Update from the 23rd Conference on Retroviruses and Opportunistic Infections (CROI), Boston, MA 22-25 Feb 2016
Charles Hicks, M.D.
April 1, 2016
UCSD HIV & Global Health Rounds
Clinical Impact of New HIV Data From the 2016 Comorbidities-Adverse Drug Reac...hivlifeinfo
In this downloadable slideset, expert faculty members Todd T. Brown, MD, PhD, and Jordan E. Lake, MD, MSc, review key studies presented at the 2016 Comorbidities/Adverse Drug Reactions Workshop.
Format: Microsoft PowerPoint (.ppt)
File size: 1.37 MB
Date posted: 10/14/2016
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
Current Controversies in Managing HIV-Infected Patients.2014Hivlife Info
This document discusses controversies in managing HIV-infected patients. It begins with a discussion on whether all naive patients should be started on an integrase inhibitor regimen. It reviews key trials demonstrating the efficacy of integrase inhibitors in treatment-naive patients. Expert panel discussion notes some integrase inhibitors have advantages like high barriers to resistance but others have drawbacks like twice-daily dosing. The next section examines the controversy around performing anal Pap smears routinely on all HIV+ MSM, reviewing guidelines and suggested screening paradigms. The final section discusses the controversy around evaluating all HIV+ patients over 50 with DXA scans. It reviews data on bone disease prevalence and recommendations, including evaluating risk factors before obtaining scans.
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: 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
This document summarizes an expert panel discussion on innovative antiretroviral therapy (ART) paradigms. The panel discussed whether positive results from two-drug and long-acting injectable regimens in clinical trials will translate to long-term efficacy and safety. They also considered the potential risks of resistance emerging with two-drug regimens and the impact of missed doses with long-acting injectables. The panel agreed that maintaining cold storage requirements for long-acting injectables may pose challenges for implementation in low- and middle-income countries but that qualitative research found patients highly satisfied with the convenience of long-acting ART.
Современное лечение ВИЧ : лечение возрастных пациентов.2017/Contemporary Management of HIV. Management of Aging Patients.2017
In this downloadable slideset, Edgar Turner Overton, MD, and Program Director Joseph J. Eron, Jr., MD, review key data on managing aging patients with HIV.
Source: Contemporary Management of HIV
Date Posted: 4/24/2017
Аллопуринол и прогрессирование ХБП и кардиоваскулярные события. РКИ / Allopur...hivlifeinfo
Allopurinol and Progression of CKD and Cardiovascular Events- Long-term Follow-up of a Randomized Clinical Trial.Am J Kidney Dis. 2015 Apr
Background:Asymptomatic hyperuricemia increases renal and cardiovascular (CV) risk. We previously
conducted a 2-year, single-blind, randomized, controlled trial of allopurinol treatment that showed improved
estimated glomerular filtration rate and reduced CV risk.
Study Design:Post hoc analysis of a long-term follow-up after completion of the 2-year trial.
Setting & Participants:113 participants (57 in the allopurinol group and 56 in the control group) initially
followed up for 2 years and 107 participants followed up to 5 additional years.
Intervention: Continuation of allopurinol treatment, 100 mg/d, or standard treatment.
Outcome:Renal event (defined as starting dialysis therapy and/or doubling serum creatinine and/or$50%
decrease in estimated estimated glomerular filtration rate) and CV events (defined as myocardial infarction,
coronary revascularization or angina pectoris, congestive heart failure, cerebrovascular disease, and peripheral vascular disease).
Results:During initial follow-up, there were 2 renal and 7 CV events in the allopurinol group compared with
6 renal and 15 CV events in the control group. In the long-term follow-up period, 12 of 56 participants taking
allopurinol stopped treatment and 10 of 51 control participants received allopurinol. During long-term follow-up,
an additional 7 and 9 participants in the allopurinol group experienced a renal or CV event, respectively, and an
additional 18 and 8 participants in the control group experienced a renal or CV event, respectively. Thus,
during the initial and long-term follow-up (median, 84 months), 9 patients in the allopurinol group had a
renal event compared with 24 patients in the control group (HR, 0.32; 95% CI, 0.15-0.69; P50.004;
adjusted for age, sex, baseline kidney function, uric acid level, and renin-angiotensin-aldosterone system
blockers). Overall, 16 patients treated with allopurinol experienced CV events compared with 23 in the
control group (HR, 0.43; 95% CI, 0.21-0.88;P50.02; adjusted for age, sex, and baseline kidney function).
Limitations:Small sample size, single center, not double blind, post hoc follow-up and analysis.
Conclusions: Long-term treatment with allopurinol may slow the rate of progression of kidney disease and
reduce CV risk.
Clinical Impact of New HIV Data From the 2016 Comorbidities-Adverse Drug Reac...hivlifeinfo
In this downloadable slideset, expert faculty members Todd T. Brown, MD, PhD, and Jordan E. Lake, MD, MSc, review key studies presented at the 2016 Comorbidities/Adverse Drug Reactions Workshop.
Format: Microsoft PowerPoint (.ppt)
File size: 1.37 MB
Date posted: 10/14/2016
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
Current Controversies in Managing HIV-Infected Patients.2014Hivlife Info
This document discusses controversies in managing HIV-infected patients. It begins with a discussion on whether all naive patients should be started on an integrase inhibitor regimen. It reviews key trials demonstrating the efficacy of integrase inhibitors in treatment-naive patients. Expert panel discussion notes some integrase inhibitors have advantages like high barriers to resistance but others have drawbacks like twice-daily dosing. The next section examines the controversy around performing anal Pap smears routinely on all HIV+ MSM, reviewing guidelines and suggested screening paradigms. The final section discusses the controversy around evaluating all HIV+ patients over 50 with DXA scans. It reviews data on bone disease prevalence and recommendations, including evaluating risk factors before obtaining scans.
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: 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
This document summarizes an expert panel discussion on innovative antiretroviral therapy (ART) paradigms. The panel discussed whether positive results from two-drug and long-acting injectable regimens in clinical trials will translate to long-term efficacy and safety. They also considered the potential risks of resistance emerging with two-drug regimens and the impact of missed doses with long-acting injectables. The panel agreed that maintaining cold storage requirements for long-acting injectables may pose challenges for implementation in low- and middle-income countries but that qualitative research found patients highly satisfied with the convenience of long-acting ART.
Современное лечение ВИЧ : лечение возрастных пациентов.2017/Contemporary Management of HIV. Management of Aging Patients.2017
In this downloadable slideset, Edgar Turner Overton, MD, and Program Director Joseph J. Eron, Jr., MD, review key data on managing aging patients with HIV.
Source: Contemporary Management of HIV
Date Posted: 4/24/2017
Аллопуринол и прогрессирование ХБП и кардиоваскулярные события. РКИ / Allopur...hivlifeinfo
Allopurinol and Progression of CKD and Cardiovascular Events- Long-term Follow-up of a Randomized Clinical Trial.Am J Kidney Dis. 2015 Apr
Background:Asymptomatic hyperuricemia increases renal and cardiovascular (CV) risk. We previously
conducted a 2-year, single-blind, randomized, controlled trial of allopurinol treatment that showed improved
estimated glomerular filtration rate and reduced CV risk.
Study Design:Post hoc analysis of a long-term follow-up after completion of the 2-year trial.
Setting & Participants:113 participants (57 in the allopurinol group and 56 in the control group) initially
followed up for 2 years and 107 participants followed up to 5 additional years.
Intervention: Continuation of allopurinol treatment, 100 mg/d, or standard treatment.
Outcome:Renal event (defined as starting dialysis therapy and/or doubling serum creatinine and/or$50%
decrease in estimated estimated glomerular filtration rate) and CV events (defined as myocardial infarction,
coronary revascularization or angina pectoris, congestive heart failure, cerebrovascular disease, and peripheral vascular disease).
