Economic evaluation. Treating genotype 1 chronic hepatitis C with alpha pegylated interferons (2a and 2b) andribavirin : a cost-effectiveness analysis.
Egypt has the highest prevalence of hepatitis C in the world, with an estimated 10-13% of the population testing positive for HCV antibodies. Hepatitis C genotype 4 is the most prevalent in Egypt. There are 6 known genotypes of hepatitis C worldwide. Most people with hepatitis C do not show symptoms, though acute infection can cause fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, and joint pain. Without a vaccine, prevention focuses on not sharing personal items that may transmit blood and receiving properly screened blood transfusions. Complications of chronic hepatitis C include liver scarring, cancer, and failure.
David L. Wyles, M.D., of UCSD, presents "On again, off again... on again? Resistance testing for the management of HCV infection" at AIDS Clinical Rounds
This document provides an overview and update on treatments for Hepatitis C genotype 4. It discusses direct-acting antiviral (DAA) medications including NS3/4A protease inhibitors, NS5A inhibitors, NS5B polymerase inhibitors, and specific medications from each class. It covers dosing, mechanisms of action, drug interactions and side effects for medications like sofosbuvir, simeprevir, daclatasvir, and paritaprevir/ombitasvir. Guidelines from EASL and AASLD are summarized for genotype 4 treatment and special populations like renal impairment, HIV co-infection, and treatment failure.
Case 1 presents a 22-month old boy with weakness, fatigue, failure to thrive and vomiting. He has a history of frequent vomiting and is found to have metabolic alkalosis, hypertension and hypokalemia. His urine chloride is greater than 20Meq/L. He is diagnosed with Liddle syndrome.
Case 2 presents a 6-day old infant with vomiting since birth, refusal to feed and no bowel movements. He is found to have metabolic alkalosis while normotensive and normokalemic. His urine chloride is less than 15Meq/L. He is diagnosed with annular pancreas.
The document discusses approaches to metabolic alkalosis, distinguishing chloride responsive from chloride
Metabolic alkalosis is a condition where the pH of the blood is elevated beyond the normal range due to a higher than normal bicarbonate level. This can be caused by loss of hydrochloric acid through vomiting or diarrhea, or by excessive intake of bicarbonate. The kidneys compensate by retaining bicarbonate, leading to hypokalemia and hypocalcemia. Symptoms include confusion, seizures, and muscle cramps or weakness. The condition is diagnosed based on arterial blood gas values showing elevated pH and bicarbonate levels. Treatment focuses on replacing fluid and electrolyte losses and identifying the underlying cause.
The document discusses the rapidly evolving landscape of direct-acting antiviral (DAA) treatments for hepatitis C virus (HCV) infection. Three key studies demonstrated that all-oral, interferon-free combinations of DAAs achieved high sustained virologic response rates (SVR) of over 90% for various genotypes and patient populations. These include a combination of sofosbuvir and ledipasvir, a triple therapy of ABT-450/r, ABT-267 and ABT-333, and a combination of daclatasvir and asunaprevir. Several DAAs are now approved or in late-stage trials. These new interferon-free regimens have the potential
The document discusses the evolution of hepatitis C virus (HCV) therapy from interferon-based regimens to all-oral, interferon-free direct-acting antiviral (DAA) combinations. Clinical trials demonstrated that combinations of NS5A inhibitors like ledipasvir or daclatasvir with NS5B inhibitors like sofosbuvir achieved high sustained virologic response rates of over 90%, including in difficult-to-treat groups. New DAA combinations including two or three-drug regimens from AbbVie, Gilead, and BMS were shown to cure HCV in the majority of patients with 8-12 weeks of therapy. While these new therapies represent significant advances, challenges remain
Egypt has the highest prevalence of hepatitis C in the world, with an estimated 10-13% of the population testing positive for HCV antibodies. Hepatitis C genotype 4 is the most prevalent in Egypt. There are 6 known genotypes of hepatitis C worldwide. Most people with hepatitis C do not show symptoms, though acute infection can cause fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, and joint pain. Without a vaccine, prevention focuses on not sharing personal items that may transmit blood and receiving properly screened blood transfusions. Complications of chronic hepatitis C include liver scarring, cancer, and failure.
