Incivek for the treatment of HCV genotype 1.
The document discusses issues related to meningococcal B (MenB) vaccines before and after implementation. It addresses questions such as whether vaccine components are immunogenic, if vaccines can be incorporated into routine schedules, vaccine tolerability, and how to assess effectiveness. Studies show MenB vaccines have immunogenic components and can be given according to routine schedules with minimal interference or reduction in immune response. The vaccines demonstrate a good safety profile in clinical trials with few serious adverse events potentially related to vaccination. Overall, the document evaluates key considerations for MenB vaccines prior to and following widespread use.
The Beckoning Future: How Hepatitis C Drugs in Development May Affect Practic...Clinical Care Options
Review the current benefits and limitations with protease inhibitor-based HCV therapies, and the emerging data on potential future regimens, and the advances they represent
This document summarizes new therapeutic approaches for hepatitis B. It discusses combination therapies using pegylated interferon and nucleoside analogues, which aim to additively or synergistically suppress HBV replication and induce cccDNA loss or control. It also reviews immune modulation strategies like toll-like receptor agonists and anti-PD1 antibodies to restore T cell function. Targeting the HBV cccDNA minichromosome using gene editing techniques such as zinc fingers, TALENs, and CRISPR/Cas9 is also discussed as a potential cure strategy by cleaving cccDNA. Overall, the document outlines current and emerging strategies focused on both directly targeting cccDNA and modulating the immune response
Современное лечение и профилактика ВИЧ : передовые стратегии лечения у пациен...hivlifeinfo
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Volker Diehl, M.D., Professor, University of Cologne, Germany Customization: The Treatment of Hodgkin's Disease
Presented at New Frontiers in the Management of Solid and Liquid Tumors hosted by the John Theurer Cancer Center at Hackensack University Medical Center. jtcancercenter.org/CME
This document summarizes information about viral hepatitis, with a focus on hepatitis C. It discusses the discovery of hepatitis B and hepatitis C viruses, the clinical manifestations of hepatitis C infection, diagnostic tests for hepatitis C including antibody and RNA tests, natural history and progression of hepatitis C disease, and treatment recommendations for chronic hepatitis C. Epidemiological data on hepatitis C prevalence globally and in Thailand is also presented.
David L. Wyles, MD of UC San Diego Department of Medicine presents"Acute HCV Infection in HIV+ MSM: Sexual Transmission of a Non-Sexually Transmitted Disease?"
Chronic hepatitis refers to ongoing liver inflammation that persists for over 6 months. It can be caused by hepatitis B or C viruses, autoimmune conditions, drugs, alcohol, or genetic disorders. Diagnosis involves blood tests showing elevated liver enzymes and dysfunction. Histopathological grading assesses necrosis and staging evaluates fibrosis progression which can lead to cirrhosis. Chronic hepatitis B infection may be HBeAg positive or negative and natural history depends on factors like viral genotype and host immunity. Treatment algorithms consider liver enzyme levels and biopsy findings to determine if antiviral therapy is needed.
This document provides an overview of hepatitis A-E viruses. Hepatitis A virus is transmitted through the fecal-oral route and does not cause chronic infection. Hepatitis B virus can cause chronic infection and is transmitted through blood and bodily fluids. Hepatitis C virus is transmitted through blood exposure and often causes chronic infection leading to complications like cirrhosis and liver cancer. The viruses are classified into genotypes with different geographical distributions and disease outcomes. Laboratory tests are used to diagnose acute and chronic viral hepatitis infections.
This document summarizes HCV diagnostic strategies and monitoring tools. It describes the kinetics of various HCV markers like RNA, core antigen, and antibodies during acute and chronic infection. It also discusses various virological tests for HCV including assays for genotype determination, RNA quantification, and new tests like core antigen detection. Emerging tools for resistance testing using next-generation sequencing techniques are also covered.
1) The document summarizes an ECHO session on hepatitis B that included introductions, a didactic presentation on anti-HBc by Dr. Robert Gish, and a case presentation with feedback.
