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
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
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
Clinical Impact of New Data From AIDS 2020hivlifeinfo
current ART in principal populations, including older patients and women who become pregnant; metabolic outcomes during ART; HIV and COVID-19; investigational ART strategies; and HIV prevention.
Clinical Impact of New Data From IAS 2019hivlifeinfo
July 21-24, 2019; Mexico City, Mexico
Download slide highlights of key studies addressing current issues in HIV care, as reported at this important annual conference.
Современное лечение ВИЧ.Объединенные данные с конференции IAS 2019 / Contemp...hivlifeinfo
Review key HIV data from IAS 2019 on the updated NTD risk in women receiving ART at conception, PrEP, first-line and switch options, and early-phase investigational strategies.
Confronting the Challenges of HIV Care in an Aging Population.2019hivlifeinfo
Еxpert faculty use case-based examples to examine considerations for aging patients with HIV. Topics include ART modification, bone loss, renal impairment, cardiovascular risk, and cognitive decline.
Слайдсет о новом в лечении ВИЧ.Key Slides on What’s Hot in HIV Treatment.2020 hivlifeinfo
Expert-authored slides on the latest issues relating to HIV care, featuring patient cases and considerations for optimal treatment approaches. Topics include integrating newer ARVs, individualizing ART for women of childbearing potential and during pregnancy, adverse events during ART, and anticipated roles of emerging ART strategies.
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусологической супре...hivlifeinfo
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусологической супрессией (2021) / Contemporary Management of HIV: Modifying ART in Virologically Suppressed Patients 2021
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
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
Clinical Impact of New Data From AIDS 2020hivlifeinfo
current ART in principal populations, including older patients and women who become pregnant; metabolic outcomes during ART; HIV and COVID-19; investigational ART strategies; and HIV prevention.
Clinical Impact of New Data From IAS 2019hivlifeinfo
July 21-24, 2019; Mexico City, Mexico
Download slide highlights of key studies addressing current issues in HIV care, as reported at this important annual conference.
Современное лечение ВИЧ.Объединенные данные с конференции IAS 2019 / Contemp...hivlifeinfo
Review key HIV data from IAS 2019 on the updated NTD risk in women receiving ART at conception, PrEP, first-line and switch options, and early-phase investigational strategies.
Confronting the Challenges of HIV Care in an Aging Population.2019hivlifeinfo
Еxpert faculty use case-based examples to examine considerations for aging patients with HIV. Topics include ART modification, bone loss, renal impairment, cardiovascular risk, and cognitive decline.
Слайдсет о новом в лечении ВИЧ.Key Slides on What’s Hot in HIV Treatment.2020 hivlifeinfo
Expert-authored slides on the latest issues relating to HIV care, featuring patient cases and considerations for optimal treatment approaches. Topics include integrating newer ARVs, individualizing ART for women of childbearing potential and during pregnancy, adverse events during ART, and anticipated roles of emerging ART strategies.
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусологической супре...hivlifeinfo
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусологической супрессией (2021) / Contemporary Management of HIV: Modifying ART in Virologically Suppressed Patients 2021
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.
Key Slides on Individualizing ART Management Based on Treatment Safety and To...hivlifeinfo
Обзор последних рекомендаций DHHS , индивидуализация лечения в отдельных группах пациентов, минимизация побочных эффектов и межлекарственных взаимодействий
Современное лечение ВИЧ: новые подходы к оптимизации АРТ/Contemporary Managem...hivlifeinfo
Вопросы, связанные с АРТ первого ряда, смена арв-стратегии для пациентов с вирусной супрессией, акцентом на возрастающую роль новыхантиретровирусных стратегий.
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.
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
Оптимизация лечения ВИЧ в 2018 году / HIV Treatment Optimization: 2018hivlifeinfo
HIV Treatment Optimization: 2018
In this downloadable slideset, Eric S. Daar, MD, provides a comprehensive update on ART management.
Format: Microsoft PowerPoint (.ppt)
File Size: 723 KB
Released: April 26, 2018
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
Contemporary Management of HIV.How Aging Affects ART Management.2018hivlifeinfo
In this downloadable slideset, Expert Faculty review key data on managing aging patients with HIV.
Format: Microsoft PowerPoint (.ppt)
File size: 720 KB
Date posted: 3/7/2018
HIV Alert:ART Considerations for Aging Patients.2018hivlifeinfo
In this downloadable slideset, Eric S. Daar, MD, and David A. Wohl, MD, provide expert recommendations for older patients with HIV, both in terms of ART selection and general management.
Format: Microsoft PowerPoint (.ppt)
File size: 545 KB
Date posted: 2/12/2018
Pharmacy Essentials for HIV Screening and Management.2019hivlifeinfo
Pharmacy Essentials for HIV Screening and Management
This downloadable slideset provides an in-depth review of key pharmacy strategies for expanding and supporting safe and effective HIV screening and treatment services to patients at risk of or living with HIV infection.
Jennifer Cocohoba Headshot
Jennifer Cocohoba, PharmD
Format: Microsoft PowerPoint (.ppt)
File Size: 1.93 MB
Released: January 31, 2019
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусной супрессией и ...hivlifeinfo
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусной супрессией и у пациентов с вирусологической неудачей. /Contemporary Management of HIV. Modifying Antiretroviral Therapy in Virologically Suppressed Patients and Those With Treatment Failure.2016
In this downloadable slideset, W. David Hardy, MD, and Program Director Eric S. Daar, MD review key data and optimal approaches for modifying ART in patients who are virologically suppressed or have experienced treatment failure.
Format: Microsoft PowerPoint (.ppt)
File size: 2.07 MB
In this downloadable slideset, Joel E. Gallant, MD, MPH, reviews the evidence behind the latest antiretroviral guidelines and offers a glimpse at upcoming agents currently under investigation.
Format: Microsoft PowerPoint (.ppt)
File size: 3.00 MB
Date posted: 6/15/2015
Сравнение режимов лечения ВИЧ в разрезе различных клинических сценариев.ART...hivlifeinfo
This downloadable slideset summarizes optimal evidence-based antiretroviral therapy management strategies for a series of challenging clinical cases and is based on a satellite symposium presented at HIV Glasgow 2016.
Format: Microsoft PowerPoint (.ppt)
File size: 1.32 MB
Date posted: 11/11/2016
Современное лечение ВИЧ: АРТ у пациентов с сопутствующими заболеваниями.Conte...hivlifeinfo
Современное лечение ВИЧ:АРТ у пациентов с сопутствующими заболеваниями.//Contemporary Management of HIV. Managing ART in HIV-Infected Patients With Common Comorbidities. 2016
In this downloadable slideset, David A. Wohl, MD, and Program Director Eric S. Daar, MD, review key data and optimal approaches for managing ART in the context of common comorbidities.
Format: Microsoft PowerPoint (.ppt)
File size: 3.51 MB
Современное лечение и профилактика ВИЧ : передовые стратегии лечения у пациен...hivlifeinfo
Стратегии смены АРТ у пациентов с вирусной супрессией, включая смену АРТ при резистентности, рекомендации по инъекционным препаратам длительного действия , смена АРТ до или во время беременности
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.
Key Slides on Individualizing ART Management Based on Treatment Safety and To...hivlifeinfo
Обзор последних рекомендаций DHHS , индивидуализация лечения в отдельных группах пациентов, минимизация побочных эффектов и межлекарственных взаимодействий
Современное лечение ВИЧ: новые подходы к оптимизации АРТ/Contemporary Managem...hivlifeinfo
Вопросы, связанные с АРТ первого ряда, смена арв-стратегии для пациентов с вирусной супрессией, акцентом на возрастающую роль новыхантиретровирусных стратегий.