David L. Wyles, M.D., of UCSD, presents "On again, off again... on again? Resistance testing for the management of HCV infection" at AIDS Clinical Rounds
This document provides an overview and update on treatments for Hepatitis C genotype 4. It discusses direct-acting antiviral (DAA) medications including NS3/4A protease inhibitors, NS5A inhibitors, NS5B polymerase inhibitors, and specific medications from each class. It covers dosing, mechanisms of action, drug interactions and side effects for medications like sofosbuvir, simeprevir, daclatasvir, and paritaprevir/ombitasvir. Guidelines from EASL and AASLD are summarized for genotype 4 treatment and special populations like renal impairment, HIV co-infection, and treatment failure.
Case 1 presents a 22-month old boy with weakness, fatigue, failure to thrive and vomiting. He has a history of frequent vomiting and is found to have metabolic alkalosis, hypertension and hypokalemia. His urine chloride is greater than 20Meq/L. He is diagnosed with Liddle syndrome.
Case 2 presents a 6-day old infant with vomiting since birth, refusal to feed and no bowel movements. He is found to have metabolic alkalosis while normotensive and normokalemic. His urine chloride is less than 15Meq/L. He is diagnosed with annular pancreas.
The document discusses approaches to metabolic alkalosis, distinguishing chloride responsive from chloride
Metabolic alkalosis is a condition where the pH of the blood is elevated beyond the normal range due to a higher than normal bicarbonate level. This can be caused by loss of hydrochloric acid through vomiting or diarrhea, or by excessive intake of bicarbonate. The kidneys compensate by retaining bicarbonate, leading to hypokalemia and hypocalcemia. Symptoms include confusion, seizures, and muscle cramps or weakness. The condition is diagnosed based on arterial blood gas values showing elevated pH and bicarbonate levels. Treatment focuses on replacing fluid and electrolyte losses and identifying the underlying cause.
The document discusses the rapidly evolving landscape of direct-acting antiviral (DAA) treatments for hepatitis C virus (HCV) infection. Three key studies demonstrated that all-oral, interferon-free combinations of DAAs achieved high sustained virologic response rates (SVR) of over 90% for various genotypes and patient populations. These include a combination of sofosbuvir and ledipasvir, a triple therapy of ABT-450/r, ABT-267 and ABT-333, and a combination of daclatasvir and asunaprevir. Several DAAs are now approved or in late-stage trials. These new interferon-free regimens have the potential
The document discusses the evolution of hepatitis C virus (HCV) therapy from interferon-based regimens to all-oral, interferon-free direct-acting antiviral (DAA) combinations. Clinical trials demonstrated that combinations of NS5A inhibitors like ledipasvir or daclatasvir with NS5B inhibitors like sofosbuvir achieved high sustained virologic response rates of over 90%, including in difficult-to-treat groups. New DAA combinations including two or three-drug regimens from AbbVie, Gilead, and BMS were shown to cure HCV in the majority of patients with 8-12 weeks of therapy. While these new therapies represent significant advances, challenges remain
NEOADJUVANT THERAPY IN PANCREATIC CANCER.pptxSujan Shrestha
1) Several studies provide evidence supporting the use of neoadjuvant therapy for resectable pancreatic cancer. The PREOPANC-1 trial found no survival benefit for neoadjuvant chemoradiotherapy compared to upfront surgery in resectable pancreatic cancer. However, the Prep-02/JSAP-05 and PACT-15 trials found significantly improved survival with neoadjuvant chemotherapy compared to upfront surgery.