2) Dr. Gish's presentation covered epidemiology of HBV, HBV testing including the importance of anti-HBc, concepts about HBV persistence and reactivation risk.
3) Data was presented on rates of occult HBV and HBV DNA detection in donors with isolated or combined anti-HBc and anti-HBs.
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
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This document discusses Harvoni and its role in treating Hepatitis C. It provides an overview of Hepatitis C, including epidemiology and clinical presentation. It describes the mechanism of action and pharmacokinetics of the two drugs in Harvoni - Ledipasvir and Sofosbuvir. It summarizes several clinical trials that evaluated Harvoni's efficacy and safety in treating genotype 1 Hepatitis C in treatment-naive and experienced patients, with and without cirrhosis, finding high sustained virologic response rates with 12 weeks of Harvoni treatment.
Palestra Novos Conceitos na Terapia com Inibidores de Protease - Dr. Jordan FeldFabiane Martins
Protease inhibitors like boceprevir provide improved cure rates for hepatitis C, but require careful use to minimize resistance and side effects. Response-guided therapy allows shortening treatment for many patients by stopping the protease inhibitor early if they achieve an early viral load reduction. While resistance to protease inhibitors preexists, multiple factors work together to limit the growth and persistence of resistant viral strains. Careful patient selection and monitoring can maximize benefits while reducing risks of protease inhibitor treatment.
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Virología virus de las hepatitis (parte 2.2) hepatitis b ¿sabes cómo evolucio...119WilliamMezarinaCa
1. The document discusses the evolution of hepatitis B infection and its diagnosis based on serological markers.
2. There are several stages of infection: susceptible, acute infection, past infection/cure, and chronic infection. Different serological markers are present or absent depending on the stage.
3. The accurate diagnosis of hepatitis B requires determining the presence or absence of specific viral antigens and antibodies through serological tests. The results of these tests vary according to the phase of infection.
This document discusses advances in treatment for hepatitis C virus (HCV) infection. It provides information on:
- The primary goals of HCV treatment as viral eradication and prevention of liver disease progression.
- Definitions of sustained virological response (SVR) and response rates achieved with pegylated interferon and ribavirin treatment.
- New direct-acting antiviral drugs in development that target specific steps in the HCV lifecycle, including protease, polymerase, and NS5A inhibitors.
The study analyzed 139 fecal samples from 15 age groups of pigs on a farm experiencing acute diarrhea to determine prevalence and viral load of porcine epidemic diarrhea virus (PEDV), transmissible gastroenteritis virus (TGE), porcine deltacoronavirus (PDCoV), and rotavirus (RVA, RVB, RVC). PEDV was present in all samples and age groups but with significantly higher viral loads in post-weaned pigs. TGE and PDCoV were rarely detected. Rotaviruses were detected exclusively in post-weaned pigs. The results suggest PEDV incidence and load may depend on age and some viruses were co-infecting pigs.
This document discusses several methods for diagnosing infections based on detecting DNA and RNA, including polymerase chain reaction (PCR) and real-time PCR. It provides details on PCR, describing how it exponentially amplifies DNA or RNA sequences. It also explains that real-time PCR can detect results more rapidly and sensitively than conventional PCR. The document outlines several applications of these molecular diagnostic techniques for specific infections.
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This document provides information about Hepatitis B virus (HBV) including its definition, structure, pathogenesis, laboratory diagnosis, and prevention/treatment. It defines HBV as a hepatotropic DNA virus that causes both acute and chronic liver infection. The key points covered are:
I. HBV is a partially double-stranded DNA virus that attacks the liver and can cause acute or chronic infection.
II. HBV infection is diagnosed through serological markers including HBsAg, HBeAg, Anti-HBc IgM/IgG, and Anti-HBs.
III. HBV can be prevented through vaccination and immunoglobulin treatment for those exposed to the virus. Chronic infection can
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1) The document discusses the development of the drug Incivek for the treatment of hepatitis C virus (HCV) genotype 1.