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.
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
Оптимизация лечения ВИЧ в 2018 году / HIV Treatment Optimization: 2018hivlifeinfo
HIV Treatment Optimization: 2018
In this downloadable slideset, Eric S. Daar, MD, provides a comprehensive update on ART management.
Format: Microsoft PowerPoint (.ppt)
File Size: 723 KB
Released: April 26, 2018
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
Contemporary Management of HIV.How Aging Affects ART Management.2018hivlifeinfo
In this downloadable slideset, Expert Faculty review key data on managing aging patients with HIV.
Format: Microsoft PowerPoint (.ppt)
File size: 720 KB
Date posted: 3/7/2018
HIV Alert:ART Considerations for Aging Patients.2018hivlifeinfo
In this downloadable slideset, Eric S. Daar, MD, and David A. Wohl, MD, provide expert recommendations for older patients with HIV, both in terms of ART selection and general management.
Format: Microsoft PowerPoint (.ppt)
File size: 545 KB
Date posted: 2/12/2018
Pharmacy Essentials for HIV Screening and Management.2019hivlifeinfo
Pharmacy Essentials for HIV Screening and Management
This downloadable slideset provides an in-depth review of key pharmacy strategies for expanding and supporting safe and effective HIV screening and treatment services to patients at risk of or living with HIV infection.
Jennifer Cocohoba Headshot
Jennifer Cocohoba, PharmD
Format: Microsoft PowerPoint (.ppt)
File Size: 1.93 MB
Released: January 31, 2019
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусной супрессией и ...hivlifeinfo
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусной супрессией и у пациентов с вирусологической неудачей. /Contemporary Management of HIV. Modifying Antiretroviral Therapy in Virologically Suppressed Patients and Those With Treatment Failure.2016
In this downloadable slideset, W. David Hardy, MD, and Program Director Eric S. Daar, MD review key data and optimal approaches for modifying ART in patients who are virologically suppressed or have experienced treatment failure.
Format: Microsoft PowerPoint (.ppt)
File size: 2.07 MB
In this downloadable slideset, Joel E. Gallant, MD, MPH, reviews the evidence behind the latest antiretroviral guidelines and offers a glimpse at upcoming agents currently under investigation.
Format: Microsoft PowerPoint (.ppt)
File size: 3.00 MB
Date posted: 6/15/2015
Сравнение режимов лечения ВИЧ в разрезе различных клинических сценариев.ART...hivlifeinfo
This downloadable slideset summarizes optimal evidence-based antiretroviral therapy management strategies for a series of challenging clinical cases and is based on a satellite symposium presented at HIV Glasgow 2016.
Format: Microsoft PowerPoint (.ppt)
File size: 1.32 MB
Date posted: 11/11/2016
Современное лечение ВИЧ: АРТ у пациентов с сопутствующими заболеваниями.Conte...hivlifeinfo
Современное лечение ВИЧ:АРТ у пациентов с сопутствующими заболеваниями.//Contemporary Management of HIV. Managing ART in HIV-Infected Patients With Common Comorbidities. 2016
In this downloadable slideset, David A. Wohl, MD, and Program Director Eric S. Daar, MD, review key data and optimal approaches for managing ART in the context of common comorbidities.
Format: Microsoft PowerPoint (.ppt)
File size: 3.51 MB
Современное лечение и профилактика ВИЧ : передовые стратегии лечения у пациен...hivlifeinfo
Стратегии смены АРТ у пациентов с вирусной супрессией, включая смену АРТ при резистентности, рекомендации по инъекционным препаратам длительного действия , смена АРТ до или во время беременности
Contemporary Management of HIV.How Common Comorbidities Affect ART Management...hivlifeinfo
In this downloadable slideset, expert faculty review key data and offer important guidance on managing HIV treatment in patients with frequently encountered comorbidities, including cardiovascular disease, osteopenia, and HCV coinfection.
Format: Microsoft PowerPoint (.ppt)
File size: 2.27 MB
Date posted: 2/12/2018
Современное лечение ВИЧ: лечение ВИЧ у женщин.2017/Contemporary Management of...hivlifeinfo
In this downloadable slideset, Kathleen E. Squires, MD, and Program Director Joseph J. Eron, Jr., MD, review key data and optimal strategies in caring for HIV-infected women, including ART safety and efficacy in women, reproductive health management, ART and pregnancy, and preventing HIV infection in women.
Format: Microsoft PowerPoint (.ppt)
File size: 1.59 MB
Date posted: 4/25/2017
Современное лечение ВИЧ.Обобщённые данные с конференции CROI 2020 / Contempor...hivlifeinfo
Современное лечение ВИЧ.Обобощенные данные с конференции CROI 2020 / Contemporary Management of HIV.Integrating New Data From CROI 2020
Широкий спектр вопросов, включая стратегии АРТ на поздних стадихя заболевания, менеджмент ожирения, метаболические исходы АРТ, данные по АРТ во время беременности и пр
Format: Microsoft PowerPoint (.ppt)
File Size: 554 KB
Released: April 14, 2020
Современное лечение ВИЧ: лечение ВИЧ у пациентов с вирусными гепатитами.Conte...hivlifeinfo
Современное лечение ВИЧ: лечение ВИЧ у пациентов с вирусными гепатитами.Contemporary Management of HIV. Managing HIV in Viral Hepatitis Coinfection.2016
In this downloadable slideset, David L. Wyles, MD, and Program Director Eric S. Daar, MD, review key data and optimal approaches for ART management in patients with HIV and viral hepatitis coinfection.
Format: Microsoft PowerPoint (.ppt)
File size: 1.85 MB
Новые данные с конференции по ВИЧ-инфекции CROI 2017/Clinical Impact of New D...hivlifeinfo
Clinical Impact of New Data From CROI 2017
Expert faculty members Joel E. Gallant, MD, MPH, and Charles B. Hicks, MD, summarize key studies from this important annual conference.
Format: Microsoft PowerPoint (.ppt)
File size: 1.25 MB
Date posted: 3/3/2017
Cовременное лечение ВИЧ : новые данные с конференции CROI 2017/ Contemporary...hivlifeinfo
Cовременное лечение ВИЧ : новые данные с конференции CROI 2017/ Contemporary Management of HIV. New Data From CROI 2017
In this downloadable slideset, Charles B. Hicks, MD, and Program Director Joseph J. Eron, Jr., MD, review key new HIV data presented at the Seattle 2017 meeting.
Topics include:
-Prevention
-New data on currently available ART
-Switch/simplification strategies for virologically suppressed patients
-Investigational ARV agents
-Treatment complications and comorbidities
Случаи и разногласия по ВИЧ в 2019 году: европейские перспективы / Cases and...hivlifeinfo
Learn unique perspectives across Europe on PrEP, rapid ART initiation, ART in women, and options for switching ART.
Format: Microsoft PowerPoint (.ppt)
File Size: 1.33 MB
Released: July 10, 2019
Evolving Switch Strategies for Virologically Suppressed HIV-Infected Patients...Hivlife Info
Доктор David A. Wohl при участии группы экспертов, рассматривает основные исследования о том, когда и как, при каких условиях переводить пациентов со стабильной супрессией ВИЧ на новые методы лечения .
