Robert S. Brown, Jr., MD, MPH, reviews data on the efficacy and safety of the various approved anti-HBV agents in patients with decompensated cirrhosis.
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
Join expert faculty members Joseph J. Eron, Jr., MD, and Kimberly Y. Smith, MD, MPH, for a review of the HIV highlights of this important annual conference.
PrEP and My Patients: Guidance for LGBT Community–Based Primary Care Provider...Clinical Care Options
Expert faculty Jared Baeten, MD, PhD; Susan Buchbinder, MD; Connie L. Celum, MD, MPH; and Albert Liu, MD, MPH review emerging data on pre-exposure prophylaxis and antiretroviral therapy as prevention and discuss implications for community providers.
Advances in Preventing HIV Transmission Using Antiretroviral Therapy: The Rol...Clinical Care Options
Advances in Preventing HIV Transmission Using Antiretroviral Therapy
This presentation reviewed current strategies for preventing mother-to-child transmission of HIV using antiretroviral therapy. It discussed initiating lifelong antiretroviral treatment for all HIV-infected pregnant women to achieve viral suppression and prevent transmission. Some remaining challenges include late diagnosis, treatment interruptions, and unclear guidance around continuing antiretrovirals postpartum. New concepts like pre-exposure prophylaxis may further reduce transmission between serodiscordant couples.
Managing cirrhotic HCV patients. Whom to treat, how to treat.2014Hivlife Info
Marc Bourlière, MD and Graham R. Foster, FRCP, PhD presented on managing cirrhotic HCV patients. They discussed which cirrhotic patients should be treated, how to treat them, and ensuring informed decision making. Patients with Child-Pugh A cirrhosis should be strongly advised to undergo therapy, while more advanced cases require careful consideration. New direct-acting antiviral regimens have increased sustained virologic response rates in cirrhotic patients, but they still face higher risks of side effects and disease progression if treatment is delayed. Physicians must fully inform patients of risks from both immediate treatment and deferring treatment to facilitate shared decision making.
New Data on Resistance to DAAs and Implications for Therapy.2015hivlifeinfo
This document provides an overview of a presentation on new data regarding resistance to direct-acting antivirals (DAAs) and implications for HCV therapy. It includes the faculty list and their disclosures, as well as slides summarizing recent studies on DAA resistance variants, their impact on treatment outcomes, and persistence after treatment failure. Key findings discussed are the role of NS3 Q80K testing prior to simeprevir + sofosbuvir in genotype 1a patients, effectiveness of DAA regimens against prior protease inhibitor resistance, and durability of NS5A resistance variants.
This document summarizes a presentation on non-invasive methods for evaluating liver disease severity and prognosis, focusing on measurement of liver stiffness. It discusses two main complementary approaches: biomarkers and physical measurements. For physical measurements, transient elastography (FibroScan) and acoustic radiation force impulse imaging (ARFI) are presented. While transient elastography is well validated and recommended, its applicability is limited in 20% of cases by obesity, operator experience, and other technical factors. The XL probe improves applicability in obese patients but appropriate cut-offs need validation. Food intake and other clinical factors can impact liver stiffness measurements. Reliable interpretation requires considering pre-test probability, confidence intervals, and contextual clinical factors. ARFI
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
Join expert faculty members Joseph J. Eron, Jr., MD, and Kimberly Y. Smith, MD, MPH, for a review of the HIV highlights of this important annual conference.
PrEP and My Patients: Guidance for LGBT Community–Based Primary Care Provider...Clinical Care Options
Expert faculty Jared Baeten, MD, PhD; Susan Buchbinder, MD; Connie L. Celum, MD, MPH; and Albert Liu, MD, MPH review emerging data on pre-exposure prophylaxis and antiretroviral therapy as prevention and discuss implications for community providers.
Advances in Preventing HIV Transmission Using Antiretroviral Therapy: The Rol...Clinical Care Options
Advances in Preventing HIV Transmission Using Antiretroviral Therapy
This presentation reviewed current strategies for preventing mother-to-child transmission of HIV using antiretroviral therapy. It discussed initiating lifelong antiretroviral treatment for all HIV-infected pregnant women to achieve viral suppression and prevent transmission. Some remaining challenges include late diagnosis, treatment interruptions, and unclear guidance around continuing antiretrovirals postpartum. New concepts like pre-exposure prophylaxis may further reduce transmission between serodiscordant couples.
Managing cirrhotic HCV patients. Whom to treat, how to treat.2014Hivlife Info
Marc Bourlière, MD and Graham R. Foster, FRCP, PhD presented on managing cirrhotic HCV patients. They discussed which cirrhotic patients should be treated, how to treat them, and ensuring informed decision making. Patients with Child-Pugh A cirrhosis should be strongly advised to undergo therapy, while more advanced cases require careful consideration. New direct-acting antiviral regimens have increased sustained virologic response rates in cirrhotic patients, but they still face higher risks of side effects and disease progression if treatment is delayed. Physicians must fully inform patients of risks from both immediate treatment and deferring treatment to facilitate shared decision making.
New Data on Resistance to DAAs and Implications for Therapy.2015hivlifeinfo
This document provides an overview of a presentation on new data regarding resistance to direct-acting antivirals (DAAs) and implications for HCV therapy. It includes the faculty list and their disclosures, as well as slides summarizing recent studies on DAA resistance variants, their impact on treatment outcomes, and persistence after treatment failure. Key findings discussed are the role of NS3 Q80K testing prior to simeprevir + sofosbuvir in genotype 1a patients, effectiveness of DAA regimens against prior protease inhibitor resistance, and durability of NS5A resistance variants.