2) Guidelines such as ESMO and NCCN provide classifications for resectability and recommend considering neoadjuvant therapy for resectable pancreatic cancer with certain high-risk features or comorbidities.
3) Potential advantages of neoadjuvant therapy include managing micro
Report Back from San Antonio Breast Cancer Symposium: Spotlight on MBCbkling
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Integration of pharmacokinetics (PK)-pharmacodynamics (PD) data to predict th...Ahmed Ali
1. The document discusses using a PK/PD approach to predict the efficacy of repurposed antiviral drugs for COVID-19. It analyzes drugs like lopinavir/ritonavir, remdesivir, favipiravir, and hydroxychloroquine.
2. For lopinavir/ritonavir, the high protein binding restricts achievement of therapeutic drug levels in the lungs. Clinical trials showed a lack of efficacy.
3. For remdesivir, the prodrug is converted to a nucleoside metabolite with low levels in the lungs. While initial trials showed clinical improvement, more data is still needed.
Maile Young Karris, MD
Associate Professor
Co-Director San Diego Center for AIDS Research Clinical Investigations Core
Divisions of Infectious Diseases & Global Public Health and Geriatrics & Gerontology
Department of Medicine
University of California San Diego
The study found that Ivermectin, an FDA-approved anti-parasitic drug, is able to inhibit the replication of SARS-CoV-2, the virus that causes COVID-19, in vitro. A single dose of Ivermectin resulted in a 5000-fold reduction in viral RNA at 48 hours in infected Vero-hSLAM cells. The authors hypothesize that Ivermectin acts by inhibiting the nuclear import of viral proteins through interaction with importin proteins. They conclude that Ivermectin warrants further investigation for potential benefits against COVID-19 in humans.
The study found that Ivermectin, an FDA-approved drug used to treat parasites, inhibited the replication of SARS-CoV-2, the virus that causes COVID-19, in vitro. A single dose of Ivermectin resulted in a 5000-fold reduction in viral RNA at 48 hours in infected cells. The authors hypothesize this is likely through inhibiting the nuclear import of viral proteins. They conclude Ivermectin warrants further investigation for possible benefits in humans and could help limit viral load and prevent severe disease if given early in infection.
The study found that Ivermectin, an FDA-approved anti-parasitic drug, is able to inhibit the replication of SARS-CoV-2, the virus that causes COVID-19, in vitro. A single dose of Ivermectin resulted in a ~5000-fold reduction in viral RNA at 48 hours when added to infected cells. Ivermectin is believed to work by inhibiting the nuclear import of viral proteins through interaction with importin proteins. The study suggests Ivermectin warrants further investigation for potential benefits against COVID-19 in humans.
Prediction of efficacy of repurposed antiviral drugs against COVID-19Ahmed Ali
This document discusses using a PK/PD approach to predict the efficacy of repurposed antiviral drugs for COVID-19. The objectives are to integrate PK and PD data to predict efficacy in clinical settings and validate hypotheses. The document analyzes several drugs including lopinavir/ritonavir, remdesivir, favipiravir and hydroxychloroquine. For each drug, it summarizes PK parameters, in vitro efficacy data, and clinical trial results. It predicts that most drugs like lopinavir/ritonavir are unlikely to achieve therapeutic levels in the lungs due to high protein binding and short half-lives. The document concludes that a PK/PD approach is an effective tool to predict efficacy
1) The document describes the synthesis and antiproliferative effects of novel berberine derivatives in HER2+ breast cancer cells. Berberine shows anticancer activity but the authors developed derivatives to improve properties.
2) Compounds NAX012, NAX013, NAX014, and NAX035 showed stronger antiproliferative effects than berberine against HER2+ breast cancer cells. NAX014 in particular had the most potent effects.