HIV Alert:Новые стратегии и агенты в лечении ВИЧ/Novel Strategies and Agents ...hivlifeinfo
HIV Alert-Новые стратегии и агенты в лечении ВИЧ/Novel Strategies and Agents for HIV Management.2017
In this downloadable slideset, Daniel R. Kuritzkes, MD, and Paul E. Sax, MD, review potential future HIV treatment strategies—including dual-therapy regimens, long-acting ART, and investigational agents—and discuss where these might fit into the current therapeutic landscape.
Format: Microsoft PowerPoint (.ppt)
File size: 570 KB
Date posted: 9/27/2017
Основы ведения АРТ у многократно леченных пациентов 2022 / Foundations of ART...hivlifeinfo
Основы ведения АРТ у многократно леченных пациентов (2022)
Тактики ведения пациентов с большим опытом лечения, включая анализ резистентности, последние рекомендации и данные по новым схемам АРТ
Дискуссии о здоровом старении с ВИЧ /Key Slides on Healthy Aging With HIV.2022hivlifeinfo
Дискуссии о здоровом старении с ВИЧ
Узнайте о медицинских и немедицинских проблемах, с которыми сталкиваются стареющие пациенты с ВИЧ, включая дополнительные проблемы, с которыми сталкиваются пожилые женщины и пожилые люди, живущие в условиях ограниченных ресурсов.
Гиперлипопротеидемия(а) как опасное генетически обусловленное нарушение липид...hivlifeinfo
Гиперлипопротеидемия(а) как опасное генетически обусловленное нарушение липидного обмена и фактор риска атеротромбоза и сердечно-сосудистых заболеваний
Липопротеид(а) [Лп(а)] представляет собой сложный надмолекулярный комплекс, принадлежащий к апоВ100 содержащим липопротеидам. Лп(а) состоит из ЛНП-подобной частицы, в которой молекула апобелка В100 ковалентно связана дисульфидной связью с уникальной полиморфной молекулой апобелка(а). Концентрация Лп(а) генетически контролируется, при этом варьирует в очень широком диапазоне. Повышенный уровень Лп(а) является независимым фактором риска атеросклероза коронарных, сонных и периферических артерий, ИБС и стеноза аортального клапана, сопутствующих сердечно-сосудистых осложнений, а также осложнений после операций реваскуляризации миокарда. Несмотря на это, уровень Лп(а) по-прежнему не учитывается в стратификации риска сердечно-сосудистых заболеваний. Отчасти, это может быть связано с тем, что ни современная лекарственная терапия, ни новые поколения биологических гиполипидемических препаратовтерапия практически не влияют на концентрацию Лп(а), за исключением 20-30% снижения Лп(а) никотиновой кислотой и ингибиторами пропротеиновой конвертазы субтилизин-кексин 9 типа (PCSK9).
Лекция освящает современные представления о Лп(а), как факторе риска сердечно-сосудистых заболеваний, возможности и целесообразности его определения, а также посвящена современным возможностям коррекции гиперлипопротеидемии(а).
Физическая активность и физические тренировки как метод профилактики сердечно...hivlifeinfo
Чушкин М.И., Мандрыкин С.Ю., Карпина Н.Л., Попова Л.А. Физическая активность и физические тренировки как метод профилактики сердечно-сосудистых заболеваний. Кардиология. 2018;58(9S):10-18
Большое число данных свидетельствует, что функциональные возможности кардиореспираторной системы являются не менее важным фактором прогноза летальности, чем курение, артериальная гипертензия, ожирение, гиперхолестеринемия, СД. Пациенты с большей физической активностью имеют значительно меньший риск ССЗ, чем пациенты, ведущие неактивный образ жизни. В данном обзоре авторы показали возможности оценки физической активности и основные положения назначения физических тренировок для сохранения и повышения функциональных возможностей кардиореспираторной системы.
Свобода интернета 2018: делегирование репрессий.Доклад Международной Агорыhivlifeinfo
«Настоящий доклад посвящен обзору вмешательства в свободу интернета в России в 2018 году и основан на данных постоянного мониторинга ситуации, который мы ведем более 10 лет.
Как обычно, доклад состоит из двух основных разделов, первый из которых посвящен описанию результатов мониторинга с приведением наиболее показательных примеров, а второй – авторской оценке состояния свободы интернета. В приложении даны сводные результаты мониторинга в виде таблицы со ссылкой на дату, источник, регион и вид ограничения по каждому известному эпизоду, а также карта нарушений, на которой цветом обозначен уровень относительной свободы интернета в отдельных субъектах Федерации.»
https://guides.files.bbci.co.uk/bbc-russian/AGORA_Freedom-of-the-Internet-2018.pdf
Предиабет-определение, риски, подходы к диагностике и профилактике сахарного ...hivlifeinfo
Предиабет-определение, риски, подходы к диагностике и профилактике сахарного диабета 2 типа и сердечно-сосудистых осложнений.Консенсус экспертов РКО.2019
"Результаты международного эпидемиологического проекта HAPIEЕ показали, что распространенность преддиабета в Российской Федерации (РФ), определяемого по нарушенной гликемии натощак, может быть еще выше — от 28,1% при отрезной точке по уровню глюкозы плазмы ≥6,1 ммоль/л (критерий Российской ассоциации эндокринологов) до 54.8 % при при отрезной точке по уровню глюкозы плазмы ≥5,6 ммоль/л (критерий ADA), соответственно."
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- 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
Hemodialysis: Chapter 3, Dialysis Water Unit - Dr.Gawad
Key Slides on ART for HIV : Evolving Concepts and Innovative Strategies.2020
1. Key Slides on ART for HIV: Evolving Concepts and
Innovative Strategies
This program is supported by educational grants from Merck Sharp & Dohme Corp.
and ViiV Healthcare
2. About These Slides
Please feel free to use, update, and share some or all of these slides in
your noncommercial presentations to colleagues or patients
When using our slides, please retain the source attribution:
These slides may not be published, posted online, or used in
commercial presentations without permission. Please contact
permissions@clinicaloptions.com for details
Slide credit: clinicaloptions.com
3. Chair
W. David Hardy, MD
Scientific and Medical Consultant
Adjunct Professor of Medicine
Division of Infectious Diseases
Johns Hopkins University School of Medicine
Baltimore, Maryland
W. David Hardy, MD, has disclosed that he has received consulting fees from
Enochian Biosciences, Gilead Sciences, Merck, and ViiV/GlaxoSmithKline.
4. Faculty
Michelle S. Cespedes, MD, MS
Associate Professor of Medicine
Division of Infectious Disease
Department of Medicine
Icahn School of Medicine at Mount Sinai
Attending Physician
Mount Sinai Medical Center
New York, New York
Michelle S. Cespedes, MD, MS, has disclosed that she has received consulting
fees from Gilead Sciences and ViiV Healthcare.