This document summarizes a presentation on non-invasive methods for evaluating liver disease severity and prognosis, focusing on measurement of liver stiffness. It discusses two main complementary approaches: biomarkers and physical measurements. For physical measurements, transient elastography (FibroScan) and acoustic radiation force impulse imaging (ARFI) are presented. While transient elastography is well validated and recommended, its applicability is limited in 20% of cases by obesity, operator experience, and other technical factors. The XL probe improves applicability in obese patients but appropriate cut-offs need validation. Food intake and other clinical factors can impact liver stiffness measurements. Reliable interpretation requires considering pre-test probability, confidence intervals, and contextual clinical factors. ARFI
The document discusses hepatitis B, including its epidemiology, transmission, clinical presentations, natural history, and virology. Some key points:
- Hepatitis B is endemic in many parts of Asia and Africa, with transmission primarily vertical or sexual.
- Acute hepatitis B often resolves on its own but can lead to chronic infection in 5-10% of cases.
- Chronic hepatitis B can take forms associated with wild type virus or pre-core mutants, and may progress to cirrhosis or liver cancer over decades.
- The virus replicates via an RNA intermediate and reverse transcription, forming cccDNA in the nucleus that maintains infection.
This document summarizes treatment options and long-term benefits for hepatitis B. It discusses phases of infection and treatment guidelines. Several nucleoside and nucleotide analog drugs are approved to treat chronic hepatitis B by suppressing viral replication. Long-term studies show high rates of viral suppression are maintained for years with entecavir and tenofovir, which have high genetic barriers to resistance. Tenofovir remains effective in patients previously treated with other drugs.
Современное лечение ВИЧ: новые парадигмы в АРТ / Contemporary Management of H...hivlifeinfo
Набор слайдов c рассмотрением важных вопросов об АРТ первого ряда, арв-препаратами пролонгированного действия и схемами АРТ с двумя препаратами, акцент в публикации на роль новых стратегий.
Clinical Impact of New Data From AASLD 2015hivlifeinfo
In this downloadable slideset, David R. Nelson, MD, and Norah Terrault, MD, MPH, review key HCV studies presented at the 2015 Annual Meeting of the European Association for the Study of the Liver.
Format: Microsoft PowerPoint (.ppt)
File size: 2.19 MB
Date posted: 12/2/2015
АРТ в 2016-2017 гг: неизменная потребность в индивидуализации лечения для улу...hivlifeinfo
PB has several considerations for her antiretroviral regimen:
- She wants a single tablet regimen
- Her CD4+ count and viral load make her a good candidate for most regimens
- She has HCV genotype 1a infection
- She takes lovastatin for hyperlipidemia
The best regimen for PB would be:
- DTG/ABC/3TC as it is recommended for most patients, has few drug interactions, and does not interact with lovastatin.
Close monitoring of her liver function would be needed if she initiates HCV treatment in the future while on an antiretroviral regimen.
Современное лечение ВИЧ.Усилить или не усилить : преимущества и недостатки бу...hivlifeinfo
Современное лечение ВИЧ.Усилить или не усилить : преимущества и недостатки бустированных режимов АРТ / Contemporary Management of HIV.To Boost or Not to Boost-Advantages and Disadvantages of Boosted ART.2017
In this downloadable slideset, Eric S. Daar, MD, and Program Director Joseph J. Eron, Jr., MD, review advantages and disadvantages of boosted ART regimens for managing patients with HIV.
Format: Microsoft PowerPoint (.ppt)
File size: 514 KB
Date posted: 6/16/2017
Clinical Impact of New HIV Data From CROI 2019hivlifeinfo
March 4-7, 2019; Seattle, Washington
In this downloadable slideset, expert faculty members summarize key studies from this important annual conference.
Format: Microsoft PowerPoint (.ppt)
File Size: 576 KB
Released: March 22, 2019
This document discusses contemporary management of HIV with a focus on individualizing first-line antiretroviral therapy (ART). It provides an overview of recommended first-line ART regimens including integrase strand transfer inhibitors (INSTIs), discusses clinical trial data comparing different INSTI and protease inhibitor options, and considers factors in choosing among available single-tablet regimen options. It also addresses the potential roles of newer non-nucleoside reverse transcriptase inhibitors and tenofovir alafenamide versus tenofovir disoproxil fumarate in first-line ART.
Key Slides on ART for HIV : Evolving Concepts and Innovative Strategies.2020hivlifeinfo
Expert-authored slides on evolving ART concepts, including simplification to 2-drug therapy, ART safety during pregnancy, weight gain, and long-acting injectable ART.
File Size: 580 KB
Released: October 20, 2020
In this downloadable slideset, expert faculty members Andrew Carr, MBBS, MD, FRACP, FRCPA; Daniel R. Kuritzkes, MD; and Ian M. Sanne, MBBCH, FCP(SA), review key studies presented at the 2016 International AIDS Conference.
Format: Microsoft PowerPoint (.ppt)
File size: 1.28 MB
Date posted: 8/5/2016
Choosing Among Current Antiretroviral Regimens.The Relevance of Drug–Drug Int...hivlifeinfo
In this downloadable slideset, Jürgen K. Rockstroh, MD, reviews how selection of antiretroviral therapy is influenced by drug–drug interactions and differing antiretroviral genetic barriers to resistance.
Format: Microsoft PowerPoint (.ppt)
File size: 1.17 MB
Date posted: 11/4/2016
Современное лечение ВИЧ: лечение многократно леченных пациентов с резистентно...hivlifeinfo
This document discusses management of HIV in heavily treatment-experienced patients with multiclass resistance and limited treatment options. It provides an overview of the problem, including that some older patients were treated early in the HIV epidemic with less potent regimens, resulting in resistance. Younger patients may have congenital HIV and been treated long-term. Assessment of virologic failure and resistance testing are important to select an effective new regimen. Current options for active drugs in these patients include maraviroc, ibalizumab, fostemsavir, and enfuvirtide, which have novel mechanisms of action. Adherence assessment is also critical to determine if the current regimen may still be effective if taken as prescribed.