Results:During initial follow-up, there were 2 renal and 7 CV events in the allopurinol group compared with
6 renal and 15 CV events in the control group. In the long-term follow-up period, 12 of 56 participants taking
allopurinol stopped treatment and 10 of 51 control participants received allopurinol. During long-term follow-up,
an additional 7 and 9 participants in the allopurinol group experienced a renal or CV event, respectively, and an
additional 18 and 8 participants in the control group experienced a renal or CV event, respectively. Thus,
during the initial and long-term follow-up (median, 84 months), 9 patients in the allopurinol group had a
renal event compared with 24 patients in the control group (HR, 0.32; 95% CI, 0.15-0.69; P50.004;
adjusted for age, sex, baseline kidney function, uric acid level, and renin-angiotensin-aldosterone system
blockers). Overall, 16 patients treated with allopurinol experienced CV events compared with 23 in the
control group (HR, 0.43; 95% CI, 0.21-0.88;P50.02; adjusted for age, sex, and baseline kidney function).
Limitations:Small sample size, single center, not double blind, post hoc follow-up and analysis.
Conclusions: Long-term treatment with allopurinol may slow the rate of progression of kidney disease and
reduce CV risk.
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.
Integrating Recent Data When Selecting First-line Antiretroviral Therapy.2015...Hivlife Info
Joseph J. Eron Jr., MD
W. David Hardy, MD
Paul E. Sax, MD
How do leading experts select first-line antiretroviral therapy for their HIV-infected patients?
Review these downloadable slides for key clinical trial data and the latest DHHS recommendations for first-line antiretroviral therapy.
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
Топ достижений лечения ВИЧ в 2017 г / Top Advances in ART for 2017hivlifeinfo
Top Advances in ART for 2017
In this downloadable slideset, Joel E. Gallant, MD, MPH, provides a comprehensive update on ART management.
Format: Microsoft PowerPoint (.ppt)
File size: 579 KB
Date posted: 3/29/2017
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.
This systematic review examined the association between hormonal contraceptive use and HIV disease progression among women living with HIV. The review included 12 studies, with 1 randomized controlled trial and 11 observational studies. Most studies found no association between hormonal contraceptive use, including oral contraceptives and injectables, and mortality or progression to AIDS. However, the randomized trial found increased rates of disease progression markers among hormonal contraceptive users compared to IUD users. The review also examined changes in CD4 count and viral load with hormonal contraceptive use, with most observational studies finding no adverse effects. Overall, the evidence suggests hormonal contraceptives do not negatively impact HIV disease, though limitations in the current research were noted.
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
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.
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.
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
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.
(Ohio State's 2016 ASH Review) ASH 2015 REVIEW – LYMPHOMA ABSTRACTSOSUCCC - James
This document summarizes key abstracts presented at the American Society of Hematology (ASH) 2015 conference related to lymphoma subtypes including mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and Hodgkin's lymphoma (HL). For MCL, abstracts showed that bortezomib maintenance after immunochemotherapy and stem cell transplant improved progression-free survival compared to consolidation or historical controls. Pre-transplant treatment with R-bendamustine induced high rates of minimal residual disease negativity associated with improved outcomes. For DLBCL, adding bortezomib to R-CHOP in non-germinal center subtype showed improved response rates
Современное лечение ВИЧ: когда начинать, чем начинать. Contemporary Managemen...hivlifeinfo
.Contemporary Management of HIV. When to Start, What to Start.2016/Современное лечение ВИЧ: когда начинать, чем начинать.
In this downloadable slideset, Daniel R. Kuritzkes, MD, and Program Director Eric S. Daar, MD review key data and optimal approaches for first-line ART with contemporary HIV regimens.
Format: Microsoft PowerPoint (.ppt)
File size: 2.53 MB
Date posted: 2/9/2016
This document provides an overview and summary of recent data on antiretroviral therapy (ART) for HIV. Key findings include:
- A study in Thailand found that daily oral tenofovir reduced HIV infection risk among injection drug users by 48.9%, leading to new guidelines recommending PrEP for high-risk drug users.
- US demonstration projects found high adherence to PrEP among at-risk populations, with tenofovir levels indicating protection.
- Multiple studies found dolutegravir to be superior to other regimens in suppressing HIV and had fewer side effects, establishing it as a preferred integrase inhibitor.
- No transmissions occurred in a large study of serod
Highlights of IAS 2013.CCO Official Conference Coverage of the 7th IAS Confer...Hivlife Info
The document summarizes highlights from the 7th IAS Conference on HIV Pathogenesis, Treatment, and Prevention held in Kuala Lumpur, Malaysia in June-July 2013. Key findings included the WHO updating treatment guidelines to recommend initiating ART at CD4 counts ≤500 cells/mm3 and preferring TDF+3TC(FTC)+EFV as the initial regimen. Studies found noninferiority of 400mg EFV and demonstrated the efficacy of second-line LPV/r-based ART and PrEP with TDF in specific populations. Adherence to treatment was an important factor in outcomes.
HIV and Cardiovascular Disease.How Worried Should We Be ? 2015Hivlife Info
In this downloadable slideset, David A. Wohl, MD, reviews the association between HIV and cardiovascular disease, including potential contributing factors and best practices in prevention.
Format: Microsoft PowerPoint (.ppt)
File size: 5.01 MB
Date posted: 6/26/2015
In this downloadable slideset, Joseph J. Eron, Jr., MD, reviews the evidence behind the latest antiretroviral guidelines and offers a glimpse at potential future agents and strategies currently under investigation.
Format: Microsoft PowerPoint (.ppt)
File size: 2.06 MB
Date posted: 6/1/2016
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
Update on HIV Prevention Issues Presented at 2016 CROI
Helen King MD
Jill Blumenthal MD
Susannah Graves MD
May 13, 2016
UCSD HIV & Global Health Rounds
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
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.
Integrating Recent Data When Selecting First-line Antiretroviral Therapy.2015...Hivlife Info
Joseph J. Eron Jr., MD
W. David Hardy, MD
Paul E. Sax, MD
How do leading experts select first-line antiretroviral therapy for their HIV-infected patients?
Review these downloadable slides for key clinical trial data and the latest DHHS recommendations for first-line antiretroviral therapy.
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
Топ достижений лечения ВИЧ в 2017 г / Top Advances in ART for 2017hivlifeinfo
Top Advances in ART for 2017
In this downloadable slideset, Joel E. Gallant, MD, MPH, provides a comprehensive update on ART management.
Format: Microsoft PowerPoint (.ppt)
File size: 579 KB
Date posted: 3/29/2017
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.
This systematic review examined the association between hormonal contraceptive use and HIV disease progression among women living with HIV. The review included 12 studies, with 1 randomized controlled trial and 11 observational studies. Most studies found no association between hormonal contraceptive use, including oral contraceptives and injectables, and mortality or progression to AIDS. However, the randomized trial found increased rates of disease progression markers among hormonal contraceptive users compared to IUD users. The review also examined changes in CD4 count and viral load with hormonal contraceptive use, with most observational studies finding no adverse effects. Overall, the evidence suggests hormonal contraceptives do not negatively impact HIV disease, though limitations in the current research were noted.
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
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.
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.
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
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.
(Ohio State's 2016 ASH Review) ASH 2015 REVIEW – LYMPHOMA ABSTRACTSOSUCCC - James
This document summarizes key abstracts presented at the American Society of Hematology (ASH) 2015 conference related to lymphoma subtypes including mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and Hodgkin's lymphoma (HL). For MCL, abstracts showed that bortezomib maintenance after immunochemotherapy and stem cell transplant improved progression-free survival compared to consolidation or historical controls. Pre-transplant treatment with R-bendamustine induced high rates of minimal residual disease negativity associated with improved outcomes. For DLBCL, adding bortezomib to R-CHOP in non-germinal center subtype showed improved response rates
Современное лечение ВИЧ: когда начинать, чем начинать. Contemporary Managemen...hivlifeinfo
.Contemporary Management of HIV. When to Start, What to Start.2016/Современное лечение ВИЧ: когда начинать, чем начинать.