5. Overview
Simplifying ART to 2-drug regimens
Safety of dolutegravir in pregnancy
ARV-associated weight gain
Future ART innovations
7. Case 1: ART Simplification
A 32-yr-old African American woman with perinatally acquired HIV infection visits
your office for the first time following relocating from Atlanta to request an ART
regimen with as few pills as possible
CD4+ cell count: 326 cells/mm3; HIV-1 RNA: 45 copies/mL
History of cervical dysplasia yrs ago, serial cervical PAPs with normal cytology,
HPV cotesting negative for hrHPV, no other significant PMH
ARV history (the patient cannot recall the yrs she started some meds)
‒ ? ZDV
‒ ? ABC/3TC/ZDV
‒ 2003 LPV/RTV + ZDV/3TC
‒ 2006 EFV/TDF/FTC (stopped meds for ~ 1.5 yrs due to lost insurance and fell out of care)
‒ 2014 ATV/RTV + TDF/FTC (reinitiated ARV for PMTC)
‒ 2018 DRV/COBI + TDF/FTC
8. Case 1: Additional Information
The patient reports having stopped ART
before but has been consistent since the birth
of her son 5 yrs ago
States that her former doctor switched her
meds from time to time “when a better
treatment option was available”
Works as a teacher’s aide, lives with her sister
and her son, good family and social support—
all are aware of her HIV status
Never smoked, occasional alcohol use, no
previous or current illicit drug use
Laboratory Parameter Result
WBC, x 109/L 6.2
Hemoglobin, g/dL 12
Platelets, x 109/L 289
Na/K, mmol/L 138/3.9
Creatinine, mg/dL 0.89
Albumin, g/dL 3.9
AST/ALT, u/L 26/22
Hepatitis A virus Immune
Hepatitis B virus Immune
Hepatitis C virus Ab negative
HLA-B*5701 Negative
Historical genotype (> 15 yrs ago) M184V
Archive genotype No predicted resistance
9. Outcomes of Switch to BIC/FTC/TAF in Patients With
Virologic Suppression and Preexisting M184V
Retrospective study of stably suppressed patients
switched to BIC/FTC/TAF in Newark and Patterson,
NJ (N = 54)
‒ All patients undetectable (HIV-1 RNA < 50 c/mL) at
time of switch
15 patients had M184V plus other clinically
significant NRTI and/or INSTI mutations
Resistance testing: Proviral archive DNA genotype
(53%); traditional genotype (47%)
Demographics: 67% Black race, mean age 57 yrs
All patients maintained HIV-1 RNA < 200 c/mL,
suggesting durable viral suppression with
BIC/FTC/TAF even if mutations beyond M184V are
present; study limited by small sample size
Mutation Category
(N = 15)
Baseline
Mutations,
n (%)
HIV-1 RNA < 50 c/mL
at Latest Visit on
BIC/FTC/TAF, n/N (%)
HIV-1 RNA < 200 c/mL
at Latest Visit on
BIC/FTC/TAF, n/N (%)
Mean Duration of
BIC/FTC/TAF, Mos
(Range)
M184V + TAMs 13 (86) 12/13 (92) 13/13 (100) 11 (6-17)
M184V + other NRTI mutation 1 (7) 1/1 (100) 1/1 (100) 19
M184V + INSTI mutation 1 (7) 1/1 (100) 1/1 (100) 21
Natali. AIDS 2020. Abstr PEB0252. Slide credit: clinicaloptions.com
10. Comorbidity, n (%)
Treatment Experienced
Suppressed
(n = 671)
Not Suppressed
(n = 197)
Any 587 (87.5) 159 (80.7)
Autoimmune disease 29 (4.3) 8 (4.1)
Cardiovascular disease 89 (13.3) 20 (10.2)
Invasive cancer 80 (11.9) 15 (7.6)
Endocrine disorder 422 (62.9) 94 (47.7)
Mental health disorder 232 (34.6) 58 (29.4)
Liver disease 115 (17.1) 40 (20.3)
Bone disorder 52 (7.7) 17 (8.6)
Peripheral neuropathy 83 (12.4) 27 (13.7)
Renal disease 198 (29.5) 51 (25.9)
Hypertension 290 (43.2) 77 (39.1)
Substance use 92 (13.7) 31 (15.7)
Real-World Experience With DTG/RPV in the
United States
Retrospective analysis of clinical characteristics and
outcomes in PWH switching to DTG/RPV between
Jan 2018 and Dec 2018 in OPERA study (N = 880)
BL characteristics: 68% had CD4+ cell count
> 500 cells/mm3, 63% initiated ART after 2013
88% remained on drug at 12 mos, virologic failure
occurred in 1.5%; of 42 patients who discontinued,
41% were virologically suppressed
Pierone. IDWeek 2019. Abstr 2483. Slide credit: clinicaloptions.com
Region (South)
Age (50+)
Risk Factor (MSM)
Race (Black)
Ethnicity (Hispanic)
Sex (Female)
0 10 20 30 40 50 60 70 80 90 100
Baseline Demographics of Patients Initiating DTG/RPV (N = 880)
DTG/RPV initiators
OPERA population
63%
57%
54%
38%
35%
60%
35%
44%
28%
25%
18%
17%
11. GEMINI-1 and -2: Virologic Response Through Wk 96
With DTG + 3TC for Treatment-Naive Patients
Parallel, randomized, double-blind phase III noninferiority studies (N = 1433)
HIV-1 RNA < 50 c/mL at Wk 96:
‒ All patients: DTG + 3TC 86.0% vs DTG + FTC/TDF 89.5%
‒ Patients with BL CD4+ cell count < 200 cells/mm3: 68% vs 87%
‒ 3 patients with CVW, 2 patients with HIV-1 RNA ≥ 50 copies/mL in window,
2 patients discontinued due to nontreatment-related AEs, 1 patient
discontinued due to treatment-related AEs, 2 patients with protocol violation,
3 patients LTFU, 4 patients withdrew consent, 1 change in ART due to
incarceration
Cahn. JAIDS. 2020;83:310. Slide credit: clinicaloptions.com
12. Key Secondary Endpoint
(HIV-1 RNA < 50 c/mL)
DTG/3TC noninferior to
continued TAF-based ART
TANGO: Switch to DTG/3TC vs Continuing TAF-Based
3-Drug or 4-Drug Regimen
Slide credit: clinicaloptions.com
0.5
Patients(%)
100
80
40
60
20
0
HIV-1 RNA
≥ 50 c/mL
HIV-1 RNA
< 50 c/mL
No Virologic
Data
0.3
93.2 93.0
6.5 6.5
Switch to DTG/3TC
(n = 369)
Continue TAF-based ART
(n = 372)
Virologic Outcomes by FDA Snapshot (ITT-E) at Wk 48 Adjusted Treatment Difference (95% CI)*
Primary Endpoint
(HIV-1 RNA ≥ 50 c/mL)
DTG/3TC noninferior to
continued TAF-based ART
*Adjusted for baseline third agent class.
Difference (%)
-3.4
0.2
-8 -6 -4 -2 0 2 4 6 8
3.9
-8% NI
margin
TAF-Based ARTDTG/3TC
TAF-Based ART DTG/3TC
-1.2 0.7
-0.3
-8 -6 -4 -2 0 2 4 6 8
4% NI
margin
van Wyk. IAS 2019. Abstr WEAB0403LB.
No CVW in DTG/3TC arm, CVW in 1 (< 1%) patient in
TAF-based ART arm; no resistance detected at failure
All 7 patients (4 in DTG/3TC group, 3 in TAF-based ART
group) with proviral M184V/I mutation at baseline
maintained HIV-1 RNA < 50 c/mL at Wk 48
International, randomized, open-label phase III noninferiority study in adults with HIV-1 RNA < 50 c/mL for
> 6 mos on TAF-based ART
13. DOLULAM 4-Yr Follow-up: DTG/3TC in Heavily
Treatment Experienced PWH
French prospective study of switching stably
suppressed (HIV-1 RNA < 50 c/mL for > 12 mos,
with no INSTI resistance) PWH to DTG/3TC (N = 27)
Demographics: 74% male, 100% white, median age
59 yrs, 56% had pretreatment HIV-1 RNA
> 100,000 c/mL, median duration of ARV 215 mos
(range: 22-329)
Regimen immediately prior to switch: 48% TDF,
81% PI/RTV, 26% RAL; median duration of current
ART: 51 mos (range: 13-108)
10 (37%) patients had a history of genotypic test
with M184V mutation prior to switch
Median weight change from BL to 4 yrs: 0 kg
(range: -6 to +7)
Results suggest that in stable HTE patients with or
without history of M184V, DTG/3TC dual therapy
is an effective and durable maintenance strategy
Limitations: small sample size
Reynes. IAS 2020. Abstr PEB0241. Slide credit: clinicaloptions.com
Patient Disposition After 4 Yrs, n N = 17
Virologic failure (HIV-1 RNA > 200 c/mL) 0
Treatment-related discontinuation
Due to AE*
Patient decision
Persistent low-level viremia
(HIV-1 RNA 50-200 c/mL)
4
2
1
1
LTFU/severe biological AE 0/0
*Fatigue (n = 2), intestinal discomfort (n = 1).