2) It describes two phase 3 clinical trials called ADVANCE and ILLUMINATE that evaluated the efficacy and safety of Incivek in combination with pegylated interferon and ribavirin.
3) The trials found high sustained viral response rates, particularly in patients who achieved an early viral response, supporting the approval of Incivek for the treatment of HCV genotype 1.
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1) The document summarizes an ECHO session on hepatitis B that included introductions, a didactic presentation on anti-HBc by Dr. Robert Gish, and a case presentation with feedback.
2) Dr. Gish's presentation covered epidemiology of HBV, HBV testing including the importance of anti-HBc, concepts about HBV persistence and reactivation risk.
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These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
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- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
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Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
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Our backs are like superheroes, holding us up and helping us move around. But sometimes, even superheroes can get hurt. That’s where slip discs come in.
4. Prevalência Mundial (2,2%): 170 a 200 milhões
Incidência: 3 a 4 milhões/ano; 300 mil óbitos/ano
Anti-VHC: 2,7 milhões (1,38%)
PCR-VHC: 1,3 milhões (0,67%)
WHO, 2012
Casos Notificados: 70 mil Inquérito Nacional das Hepatites Virais, MS-Brasil, 2010
Barbosa AN, 2012
6. Nearly 100% of patients who achieve SVR remain undetectable
during long-term follow-up[1-4]
99[1] 99[2] 100[3] 100[4]
100
Patients With SVR
80
60
(%)
40
20
0
3.9 yrs 3.4 yrs 3.3 yrs 5.4 yrs
(mean) (median) (median) (median)
Duration of Follow-up
1. Swain MG, et al. Gastroenterology. 2010;139:1593-1601. 2. Giannini EG, et al. Aliment Pharmacol Ther. 2010;31:502-508. 3. Maylin S, et al. Gastroenterology.
2008;135:821-829. 4. George SL, et al. Hepatology. 2009;49:729-738.
Barbosa AN, 2012
7. Fluxograma de Tratamento (PEG-IFN + RBV)
Sem 4 Sem 12 Sem 24 Sem 48 Sem 72
PCR VHC
(-)
PCR VHC (-) Sem 4:
Resposta Virológica Rápida
RVS: 90%
Barbosa AN, 2012
8. Fluxograma de Tratamento (PEG-IFN + RBV)
Sem 4 Sem 12 Sem 24 Sem 48 Sem 72
G2/3 Tto: 24 semanas
PCR VHC
(-) G1 Tto: 48 semanas
PCR VHC (-) Sem 4:
Resposta Virológica Rápida
RVS: 90%
Barbosa AN, 2012
9. Fluxograma de Tratamento (PEG-IFN + RBV)
Sem 4 Sem 12 Sem 24 Sem 48 Sem 72
PCR VHC (-) Sem 12:
Resposta Virológica
PCR VHC
(-)
Precoce Completa
PCR VHC
(+)
RVS: 66%
Barbosa AN, 2012