3) In a mouse model of HER2+ breast cancer, oral and injected administration of NAX014 delayed tumor onset and progression at well-tolerated doses, and also reduced lung metastases. NAX014 shows promise as an anticancer agent
Immunotherapy maintenence for advanced urothelial cancerChandan K Das
- JAVELIN Bladder 100 was a phase 3 trial investigating avelumab maintenance therapy after platinum-based chemotherapy in patients with advanced urothelial carcinoma.
- The trial found avelumab maintenance significantly improved overall survival compared to best supportive care alone, with a 31% reduction in risk of death. Progression-free survival was also significantly improved.
- Subgroup analyses found overall survival benefits were consistent across all patient subgroups, including those with PD-L1-negative tumors. Response rates were also higher with avelumab maintenance.
- The safety profile of avelumab was manageable, with most treatment-related adverse events being grade 1-2 in severity and no new safety signals
Discovery of BMS-955176, a Second Generation HIV‑1 Maturation Inhibitor with ...Ira Dicker
This document summarizes the discovery of BMS-955176, a second generation HIV maturation inhibitor. Maturation inhibitors prevent HIV replication by blocking the final cleavage of the viral polyprotein, but the first generation drug bevirimat had limited effectiveness due to polymorphisms. BMS-955176 was designed to maintain activity against polymorphisms like V370A while improving oral exposure. A series of analogs led to BMS-955176, which has potent and broad activity against wild-type and polymorphic viruses and good oral exposure in rats. BMS-955176 is currently in Phase II clinical trials.
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,
KIN-219 shows promise for treating oral mucositis and inflammatory bowel disease. In animal studies, KIN-219, a small molecule mimetic of antimicrobial peptides, reduced severe oral mucositis by over 90% and reduced severity of colitis. Kinnear Pharmaceuticals is developing KIN-219 as a rinse for oral mucositis and as a drug for IBD, with plans to conduct preclinical and clinical trials over the next 3 years. If successful, KIN-219 could generate over $500 million annually in sales and help address significant unmet needs in oncology supportive care and gastrointestinal diseases.
The document discusses management options for hepatitis C virus (HCV) patients who do not respond to standard antiviral therapy. It describes trials showing that retreatment of nonresponders with pegylated interferon and ribavirin can achieve sustained virologic response rates of 12-30%. Maintenance interferon therapy may prevent liver fibrosis progression in histologic responders. New immunotherapies and directly acting antiviral agents currently in clinical trials offer additional treatment options for nonresponders.
Management strategies in inflammatory bowel disease. https://youtu.be/ZVtMSTH...Yasser Abdel-Halim
https://youtu.be/ZVtMSTHb-JM
Modern strategies used in IBD (inflammatory bowel disease), (Crohn's disease & ulcerative colitis) with the most recent data from Network Meta-Analysis & AGA guidelines. We have one goal. Which is to block the structural bowel damage progression before it becomes irreversible, with the least possible side effects. & We have three clinical objectives, Early Remission, Maintaining Remission, De-escalation when Longstanding Remission. & To achieve objectives, we have four strategies. Early effective therapy for high-risk patient strategy, Treat to Target strategy, Tight Control strategy & Exit Strategy.
The document summarizes research on the efficacy of the Circovac vaccine in controlling PCVD (Porcine Circovirus Disease) under field conditions in Brazil. Two trials were conducted involving 1200 piglets total across two farms. Piglets vaccinated with Circovac at weaning showed lower wasting and mortality rates compared to non-vaccinated piglets. Vaccinated piglets also exhibited increased daily weight gain and improved feed conversion. Post-mortem examination found vaccinated piglets had significantly fewer lung lesions. The research concluded that Circovac vaccination of weaned piglets can effectively control PCVD and improve productivity on farms in Brazil.
Economic evaluation, reimbursement and context. How to assess personalised me...HTAi Bilbao 2012
Developed a national framework for Australia to assess personalised medicines for reimbursement decisions. The framework provides:
1) Guidelines for evaluating the analytical validity, clinical validity and clinical utility of pharmacogenetic/genomic tests.