14. Resistance Emergence on Long-Acting CAB + RPV
ATLAS/FLAIR: 1.2% of patients with confirmed
virologic failure across both studies[1,2]
‒ 6 LA CAB + RPV subjects developed resistance
‒ CAB and RPV concentration at failure below
population means, but within range for the
majority who maintained suppression
LATTE-2 6-yr results: 181 randomized to LA,
110 completed study at Wk 312[3]
‒ Among patients who began CAB + RPV at Wk
24, 66% maintained HIV-1 RNA < 50 c/mL, 9%
had HIV-1 RNA ≥ 50 c/mL, 25% had no
virologic data by Snapshot at Wk 312
‒ PDVF in 8 patients, of whom 3 developed
treatment-emergent major INSTI resistance
mutations, 2 of which were after Wk 144
Study
HIV-1
Sub-
type
Wk of
Failure
NNRTI RAMs INSTI RAMs
BL Failure BL Failure
ATLAS[1]
A/A1 8 E138E/A E138A L74I L74I
AG 12
V108V/I,
E138K
V108I,
E138K
None None
A/A1 20 None E138E/K L74I L74I, N155H
FLAIR[2]
A1 20 None E138E/A/K/T L74I L74I, Q148R
A1 28 None K101E L74I L74I, G140R
A1 48 None E138K L74I L74I, Q148R
1. Swindells. NEJM. 2020;382:1112. 2. Orkin. NEJM. 2020;382:1124. 3. Margolis. IDWeek 2019. Abstr 2840. Slide credit: clinicaloptions.com
15. ATLAS and FLAIR: Switch to Long-Acting CAB + RPV vs
Continued 3-Drug ART in Virologically Suppressed Patients
Teichner. IDWeek 2019. Abstr 884.
Virologic Snapshot Outcomes at Wk 48 (ITT-E)
1.7
ProportionofParticipants(%)
100
80
40
60
20
0
Virologic
Nonresponse
≥ 50 c/mL
Virologic
Success
< 50 c/mL
No Virologic
Data
1.9
93.1 94.4
5.1 3.9
LA CAB + RPV
(n = 591)
CAR
(n = 591)
Virologic Outcomes
Adjusted Treatment Difference (95% CI)*
Primary Endpoint:
LA noninferior to CAR
(HIV-1 RNA ≥ 50 c/mL)
at Wk 48
Difference (%)
-4.1
-1.4
1.4
-10% NI
margin
CARLA CAB + RPV
CAR LA CAB + RPV
-1.4 1.7
0.2
-8 -6 -4 -2 0 2 4 6 8
4% NI
margin
10-10
Key Secondary Endpoint:
LA noninferior to CAR
(HIV-1 RNA ≥ 50 c/mL) at
Wk 48
-8 -6 -4 -2 0 2 4 6 8 10-10
Slide credit: clinicaloptions.com
16. ATLAS and FLAIR: Favorable Adherence and Tolerability
at Wk 48
High rates of adherence to injection visits through Wk 48 in patients receiving CAB LA +
RPV LA
‒ 98% of injection visits occurred within the allowed ± 7-day dosing window
Oral bridging with CAB and RPV was an effective strategy for maintaining virologic
suppression to cover missed injection visits
‒ 7 patients received oral bridging covering 8 planned missed injection visits; all maintained virologic
suppression < 50 c/mL
25% (3663/14,682) of injections associated with local ISRs
‒ Pain was most common ISR: 84% (3087/3663)
‒ 99% of ISRs were grade 1/2 with median duration 3 days, < 1% associated with discontinuation
Orkin. NEJM. 2020;382:1124. Teichner. IDWeek 2019. Abstr 884. Slide credit: clinicaloptions.com
17. ATLAS-2M: Switch to CAB LA + RPV LA Every 2 Mos vs
Switch to CAB LA + RPV LA Monthly Injections
Multicenter, randomized, open-label phase III noninferiority study of CAB LA + RPV LA every 8 wks
vs every 4 wks in virologically suppressed patients with no prior virologic failure (N = 1045)
Slide credit: clinicaloptions.comOverton. CROI 2020. Abstr 34. Reproduced with permission.
Primary endpoint
(HIV-1 RNA ≥ 50 c/mL):
CAB LA + RPV LA Q8W
noninferior to Q4W
Key secondary endpoint
(HIV-1 RNA < 50 c/mL):
CAB LA + RPV LA Q8W
noninferior to Q4W
*Based on Cochran-Mantel-Haenszel analysis adjusting for prior CAB + RPV exposure.
Q4WQ8W
Difference (%)
-0.6 2.2
0.8
4% NI
margin
Difference (%)
-2.1 3.7
0.8
Q8WQ4W
-10% NI
margin
CAB LA + RPV LA Q8W
(n = 522)
CAB LA + RPV LA Q4W
(n = 523)
Adjusted Treatment Difference (95% CI)*Virologic Outcomes
100
80
60
40
20
0
Participants(%)
Virologic
Nonrespons
e (≥ 50 c/mL)
Virologic
Success
(< 50 c/mL)
No Virologic
Data
1
5.5
94.3 93.5
-10 -8 -6 -4 -2 0 2 4 6 8 10
-10 -8 -6 -4 -2 0 2 4 6 8 10
1.7 4.0
18. ATLAS-2M: Confirmed Virologic Failures
CVF in CAB LA + RPV LA Q8W arm: n = 8
‒ 5 had preexisting major RPV RAMs (E138A,
Y188L, Y181Y/C, H221H/Y, E138E/A,
Y188Y/F/H/L)
‒ 1 had preexisting major INSTI RAM (G140G/R)
‒ 5 had L74I polymorphism (3 subtype A/A1,
1 subtype C, 1 complex subtype)
Fully active oral ART resulted in viral
resuppression in 9/10 patients with CVF
‒ 1 patient noncompliant on PI-based ART
In all patients with CVF (n = 10), virus
maintained phenotypic sensitivity to DTG
Slide credit: clinicaloptions.comOverton. CROI 2020. Abstr 34.
Characteristic
CAB LA + RPV LA
Q8W
(n = 522)
CAB LA + RPV LA
Q4W
(n = 523)
CVF, n (%) 8 (1.5) 2 (0.4)
CVF with RPV
RAMs,* n/N
6/8 1/2
Treatment-
emergent RPV
RAMs
K101E, E138E/K,
E138A, Y188L
K101E, M230L
CVF with INSTI
RAMs,* n/N
5/8 2/2
Treatment-
emergent INSTI
RAMs
Q148R, N155H† E138E/K,Q148R,
N155N/H
*Post hoc BL PBMC HIV-1 DNA testing. †Or a mixture.