In this downloadable slideset, Daniel R. Kuritzkes, MD, and Program Director Eric S. Daar, MD review key data and optimal approaches for first-line ART with contemporary HIV regimens.
Format: Microsoft PowerPoint (.ppt)
File size: 2.53 MB
Date posted: 2/9/2016
This document provides an overview and summary of recent data on antiretroviral therapy (ART) for HIV. Key findings include:
- A study in Thailand found that daily oral tenofovir reduced HIV infection risk among injection drug users by 48.9%, leading to new guidelines recommending PrEP for high-risk drug users.
- US demonstration projects found high adherence to PrEP among at-risk populations, with tenofovir levels indicating protection.
- Multiple studies found dolutegravir to be superior to other regimens in suppressing HIV and had fewer side effects, establishing it as a preferred integrase inhibitor.
- No transmissions occurred in a large study of serod
Highlights of IAS 2013.CCO Official Conference Coverage of the 7th IAS Confer...Hivlife Info
The document summarizes highlights from the 7th IAS Conference on HIV Pathogenesis, Treatment, and Prevention held in Kuala Lumpur, Malaysia in June-July 2013. Key findings included the WHO updating treatment guidelines to recommend initiating ART at CD4 counts ≤500 cells/mm3 and preferring TDF+3TC(FTC)+EFV as the initial regimen. Studies found noninferiority of 400mg EFV and demonstrated the efficacy of second-line LPV/r-based ART and PrEP with TDF in specific populations. Adherence to treatment was an important factor in outcomes.
HIV and Cardiovascular Disease.How Worried Should We Be ? 2015Hivlife Info
In this downloadable slideset, David A. Wohl, MD, reviews the association between HIV and cardiovascular disease, including potential contributing factors and best practices in prevention.
Format: Microsoft PowerPoint (.ppt)
File size: 5.01 MB
Date posted: 6/26/2015
In this downloadable slideset, Joseph J. Eron, Jr., MD, reviews the evidence behind the latest antiretroviral guidelines and offers a glimpse at potential future agents and strategies currently under investigation.
Format: Microsoft PowerPoint (.ppt)
File size: 2.06 MB
Date posted: 6/1/2016
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
Update on HIV Prevention Issues Presented at 2016 CROI
Helen King MD
Jill Blumenthal MD
Susannah Graves MD
May 13, 2016
UCSD HIV & Global Health Rounds
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
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
Edward Cachay, MD, MAS
Professor of Medicine
Division of Infectious Diseases & Global Public Health
Department of Medicine
University of California, San Diego
This document provides an overview and summary of recent data on antiretroviral therapy (ART) for HIV. Key findings include:
- A study in Thailand found that daily oral tenofovir reduced HIV infection risk among injection drug users by 48.9%, leading to new guidelines recommending PrEP for high-risk drug users.
- US demonstration projects found high adherence to PrEP among at-risk populations, with tenofovir levels indicating protection.
- Multiple studies found dolutegravir to be superior to other regimens in treatment-naive patients, maintaining activity even at high viral loads.
- No transmissions occurred in a large study of serodiscordant couples where the
This document summarizes the results of a program implemented across the MedStar Health network to improve hepatitis C virus (HCV) testing and linkage to care. Key results include:
- Of over 50,000 patients in the birth cohort (born 1945-1965) tested for HCV antibodies, 1% (64 patients) tested positive.
- Testing was higher in women overall, but men were more likely to test HCV antibody positive.
- The next steps of the program are to improve linkage to care for those testing positive and identify barriers to broader HCV testing.
This document summarizes the results of a program implemented across the MedStar Health network to improve hepatitis C virus (HCV) testing and linkage to care. Key results include:
- Of over 50,000 patients in the birth cohort (born 1945-1965) tested for HCV antibodies, 1% (64 patients) tested positive.
- Testing was higher in women overall, but men were more likely to test HCV antibody positive.
- The next steps of the program are to improve linkage to care for those testing positive and identify barriers to testing and care.
ВИЧ-инфекция у женщин : стратегии 3 ключевых глобальных проблем.2016.HIV In...hivlifeinfo
ВИЧ-инфекция у женщин : стратегии 3 ключевых глобальных проблем.2016.HIV Infection Among Women- Strategies to Address 3 Key Global Challenges .2016
In this downloadable slideset, Catherine Hankins, MD, PhD, FRCPC, CM, reviews current global challenges for HIV-infected women and explores methods for HIV prevention and ART delivery, particularly in resource-limited settings.
Format: Microsoft PowerPoint (.ppt)
File size: 1.03 MB
Date posted: 9/1/2016
1. Hepatocellular carcinoma (HCC) is the 6th most common cancer worldwide and has a high mortality rate of over 95%.
2. Chronic infection with hepatitis B and C viruses are the leading risk factors for HCC development, with cirrhosis being a prerequisite in many cases.
3. Screening high-risk individuals such as hepatitis B carriers and cirrhotic patients can detect HCC at an early stage and improve outcomes. Treatment options include surgical resection, liver transplantation, and local ablative therapies depending on tumor stage.
1) The document discusses the HPV vaccine and summarizes data from clinical trials of the Cervarix and Gardasil vaccines. It finds that Cervarix demonstrated 93.2% efficacy against CIN3+ lesions irrespective of HPV type, while Gardasil demonstrated 43.0% efficacy against the same endpoint.
2) Long-term follow up data of the Cervarix vaccine showed sustained high antibody levels and protection against CIN3+ lesions up to 9 years post-vaccination. Challenge studies found Cervarix elicited an anamnestic response.
3) Both vaccines were well tolerated and showed cross-protection against non-vaccine HPV types. However, Cervarix demonstrated higher long
Current Controversies in Managing HIV-Infected Patients.2014hivlifeinfo
This document discusses controversies around bone density screening in HIV-positive patients. It presents recommendations from guidelines that baseline bone density screening with DXA scans should be performed for all HIV-positive postmenopausal women and men aged 50 years or older. Studies show both osteopenia and osteoporosis are more common in the HIV-positive population compared to HIV-negative controls. The odds of osteoporosis are approximately 3-4 times higher for HIV patients.
This document summarizes a presentation on tackling prostate cancer and improving treatment outcomes. It discusses that prostate cancer incidence is increasing due to aging and screening. Prostate cancer is the second most common cancer in men and is an androgenic disease related to testosterone and the androgen receptor. The presentation reviews prostate cancer risk stratification and how docetaxel added to androgen deprivation therapy can improve outcomes for metastatic hormone-sensitive prostate cancer based on clinical trial results. It also discusses therapies such as abiraterone that have shown survival benefits for castrate-resistant prostate cancer based on additional clinical trials.
Современное лечение ВИЧ: новые парадигмы в АРТ / Contemporary Management of H...hivlifeinfo
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This document discusses adrenal cortical carcinoma (ACC), a rare but aggressive form of cancer. It provides information on the epidemiology, clinical presentation, prognostic factors, treatment approaches including mitotane and chemotherapy, and clinical trials for ACC. Recent studies have found that achieving mitotane plasma levels above 14 mg/L within 3 months of treatment and maintaining these levels is associated with better outcomes for patients with ACC. Larger international collaborations are working to advance the treatment of this disease.
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.
Современное лечение ВИЧ.Обобщённые данные с конференции CROI 2020 / Contempor...hivlifeinfo
This document summarizes data presented at CROI 2020 on current and investigational antiretroviral therapies (ART) for HIV. Key findings include:
- A pooled analysis found the 3-drug regimen bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was effective and well-tolerated in people over age 50 similar to younger patients.
- The switch to BIC/FTC/TAF was noninferior to remaining on baseline regimens even in people with baseline nucleoside reverse transcriptase inhibitor resistance.