2) A methodological framework and 79-item checklist to assess biomarker/test/drug packages based on evidence of treatment effect modification, prognostic impact and cost-effectiveness.
3) A decision framework to inform reimbursement of tests and drugs based on 4 scenarios of cost-effectiveness with and without considering biomarker status.
Transitional Care for Pediatric Patients with Neuromuscular Diseases: A Healt...HTAi Bilbao 2012
Transitional Care for Pediatric Patients with Neuromuscular Diseases: A Health Technology Assessment
Jackie Tran, MD
University of Medicine and Dentistry of New Jersey, USA
HTAi 9th Annual Meeting, Bilbao
Integrated Care for a Patient Centered System
25 June, 2012
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2. For lopinavir/ritonavir, the high protein binding restricts achievement of therapeutic drug levels in the lungs. Clinical trials showed a lack of efficacy.
3. For remdesivir, the prodrug is converted to a nucleoside metabolite with low levels in the lungs. While initial trials showed clinical improvement, more data is still needed.
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Co-Director San Diego Center for AIDS Research Clinical Investigations Core
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Department of Medicine
University of California San Diego
The study found that Ivermectin, an FDA-approved anti-parasitic drug, is able to inhibit the replication of SARS-CoV-2, the virus that causes COVID-19, in vitro. A single dose of Ivermectin resulted in a 5000-fold reduction in viral RNA at 48 hours in infected Vero-hSLAM cells. The authors hypothesize that Ivermectin acts by inhibiting the nuclear import of viral proteins through interaction with importin proteins. They conclude that Ivermectin warrants further investigation for potential benefits against COVID-19 in humans.
The study found that Ivermectin, an FDA-approved drug used to treat parasites, inhibited the replication of SARS-CoV-2, the virus that causes COVID-19, in vitro. A single dose of Ivermectin resulted in a 5000-fold reduction in viral RNA at 48 hours in infected cells. The authors hypothesize this is likely through inhibiting the nuclear import of viral proteins. They conclude Ivermectin warrants further investigation for possible benefits in humans and could help limit viral load and prevent severe disease if given early in infection.
The study found that Ivermectin, an FDA-approved anti-parasitic drug, is able to inhibit the replication of SARS-CoV-2, the virus that causes COVID-19, in vitro. A single dose of Ivermectin resulted in a ~5000-fold reduction in viral RNA at 48 hours when added to infected cells. Ivermectin is believed to work by inhibiting the nuclear import of viral proteins through interaction with importin proteins. The study suggests Ivermectin warrants further investigation for potential benefits against COVID-19 in humans.
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This document discusses using a PK/PD approach to predict the efficacy of repurposed antiviral drugs for COVID-19. The objectives are to integrate PK and PD data to predict efficacy in clinical settings and validate hypotheses. The document analyzes several drugs including lopinavir/ritonavir, remdesivir, favipiravir and hydroxychloroquine. For each drug, it summarizes PK parameters, in vitro efficacy data, and clinical trial results. It predicts that most drugs like lopinavir/ritonavir are unlikely to achieve therapeutic levels in the lungs due to high protein binding and short half-lives. The document concludes that a PK/PD approach is an effective tool to predict efficacy
1) The document describes the synthesis and antiproliferative effects of novel berberine derivatives in HER2+ breast cancer cells. Berberine shows anticancer activity but the authors developed derivatives to improve properties.
2) Compounds NAX012, NAX013, NAX014, and NAX035 showed stronger antiproliferative effects than berberine against HER2+ breast cancer cells. NAX014 in particular had the most potent effects.
3) In a mouse model of HER2+ breast cancer, oral and injected administration of NAX014 delayed tumor onset and progression at well-tolerated doses, and also reduced lung metastases. NAX014 shows promise as an anticancer agent
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- JAVELIN Bladder 100 was a phase 3 trial investigating avelumab maintenance therapy after platinum-based chemotherapy in patients with advanced urothelial carcinoma.