20. Case 1
Prior to initiating her new regimen, a pregnancy test is administered, and it is
negative
Upon asking about her fertility desires, you learn that:
‒ She identifies as a woman and describes her sexual orientation as bisexual
‒ She is not currently in a relationship; her last long-term relationship was with a man and ended
6 mos ago
‒ She uses condoms for birth control
‒ Not planning to get pregnant anytime soon but would not be opposed to having another child
before she “gets too old”
32-yr-old African American woman; wants to take as few pills as possible
CD4+ cell count: 326 cells/mm3; HIV-1 RNA: 45 c/mL
HLA-B*5701 negative, no predicted RAMs, history of M184V
21. Tsepamo Birth Outcomes Surveillance Study in
Botswana: Background
In May 2018, unplanned analysis of Tsepamo birth outcomes surveillance study
found increase in NTD incidence among Botswanan women who conceived on DTG[1]
‒ DTG vs non-DTG ART: 0.94% (95% CI: 0.37-2.4) vs 0.12% (95% CI: 0.07-0.21)
‒ Prevalence difference: 0.82% (95% CI: 0.24-2.3)
Analysis of data through April 2019 found NTD prevalence among women who
received DTG at conception lower than previous analysis, but still higher than other
exposure groups[2]
‒ DTG vs non-DTG ART: 0.30% (95% CI: 0.13-0.69) vs 0.10% (95% CI: 0.06-0.17)
‒ Prevalence difference: 0.20% (95% CI: 0.01-0.59)
Current analysis reports data from Tsepamo through April 2020[3]
1. Zash. NEJM. 2018; 379:979. 2. Zash. IAS 2019. Abstr MOAX0105LB. 3. Zash. AIDS 2020. Abstr OAXLB01. Slide credit: clinicaloptions.com
22. Tsepamo Update: Prevalence of NTDs by ARV Exposure
Zash. AIDS 2020. Abstr OAXLB01. Slide credit: clinicaloptions.com
Parameter
Conception Pregnancy
HIV Negative
(n = 119,630)DTG
(n = 3591)
Non-DTG
(n = 19,361)
EFV
(n = 10,958)
DTG
(n = 4581)
Total NTDs per exposures, n/N 7/3591 21/19,361 8/10,958 2/4581 87/119,630
NTD prevalence, % (95% CI)
April 2019
April 2020
0.30
(0.13-0.69)
0.19
(0.09-0.40)
0.10
(0.06-0.17)
0.11
(0.07-0.17)
0.04
(0.01-0.11)
0.07
(0.03-0.17)
0.03
(0.00-0.15)
0.04
(0.01-0.16)
0.08
(0.06-0.10)
0.07
(0.06-0.09)
Prevalence diff. with DTG
conception, Apr 2020, % (95% CI)
Ref
0.09
(-0.03 to 0.30)
0.12
(0 to 0.32)
0.15
(0 to 0.36)
0.12
(0.01 to 32.0)
NTDs per exposure between April
2019 and April 2020, n/N
2/1908* 6/4569 5/2999 1/741 17/30,258
*Includes 1 lumbosacral myelomeningocele (spina bifida) and 1 encephalocele.
23. Pregnancy Outcomes With Raltegravir Exposure
Pooled analysis of 2550 prospective pregnancy outcomes following RAL exposure (51% first trimester
exposure, including 34% RAL use at periconception)
No association between RAL and adverse outcomes; spontaneous abortions, stillbirths, major anomalies
comparable to gen population
Data supports treatment guideline use of RAL in women of childbearing potential and during pregnancy
‒ No neural tube defects among the 765 peri-conception exposures
Prospective Outcomes,
Birth Outcome N
(Pregnancy Exposure n)
Earliest Trimester of Exposure
Periconception,
328 (325)
Other First,
173 (169)
Second/Third,
450 (442)
Unknown,
25 (25)
Total,
976 (961)
Live births 290 (288) 143 (139) 440 (433) 19 (19) 892 (879)
Major congenital abnormality
NTD
5 (5)
0
4 (4)
0
23 (21)
0
1 (1)
0
33 (31)
0
Spontaneous abortions 20 (19) 13 (13) 2 (2) 1 (1) 36 (35)
Stillbirth or fetal death 2 (2) 3 (3) 6 (5) 0 11 (10)
Elective terminations 15 (15) 13 (13) 2 (2) 5 (5) 35 (35)
Ectopic pregnancies 1 (1) 1 (1) 0 0 2 (2)
Shamsuddin. IDWeek 2019. Abstr 886. Slide credit: clinicaloptions.com
24. Periconception INSTI Use and NTDs
DHHS on DTG in United States: “ . . . because of mandatory food folate
fortification, the overall risk of NTDs in the United States is low in the
general population, and there are currently insufficient DTG
periconception exposures reported to the Antiretroviral Pregnancy
Registry to be able to determine whether there is an increase in the risk
of NTDs in the United States.”
BIC: Insufficient data
RAL: Data from APR, drug manufacturer, and multinational cohort
study
DHHS Guidelines. December 2019. Slide credit: clinicaloptions.com
25. Current Guidance on DTG Use in Treatment-Naive
Women of Childbearing Potential
DTG can be prescribed for adult
women and adolescent girls of
childbearing age or potential who
wish to become pregnant or who are
not otherwise using or accessing
consistent and effective contraception
if they have been fully informed of
the potential increase in the risk of
neural tube defects (at conception
and until the end of the first
trimester)
DTG a “preferred” ARV for pregnant
women, irrespective of trimester
‒ Based on higher rate of virologic
suppression, faster rate of HIV-1 RNA
decline, and higher genetic barrier of
DTG vs other ARVs
DTG an “alternative” ARV for women
trying to conceive
‒ Rationale: More time to reach
virologic suppression using
DTG-sparing ART in these cases
1. WHO ARV Policy Update. July 2019. 2. DHHS Perinatal Guidelines. April 2020. Slide credit: clinicaloptions.com
WHO Guidance[1] DHHS Guidance[2]
28. Case 2
60-yr-old white man with HIV infection well controlled on DTG/ABC/3TC
‒ CD4+ cell count: 532 cells/mm3
Receiving lisinopril for HTN
Presents with 2 mos intermittent malaise, generalized weakness, now with several
wks of diarrhea, 2 wks of poor PO intake
BMI: 24 kg/m2
Nonsmoker, denies alcohol use, distant cocaine use “in the 80s,” denies recent
illicit drug use
He had been reluctant to present to clinic during COVID-19 lockdowns but has
tested negative for SARS-CoV-2 at a walk-in clinic twice in the past 2 mos
In clinic, he is normotensive and afebrile but slightly slow to respond to questions
and states that he does not feel like himself
29. Additional workup during hospitalization
significant for:
‒ ANA positive, +dsDNA, pattern c/w SLE
Reports sister died from lupus in her 30s
Understands that he may need to change his
HIV regimen because of his kidney function
States that he is very concerned about
weight gain since he saw his sister gain
weight after she was diagnosed with lupus
Case 2
Patient is sent to the ED from clinic;
evaluation in ED notable for:
‒ WBC: 4 x 109/L, hemoglobin: 10.1 g/dL (BL 12
g/dL), platelets: 117 x 109/L
‒ Creatinine: 6 mg/dL (BL 0.9 mg/dL), K: 7
mmol/L with EKG changes, BUN: 72 mg/dL
Noncontrast head CT: negative; CT abd/pel:
negative, no evidence of obstruction
Urine sediment with RBC
Required emergent HD x 1 session
Creatinine stabilized to 1.8 mg/dL;
GFR: 40 mL/min (CKD stage 3B:
GFR 30-44 mL/min)
30. ADVANCE: Mean Weight Change by Sex
Greater weight increase with DTG vs EFV, with TAF vs TDF; plateau in weight gain after
Wk 48 observed in men but not in women
‒ Same patterns observed for percentage change in weight and change in BMI category over time
Slide credit: clinicaloptions.com
Men Women
0 4 12 24 36 48 60 72 84 96
0
2
10
4
6
8
MeanWeightChange(kg)
Wk
12
DTG + FTC/TAF
DTG + FTC/TDF
EFV/FTC/TDF
+6 kg
+3 kg
+1 kg
0 4 12 24 36 48 60 72 84 96
0
2
10
4
6
8
MeanWeightChange(kg) Wk
12
+9 kg
+5 kg
+3 kg
McCann. EACS 2019. Abstr PS3/3. Venter. NEJM. 2019;381:803.