- Through week 96, dolutegravir plus lamivudine was similarly effective
Antibiotic prophylaxis in sever Acute PanceriatitisSaeed Al-Shomimi
This document summarizes a systematic review and meta-analysis of randomized controlled trials examining whether antibiotic prophylaxis is protective in severe acute pancreatitis. The review included 502 patients from studies comparing antibiotic prophylaxis to placebo. The meta-analysis found no significant difference in mortality between the antibiotic and placebo groups, with a relative risk of 0.76. Sensitivity analyses also found no benefit of antibiotics on outcomes like infected necrosis, surgical interventions, or mortality in higher quality studies. The only benefit seen was a reduction in non-pancreatic infections with antibiotics.
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.
Similar to Update from the 23rd Conference on Retroviruses and Opportunistic Infections (CROI), Boston, MA 22-25 Feb 2016 (20)
Katherine Promer Flores, MD (she/her)
Staff Physician
Division of Infectious Diseases and Global Public Health
Department of Medicine
University of California San Diego
Daniel Lee, MD
Clinical Professor of Medicine
Division of Infectious Diseases & Global Public Health
Department of Medicine
University of California, San Diego
Leandro Mena, MD, MPH
Chair and Professor of Population Health Science
Department of Population Health Science
University of Mississippi Medical Center
Maile Young Karris, MD
Associate Professor
Co-Director San Diego Center for AIDS Research Clinical Investigations Core
Divisions of Infectious Diseases & Global Public Health and Geriatrics & Gerontology
Department of Medicine
University of California San Diego
Gabriel Wagner, MD
Associate Clinical Professor
Division of Infectious Diseases & Global Public Health
Department of Medicine
University of California, San Diego
Jocelyn Keehner, MD
Infectious Disease Fellow
Division of Infectious Diseases & Global Public Health
Department of Medicine
University of California, San Diego
This presentation summarizes research on cryptococcal antigen screening and treatment in resource-limited settings. It finds that screening individuals with CD4 counts <100 cells/uL and <200 cells/uL can reduce mortality, and point-of-care tests now enable screening in primary care clinics. Studies of simplified treatment regimens show promise, such as using high-dose liposomal amphotericin B for only 1-2 weeks. Field work in Mozambique demonstrated a 7.3% prevalence of cryptococcal antigenemia through screening at two clinics, and identified opportunities to improve care through expanded screening and ambulatory treatment models.
Richard Garfein, PhD, MPH
Professor
Herbert Wertheim School of Public Health and Human Longevity Science
Adjunct Professor
Division of Infectious Disease and Global Public Health
Department of Medicine
University of California, San Diego
Este documento fornece informações sobre uma sessão de treinamento virtual sobre HIV/AIDS para militares internacionais. A agenda inclui atualizações sobre a vacina COVID-19 e sua implementação na Nigéria, com discussões sobre implicações para pessoas vivendo com HIV. A sessão é conduzida pelo programa MIHTP-ECHO com o objetivo de melhorar o atendimento e prevenção de HIV em militares em todo o mundo.
This document provides information about a MIHTP-ECHO training session on COVID-19 vaccines. It includes the agenda, presenters, and an overview of MIHTP and the ECHO model. The presentation by Dr. Allen McCutchan will discuss COVID epidemiology, vaccine mechanisms of action, effectiveness, safety, and duration of protection. It will also cover implications for people living with HIV and emerging variants. A presentation by Captain UO Adekanye will provide an update on Nigeria's COVID vaccine rollout and implications for people living with HIV. The session aims to inform participants and facilitate discussion on these topics.
Laura Bamford, MD, MSCE
Associate Professor of Medicine
Medical Director, Owen Clinic
Division of Infectious Diseases and Global Public Health
Department of Medicine
University of California, San Diego
Davey Smith, MD, MAS
Professor of Medicine
Chief, Division of Infectious Diseases and Global Public Health
Co-Director, San Diego Center for AIDS Research (CFAR)
Department of Medicine
University of California, San Diego
Elliot Welford, MD
Infectious Diseases Fellow
Division of Infectious Diseases & Global Public Health
Department of Medicine
University of California, San Diego
Darcy Wooten, MD
Assistant Professor of Medicine
Associate Program Director, Infectious Diseases Fellowship
Division of Infectious Diseases & Global Public Health
Department of Medicine
University of California, San Diego
This document summarizes a presentation on new and investigational antiretrovirals given at the UC San Diego HIV & Global Health Rounds. The presentation reviewed fostemsavir, cabotegravir/rilpivirine, leronlimab, islatravir, and lenacapavir. For each drug, the presenter discussed indications, dosing, efficacy and safety data from clinical trials, resistance profiles, and potential advantages and limitations. The goal of the HIV & Global Health Rounds is to provide clinicians and researchers with the most up-to-date information on HIV, hepatitis, tuberculosis, and other infectious diseases.
This document summarizes a presentation on hepatitis C virus (HCV) epidemiology and screening recommendations. It discusses global and local HCV prevalence, the health impacts and economic costs of HCV infection, and the potential for HCV elimination with new direct-acting antiviral treatments. It also reviews evolving HCV screening guidelines and epidemiologic trends in the US, including increasing infections associated with opioid epidemics. Risk factors for HCV transmission are identified based on a study of HCV-positive blood donors.
Winston Tilghman, MD
Medical Director, STD Controller
HIV, STD & Hepatitis Branch of Public Health Services
County of San Diego Health & Human Services Agency
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Update from the 23rd Conference on Retroviruses and Opportunistic Infections (CROI), Boston, MA 22-25 Feb 2016
1.
2. Update from the 23rd
Conference on Retroviruses and
Opportunistic Infections (CROI),
Boston, MA
22-25 Feb 2016
Charles Hicks, M.D.
Professor of Clinical Medicine
Director, Owen Clinic
University of California, San Diego
3. Speaker Disclosures – April 2016
Charles Hicks, MD
• Royalties: UpToDate, Inc.
• Consulting Fees: BMS, ViiV, Merck, Janssen Virology
• IDMC: Medimmune (D5170C00002 Study)
• Other: Massachusetts Medical Society/NEJM: Associate
Editor and Contributor for Journal Watch-ID
6. CDC Estimated Lifetime Risk for HIV Infection
for Men in the United States
64
20
48
82
129 132
174
0
20
40
60
80
100
120
140
160
180
200
Risk(1inn)
Total Black Hispanic NHOPI AI/AN White Asian
Hess K, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 52.
7. CDC Estimated Lifetime Risk for HIV Infection
for Women in the United States
Risk(1inn)
Total Black Hispanic NHOPI AI/AN White Asian
227
48
227
385 399
880 883
0
100
200
300
400
500
600
700
800
900
1000
Hess K, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 52.
8. U.S. Clinics: Changes in Viral Load Over Time
CFAR Network of Integrated Clinical Systems (CNICS)
Cohort 29,467 Participants at 8 HIV Clinics
0
10
20
30
40
50
60
70
80
90
100
1997 1999 2001 2003 2005 2007 2009 2011 2013
Calendar Year
Percentage of Suppressed Viral Load Over Time
30%
87%
OR Std Err 95% CI P-value
Integrase Use 2.40 0.12 [2.17-2.66] <0.01
Male 1.42 0.09 [1.23-1.61] <0.01
Age (per year) 1.05 0.00 [1.04-1.05] <0.01
Race (White=Ref)
Black 0.48 0.03 [0.43-0.53] <0.01
Hispanic 1.09 0.08 [0.94-1.26] 0.27
Other/Missing 1.24 0.14 [0.99-1.55] 0.06
Years from Baseline 2.95 0.10 [2.76-3.14] <0.01
Simoni J, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 1034.
PercentofSubjects
9. Increasing Rates of Viral Suppression in
United States From 2009 to 2013
Medical Monitoring Project 2009-2013: surveillance data on
ART prescription and viral suppression in adults
Bradley H, et al. CROI 2016. Abstract 53.