Ключевые слайды по индивидуальному выбору АРТ / Key Slides on Individualized ...hivlifeinfo
Слайды с последними данные и рекомендациями по выбору АРТ, как для пациентов, ранее не получавших лечения, так и пациентов с вирусологической супрессией. Оценки разных вариантов лечения, индивидуализация АРТ для женщин детородного возраста и во время беременности, пациентов с опортунистическими инфекциями и новые данные об исследовательских стратегиях АРТ.
FLAIR: Switch to Long-Acting CAB + RPV Following Oral Induction in ART-Naive ...hivlifeinfo
March 4-7, 2019; Seattle, Washington
Higher patient-reported satisfaction with monthly injectable dual regimen compared with daily oral tablets.
Released: March 11, 2019
The Role of New HCV Agents in Managing HIV/HCV Coinfection.2014Hivlife Info
This document summarizes a presentation on new agents for treating hepatitis C virus (HCV) infection in patients coinfected with HIV. It discusses FDA-approved regimens containing simeprevir or sofosbuvir, dosing and administration, treatment guidelines from AASLD/IDSA, and clinical trial data on sofosbuvir and simeprevir in HIV/HCV coinfected patients, showing high sustained virologic response rates.
Preventing and managing sexually transmitted diseases in hiv infected patient...Hivlife Info
This document provides a summary of a presentation by Dr. Khalil Ghanem on preventing and managing sexually transmitted diseases (STDs) in HIV-infected patients. The presentation objectives are to review components of history and physical exams relevant to STD screening, describe recommended screening approaches for common STDs, and identify treatment regimens. STD screening recommendations are provided for gonorrhea, chlamydia, trichomoniasis, syphilis, and herpes based on risk factors and anatomical sites. Re-screening is advised for certain STDs due to high reinfection rates.
This document summarizes interim analysis results from a randomized phase 3 study of abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer. The study showed a statistically significant improvement in radiographic progression-free survival with a median of not reached for abiraterone acetate versus 8.3 months for placebo. There was also a strong trend towards improved overall survival with a median of not reached for abiraterone acetate versus 27.2 months for placebo and a 25% reduction in risk of death. Benefits were seen across patient subgroups.
Poster Presentation Title: A Phase 1 clinical trial of a therapeutic prostate cancer vaccine containing PSA/IL-2/GM-CSF in PSA defined biochemical recurrent prostate cancer patients
Meeting: CRI-CIMT-EATI-AACR: Inaugural International Cancer Immunotherapy Conference: Translating Science Into Survival
Immunotherapy for cancer has had two main approaches that have lead to clinical applications. The first is stimulating immune responses to tumor cells with cytokines or cellular immunotherapy and the second is blocking tumor immune evasion and the associated inhibition of T-cell activation with antibodies to the CTLA-4 receptor, PD-1 receptor or PD-L1. At OncBioMune, we have taken a different approach and have developed therapeutic cancer vaccines that are a combination of tumor antigens (whole cells or proteins) with biological adjuvants (the cytokines IL-2 and GM-CSF). This study is a Phase 1a/1b clinical trial of a PSA/IL-2/GM-CSF vaccine in recurrent prostate cancer in hormone-naïve and hormone-independent patients. Major inclusion criteria include adenocarcinoma of the prostate, rising serum PSA and no measurable disease. Phase 1a examines the rate of dose limiting adverse events (DLAEs) in an initial course of 6 vaccinations (“induction vaccination”). The Phase 1b examines the rate of DLAEs with a continued coarse of an additional 6 vaccinations (“maintenance vaccine”). All patients will receive intradermal injections of the PSA/IL-2/GM-CSF vaccine at weeks 1, 2, 3, 7, 11, and 15. In an additional 28 patients the six maintenance vaccines will alternate IL-2 and the complete vaccine (PSA/IL-2/GM-CSF) at weeks 23, 27, 31, 35, 39 and 43. To date, twelve of twenty patients in the Phase 1a portion of the trial have received at least one vaccine injection and ten patients have received all 6 vaccines. Seven of the ten patients that have received 3 vaccines had increased responses to PSA in a lymphocyte blastogenesis assay and five of the nine patients had an increase in their response after 6 vaccines. None of the patients vaccinated in the Phase 1a portion have had a DLAE and enrollment continues in the Phase 1a.
1) Hepatitis C virus genotype 4 is predominant in Egypt, with a prevalence of around 9%.
2) New direct-acting antiviral agents have improved treatment outcomes, but the virus's ability to mutate rapidly can lead to resistance.
3) The document provides treatment recommendations and regimens using direct-acting antivirals like sofosbuvir and daclatasvir to treat hepatitis C genotype 4, including for different patient populations and treatment experiences. It establishes guidelines for Egyptian treatment protocols.
Downloadable slides highlighting key concepts in colorectal cancer screening and appropriate therapy selection and application in the adjuvant setting and beyond.
HBV has been associated with humans for over 1,000 years. Recent evidence from a mummified Korean child who tested positive for HBV DNA establishes that HBV has been present in humans for at least 500 years. Treatment guidelines recommend antiviral therapy for patients with chronic HBV based on HBV DNA levels and ALT levels. Tenofovir and entecavir are preferred first-line treatments due to their superior efficacy, tolerability and low resistance profiles. Long-term antiviral therapy can reduce the risk of liver decompensation, hepatocellular carcinoma, and death in patients with chronic HBV.
The document discusses hepatitis B, including its epidemiology, transmission, clinical presentations, natural history, and virology. Some key points:
- Hepatitis B is endemic in many parts of Asia and Africa, with transmission primarily vertical or sexual.
- Acute hepatitis B often resolves on its own but can lead to chronic infection in 5-10% of cases.