10. Fluxograma de Tratamento (PEG-IFN + RBV)
Sem 4 Sem 12 Sem 24 Sem 48 Sem 72
G2/3 Tto: 24 semanas
PCR VHC
(-) G1 Tto: 48 semanas
PCR VHC G2/3
(-) G1
PCR VHC PCR VHC (-) Sem 12:
(+) Resposta Virológica
Precoce Completa
RVS: 66%
Barbosa AN, 2012
11. Fluxograma de Tratamento (PEG-IFN + RBV)
Sem 4 Sem 12 Sem 24 Sem 48 Sem 72
Queda de 2 logs Sem 12:
Resposta Virológica
PCR VHC
(-)
Precoce Parcial
PCR VHC
(+)
RVS: 45%
Queda de
2 logs
Barbosa AN, 2012
12. Fluxograma de Tratamento (PEG-IFN + RBV)
Sem 4 Sem 12 Sem 24 Sem 48 Sem 72
G2/3 Tto: 24 semanas
PCR VHC
(-) G1 Tto: 48 semanas
PCR VHC Tto: 72 semanas
G2/3
(-)
PCR VHC G1
(+) Queda de
Queda de 2 logs Sem 12:
2 logs G1
Resposta Virológica
Precoce Parcial
RVS: 45%
Barbosa AN, 2012
13. Fluxograma de Tratamento (PEG-IFN + RBV)
Sem 4 Sem 12 Sem 24 Sem 48 Sem 72
PCR VHC Sem Queda de 2 logs
(-)
PCR VHC Sem 12: Resposta Nula
(+) Queda de RVS: 2 %
2 logs
Sem queda
De 2 logs
Barbosa AN, 2012
14. Fluxograma de Tratamento (PEG-IFN + RBV)
Sem 4 Sem 12 Sem 24 Sem 48 Sem 72
G2/3 Tto: 24 semanas
PCR VHC
(-) G1 Tto: 48 semanas
Tto: 72 semanas
PCR VHC G2/3
(-) G1
PCR VHC
(+) Queda de Sem Queda de 2 logs
G1
2 logs Sem 12: Resposta
Nula
Sem queda
G1
De 2 logs
Tto: Suspenso
Barbosa AN, 2012
15. Fluxograma de Tratamento (PEG-IFN + RBV)
Sem 4 Sem 12 Sem 24 Sem 48 Sem 72
G2/3 Tto: 24 semanas
PCR VHC
(-) G1 Tto: 48 semanas
Tto: 72 semanas
PCR VHC G2/3
(-) G1
PCR VHC
(+) Queda de
G1
2 logs
Sem queda
G1
De 2 logs
PCR VHC Tto: Suspenso
(+)
Barbosa AN, 2012
16. 100
PegIFN/
80 ribavirin
(6-12 mos)[6,7]
Interferon/
50-60
SVR (%)
60 ribavirin PegIFN
(6-12 mos)[3,4] monotherapy
Standard 38-43 (6-12 mos)[5,6]
40 Standard interferon
(12-18 mos)[2,3] 25-30
interferon
(6 mos)[1] 15-20
20
8-12
0
1991 1995 1998 2001
1. Carithers RL Jr., et al. Hepatology. 1997;26(3 suppl 1):83S-88S. 2. Zeuzem S, et al. N Engl J Med. 2000;343:1666-1672. 3. Poynard T, et al. Lancet. 1998;352:1426-1432. 4.
McHutchison JG, et al. N Engl J Med. 1998;339:1485-1492. 5. Lindsay KL, et al. Hepatology. 2001;34:395-403. 6. Fried MW, et al. N Engl J Med. 2002;347:975-982. 7. Manns MP,
et al. Lancet. 2001;358:958-965.
Barbosa AN, 2012
36. Recommendation: Noncirrhotic patients can be considered for
response-guided therapy with TVR
HCV RNA
Undetectable Undetectable
TVR + PegIFN + RBV PegIFN + RBV eRVR; stop at Wk 24, f/u 24 wks
0 4 12 24 48
HCV RNA
Detectable Undetectable or
(≤ 1000 IU/mL) detectable (≤ 1000 IU/mL)
No eRVR; extend pegIFN + RBV to Wk 48; f/u 24 wks
TVR + PegIFN + RBV PegIFN + RBV
0 4 12 24 48
Telaprevir [package insert]. May 2011. Ghany MG, et al. Hepatology. 2011;54:1433-1444.