*HIV-1 RNA < 200 c/mL at last test. †HIV-1 RNA < 200 c/mL at all tests from previous 12 mos.
100
80
60
40
20
0
Patients(%)
2009 2010 2011 2012 2013
Yr
βtrend = .01
βtrend = .02
βtrend = .03
58 60 62 66 68
72 74 76 77 80
89 90 92 93 94
ART prescription Viral suppression* Sustained viral suppression†
Slide credit: clinicaloptions.com
10. CDC: Change in Rates of HIV Suppression
in the United States: 2009 - 2013
2009 2013
% 95% CI % 95% CI
β
trend
change
Overall 72 69-74 80 78-83 0.02 +8
Women 66 62-70 77 73-80 0.02 +11
18-29 year olds 56 50-62 68 63-72 0.03 +12
30-39 year olds 62 58-65 75 70-80 0.03 +13
African Americans 64 61-68 76 72-79 0.03 +12
Bradley H, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 53.
OVERALL
12. HIV positive
Expected
yrs of life
remaining
at age 20
(dots)
Slide credit: clinicaloptions.com
Kaiser Permanente: Life Expectancy in
HIV-Infected vs Uninfected Persons
Analysis of life expectancy in 24,768 HIV-infected and 257,600 HIV-uninfected
adult pts in Kaiser Permanente California 1996-2011
2 groups matched for age, sex, medical center, year
Marcus JL, et al. CROI 2016. Abstract 54.
HIV negative
Deaths
per
100,000
person-
yrs (lines)
8000
6000
4000
2000
0
80
60
40
20
0
439
19
63
7077
65
53
1054
381
P < .001
P = .062
13-Yr Gap
1996-
1997
1998-
1999
2000-
2001
2002-
2003
2004-
2005
2006 2007 2008 2009 2010 2011
13. Slide credit: clinicaloptions.com
Kaiser Permanente: Factors Contributing to
Reduced Life Expectancy With HIV (2008-11)
Marcus JL, et al. CROI 2016. Abstract 54.
Factor
Expected Years of Life Remaining at Age 20 Years
HIV Infected and
Began ART With
CD4+ ≥ 500
cells/mm3
HIV Uninfected
Difference
(95% CI)
Overall 54.5 62.3 7.9 (5.1-10.6)
No HBV or HCV 55.4 62.6 7.2 (4.4-10.0)
No drug or
alcohol abuse
57.2 63.8 6.6 (3.9-9.3)
No smoking 58.9 64.3 5.4 (2.2-8.7)
None of the
above
59.2 65.0 5.7 (2.4-9.0)
14. ACTG A5257: Sex and Racial Disparities in
Virologic Outcomes With ART
ACTG A5257: randomized phase III comparison of ATV/RTV vs RAL
vs DRV/RTV (each with FTC + TDF) in ART-naive pts
Current analysis compared virologic outcomes in A5257 by sex and
race/ethnicity
Ribaudo HJ, et al. CROI 2016. Abstract 476.
0.5
0.4
0.3
0.2
0.1
0.0
CumulativeVFProbability
Wks since study entry
0 19224 48 64 80 128 16096
Women
Men
Wk 96 Unadjusted HR Women vs Men:
1.4 (95% CI: 1.1-1.9; P = .026)
Slide credit: clinicaloptions.com
0.5
0.4
0.3
0.2
0.1
0.0
Wks since study entry
0 19224 48 64 80 11212814416017696
Black
Hispanic
White
Wk 96 Unadjusted HR Black vs White:
2.8 (95% CI: 2.0-3.8; P < .001)
Wk 96 Unadjusted HR Hispanic vs
White: 2.0 (95% CI: 1.4-2.8; P = .001)
112 144 176
15. ACTG A5257: Multivariable Analysis of
Risk Factors Assoc. With Virologic Failure
Race/ethnicity adjustment eliminated excess VF risk
for women (P = .20)
Sociodemographic factor adjustment eliminated excess
VF risk for Latinos, but not for black pts
– aHR for Latinos: 1.16 (95% CI: 0.74-1.84)
– aHR for black pts: 1.68 (95% CI: 1.14-2.46)
Additional factors associated with increased VF risk
– Younger age
– Recent nonadherence
– High baseline HIV-1 RNA
– Underweight
Ribaudo HJ, et al. CROI 2016. Abstract 476.
– Low income
– Less education
– History of IV drug use
Slide credit: clinicaloptions.com
17. BMD Substudy of iPrEx: TDF/FTC PrEP vs
Placebo in HIV-Neg. High-Risk MSM/TGW
iPrEx: double-blind, randomized trial (N = 2499): 44% relative
reduction in cumulative HIV risk TDF/FTC vs PBO (P = .005)[1]
iPrEx DXA BMD substudy: (N = 498)[2]
– Small net decrease in spine (-0.91%) and total hip (-0.61%) BMD
with TDF/FTC vs PBO at Wk 24 (P = .001 for both); no difference
in fracture rate between groups (P = .62)
Current analysis evaluated BMD changes after PrEP stop visit[3]
Slide credit: clinicaloptions.com
1. Grant RM, et al. NEJM. 2010;363:2587-2599. 2. Mulligan K, et al. Clin
Infect Dis. 2015;61:572-580. 3. Grant R, et al. CROI 2016. Abstract 48LB.
DXA:
iPrEx RCT
Median: 1.2 yrs
PrEP Gap
Median: 1.5 yrs
iPrEx OLE
1.4 yrs
BL Every 24 Wks PrEP
Discont.
6 Mos Post
Discont.
OLE
Enroll
…
18. BMD Substudy of iPrEx: BMD Recovery
After Discontinuation of TDF/FTC PrEP
Slide credit: clinicaloptions.comGrant R, et al. CROI 2016. Abstract 48LB.
*P < .05; **P < .001.
ChangeinBMDFrom
iPrExEnrollment(%)
ChangeinBMDFrom
iPrExEnrollment(%)
SpineHip
BL Wk 24 Discont. 6-mos Post
Discont.
OLE
Enroll
BL Wk 24 Discont. 6-mos Post
Discont.
OLE
Enroll
2.0
1.5
1.0
0.5
0
-0.5
-1.0
-1.5
2.0
1.5
1.0
0.5
0
-0.5
-1.0
-1.5
3.0
2.0
1.0
0
-1.0
-2.0
-3.0
3.0
2.0
1.0
0
-1.0
-2.0
-3.0
Age younger than 25 yrs
Placebo
TFV-DP < 16 at Wk 24
TFV-DP ≥ 16 at Wk 24
Age 25 yrs or older
Age younger than 25 yrs
Age 25 yrs or older
**
**
** *
**
**
Data compared for TVF-DP < or ≥ 16 fmol/M viable PBMC, concentration associated
with 90% reduction in HIV infection risk in MSM/TGW
19.
20. HPTN-069/A5305: Maraviroc-Based PrEP
for MSM
Randomized, double-blind phase II trial
– Primary endpoints: safety (grade ≥ 3 AEs), tolerability
(rate/time to discontinuation of study drug)
Gulick R, et al. CROI 2016. Abstract 103.
Maraviroc*
(n = 101)
Maraviroc + FTC*
(n = 106)
- HIV-uninfected adults
- Condomless anal
intercourse with ≥ 1
HIV+ or HIV unknown
man in previous 90
days (N = 406)
Wk 48
*All standard dosing.