- Chronic hepatitis B can take forms associated with wild type virus or pre-core mutants, and may progress to cirrhosis or liver cancer over decades.
- The virus replicates via an RNA intermediate and reverse transcription, forming cccDNA in the nucleus that maintains infection.
This document summarizes treatment options and long-term benefits for hepatitis B. It discusses phases of infection and treatment guidelines. Several nucleoside and nucleotide analog drugs are approved to treat chronic hepatitis B by suppressing viral replication. Long-term studies show high rates of viral suppression are maintained for years with entecavir and tenofovir, which have high genetic barriers to resistance. Tenofovir remains effective in patients previously treated with other drugs.
Современное лечение ВИЧ: новые парадигмы в АРТ / Contemporary Management of H...hivlifeinfo
Набор слайдов c рассмотрением важных вопросов об АРТ первого ряда, арв-препаратами пролонгированного действия и схемами АРТ с двумя препаратами, акцент в публикации на роль новых стратегий.
Clinical Impact of New Data From AASLD 2015hivlifeinfo
In this downloadable slideset, David R. Nelson, MD, and Norah Terrault, MD, MPH, review key HCV studies presented at the 2015 Annual Meeting of the European Association for the Study of the Liver.
Format: Microsoft PowerPoint (.ppt)
File size: 2.19 MB
Date posted: 12/2/2015
АРТ в 2016-2017 гг: неизменная потребность в индивидуализации лечения для улу...hivlifeinfo
PB has several considerations for her antiretroviral regimen:
- She wants a single tablet regimen
- Her CD4+ count and viral load make her a good candidate for most regimens
- She has HCV genotype 1a infection
- She takes lovastatin for hyperlipidemia
The best regimen for PB would be:
- DTG/ABC/3TC as it is recommended for most patients, has few drug interactions, and does not interact with lovastatin.
Close monitoring of her liver function would be needed if she initiates HCV treatment in the future while on an antiretroviral regimen.
Современное лечение ВИЧ.Усилить или не усилить : преимущества и недостатки бу...hivlifeinfo
Современное лечение ВИЧ.Усилить или не усилить : преимущества и недостатки бустированных режимов АРТ / Contemporary Management of HIV.To Boost or Not to Boost-Advantages and Disadvantages of Boosted ART.2017
In this downloadable slideset, Eric S. Daar, MD, and Program Director Joseph J. Eron, Jr., MD, review advantages and disadvantages of boosted ART regimens for managing patients with HIV.
Format: Microsoft PowerPoint (.ppt)
File size: 514 KB
Date posted: 6/16/2017
Clinical Impact of New HIV Data From CROI 2019hivlifeinfo
March 4-7, 2019; Seattle, Washington
In this downloadable slideset, expert faculty members summarize key studies from this important annual conference.
Format: Microsoft PowerPoint (.ppt)
File Size: 576 KB
Released: March 22, 2019
This document discusses contemporary management of HIV with a focus on individualizing first-line antiretroviral therapy (ART). It provides an overview of recommended first-line ART regimens including integrase strand transfer inhibitors (INSTIs), discusses clinical trial data comparing different INSTI and protease inhibitor options, and considers factors in choosing among available single-tablet regimen options. It also addresses the potential roles of newer non-nucleoside reverse transcriptase inhibitors and tenofovir alafenamide versus tenofovir disoproxil fumarate in first-line ART.
Key Slides on ART for HIV : Evolving Concepts and Innovative Strategies.2020hivlifeinfo
Expert-authored slides on evolving ART concepts, including simplification to 2-drug therapy, ART safety during pregnancy, weight gain, and long-acting injectable ART.
File Size: 580 KB
Released: October 20, 2020
In this downloadable slideset, expert faculty members Andrew Carr, MBBS, MD, FRACP, FRCPA; Daniel R. Kuritzkes, MD; and Ian M. Sanne, MBBCH, FCP(SA), review key studies presented at the 2016 International AIDS Conference.
Format: Microsoft PowerPoint (.ppt)
File size: 1.28 MB
Date posted: 8/5/2016
Choosing Among Current Antiretroviral Regimens.The Relevance of Drug–Drug Int...hivlifeinfo
In this downloadable slideset, Jürgen K. Rockstroh, MD, reviews how selection of antiretroviral therapy is influenced by drug–drug interactions and differing antiretroviral genetic barriers to resistance.
Format: Microsoft PowerPoint (.ppt)
File size: 1.17 MB
Date posted: 11/4/2016
Современное лечение ВИЧ: лечение многократно леченных пациентов с резистентно...hivlifeinfo
This document discusses management of HIV in heavily treatment-experienced patients with multiclass resistance and limited treatment options. It provides an overview of the problem, including that some older patients were treated early in the HIV epidemic with less potent regimens, resulting in resistance. Younger patients may have congenital HIV and been treated long-term. Assessment of virologic failure and resistance testing are important to select an effective new regimen. Current options for active drugs in these patients include maraviroc, ibalizumab, fostemsavir, and enfuvirtide, which have novel mechanisms of action. Adherence assessment is also critical to determine if the current regimen may still be effective if taken as prescribed.
Ключевые слайды по индивидуальному выбору АРТ / Key Slides on Individualized ...hivlifeinfo
Слайды с последними данные и рекомендациями по выбору АРТ, как для пациентов, ранее не получавших лечения, так и пациентов с вирусологической супрессией. Оценки разных вариантов лечения, индивидуализация АРТ для женщин детородного возраста и во время беременности, пациентов с опортунистическими инфекциями и новые данные об исследовательских стратегиях АРТ.
FLAIR: Switch to Long-Acting CAB + RPV Following Oral Induction in ART-Naive ...hivlifeinfo
March 4-7, 2019; Seattle, Washington
Higher patient-reported satisfaction with monthly injectable dual regimen compared with daily oral tablets.