31. Multivariate Analysis of Weight Gain Following ART
Initiation in RCTs
Pooled analysis of weight gain across 8 randomized phase III clinical trials of
first-line ART initiation occurring in 2003-2015 (N = 5680)
Slide credit: clinicaloptions.comSax. Clin Infect Dis. 2019;[Epub].
Female
Male
0.5
0
2.5
LSMWeightΔ,kg(95%CI)
Wks
12 24 36 48 60 72 84 96
1.0
*
4.5
3.5
3.0
1.5
2.0
Black
Nonblack
0.5
0
2.5
LSMWeightChange(kg)
Wks
12 24 36 48 60 72 84 96
1.0
4.0
3.5
3.0
1.5
2.0
5.0
Black female
Black male
Nonblack female
Nonblack male
1
0
6
5
LSMWeightChange(kg)
Wks
12 24 36 48 60 72 84 108
2
3
4
96
*
*
*
*
* *
*
*
* *
*
*†
*Color-coded to match respective comparators, denoting P < .05 vs male (first panel), nonblack (second panel), or nonblack females
(last panel). †P < .05 vs black males.
*†
*† *†
*† *†
4.0 4.5
32. INSTIs and TAF Associated With Greater Weight Gain vs
Other ARVs
OR (95% CI)
P Value
.82
.44
.31
.003
.034
.003
.73
.026
.035
.002
ABC vs ZDV
TDF vs ZDV
TDF vs ABC
TAF vs TDF
TAF vs ZDV
TAF vs ABC
ATV/RTV vs EFV
EVG/COBI vs EFV
RPV vs EFV
BIC or DTG vs EFV
4-2 -1 0 1 2 3
Decreased Risk Increased Risk
Sax. Clin Infect Dis. 2019;[Epub].
Risk of Weight Gain ≥ 10%[1]
Slide credit: clinicaloptions.com
33. Normal/Underweight
(< 25.0 kg/m2)
Overweight
(25.0-29.9 kg/m2)
Obese
(≥ 30 kg/m2)
BMI Changes Over Time by HIV Status and Baseline BMI
Kaiser Permanente EMR database (N = 138,222) of PWH ≥ 21 yrs of age who initiated ART
between 2006 and 2016 with available baseline BMI; uninfected controls matched 1:10 by
age, sex, race/ethnicity, clinic, yr
Slide credit: clinicaloptions.comSilverberg. AIDS 2020. Abtstr OQB0603.
Yrs From Baseline
BMI(kg/m2)
28
26
24
22
20
120 2 4 6 8 10
Uninfected (n = 32,038)
PWH (n = 3852)
0.31 kg/m2/yr
(P < .001)
0.20 kg/m2/yr
(reference)
25.1
22.0 24.2
21.6
32
30
28
26
24
120 2 4 6 8 10
Uninfected (n = 49,602)
PWH (n = 2927)
0.18 kg/m2/yr
(P < .001)
0.09 kg/m2/yr
(reference)
28.3
26.3
27.4
26.2
38
36
34
32
30
120 2 4 6 8 10
Uninfected (n = 48,326)
PWH (n = 1477)
0.07 kg/m2/yr
(P = .09)
-0.02 kg/m2/yr
(reference)
33.5
33.5
33.2
32.6
34. OPERA: Weight Change With Switch From TDF to TAF
While Maintaining Other ARVs by Class of Anchor Agent
Mallon. AIDS 2020. Abstr OAB0604. Reproduced with permission. Slide credit: clinicaloptions.com
Mos From Switch
Weight(kg)
INSTI NNRTI Boosted PI
92
90
88
86
84
82
80
78
0
-60-54-48-42-36-30-24-18-12-6 0 6 1218243036 4248
92
90
88
86
84
82
80
78
0
-60-54-48-42-36-30-24-18-12-6 0 6 1218243036 4248
92
90
88
86
84
82
80
78
0
-60-54-48-42-36-30-24-18-12-6 0 6 1218243036 4248
Estimated Weight Δ by Time From TDF
to TAF Switch, kg/yr (95% CI)
INSTI
(n = 3281)
NNRTI
(n = 1452)
Boosted PI
(n = 746)
-60 to 0 mos 0.42 (0.26 to 0.59) 0.66 (0.51 to 0.81) 0.31 (-0.02 to 0.64)
0 to 9 mos 2.64 (2.26 to 3.01) 2.25 (1.78 to 2.71) 1.98 (1.13 to 2.83)
9+ mos 0.29 (0.08 to 0.51) 0.20 (-0.14 to 0.54) -0.11 (-0.57 to -0.35)
35. BMI and ASCVD Changes With Switch From TDF to TAF
Retrospective observational study, 6-12 mos after suppressed patients switched from TDF to TAF
without switching any other ART regimen components (N = 110)
Switch from TDF to TAF led to 0.45 BMI increase (95% CI: 0.14-0.76; P < .01) and 13% increase in
ASCVD 10-yr risk score (95% CI: 4-23; P < .01)
‒ Shifted 50.7% of patients to ASCVD scores indicating use of a statin
Outcome Variable Preswitch (TDF) Postswitch (TAF) Change (Post–Pre) P Value
Median weight, lbs (IQR) 185.4 (55.8) 190.5 (60.5) 3.0 (9.2) < .01
Median BMI, kg/m2
(IQR) 28.0 (10.8) 28.2 (10.0) 0.5 (1.4) < .01
Median total cholesterol, (IQR) 173.8 (44.0) 195.0 (42.0) 12.5 (32.3) < .01
Median LDL cholesterol, (IQR) 98.6 (40.2) 112.1 (46.6) 8.2 (21.0) < .01
Median HDL cholesterol, (IQR) 51.0 (19.0) 55.8 (24.0) 3.0 (12.0) < .01
Median total to HDL cholesterol ratio, (IQR) 3.5 (1.6) 3.5 (1.7) 0.1 (0.6) .25
Median triglyceride levels, (IQR) 103.5 (68.0) 109.5 (93.0) 4.0 (64.0) .28
Median atherosclerotic CVD risk score, (IQR) 6.9 (8.1) 8.1 (10.9) 0.4 (1.9) < .01
Slide credit: clinicaloptions.comSchafer. Open Forum Infect Dis. 2019;[Epub].