Maraviroc + TDF*
(n = 99)
FTC + TDF*
(n = 100)
Slide credit: clinicaloptions.com
21. HPTN-069/A5305
Safety, Tolerability, and Efficacy
67 grade 3/4 AEs; rates similar across arms
9% discontinued study drug early
– Rates of study drug discontinuation (P = .6) and time to permanent
discontinuation (P = .6) similar across arms
5 new HIV infections occurred during study for annual incidence rate
of 1.4% (95% CI: 0.8-2.3); all R5 tropic; no transmitted drug resistance
Age and Race of
Newly Infected Pt
Study Arm
First HIV+
Test (Wk)
HIV-1 RNA
(c/mL)
Plasma Drug Conc. at
Seroconv. Visit (ng/mL)*
20, black MVC + TDF 4 122,150 MVC: 0† TFV: 0
61, Asian MVC alone 16 981 MVC: 145
21, mixed race MVC alone 24 106,240 MVC: 0†
35, white MVC alone 32 13,626 MVC: 6.7
36, black MVC alone 48 52,191 MVC: 0.7
Gulick R, et al. CROI 2016. Abstract 103.
*Anticipated predose steady-state MVC concentration: 32 ng/mL. †Undetectable plasma drug
concentrations at every study visit.
Slide credit: clinicaloptions.com
22. McGowan I, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 104.
Maraviroc Less Effective at Inhibiting HIV
Following Infection of Tissue Explants
0
100
200
300
400
500
MVC only
MVC + FTC
MVC + TDF
TDF + FTC
HIV-1p24(pg/mL)
Baseline Week 24 Week 48 Week 49
23.
24. ÉCLAIR: Cabotegravir LA in HIV-Negative
Men at Low Risk for HIV Infection
Cabotegravir: potent InSTI formulated as oral tablet and for
long-acting (LA) IM injection
Randomized, double blind, phase IIa trial
– Primary endpoint: safety, tolerability of CAB LA IM injections
– No HIV seroconversions occurred during CAB LA dosing period
CAB LA 800 mg IM Q12W
(n = 106)
Saline Placebo IM Q12W
(n = 21)
Healthy adult
men at low risk
of HIV infection
(N = 127)
Oral Phase Injection Phase
CAB 30 mg
PO QD
Placebo
PO QD
Wk 4 Wk 5 Wk 41
Markowitz M, et al. CROI 2016. Abstract 106.
40-Wks of
follow-up
Slide credit: clinicaloptions.com
25. ÉCLAIR: Predicted vs Observed
Cabotegravir LA Pharmacokinetics
Peak CAB LA exposure higher and trough exposure lower than
predicted because of more rapid absorption rate after injection
– 15% to 31% Ctrough measures < protein-binding adjusted IC90; Q8W
dosing now under investigation
Mean(SD)PlasmaCAB
Concentration(μg/mL)
Time From First IM Dose (Wks)
Markowitz M, et al. CROI 2016. Abstract 106.
Geometric mean
Ctrough with 10 mg PO
QD: 1.35 μg/mL
(LATTE)
4 x Protein-binding
adjusted IC90: 0.664
μg/mL
Protein-binding
adjusted IC90: 0.166
μg/mL
10
1
0.1
0.01
0 1 4 8 1213 18 2425 30 36
Observed CAB 800 mg IM Q12W (ÉCLAIR; n = 94)
Simulated CAB 800 mg IM Q12W (males)
Slide credit: clinicaloptions.com
26. 0
10
20
30
40
50 Injection 1
Injection 2
Injection 3
ÉCLAIR Study: CAB Trough Concentrations
Following Each Injection
Desired trough
concentration
Markowitz M, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 106.
<1 x PA-IC90 1 x to <4 x PA-IC90 ≥4 x PA-IC90
24%
31%
15%
45%
37%
31%
30%
32%
55%
PercentofSubjects
27. ÉCLAIR: Patient Satisfaction With IM
Therapy vs Oral Phase
Slide credit: clinicaloptions.com
1. Markowitz M, et al. CROI 2016. Abstract 106.
2. Andrews CD, et al. CROI 2016. Abstract 104.
Patients(%)
How satisfied are you with your
current treatment?
100
80
60
40
20
0
Placebo (n = 21)CAB (n = 91)
More Neutral Less
100
80
60
40
20
0
How satisfied would you be to continue
with your present form of treatment?
62
23
71 29 74
81
15
24
5
Placebo (n = 21)CAB (n = 91)
15 11
19
0
Pt satisfaction assessed by questionnaire at Wk 18 of IM treatment
(one week after second injection)
28.
29. Baeten J, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 109LB.
ASPIRE Study:
Phase III Trial of Dapivirine Vaginal Ring
30. MTN-020/ASPIRE & IPM-027: Dapivirine
Vaginal Ring for HIV Prevention in Women
Silicone elastomer vaginal matrix ring containing NNRTI dapivirine 25
mg; new ring inserted Q4W
Randomized, double-blind, placebo-contolled, phase III trials
– MTN-020/ASPIRE[1,2]: Malawi, S. Africa, Uganda, Zimbabwe
– IPM-027 (The Ring Study)[3]: S. Africa, Uganda
– Primary endpoints: efficacy and safety
1. Baeten JM, et al. CROI 2016. Abstract 109LB. 2. Baeten JM, et al. N
Engl J Med. 2016;[Epub ahead of print]. 3. Nel A, et al. CROI 2016.
Abstract 110LB.
Dapivirine 25 mg Vaginal Ring Q4W
+ HIV Prevention Service Package
(ASPIRE: n = 1313; IPM-027: n = 1300)
Placebo Vaginal Ring Q4W
+ HIV Prevention Service Package
(ASPIRE: n = 1316; IPM-027: n = 650)
Sexually active HIV-
uninfected adult
women
(ASPIRE: N = 2629;
IPM-027: N = 1959)
≥ 1 Yr; Endpoint-
driven duration
Slide credit: clinicaloptions.com
32. ASPIRE: Phase III Trial of Dapivirine Vaginal Ring
Efficacy and Adherence
Adherence by Plasma Drug Concentration
and Concentration in Returned RingEfficacy
Age 18 – 21
-27% (-133, 31)
Placebo incidence – 5.4%/y
Age 22 – 26
+56% (19, 76)
Placebo incidence – 6.1%/y
Age 27 – 45
+51% (8, 74)
Placebo incidence – 3.0%/y
Baeten J, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 109LB.
Age 27-45
Age 22-26
Age 18-21
3 6 9 12 16 18 21 24 27 30 33
100
90
80
70
60
50
Month since randomization
PercentofSubjects
33. IPM027 Study:
Phase III Trial of Dapivirine Vaginal Ring
Nel A, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 110LB.
Variable
Dapivirine
(N = 1300)
Placebo
(N = 650)
Number of confirmed seroconversions 77 (5.9%) 56 (8.6%)
Total person years of follow-up (years) 1888 917
HIV-1 seroconversion rate
(per 100 person-years)
4.1 6.1
% reduction in HIV-1 seroconversion
(95% Cl)
[p-value]
31%
[0.9%, 51.5%)
[0.040]
34. IPM027 Study:
Efficacy by Residual Drug Level
Nel A, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 110LB.
Cut-off ring residual
level (mg)
Adherent vs. Non-adherent
% Reduction in HIV-
1 seroconversion
95% Cl
20 65% 21% to 84%
21 44% 7% to 67%
22 36% -8% to 62%
23.5 22% -40% to 56%
40. 0.2 0.5 1.0 2.0 5.0 10
START Trial: Impact on Cancer
• Results: Immediate vs. deferred ART initiation and the risk of any type cancer, infection-related
and infection-unrelated cancers in the START study
Borges A, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 160.