Released: March 11, 2019
The Role of New HCV Agents in Managing HIV/HCV Coinfection.2014Hivlife Info
This document summarizes a presentation on new agents for treating hepatitis C virus (HCV) infection in patients coinfected with HIV. It discusses FDA-approved regimens containing simeprevir or sofosbuvir, dosing and administration, treatment guidelines from AASLD/IDSA, and clinical trial data on sofosbuvir and simeprevir in HIV/HCV coinfected patients, showing high sustained virologic response rates.
Preventing and managing sexually transmitted diseases in hiv infected patient...Hivlife Info
This document provides a summary of a presentation by Dr. Khalil Ghanem on preventing and managing sexually transmitted diseases (STDs) in HIV-infected patients. The presentation objectives are to review components of history and physical exams relevant to STD screening, describe recommended screening approaches for common STDs, and identify treatment regimens. STD screening recommendations are provided for gonorrhea, chlamydia, trichomoniasis, syphilis, and herpes based on risk factors and anatomical sites. Re-screening is advised for certain STDs due to high reinfection rates.
This document summarizes interim analysis results from a randomized phase 3 study of abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer. The study showed a statistically significant improvement in radiographic progression-free survival with a median of not reached for abiraterone acetate versus 8.3 months for placebo. There was also a strong trend towards improved overall survival with a median of not reached for abiraterone acetate versus 27.2 months for placebo and a 25% reduction in risk of death. Benefits were seen across patient subgroups.
Poster Presentation Title: A Phase 1 clinical trial of a therapeutic prostate cancer vaccine containing PSA/IL-2/GM-CSF in PSA defined biochemical recurrent prostate cancer patients
Meeting: CRI-CIMT-EATI-AACR: Inaugural International Cancer Immunotherapy Conference: Translating Science Into Survival
Immunotherapy for cancer has had two main approaches that have lead to clinical applications. The first is stimulating immune responses to tumor cells with cytokines or cellular immunotherapy and the second is blocking tumor immune evasion and the associated inhibition of T-cell activation with antibodies to the CTLA-4 receptor, PD-1 receptor or PD-L1. At OncBioMune, we have taken a different approach and have developed therapeutic cancer vaccines that are a combination of tumor antigens (whole cells or proteins) with biological adjuvants (the cytokines IL-2 and GM-CSF). This study is a Phase 1a/1b clinical trial of a PSA/IL-2/GM-CSF vaccine in recurrent prostate cancer in hormone-naïve and hormone-independent patients. Major inclusion criteria include adenocarcinoma of the prostate, rising serum PSA and no measurable disease. Phase 1a examines the rate of dose limiting adverse events (DLAEs) in an initial course of 6 vaccinations (“induction vaccination”). The Phase 1b examines the rate of DLAEs with a continued coarse of an additional 6 vaccinations (“maintenance vaccine”). All patients will receive intradermal injections of the PSA/IL-2/GM-CSF vaccine at weeks 1, 2, 3, 7, 11, and 15. In an additional 28 patients the six maintenance vaccines will alternate IL-2 and the complete vaccine (PSA/IL-2/GM-CSF) at weeks 23, 27, 31, 35, 39 and 43. To date, twelve of twenty patients in the Phase 1a portion of the trial have received at least one vaccine injection and ten patients have received all 6 vaccines. Seven of the ten patients that have received 3 vaccines had increased responses to PSA in a lymphocyte blastogenesis assay and five of the nine patients had an increase in their response after 6 vaccines. None of the patients vaccinated in the Phase 1a portion have had a DLAE and enrollment continues in the Phase 1a.
1) Hepatitis C virus genotype 4 is predominant in Egypt, with a prevalence of around 9%.
2) New direct-acting antiviral agents have improved treatment outcomes, but the virus's ability to mutate rapidly can lead to resistance.
3) The document provides treatment recommendations and regimens using direct-acting antivirals like sofosbuvir and daclatasvir to treat hepatitis C genotype 4, including for different patient populations and treatment experiences. It establishes guidelines for Egyptian treatment protocols.
Downloadable slides highlighting key concepts in colorectal cancer screening and appropriate therapy selection and application in the adjuvant setting and beyond.
HBV has been associated with humans for over 1,000 years. Recent evidence from a mummified Korean child who tested positive for HBV DNA establishes that HBV has been present in humans for at least 500 years. Treatment guidelines recommend antiviral therapy for patients with chronic HBV based on HBV DNA levels and ALT levels. Tenofovir and entecavir are preferred first-line treatments due to their superior efficacy, tolerability and low resistance profiles. Long-term antiviral therapy can reduce the risk of liver decompensation, hepatocellular carcinoma, and death in patients with chronic HBV.
This document discusses antiviral drugs used to treat various DNA and RNA viruses. It provides classifications of viruses based on their genome and structure. It then covers the viral replication cycles and mechanisms of different classes of antiviral drugs, including DNA polymerase inhibitors, mRNA synthesis inhibitors, immunomodulators, viral penetration/uncoating inhibitors, and release inhibitors. Specific antiviral drugs are discussed for treating infections caused by DNA viruses like herpes, hepatitis B, and cytomegalovirus as well as RNA viruses including influenza, hepatitis C, and respiratory syncytial virus. Adverse effects and mechanisms of action are provided for many of the antiviral drugs.
Motivational and Inspirational Quotes for Startups and Small BusinesssesVirtuoso Assistant
It's tough being a start-up or a small business owner. There are times when you feel on top of the world and there are times when you feel like the pits!
I've always found inspirational quotes to be a good way to give myself a kick in the pants and get my 'MoJo' back again.
I hope this collection of some of the best motivational quotes I posted in 2015 are a fun way to give yourself a boost when you're having a tough day.