Barbosa AN, 2012
37. ILLUMINATE: Response-Guided TVR
ADVANCE: TVR + PegIFN/RBV in + PegIFN/RBV in
Treatment-Naive Genotype 1 Treatment-Naive Genotype 1
58% of patients eligible for 65% of patients eligible for
shortened therapy[2] shortened therapy[1]
SVR in Pts Achieving eRVR
97
SVR in Pts Achieving eRVR
100 89 100 92 88
80 80
60 60
(%)
(%)
40 40
20 20
n/ 189/ 28/ n/ 149/ 140/
0 N= 212 29 0 N= 162 160
T12PR24 T12PR48 T12PR24 T12PR48
1. Jacobson IM, et al. N Engl J Med. 2011;364:2405-2416.
2. Sherman KE, et al. N Engl J Med. 2011;365:1014-1024.
Barbosa AN, 2012
38. BOC[1,2]
Time Point Criteria Action
Wk 12 HCV RNA ≥ 100 IU/mL Discontinue all therapy
Wk 24 HCV RNA detectable Discontinue all therapy
TVR[1,3]
Time Point Criteria Action
Wk 4 or 12 HCV RNA > 1000 IU/mL Discontinue all therapy
Wk 24 HCV RNA detectable Discontinue pegIFN/RBV
Assay should have a lower limit of HCV RNA quantification of ≤ 25 IU/mL and a limit of HCV RNA
detection of approximately 10-15 IU/mL.
1. Boceprevir [package insert]. May 2011. 2. Ghany MG, et al. Hepatology. 2011;54:1433-1444.
3. Telaprevir [package insert]. May 2011.
Barbosa AN, 2012
39. Recommendation: BOC approved for previous relapsers, partial, and null responders[1]
–
AASLD guidelines say BOC “recommended” for previous relapsers and partial responders;
advise caution in null responders given lack of definitive information from phase III studies[2]
Early response;
PegIFN BOC + PegIFN + RBV stop at Wk 36; f/u 24 wks
+ RBV BOC + PegIFN + RBV PegIFN + RBV F/u
24 wks
0 4 8 12 24 28 36 48
100 Previous partial response
80 Previous relapse 75
69
SVR (%)[3]
60 52
40
40 29
20
7
n/N = 2/29 15/51 23/57 72/105 30/58 77/103
0
PR48 BOC RGT BOC/PR48
1. Boceprevir [package insert]. 2011. 2. Ghany MG, et al. Hepatology. 2011;54:1433-1444.
3. Bacon BR, et al. N Engl J Med. 2011;364:1207-1217.
Barbosa AN, 2012
40. Recommendation: Response-guided therapy can be considered for
previous relapsers, may be considered for previous partial
responders, but not for previous null responders
HCV RNA
Undetectable < 100 IU/mL Undetectable
PegIFN Early response; stop at
+ RBV BOC + PegIFN + RBV
Wk 36; f/u 24 wks
0 4 8 12 24 28 36 48
HCV RNA
Detectable < 100 IU/mL Undetectable Slow response; PR to
Wk 48; f/u 24 wks
PegIFN
BOC + PegIFN + RBV PegIFN + RBV
+ RBV
0 4 8 12 24 28 36 48
Boceprevir [package insert]. May 2011. Ghany MG, et al. Hepatology. 2011;54:1433-1444.
Barbosa AN, 2012
41. Recommendation: TVR approved for previous relapsers, partial, and null responders[1]
– AASLD guidelines say TVR “recommended” for previous relapsers and partial responders;
“may be considered” for previous null responders[2]
Previous relapsers*[1,2] (same as naives)
eRVR; stop at Wk 24, f/u 24 wks
TVR + PegIFN + RBV PegIFN + RBV F/u
No eRVR; PegIFN + RBV
24 wks
0 4 12 24 48
Previous partial responders† and null responders[1,2]
TVR + PegIFN + RBV PegIFN + RBV F/u
24 wks
0 4 12 24 48
*Response-guided therapy not studied in relapsers in registration trials.