- The trial found avelumab maintenance significantly improved overall survival compared to best supportive care alone, with a 31% reduction in risk of death. Progression-free survival was also significantly improved.
- Subgroup analyses found overall survival benefits were consistent across all patient subgroups, including those with PD-L1-negative tumors. Response rates were also higher with avelumab maintenance.
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This document summarizes the discovery of BMS-955176, a second generation HIV maturation inhibitor. Maturation inhibitors prevent HIV replication by blocking the final cleavage of the viral polyprotein, but the first generation drug bevirimat had limited effectiveness due to polymorphisms. BMS-955176 was designed to maintain activity against polymorphisms like V370A while improving oral exposure. A series of analogs led to BMS-955176, which has potent and broad activity against wild-type and polymorphic viruses and good oral exposure in rats. BMS-955176 is currently in Phase II clinical trials.
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,
KIN-219 shows promise for treating oral mucositis and inflammatory bowel disease. In animal studies, KIN-219, a small molecule mimetic of antimicrobial peptides, reduced severe oral mucositis by over 90% and reduced severity of colitis. Kinnear Pharmaceuticals is developing KIN-219 as a rinse for oral mucositis and as a drug for IBD, with plans to conduct preclinical and clinical trials over the next 3 years. If successful, KIN-219 could generate over $500 million annually in sales and help address significant unmet needs in oncology supportive care and gastrointestinal diseases.
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The document summarizes research on the efficacy of the Circovac vaccine in controlling PCVD (Porcine Circovirus Disease) under field conditions in Brazil. Two trials were conducted involving 1200 piglets total across two farms. Piglets vaccinated with Circovac at weaning showed lower wasting and mortality rates compared to non-vaccinated piglets. Vaccinated piglets also exhibited increased daily weight gain and improved feed conversion. Post-mortem examination found vaccinated piglets had significantly fewer lung lesions. The research concluded that Circovac vaccination of weaned piglets can effectively control PCVD and improve productivity on farms in Brazil.
Economic evaluation, reimbursement and context. How to assess personalised me...HTAi Bilbao 2012
Developed a national framework for Australia to assess personalised medicines for reimbursement decisions. The framework provides:
1) Guidelines for evaluating the analytical validity, clinical validity and clinical utility of pharmacogenetic/genomic tests.
2) A methodological framework and 79-item checklist to assess biomarker/test/drug packages based on evidence of treatment effect modification, prognostic impact and cost-effectiveness.
3) A decision framework to inform reimbursement of tests and drugs based on 4 scenarios of cost-effectiveness with and without considering biomarker status.
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2 Faculty of Nursing Sciences, Université Laval, Québec, Canada.
3 Research Centre of the Centre Hospitalier Universitaire de Québec, Québec, Canada.
4 Direction of Knowledge Management and Evaluation, Department of Health and Consumer Affairs, Basque Government, Vitoria-Gasteiz, Spain.
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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.
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We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
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Economic evaluation. Treating genotype 1 chronic hepatitis C with alpha pegylated interferons (2a and 2b) andribavirin : a cost-effectiveness analysis.