The document discusses an online printing marketplace called PeoplePRINT that aims to streamline the printing process. It allows buyers to get instant pricing comparisons from multiple accredited printers and place orders online. This reduces the ordering steps from 52 to 7. The marketplace also seeks to utilize excess printer capacity and bring them new business at lower costs. It has already launched its first category website for brochure printing and plans to expand into additional categories. The goal is to capture a share of the A$15 billion commercial printing market in Australia.
This document provides an overview of CNO Financial Group's financial and operating results for the third quarter of 2014. It highlights growth in operating EPS compared to the prior year period. It notes sales results for Bankers Life, Washington National and Colonial Penn segments. Bankers Life sales were down slightly due to weakness in agent recruiting, while the other segments experienced sales growth. The document also summarizes capital levels, liquidity, earnings results and health margins for the quarter.
Mesopotamia, meaning "between two rivers" in Greek, was located between the Tigris and Euphrates Rivers in modern-day Iraq. Around 12,000 years ago, hunter-gatherers began settling in the region and eventually established farming communities due to the rich, fertile soil created by annual flooding. They developed irrigation techniques like canals to control floods and droughts, allowing for reliable agriculture and food surpluses. This led to larger, more complex settlements and the rise of the first cities between 4000-3000 BC, though agriculture remained the primary economic activity.
Reach Your Potential's Third Tech Tuesday Twitter for Business. This presentation provides an overview of Twitter and what it can do for your business, and is filled with over 80 resources.
The document discusses the electrolytic recovery of antimony from a stibnite ore sample from Egypt. It describes analyzing the ore's mineral composition and developing a hydrometallurgical process. The process involves leaching the ore with acids like hydrochloric, nitric, and sulfuric acids. This dissolves the antimony, which is then electrochemically deposited as pure metallic antimony on a cathode. The purity of the deposited antimony was found to be over 99%.
Att bygga ett starkt varumärke i en digital värld. Hur gör man?LOVEATWORK
Content is still king. Halleluja säger vi. Faktum är att innehållet blir viktigare och viktigare i all modern kommunikation – en förutsättning för att bygga ett starkt varumärke. Det gäller att ha något intressant att berätta för att människor ska lyssna. Det gäller att vara sann, äkta och bjuda på oväntad kunskap, helst något som är unikt och sticker ut i bruset. Envägskommunikation som struntar i dialog göre sig icke besvär i dagens medielandskap. Men hur gör man? Vad ska man berätta? Var ska man berätta det? När? Hur? Varför?
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Format: Microsoft PowerPoint (.ppt)
File size: 1.70 MB
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Treatment Selection for HBV-Infected Patients With Decompensated Cirrhosis
1. Treatment Selection for
HBV-Infected Patients With
Decompensated Cirrhosis
Robert S. Brown, Jr., MD, MPH
Frank Cardile Professor of Medicine
Chief, Center for Liver Disease
Columbia University College of Physicians
& Surgeons
NewYork-Presbyterian Hospital
New York, New York
This program is supported by an educational grant from
Originally posted 6/26/20112at clinicaloptions.com/ss/Cirrhosis
2. Treatment Selection for CHB Patients With Decompensated Cirrhosis
clinicaloptions.com/hepatitis
About These Slides
Users are encouraged to use these slides in their own
noncommercial presentations, but we ask that content
and attribution not be changed. Users are asked to honor
this intent
This abbreviated slideset was posted to SlideShare to
publicize the availability of the full slideset. These slides
may not be published or posted online without permission
from CCO (email permissions@clinicaloptions.com)
Disclaimer
The materials published on the Clinical Care Options Web site reflect the views of the authors of the
CCO material, not those of Clinical Care Options, LLC, the CME providers, or the companies providing
educational grants. The materials may discuss uses and dosages for therapeutic products that have not
been approved by the United States Food and Drug Administration. A qualified healthcare professional
should be consulted before using any therapeutic product discussed. Readers should verify all information
and data before treating patients or using any therapies described in these materials.
3. Treatment Selection for CHB Patients With Decompensated Cirrhosis
clinicaloptions.com/hepatitis
Faculty Disclosures
Robert S. Brown, Jr., MD, MPH, has disclosed that he has
received fees for non-CME services from Genentech and
Gilead Sciences.
4. Treatment Selection for CHB Patients With Decompensated Cirrhosis
clinicaloptions.com/hepatitis
Rationale for Treating Patients With
Advanced Liver Disease
Poor prognosis for HBV-infected patients with
decompensated cirrhosis without treatment
– Increased risk of hepatocellular carcinoma and death[1]
– Estimated 5-yr survival rate: 14%[2]
Liver transplant is effective treatment, but ongoing
shortage of donor organs and many patients on waitlists
Antiviral agents able to effectively and safely suppress
HBV replication in this population, leading to improvement
or stabilization of liver function[1]
1. Lok AS, et al. Hepatology. 2009;50:661-662. 2. de Jongh FE, et al. Gastroenterol. 1992;103:1630-
1635.
5. Treatment Selection for CHB Patients With Decompensated Cirrhosis
clinicaloptions.com/hepatitis
Approved Agents for the Treatment of
Chronic HBV Infection
7 agents approved for first-line treatment of chronic HBV infection
– Adefovir, entecavir, interferon alfa-2b, lamivudine, peginterferon alfa-2a,
telbivudine, and tenofovir
3 agents recommended as first-line therapy according to major liver disease
organizations because of their rapid onset of action, low rate of drug
resistance with prolonged use, and generally favorable safety profiles[3,4]
– Entecavir, peginterferon alfa-2a, and tenofovir
Peginterferon contraindicated in patients with decompensated liver disease
because of risk of worsening liver disease and infectious complications[3-5]
Therefore, HBV clinicians must chose between entecavir and tenofovir
for treatment of decompensated cirrhosis
3. Lok AS, et al. Hepatology. 2009;50:661-662. 4. EASL. J Hepatol. 2012;[Epub ahead of print].
5. Buster EH, et al. Hepatology. 2007;46:388-394.
6. Treatment Selection for CHB Patients With Decompensated Cirrhosis
clinicaloptions.com/hepatitis
Tenofovir for Treatment of CHB Patients
With Decompensated Cirrhosis
Tenofovir studied in a limited number of subjects with
CHB-associated decompensated cirrhosis
Currently no formal indication for the use of tenofovir in
patients with decompensated liver disease
Both tenofovir and decompensated liver disease may
affect renal function
– Therefore, the contribution of tenofovir to renal impairment in
this population is difficult to ascertain
Risk of lactic acidosis noted in package insert from
experience with HIV but no data on lactic acidosis with
tenofovir for HBV
Tenofovir [package insert]. January 2012.