†AASLD guidelines say RGT “may be considered” for prior partial responders[2] but package insert
recommends 48 weeks of therapy[1]
1. Telaprevir [package insert]. 2011. 2. Ghany MG, et al. Hepatology. 2011;54:1433-1444.
Barbosa AN, 2012
42. REALIZE: TVR + PegIFN/RBV in G1 Previous Relapsers and Partial/Null Responders
Lead-in examined but found not to influence response and not included in TVR label
PR48 T12/PR48 LI T12/PR48
Previous Relapsers Previous Partial Previous Null
100 Responders Responders
88*
83*
80
SVR (%)
59*
60 54*
40 33*
29*
24
20 15 5
n/N= 16/68 121/145 124/141 4/27 29/49 26/48 2/37 21/72 25/75
0
*P < .001 vs PR48.
Zeuzem S, et al. N Engl J Med. 2011;364:2417-2428.
Barbosa AN, 2012
43. Recommendation: Response-guided therapy recommended for previous
relapsers, but not for previous partial or null responders*[1]
HCV RNA
Undetectable Undetectable
TVR + PegIFN + RBV PegIFN + RBV eRVR; stop at Wk 24, f/u 24 wks
0 4 12 24 48
HCV RNA
Detectable Undetectable/detectable
(≤ 1000 IU/mL) (≤ 1000 IU/mL)
No eRVR; extend pegIFN + RBV to Week 48; f/u 24 wks
TVR + PegIFN + RBV PegIFN + RBV
0 4 12 24 48
*AASLD guidelines say RGT “may be considered” for previous partial responders [2] but package insert
recommends 48 wks of therapy.[1]
1. Telaprevir [package insert]. May 2011. 2. Ghany MG, et al. Hepatology. 2011;54:1433-1444.
Barbosa AN, 2012
44. Recommendation: All therapy should be discontinued in
patients with the following:
BOC[1,2]
Time Point Criteria Action
Wk 12 HCV RNA ≥ 100 IU/mL Discontinue all therapy
Wk 24 HCV RNA detectable Discontinue all therapy
TVR[1,3]
Time Point Criteria Action
Wk 4 or 12 HCV RNA > 1000 IU/mL Discontinue all therapy
Wk 24 HCV RNA detectable Discontinue pegIFN/RBV
Assay should have a lower limit of HCV RNA quantification of ≤ 25 IU/mL and a limit of HCV RNA
detection of approximately 10-15 IU/mL.
1. Boceprevir [package insert]. May 2011. 2. Ghany MG, et al. Hepatology. 2011;54:1433-1444.
3. Telaprevir [package insert]. May 2011.
Barbosa AN, 2012
48. Recommendation: All cirrhotic patients receiving TVR + PR may
benefit from 48 weeks of therapy[1,2]
100 PR48
T12PR
78 T8PR
80 73
62
SVR (%)[3,4]
60 53
47
40 33
20
n/ 134/ 226/ 205/ 24/ 45/ 45/
N= 288 290 279 73 73 85
0
No, Minimal, or Portal Fibrosis Bridging Fibrosis or Cirrhosis
1. Telaprevir [package insert]. May 2011. 2. Ghany MG, et al. Hepatology. 2011;54:1433-1444.
3. Jacobson IM, et al. AASLD 2010. Abstract 211. 4. Jacobson IM, et al. NEJM. 2011;364:2405-2416.
Barbosa AN, 2012
49. Recommendation: IL28B genotype testing may be considered prior to
therapy if more information about probability of response or treatment
duration desired
IL28B Genotype Predicts Likelihood of SVR With Triple Therapy
SPRINT-2: BOC + PR48[1] ADVANCE: T12PR48*[2]
100 100 90
80
80 71 80 71 73
59
SVR (%)
SVR (%)
60 60
40 40
20 20
n/ 44/ 82/ 26/ n/ 45/ 48/ 16/
N= 55 115 44 N= 50 68 22
0 0
CC CT TT CC CT TT
*IL28B testing in ADVANCE was in whites only.