1. Universidade Federal Fluminense Universidade do Estado do Rio de Janeiro
Instituto de Medicina Social Instituto de Medicina Social
Departamento de Saúde e Sociedade Programa de Estudos em Avaliação de
Tecnologias e Economia da Saúde
Gabriela Bittencourt Gonzalez Mosegui, Cid Manso de Mello Vianna,
Marcus Paulo da Silva Rodrigues, Renata de Mello Perez
2. HEPATITIS C INFECTION IN BRAZIL
PHARMACOLOGICAL TREATMENTS
BRAZIL´S REALITY
3. TO ANALYSIS THE COST-EFFECTIVENESS AND
BUDGET IMPACT OF RECOMMENDED
TREATMENTS FOR ADULTS INFECTED WITH
GENOTYPE 1 CRONIC HEPATITIS C, BASED ON A
COMPARISON OF ALPHA PEGUINTERFERON
COMBINED THERAPY-ASSOCIATED 2A AND 2B AND
RIBAVIRIN WITH NON-TREATMENT
4. A MARKOV MODEL
PUBLIC HEALTH SYSTEM (SUS) PERSPECTIVE
DUAL THERAPY WITH 2A ALPHA PEGUINTERFERON
VS, 2B ALPHA PEGUINTERFERON (BOTH WITH
RIBAVIRIN)
DATA
MEASURES OF EFFECTIVENESS
5. Table 1 - Effectiveness of treatment for HCV with 2a alpha peguinterferon +
ribavirin and 2b alpha peguinterferon + ribavirin
2a Alpha 2b Alpha
peginterferon + peguinterferon +
ribavirin ribavirin
Sustained viral response 0,49 0,48
(SVR)
Early viral response 0,81 0,76
(EVR)
Probability of reaching 0,6049 0,6315
SVR
Source: Malone et al, 2005.
ASSUMPTIONS
UTILITY MEASURES
6. Cost-effectiveness
Table 2 - Years of life gained according to the treatment strategies
2a Alpha 2b Alpha
Natural
Effectiveness peguinterferon peguinterferon +
History
+ ribavirin ribavirin
QUALY (5%
12,19 13,86 13,82
discount)
QUALY
(without 20,70 24,74 24,64
discount)
QUALY (10%
8,37 9,20 9,18
discount)
Costs in US dollars and effectiveness in QALYs
7. Table 3 - Cost-effectiveness of strategies for hepatitis C treatment for
a 1,000 patients for 30 year cohort
Incr
Strategy Costs Incr Costs Effectiv C/E (ICER)
Effectiv
Natural History 3,245.73 12.19 266.26
2a alpha PegInter
21,933.69 18,687.96 13.86 1.68 1,582.52 11,123.79
+ Ribavirin
2b alpha Peginter
26,752.20 4,818.51 13.82 0.04 1,935.76 (Dominated)
+ Ribavirin
All options related to the Natural History
Natural History 3,245.73 12.19 266.26
2a alpha PegInter
21,933.69 18,687.96 13.86 1.68 13,055.77 11,123.79
+ Ribavirin
2b alpha Peginter
26,752.20 23,506.47 13.82 1.63 1,935.76 14,421.15
+ Ribavirin
Costs in US dollars and effectiveness in QALYs
Quotation in 05/01/2012
8. AS THERE WERE NO SIGNIFICANT DIFFERENCES
BETWEEN THE EFFECTIVENESS OF THE TWO
ALPHA PEGUINTERFERONS
THE CHOICE BETWEEN ONE OR
ANOTHER MEDICINE DEPENDS ON THE PRICE
BEING CHARGED
SENSITIVITY ANALYSIS HAS
SHOWN THAT USING THE PRICE OF A DRUG IN THE
OTHER, IT IMPLIES A CHANGE IN THE
CONCLUSIONS ALREADY REACHED BEFORE
9. LIMITATIONS
THE RECOMMENDATION OF THE STUDY IS THAT
THE CHOICE COST-EFFECTIVE USE OF ALPHA
PEGUINTERFERON 2A OR 2B DEPENDS ON THE
PRICE YOU CAN GET IN THE ACQUISITION OF EACH
OF THESE DRUGS.
10. CONSELHO NACIONAL DE DESENVOLVIMENTO
CIENTÍFICO E TECNOLÓGICO – CNPq
UNIVERSIDADE FEDERAL FLUMINENSE
UNIVERSIDADE DO ESTADO DO RIO DE JANEIRO
PROGRAMA DE ESTUDOS EM AVALIAÇÃO DE
TECNOLOGIAS E ECONOMIA DA SAÚDE