74% reduction in risk of infection related cancers (KS, HL & NHL,HPV)
Factors associated with risk of Infection-related cancers
• Older age and Higher baseline HIV RNA
Factors associated with risk of Infection-related cancers
• Residence in high income country
A: univariable, estimated in a Cox
proportional hazards model with a single
treatment indicator
B: adjusted for baseline covariates; age,
gender, race, geographical region,
smoking, BMI, hepatitis B/C, CD4 cell
count and baseline log10 HIV RNA
C: adjusted for latest HIV RNA,
modelled as <200 copies/mL vs HIV
RNA >200 copies/mL
D: adjusted for latest CD4 cell count and
latest HIV RNA (<200 copies/mL)
Model A
Model B
Model C
Model D
Model A
Model B
Model C
Model D
Model A
Model B
Model C
Model D
Any type cancer
(n=53)
Infection-related
cancer
(n=53)
Infection-unrelated
cancer
(n=53)
41. -4
-2
0
2
4
0 12 24 36 48 60
ChangefromBaseline
Months from Randomization
Current Health
(Visual Analog Scale, 0-100)
Immediate ART
Deferred ART
No of Participants:
Imm,: 2253 2150 1797 1038 559 146
Def.: 2287 2121 1773 1026 529 156
No of Participants:
Imm,: 2091 1977 1698 1014 555 145
Def.: 2119 1949 1677 993 521 153
-4
-2
0
2
4
0 12 24 36 48 60
ChangefromBaseline Months from Randomization
General Health
(SF-12 v2, Scaled 0-100)
Lifson A, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 475.
START Trial: Increased Quality of Life with
Immediate ART Initiation
42. • Review of resistance testing results in British Columbia since 2009
• Significant decline in detected PI an RT resistance; despite increase in use of integrase
inhibitors, rate of resistance remains very low
• Declining prevalence of drug resistant strains, and low prevalence of integrase inhibitor
resistance, to date
BC Cohort: Trends in Drug Class Resistance in
Recent Treatment Era
Lepik K, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 492LB.
331
316
304 300 292 290 285
1.07 1.67 3.26 4.28 4.84 6.14 6.8
0
50
100
150
200
250
300
350
2009 2010 2011 2012 2013 2014 2015
HIVDrugresistance/1000ART-
TreatedPersons*
Year
Prevalence of Drug Resistance
RT, PI resistance/1000 ART-treated
INI resistance/1000 ART-treated
Decreasing prevalence of RT, PI resistance,
trend p<0.001, R2 0.98
Increasing prevalence of INI resistance,
trend p<0.001, R2 0.98
43. Pooled E/C/F/TAF Studies: Pooled 48 Analysis of
HIV-1 Drug Resistance
Resistance Mutations Emerging (Final Resistance Analysis Population - RAP)
Abram M, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 496.
Subject Category
E/C/F/TAF
N=866
E/C/F/TDF
N=867
RAP (%; N with data) 24 (2.8; 22) 24 (2.8; 23)
Final RAP (%; N with data) 19 (2.2; 19) 16 (1.8; 15)
Any Primary Genotypic Resistance (%) 10 (1.2) 8 (0.9)
NRTI Resistance (%) 10 (1.2) 7 (0.8)a
M184V/I 9 (1.0) 6 (0.7)
K65R/N 2 (0.2) 3 (0.3)
K70R 1 (0.1) 1 (0.1)
INSTI Resistance (%) 8 (0.9) 6(0.7)
T66I/A/V 2 (0.2) 0
E92Q 4 (0.5) 2 (0.2)
Q148R 1 (0.1) 2 (0.2)
N155H/S 2 (0.2) 2 (0.2)
No Resistance (%) 9 (1.0) 7 (0.8)
a The subject without NRTI resistance had RT assay failure
44. TenoRes: Survey of Tenofovir Resistance
Following First-Line ART
Gregson J, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 503.
Lancet 2016.
TDF + NNRTI + M184V/I TDF + NNRTI
TDF + M184V/I TDF only
49%
71%
61%
42%
60%
74%
42%
71%
59%59%
71%
82%
34%
48%
0%
20%
40%
60%
80%
100%
Numberwithresistance(%)
39%
57%
Key for tenofovir mutations
Asia
(n=365)
Eastern Africa
(n=143)
Latin America
(n=68)
North America
(n=94)
South Africa
(n=404)
West/central
Africa (n=107)
Western Europe
(n=754)
35% 22%
56%
60%
20%
• 1926 patients with treatment failure from 36 countries; all treated with TDF plus FTC or 3TC, and NVP or
EFV
• Highest rates of tenofovir resistance in Africa (56-60%)
• Significant predictors of TDF resistance: Low CD4 cell count, use of 3TC vs FTC, and NVP vs EFV
• Study results demonstrate a substantial global reservoir of TDF resistance among patients with treatment
failure
45. -3
-2.8
-2.6
-2.4
-2.2
-2
0 2 4 8 12 24
ChangeinViralLoadfrombaseline(Log10)
Week
PADDLE
SPRING
SINGLE
-3
-2.8
-2.6
-2.4
-2.2
-2
0 2 4 8 12 24
ChangeinViralLoadfrombaseline(Log10)
Week
PADDLE
SPRING-1
SINGLE
pVL change at each time point
(Mean ±Standard error of the mean)
0.0 0.0
Sued O, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 947.
Cross Study PK Comparison: Comparable Viral
Decay in Dual and Triple Dolutegravir-based ART
pVL Change at Each Timepoint
(Mean=standard Error of the Mean)
pVL Change at Each Timepoint
(Mean=standard Error of the Mean),
Normalized per Baseline pVL
48. RCT,DB,
dose-finding,
2-part study
Patients:
• HIV-1+ ART naïve
• RNA ≥1,000 c/mL
• CD4 ≥100 cells/µL
• Stratified by screening
RNA (≤/>100k c/mL)
Part 2 began after
dose selection based
on Part 1 week
24 results.
Part 1 Dose Ranging Phase
(N=210)
Part 1
Extension Phase
DOR 25 mg
DOR 50 mg
DOR 100 mg (n=42) DOR 100 mg
DOR 200 mg
EFV 600 mg (n=43) Continue EFV
Part 2: Additional Patients, DOR Selected Dose vs EFV
(N=132)
DOR 100 mg (n=66)
EFV 600 mg (n=66)
Study 007: DOR 100 mg QD vs. EFV +TDF/FTC in
Naive HIV+ Patients – Week 48 Results
Gatell J, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 470.
Study Design
Week 48
Week 48
Week 96
Week 96
52. LATTE-2 Study: Maintenance Therapy with
Injectable Cabotegravir and Rilpivirine
Induction period
Week 32
Primary analysis
Dosing regimen
selection
Day 1
Randomization
2:2:1
Week 48
Analysis
Dosing regimen
confirmation
CAB 400 mg IM + RPV 600 mg IM
Q4W (n=115)
CAB 600 mg IM + RPV 900 mg IM
Q8W (n=115)
CAB 30 mg + ABC/3TC PO QD (n=56)
Week 96
CAB loading dose at Day 1
CAB loading doses at Day 1 and Week 4
CAB 30 mg +
ABC/3TC for
20 weeks
(N=309)
Maintenance period
Add RPV
4 weeks
Margolis D, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 31LB.
53. LATTE-2 Study: Week 32 Primary Endpoint:
HIV-1 RNA <50 c/mL by Snapshot (ITT-ME)
• No resistance detected in any study arm
• 82% experienced grade 1 injection site reactions, 17% grade 2 (moderate) – most
commonly pain, swelling, or nodules; one death (epilepsy), cause unclear
• Suppressive ART with IM cabotegravir and rilpivirine appears safe and effective;
further studies planned
Virologic Outcomes Treatment Differences (95% CI)
Oral
-4.8 12.2
Q8W
-5.8 11.5
Q4W
IM
Margolis D, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 31LB.
4 5
91
4 5
0
20
40
60
80
100
Virologic
success
Virologic
non-response
No virologic
data
HIV-1RNA<50c/mL,%
Q8W (n=115)
Q4W (n=115)
oral CAB (n=56)
95* 94*
<1 <1
54. How satisfied are you with
your current treatment?
How satisfied would you be to continue
with your present form of treatment?