1. Poordad F, et al. EASL 2011. Abstract 12. 2. Jacobson IM, et al. EASL 2011. Abstract 1369.
Barbosa AN, 2012
50. Recommendation: IL28B genotype testing may be considered prior to
therapy if more information about probability of response or treatment
duration desired
IL28B Genotype Predicts Likelihood of Short-Duration Therapy
SPRINT-2: BOC + PR[1] ADVANCE: T12PR*[2]
100 100
89
78
Eligibility for RGT (%)
Eligibility for RGT (%)
80 80
60 60 57
52
45
40 40
20 20
n/ 118/ 158/ n/ 39/ 39/ 10/
N= 132 304 N= 50 68 22
0 0
CC CT/TT CC CT TT
*IL28B testing in ADVANCE was in whites only.
1. Poordad F, et al. EASL 2011. Abstract 12. 2. Jacobson IM, et al. EASL 2011. Abstract 1369.
Barbosa AN, 2012
51. Data from T12PR arm only
100
79 78 78
74
75 71
62
SVR (%)
50
25
n/ 118/ 152/ 64/ 207/ 226/ 45/
N = 149 213 82 281 290 73
0
1b 1a < 800,000 ≥ 800,000 F0-2 F3-F4
Genotype HCV RNA (IU/mL) Fibrosis
Marcellin P, et al. EASL 2011. Abstract 451.
Barbosa AN, 2012
53. Significantly higher rates of anemia, neutropenia, and
dysgeusia in BOC arms vs control
Adverse Event, % PR48 BOC + PR RGT/48
(n = 467) (n = 1225)
Anemia* 30 50
Neutropenia 19 25
Dysgeusia 16 35
*Anemia was managed with RBV reduction and/or epoetin alfa
(43% of BOC + PR and 24% of PR).
Barbosa AN, 2012
54. Higher rates of rash, anemia, and anorectal signs/symptoms in TVR
arms vs control
Adverse Event, % PR48 TVR + PR RGT/48*
(n = 493) (n = 1797)
Rash 34 56
Anemia† 17 36
Anorectal events 7 29
*Pooled results from TVR arms.
†Anemia was managed with RBV dose modification; epoetin alfa was not permitted.
In most subjects, rash was mild to moderate
– Severe rash in 4%; discontinuation due to rash in 6% of subjects
– Occurred early, usually first 4 wks, but can occur at any time during TVR
exposure
– < 1% had SJS or DRESS (11 cases DRESS and 3 cases SJS)
Telaprevir [package insert]. May 2011. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/
Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562.pdf
Barbosa AN, 2012
55. Recommendation: Anemia should be managed initially
by reducing the RBV dose[1]
Dose reduction of RBV is acceptable
Dose reduction of DAA is not acceptable
Do not discontinue pegIFN/RBV and continue DAA
DAA should not be stopped and then restarted
Monitor closely if Hb falls < 10 g/dL
ESA agents are unlabeled for HCV anemia and should
not be used if Hb > 12 g/dL
1. Ghany MG, et al. Hepatology. 2011;54:1433-1444.
Barbosa AN, 2012
56. Rash management
– Mild to moderate rash can be treated with oral
antihistamines, topical steroids
– Systemic steroids are not recommended
– Stop all 3 drugs for severe rash, DRESS, or SJS
– Important to have “go-to” dermatologist; vigilance with rash
is key
Anorectal symptom management
– Fiber, loperamide, hydrocortisone, and pramoxine topical
cream
Telaprevir [package insert]. May 2011.
Barbosa AN, 2012
57. Contraindications for BOC and TVR therapy
– Patients with previous SAEs leading to premature pegIFN/RBV discontinuation
– Pregnant women or men whose female partners are pregnant
– Coadministration with other drugs highly dependent on CYP3A4/5 for clearance
– Coadministration with potent CYP3A4/5 inducers that may significantly reduce
BOC or TVR plasma concentrations, leading to reduced efficacy
Safety and pharmacokinetics have not been studied in patients with
decompensated cirrhosis or in liver transplant recipients, patients coinfected
with HBV or HIV, or persons younger than 18 yrs of age
Assess carefully for all drug-drug interactions prior to commencing therapy
Boceprevir [package insert]. May 2011. Telaprevir [package insert]. May 2011.