7. Treatment Selection for CHB Patients With Decompensated Cirrhosis
clinicaloptions.com/hepatitis
Study 0108: Safety of TDF vs FTC/TDF vs
ETV in CHB Pts With Decomp Cirrhosis
Randomized, double-blind phase II study
Wk 48: interim analysis Wk 168
TDF 300 mg
(n = 45)
HBV-infected pts
with decompensated FTC/TDF 200/300 mg
liver disease* (n = 45)
(N = 112)
ETV 0.5 mg or 1 mg
(n = 22)
*Patients with < 2 log10 copies/mL decrease in HBV DNA at Wk 8, with virologic breakthrough (≥ 1 log 10
copies/mL increase from nadir on 2 consecutive determinations or consecutive HBV DNA ≥ 400
copies/mL after being < 400 copies/mL), or with HBV DNA levels > 400 copies/mL at or after 24 wks of
treatment could begin open-label FTC/TDF; these patients considered failures in efficacy analysis.
Liaw YF, et al. Hepatology. 2011;53:62-72.
8. Treatment Selection for CHB Patients With Decompensated Cirrhosis
clinicaloptions.com/hepatitis
Study 0108: Summary of Coprimary
Safety Endpoints Through Wk 48
Patients, % TDF FTC/TDF ETV
(n = 45) (n = 45) (n = 22)
Tolerability failures* 6.7 4.4 9.1
Confirmed ≥ 0.5 mg/dL increase in creatinine
or confirmed phosphorus < 2.0 mg/dL 8.9† 6.7 4.5
Confirmed ≥ 0.5 mg/dL increase in
creatinine 8.9† 2.2 4.5
Confirmed phosphorus < 2.0 mg/dL 2.2 4.4 0
Confirmed ≥ 0.5 mg/dL increase in
creatinine and confirmed phosphorus 2.2 0 0
< 2.0 mg/dL
*Defined as permanent discontinuation of study drug due to treatment-emergent AE; 6 pts discontinued
due to AE (only 1 due to study drug) and 1 pt temporarily discontinued and did not restart.
†
Includes the only pt reaching a coprimary endpoint after FTC/TDF switch.
Liaw YF, et al. Hepatology. 2011;53:62-72.
9. Treatment Selection for CHB Patients With Decompensated Cirrhosis
clinicaloptions.com/hepatitis
Study 0108: Median Serum Creatinine by
Study Visit
1.0
Median Creatinine (mg/dL)
0.9
0.8
0.7
0.6
0.5
0.4
0.3 0.90 TDF
0.2
0.90 TDF/FTC
0.1
0.80 ETV
0
0 4 8 12 16 20 24 28 32 36 40 44 48
Wks on Study
Pts at Risk, n
TDF 45 45 42 40 39 39 40 38 37 37 38 37 37
FTC/TDF 45 44 43 42 42 42 42 42 42 42 41 42 42
ETV 22 21 19 20 19 18 19 19 19 18 17 16 16
No cases of lactic acidosis reported in any treatment arm
Liaw YF, et al. Hepatology. 2011;53:62-72.
10. Treatment Selection for CHB Patients With Decompensated Cirrhosis
clinicaloptions.com/hepatitis
Study 0108: Efficacy Results at Wk 48
Efficacy Result TDF FTC/TDF ETV
(n = 45) (n = 45) (n = 22)
HBV DNA < 400 copies/mL, % 70.5 87.8 72.7
Median change in MELD score -2.0 -2.0 -2.0
from baseline (IQR) (-12 to 3) (-18 to 4) (-10 to 1)
CTP score ≥ 2 point decrease, % 25.9 48.0 41.7
CTP score ≥ 2 point increase, % 0 2.6 0
Median change in serum ALT from
baseline, U/L -7.0 -16.5 -25.5
HBeAg loss, % 21.4 26.7 0
HBeAg seroconversion, % 21.4 13.3 0
Liaw YF, et al. Hepatology. 2011;53:62-72.
11. Treatment Selection for CHB Patients With Decompensated Cirrhosis
clinicaloptions.com/hepatitis
Entecavir for Treatment of CHB Patients
With Decompensated Cirrhosis
Virologic, biochemical, serologic, and safety data available
from adult subjects with chronic HBV infection and
decompensated liver disease
These data led to an indication for use of entecavir in adult
patients with decompensated liver disease
– Dose should be increased to 1.0 mg/day in patients with
CrCl ≥ 50 mL/min
– Appropriate dose adjustments recommended if CrCl
< 50 mL/min
Patients with decompensated liver disease treated with
entecavir may be at higher risk for lactic acidosis
Entecavir [package insert]. December 2010.
12. Download the full PowerPoint slideset for self-study
or use in your own educational presentations at:
clinicaloptions.com/ss/Cirrhosis
Go Online for More Information on Treatment Selection for CHB
Patients With Decompensated Cirrhosis!
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Editor's Notes
HBV, hepatitis B virus.