97% 96% 71%
29%
0%
20%
40%
60%
80%
100%
Q8W (n=106) Q4W (n=100) Oral CAB (n=49)
More Neutral Less
98% 98% 71%
29%
0%
20%
40%
60%
80%
100%
Q8W (n=106) Q4W (n=100) Oral CAB (n=49)
More Neutral Less
3%
3% 2%
1%
1%
1%
Margolis D, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 31LB.
LATTE-2 Study: Patient Outcomes Comparing
Maintenance with Oral Induction Treatment
PatientPercent
55. Long-term follow-up through Week 96 (BMS-663068 1200 mg QD)Week 96
BMS-663068 1200mg QD was selected as the open-label continuation dose after Week 48
AI438011 Study:
BMS-663068 Oral HIV Attachment Inhibitor – 96 Week Results
DeJesus E, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 472.
Primary study – start of combination therapyDay 1
Data monitoring committee assessmentDay 8
Primary endpointWeek 24
Long-term follow-up through Week 48 (secondary endpoint)Week 48
BMS-663068 monotherapy sub-study: 10 subjects per study arm
BMS-663068
400 mg BID
+ RAL +TDF
N=50
BMS-663068
800 mg BID
+ RAL +TDF
N=50
BMS-663068
600 mg QD
+ RAL +TDF
N=50
BMS-663068
1200 mg QD
+ RAL +TDF
N=50
ATV/r
300/100 mg OD
+ RAL +TDF
N=50
Study Design
57. • NRTI with unique mechanism of action and unusual PK
• Active phosphorylated metabolite has prolonged intracellular persistence in human PMBCs,
with half-life of 150-160 hours
• Exploratory study of single 10 mg dose in HIV infected volunteers
• MK-8591, a novel NRT translocation inhibitor, suppresses HIV RNA by 1.75 log after a single
dose – long half life could lead to novel dosing or administration strategies
MK-8591: Long-acting NRTI
Grobler J, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 98;
Friedman E, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 437LB.
-2.5
-2
-1.5
-1
-0.5
0
0.5
0 5 10 15 20
ChangeFromBaselineHIV-1RNA
(log10c/mL)
Time (days)
TDF - 300 mg QD
TAF - 25 mg QD
MK-8591 - 10 mg QW
59. Slide credit: clinicaloptions.com
EuroSIDA: Impact of TDF Exposure on
Risk of Fractures in HIV-Infected Patients
Prospective analysis of 11,820 HIV-infected pts
Followed from baseline (Jan 2004) to last visit or death to
assess for fractures, femoral osteonecrosis
Borges AH, et al. CROI 2016. Abstract 46.
TDF Exposure
Any Fracture
IRR (95% CI)
Osteoporotic Fracture*
IRR (95% CI)
Univariate Multivariate† Multivariate†
Ever used vs never
used
1.71‡ (1.42-2.06) 1.40‡ (1.15-1.70) 1.10 (0.76-1.58)
On TDF vs not on
TDF
1.38‡ (1.16-1.64) 1.25‡ (1.15-1.70) 1.12 (0.79-1.60)
Cumulative TDF
exposure/5 yrs
1.28‡ (1.13-1.50) 1.08 (0.94-1.25) 0.99 (0.69-1.43)
*Fracture of the spine, arm, wrist, or hip. †Adjusted for demographics, HIV-specific variables, and
comorbidities. ‡P < .05.
60. Switch from F/TDF to F/TAF Efficacy at Week 48
F/TDF F/TAF
0
HIV-1RNA<50c/mL,%
94.3
0.3
5.4
93.0
1.5
5.5
0
20
40
60
80
100
Success Failure No Data
F/TAF (n=333) F/TDF (n=330)
‒10% +10%
5.1-2.5
1.3
Non-success
Treatment Difference (95% CI)Virologic Outcome
Gallant J, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 29.
62. Baseline 24 48
4
2
0
4
2
0
F/TDF to F/TAF:
Change in Bone Mineral Density through Week 48
Gallant J, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 29.
F/TAF, n 321 310 300
F/TDF, n 320 310 306
F/TAF, n 321 309 300
F/TDF, n 317 305 303
Spine
WeeksWeeks
Hip
Mean%change(95%Cl)
1.1
-0.2
P<0.001
1.5
-0.2
P<0.001
Baseline 24 48
63. ACTG 5298: Quadrivalent HPV Vax of Limited Utility
in Older HIV+ Adults
No Prevention of New Anal HPV Infections or Improvement
in HSIL Treatment Outcomes Over 2Yrs FU
Wilkin T, et al. 23rd CROI; Boston, MA; February 22-25, 2016. Abst. 161.
qHPV (n=288) Placebo (n=287) Hazard ratio ‡ (99.99% CI)
Persistent anal HPV
infection or single
detection at final visit
23/286 (8.0%) 28/283 (9.9%) 0.78 (0.31, 1.97)
Persistent anal HPV infection 9/286 (3.1%) 13/283 (4.6%) 0.66 (0.16, 2.75)
Persistent oral HPV infection
or single detection at final visit
3/288 (1.0%) 8/286 (2.8%) 0.36 (0.04, 3.33)
Persistent oral HPV Infection 0/288 (0%) 6/286 (2.1%) 0.00 (not able to calculate)
Anal HSIL on histology:
week 52 and beyond
38/288 (13.2%) 36/286 (12.5%) 1.03 (0.52, 2.05)
Abnormal cytology at baseline 182/285 (64%) 188/284 (66%) 0.96 (0.79, 1.16)
Abnormal cytology at week 52 123/231 (53%) 121/229 (53%) 1.00 (0.75, 1.33)
Abnormal cytology at week 104 94/191 (49%) 103/187 (55%) 0.90 (0.65, 1.24)
64. Variations across models anticipated given differences in outcome
ART use (ie, D:A:D score) did not improve discrimination vs ASCVD
Discrimination greater with ASCVD vs other models for all outcomes
Slide credit: clinicaloptions.com
Comparison of CVD Risk Scores in HIV-
Infected Patients
Compared expected and observed MI event rates using 4 risk scores
in 10,832 HIV-infected pts with 229 incident MI events in CNICS
– 3 general population CVD risk scores (Framingham, ATP3, 2013
ACC/AHA ASCVD) plus HIV-specific D:A:D score in CNICS pts
Crane HM, et al. CROI 2016. Abstract 42.
Risk of MI
Framingham ATP3 D:A:D ASCVD
HC CI HC CI HC CI HC CI
Type 1 MI 0.73* 0.69, 0.77 0.74* 0.70, 0.78 0.73* 0.68, 0.78 0.77 0.73, 0.81
Type 2 MI 0.63* 0.57, 0.69 0.63* 0.56, 0.69 0.62* 0.55, 0.68 0.72 0.67, 0.78
All MI 0.68* 0.65, 0.72 0.69* 0.65, 0.72 0.68* 0.64, 0.71 0.74 0.71, 0.77
*Harrell’s C significantly different vs ASCVD HC.
65. IMPAACT P1026s: DTG in Pregnancy[1]
Ongoing, nonrandomized,
open-label, phase IV study in
HIV+ pregnant women
DTG 50 mg QD: PK assessed
during 2nd trimester, 3rd
trimester, 3-12 wks postpartum,
and in infants
N = 21 women
– HIV-1 RNA ≤ 50 c/mL in 2nd
and 3rd trimester: 100%
– Med gestational age at birth:
38.9 wks
– 9/18 infants HIV-neg; HIV
status pending in 9/18
DTG trough and AUC exposure
lower in 2nd and 3rd trimester
vs postpartum
Antepartum DTG exposure
similar to levels observed in
nonpregnant adults
DTG elimination half-life > 2-
fold higher in infants vs
nonpregnant adults
Congenital anomalies in 4
infants
APR: 0/10 (1st trimester) and
1/18 (2nd or 3rd trimester) birth
defects with DTG exposure[2]
1. Mulligan N, et al. CROI 2016. Abstract 438.
2. APR. http://www.apregistry.com.
Slide credit: clinicaloptions.com