Ghany MG, et al. Hepatology. 2011;54:1433-1444.
Barbosa AN, 2012
58. Drug Class Contraindicated With BOC[1] Contraindicated With TVR[2]
Alpha 1-adrenoreceptor Alfuzosin Alfuzosin
antagonist
Anticonvulsants Carbamazepine, phenobarbital, N/A
phenytoin
Antimycobacterials Rifampin Rifampin
Ergot derivatives Dihydroergotamine, ergonovine, Dihydroergotamine, ergonovine,
ergotamine, methylergonovine ergotamine, methylergonovine
GI motility agents Cisapride Cisapride
Herbal products Hypericum perforatum (St John’s wort) Hypericum perforatum
HMG CoA reductase Lovastatin, simvastatin Atorvastatin, lovastatin, simvastatin
inhibitors
Oral contraceptives Drospirenone N/A
Neuroleptic Pimozide Pimozide
PDE5 inhibitor Sildenafil or tadalafil when used for tx of Sildenafil or tadalafil when used for tx
pulmonary arterial hypertension of pulmonary arterial hypertension
Sedatives/hypnotics Triazolam; orally administered Orally administered midazolam,
midazolam triazolam
*Studies of drug-drug interactions incomplete.
1. Boceprevir [package insert]. May 2011. 2. Telaprevir [package insert]. May 2011.
Barbosa AN, 2012
61. - ↑ RVS naïves e experimentados - Preço (R$ 60 – 70 mil)
- Menor tempo de tratamento - SUS ainda não cobre
- Maior chance de RVS para não - Resistência aos IPs
respondedores prévios - Efeitos Adversos
- Maior chance de RVS para - Interações medicamentosas
F3/F4
- Nº de comprimidos
- Maior chance de resposta IL28B
CT e TT - Boas opções no futuro
Barbosa AN, 2012
62. NS3/4A NS5B Polymerase Inhibitors NS5A Cyclophilin A
Protease Nucleos(t)ide Non- Inhibitors Inhibitors
Inhibitors Analogue nucleos(t)ide
High efficacy Mimic natural Bind to several NS5A has role Supports HCV-
Low genetic substrates of the different in assembly of specific RNA
barrier to polymerase allosteric replication replication,
resistance Incorporated into enzyme sites; complex protein
RNA chain results in Mechanism of expression
Macrocyclic conformational
or linear causing chain inhibition Interacts with
termination change under study NS2, NS5A,
Phase III: Resistance NS5B
BI 201335, Broad genotypic Phase III:
coverage more frequent Daclatasvir May regulate
TMC435 than nucs
High genetic (BMS-790052) polypeptide
barrier to Several agents processing,
resistance in phase II viral assembly
Phase III: Phase III:
PSI-7977 Alisporivir
Barbosa AN, 2012
64. Combination Therapy for Null Responders
Daclatasvir (BMS-790052) QD (NS5A inhibitor) + asunaprevir (BMS-650032)
BID (NS3 protease inhibitor) ± pegIFN/RBV for 24 wks
US Study[1] Japan Study[2]
100 Daclatasvir + Asunaprevir
90 90*
Daclatasvir + Asunaprevir + PR
80
SVR24 (%)
60
40 36
20
N/A
0
1. Lok A, et al. EASL 2011. Abstract 1356.
*all genotype 1b patients.
2. Chayama K, et al. AASLD 2011. Abstract LB-4.
Barbosa AN, 2012
65. - Experimentados SOC, F2-F4 - Naïve, F0-F2, CC
- Naïve, F3-F4, IL28B CT, TT - Experimentado F0-F1
- F3-F4: Telaprevir - Uso de medicamentos com
- Respondedor Nulo: Telaprevir interação com IP
- Contra-Indicação: IFN-Peg,
RBV ou IP
Barbosa AN, 2012