HBV, hepatitis B virus. There are several reasons to treat patients with advanced liver disease due to hepatitis B. First, the prognosis for hepatitis B virus (HBV)–infected individuals with decompensated cirrhosis is very poor without treatment. Indeed, there is an increased risk of hepatocellular carcinoma and death in these patients and a low 5‑year survival rate at 14%. Although liver transplantation is an effective treatment, there is a shortage of donor organs and long waiting lists. In addition, patients have better outcomes if they undergo transplantation with an undetectable HBV DNA. Finally, antiviral agents that can effectively and safely suppress the HBV virus may lead to improvement of liver function and removal from the wait list, thereby eliminating the requirement for transplantation.
HBV, hepatitis B virus. There are 7 approved agents for the treatment of chronic hepatitis B, including 2 nucleotides (adefovir and tenofovir), 3 nucleosides (entecavir, lamivudine and telbivudine), and 2 immunomodulatory agents (standard interferon alfa‑2b and peginterferon alfa‑2a). However, because of issues with potency, resistance, and convenience, only 3 agents have been recommended as first‑line therapy by major liver disease organizations; these are the nucleoside entecavir, the nucleotide tenofovir, and peginterferon alfa‑2a. Peginterferon is contraindicated in patients with decompensated liver disease because of worsening of the liver disease, hepatic encephalopathy, and high rates of infection and sepsis. Thus, for patients with decompensated disease, entecavir and tenofovir are the only recommended treatment options. The data on these 2 agents in this population of patients will be reviewed throughout the remainder of this program.
CHB, chronic hepatitis B; HBV, hepatitis B virus. Tenofovir has been studied in a small number of HBV-infected patients with decompensated liver disease, but there is currently no formal indication from the US Food and Drug Administration (FDA) for its use in this setting. Concerns with tenofovir in this population are largely related to its possible impact on renal function. Due to the high rate of renal dysfunction in patients with decompensated cirrhosis and portal hypertension, differentiating renal dysfunction due to the liver disease vs that due to tenofovir is difficult. Finally, there is a risk of lactic acidosis noted in the package insert. However, this is mostly due to data from HIV-infected patients, and there are no data on lactic acidosis with tenofovir when used for HBV.
CHB, chronic hepatitis B; Decomp, decompensated; ETV, entecavir; FTC, emtricitabine; HBV, hepatitis B virus; TDF, tenofovir. Data on the use of tenofovir in HBV-infected patients with decompensated disease have been generated in Study 0108. This double‑blind, phase II study compared tenofovir vs fixed-dose combination tenofovir plus emtricitabine vs entecavir in 112 patients with chronic hepatitis B and hepatic decompensation. Patients will receive treatment until Week 168; interim data are now available at Week 48 of treatment. The coprimary endpoints are tolerability failures, defined as adverse events resulting in permanent treatment discontinuation, and increases in serum creatinine ≥ 0.5 mg/dL above baseline or serum phosphorus values < 2.0 mg/dL. Secondary efficacy endpoints are HBV DNA levels, alanine aminotransferase levels, hepatitis B e antigen (HBeAg)/hepatitis B surface antigen loss and seroconversion, and Child-Turcotte-Pugh (CTP) and Model for End-Stage Liver Disease (MELD) scores.
AE, adverse event; ETV, entecavir; FTC, emtricitabine; TDF, tenofovir. Tolerability failures through Week 48 were similar among treatment arms at 6.7% for the tenofovir arm, 4.4% for the emtricitabine/tenofovir arm, and 9.1% for the entecavir arm. Renal dysfunction, defined as confirmed ≥ 0.5 mg/dL increase in creatinine, occurred in a higher percentage of patients on tenofovir monotherapy vs the other 2 arms (8.9% vs 2.2% vs 4.5% in the tenofovir, emtricitabine/tenofovir, and entecavir arms, respectively), but this did not reach statistical significance. Similarly, there were higher rates of hypophosphatemia in the 2 tenofovir-containing arms at 2.2% for the tenofovir arm, 4.4% for the emtricitabine/tenofovir arm vs 0% for the entecavir arm.
ETV, entecavir; FTC, emtricitabine; TDF, tenofovir. However, a closer examination of the median serum creatinine levels over time in the 3 arms reveals no marked differences between the 2 tenofovir arms vs the entecavir arm, and levels were relatively stable, although it is important to note that virtually all of the patients had normal renal function at study entry. There were no cases of lactic acidosis reported in any treatment arm.
ALT, alanine aminotransferase; CTP, Child-Turcotte-Pugh; ETV, entecavir; HBeAg, hepatitis B e antigen; IQR, interquartile range; FTC, emtricitabine; HBV, hepatitis B virus; MELD, Model for End-Stage Liver Disease; TDF, tenofovir. The efficacy results showed similar rates of HBV DNA < 400 copies/mL at Week 48 of treatment with 70.5% of patients in the tenofovir arm, 87.8% of patients in the emtricitabine/tenofovir arm, and 72.7% of patients in the entecavir arm achieving this endpoint. Median changes in the MELD score were similar across the 3 study arms. More patients in the combination therapy arm had decreases in CTP score, but the results were not statistically significant. Finally, the proportion of patients undergoing HBeAg loss or seroconversion were numerically higher in the tenofovir‑containing arms.
CHB, chronic hepatitis B; CrCl, creatinine clearance; HBV, hepatitis B virus. Turning now to entecavir for the treatment of decompensated HBV-related cirrhosis, recent data (discussed below) have led to a specific FDA-approved indication for the use of entecavir in adult patients with decompensated liver disease. As noted, the dose of entecavir should be increased to 1 mg/day in patients with creatinine clearances ≥ 50 mL/min regardless of previous lamivudine or other nucleoside exposure. Appropriate dose adjustments as stated in the package insert must be made if the creatinine clearance is < 50 mL/min. Finally, patients with decompensated disease treated with entecavir may be at higher risk for lactic acidosis.