36. TAF vs TDF: Analysis in Black and Latinx Participants
Pooled data from Hispanic/Latinx and Black
adults who initiated/switched to TAF vs TDF in
7 randomized trials (N = 5825)
‒ 1138 Hispanic/Latinx and 1324 Black
participants
Demographics
‒ Treatment naive (n = 1733): 15% female, 25%
Black, 19% Hispanic/Latino, median age 34 yrs
‒ Switch (n = 4092): 13% female, 22% Black,
20% Hispanic/Latino, median age 45 yrs
Those on TAF had significantly improved bone
and renal parameters, with similar rates of
virologic suppression at Wk 96
Efficacy and biomarkers were similar to the
overall study population
Significant increase in weight in those on TAF
regimens
‒ Difference ~ 2 kg at Wk 96
Slide credit: clinicaloptions.comDeJesus. IDWeek 2019. Abstr 318.
Median
Change at
Wk 96, kg
Treatment Naive Suppressed
TAF TDF
P
Value
TAF TDF
P
Value
All pts 3.2 1.4 < .001 2.5 0.5 < .001
Hispanic/
Latinx pts
3.1 1.2 .01 2.3 0.5 < .001
Black pts 3.7 3.2 .55 2.7 0.4 < .001
38. Slide credit: clinicaloptions.com
Agent MoA Phase Innovation
Elsulfavirine[1] NNRTI I Long acting
Lenacapavir (GS-6207)[2] Capsid inhibitor I
Long acting, fewer than 3
drugs
Islatravir (MK-8591)[3] NRTTI II
Long acting, fewer than 3
drugs
Leronlimab (PRO 140)[4] Anti-CCR5 mAb IIb/III
Long acting, fewer than 3
drugs
CAB + RPV[5,6] INSTI + NRTI III
Long acting, fewer than 3
drugs
1. NCT03730311. 2. Sager. CROI 2019. Abstr 141. 3. Grobler. CROI 2019. Abstr 0481.
4. Dhody. CROI 2019. Abstr 486. 5. Swindells. NEJM. 2020;382:1112. 6. Orkin. NEJM. 2020;382:1124
Novel ART Strategies Under Investigation
39. Matthews, IAS 2019, #4843 Slide credit: clinicaloptions.comMatthews. IAS 2019. Abstr 4843.
Islatravir (MK-8591, ISL): Novel Nucleoside Reverse
Transcriptase Translocation Inhibitor
First-in-class NRTTI
‒ High potency; half-life up to 128
hrs, once per yr dosing feasible
HIV prevention
‒ Islatravir implant inserted into
upper arm for 12 wks, then
removed
‒ PK modeling indicated ISL-TP
levels remain > level needed for
HIV prevention for > 12 mos
ISLPlasmaConcentrations
(µM)
ISL-TPConcentrations
(pmol/106Cells)
Projected CWk52 ISL-TP:
~ 0.076 pmol/106 cells
0.000
0.005
0.010
0.015
0.020
0 10 20 30 40 50
Wks
0.00
0.02
0.04
0.06
0.08
Projected ISL-TP
PrEP PK threshold: 0.05 pmol/106 cells
Mean observed plasma data
Model fit
O
N
N
N N
F
NH3
OH
HOTranslocation Inhibition
Due to the 4’-ethynyl group
vRNA
vDNA
*Prevents nucleotide binding and
incorporation to the DNA chain, resulting
in immediate chain termination
vRNA
vDNA
*Prevents nucleotide incorporation even
in the event of translocation
*ISL is no longer susceptible to resistance-
conferring mutations, once out of the
active site
Delayed Chain Termination
Due to the 4’-ethynyl and 3’-hydroxyl groups
40. P011: ISL + DOR Following ISL, DOR, 3TC Induction in
Treatment-Naive Patients
Analysis of patients discontinuing international, randomized, double-blind phase IIb trial with PDVF
PDVF defined as: Viral rebound (HIV-1 RNA ≥ 50 c/mL after initial response < 50 c/mL on study; or confirmed HIV-1 RNA
> 1 log increase from nadir after a > 1 log decrease vs BL on study); or nonresponse (HIV-1 RNA ≥ 200 c/mL at any time from
Wk 24 through Wk 48; or confirmed HIV-1 RNA ≥ 50 c/mL at Wk 48)
Initial PDVF HIV-1 RNA level must be confirmed by subsequent measurement within 2 wks
Orkin. AIDS 2020. Abstr OAB0302. DeJesus. AIDS 2020. Abstr OAB0305.
Treatment-naive adults with
HIV-1 RNA ≥ 1000 c/mL,
CD4+ count ≥ 200 cells/mm3,
no ARV drug resistance,
no active HCV or HBV
coinfection
(N = 121)
Part 1:
3-Drug Dose Ranging
ISL 0.25 mg + DOR + 3TC QD*
(n = 29)
DOR/3TC/TDF QD†
(n = 31)
ISL 0.75 mg + DOR + 3TC QD*
(n = 30)
ISL 2.25 mg + DOR + 3TC QD*
(n = 31)
Stratified by screening HIV-1 RNA
(≤ vs > 100,000 c/mL)
ISL 0.25 mg + DOR QD
(n = 29)
DOR/3TC/TDF QD
(n = 28)
ISL 0.75 mg + DOR QD
(n = 30)
ISL 2.25 mg + DOR QD
(n = 27)
Part 2:
2-Drug Dose Ranging
If HIV-1 RNA < 50 c/mL at Wk 20
without meeting any VF criteria‡
Wk 24 Wk 48
Maintenance phase
*Received placebo for DOR/3TC/TDF QD.
†Received placebo for ISL + DOR + 3TC QD.
‡If HIV-1 RNA ≥ 50 c/mL at Wk 20,
continued Part 1 until HIV-1 RNA < 50 c/mL
and, if not meeting any VF criteria,
transitioned to Part 2.
Slide credit: clinicaloptions.com
41. P011: Virologic Outcomes Through Wk 48 (FDA Snapshot)
Orkin. AIDS 2020. Abstr OAB0302. Reproduced with permission.
HIV-1 RNA < 50 copies/mL HIV-1 RNA ≥ 50 copies/mL No Virologic Data in Window
ISL 0.25 mg + DOR* QD
ISL 0.75 mg + DOR* QD
ISL 2.25 mg + DOR* QD
DOR/3TC/TDF QD
Patients(%)
26/29 27/30 24/31 26/31 2/29 2/30 4/31
*Participants initially received ISL + DOR + 3TC and switched to ISL + DOR during the Wk 24-48 period of the study.
Slide credit: clinicaloptions.com
n/N =
89.7
6.9
3.4
90
6.7
3.3
77.4
12.9
9.7
83.9
6.5
9.7
0
20
40
60
80
100
2/31 1/29 1/30 3/31 3/31
42. Lenacapavir Pharmacokinetic Profile
Lenacapavir (GS-6207): First-in-class selective HIV-1 capsid protein inhibitor with PO and
SC long-acting formulations in development
Randomized, double-blind, placebo controlled, single-ascending SC dose phase I study in HIV-negative
participants (N = 30)
Begley. AIDS 2020. Abstr PEB0265. Slide credit: clinicaloptions.com
LEN 900 mg (3 x 1 mL; n = 8)
LEN 300 mg (1 x 1 mL; n = 8)
LEN 900 mg (2 x 1.5 mL; n = 8)
Mean LEN Single-Dose Plasma Concentration-Time Profiles
6 mos
(26 wks)
24 ng/mL;
mean IQ ≥ 6*
Wks Post-SC Dose
560 4 8 12 16 20 24 28 32 36 40 44 48 52
100
10
1
0.1
MeanLEN,ng/mL(SD)
*Protein-adjusted EC95:
macrophages, 1.16 ng/mL;
CD4+ cells, 2.32 ng/mL, MT-4
cells, 3.87 ng/mL.
43. clinicaloptions.com/hiv
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