Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1

Emu, Brinda; Fessel, Jeffrey; Schrader, Shannon; Kumar, Princy; Richmond, Gary; Win, Sandra S.; Weinheimer, Steven P.; Marsolais, Christian; Lewis, Stanley T.

doi:10.1056/nejmoa1711460

Cited by 183 publications

(180 citation statements)

References 33 publications

Supporting

Mentioning

172

Contrasting

Unclassified

Order By: Relevance

“…This was the motivation behind the development of ibalizumab, an anti-CD4 monoclonal antibody recently approved by the FDA for use in patients who have failed previous HIV regimens. 30 This is also the reasoning behind continued development of PRO140, an anti-CCR5 monoclonal antibody for use in a similar patient population. 31 Both of these agents are expensive and must be given parenterally, limiting their use to high-income countries.…”

Section: New Drugs New Formulationsmentioning

confidence: 99%

“…First is the concern that more and more infected patients will harbor HIV that is resistant to available drugs. This was the motivation behind the development of ibalizumab, an anti‐CD4 monoclonal antibody recently approved by the FDA for use in patients who have failed previous HIV regimens . This is also the reasoning behind continued development of PRO140, an anti‐CCR5 monoclonal antibody for use in a similar patient population .…”

Section: New Drugs New Formulationsmentioning

confidence: 99%

See 1 more Smart Citation

Modern Human Immunodeficiency Virus Therapy: Progress and Prospects

Flexner

2018

Clin Pharma and Therapeutics

View full text Add to dashboard Cite

Safe and effective lifelong treatment to control human immunodeficiency virus (HIV) infection is one of the greatest scientific and public health achievements of the past century. The majority of infected individuals able to maintain a daily oral regimen now have a normal or near‐normal life expectancy. More than 30 approved drugs and dozens of formulations have produced thousands of possible drug combinations used clinically in the past, but today most patients receive only a handful of high priority and rigorously tested regimens. Unique features of antiretroviral therapy include the need for lifelong treatment to control virus replication and the possibility of rapid emergence of permanent drug resistance if these agents are not properly used. Although three‐drug combination oral regimens have radically altered the course of this epidemic, the future will include long‐acting injectable and implantable drugs and devices to treat and prevent infection.

show abstract

Section: New Drugs New Formulationsmentioning

confidence: 99%

Section: New Drugs New Formulationsmentioning

confidence: 99%

Modern Human Immunodeficiency Virus Therapy: Progress and Prospects

Flexner

2018

Clin Pharma and Therapeutics

View full text Add to dashboard Cite

show abstract

“…Maintaining FTC in the current regimen may not be necessary, but using agents with partial virologic activity (TAF) is a recommended strategy in MDR HIV . New ARV options for MDR HIV are now available and include ibalizumab or doravirine (based on its unique resistance profile) and could be an option for future ARV simplification …”

Section: What Is New and Conclusionmentioning

confidence: 99%

“…2,22 New ARV options for MDR HIV are now available and include ibalizumab or doravirine (based on its unique resistance profile) and could be an option for future ARV simplification. [23][24][25]…”

Section: What Is Ne W and Con Clus I Onmentioning

confidence: 99%

Successful use of once‐daily high‐dose darunavir and dolutegravir in multidrug‐resistant HIV

et al. 2019

View full text Add to dashboard Cite

What is known and objective? Antiretroviral (ARV) resistance may result during periods of consistently poor adherence. We report the successful use of a novel once‐daily (QD) ARV regimen in a patient with multidrug‐resistant (MDR) HIV. Case summary Once‐daily darunavir 1200 mg/ritonavir 100 mg, dolutegravir and emtricitabine/tenofovir alafenamide was initiated with directly observed therapy. With the assistance of therapeutic drug monitoring, dolutegravir dosing was increased to 150 mg daily. The patient maintained virologic suppression for 18 months. What is new and conclusions? In this case, QD darunavir/ritonavir achieved similar trough concentrations to twice daily dosing with dolutegravir dose titration necessitated and resulted in HIV virologic control.

show abstract

“…For example, an FDA-approved CCR5 receptor antagonist maraviroc (MVC) is effective to inhibit R5tropic HIV-1 entry into cells [6]. Treatment with the humanized IgG4 monoclonal antibody ibalizuman, which blocks the entry of HIV-1 into cells by noncompetitive binding to CD4, showed that 43% and 50% of patients had a viral load <50 and 200 copies per milliliter, respectively, at week 25 [7]. However, it is unclear which side-effects result from long-term use of HTAs.…”

Section: Introductionmentioning

confidence: 99%

Repurposing host-based therapeutics to control coronavirus and influenza virus

Wang

2019

Drug Discovery Today

View full text Add to dashboard Cite

Teaser This communication focuses on the repurposing of clinically approved drugs and promising preclinical drug candidates for therapeutic development of host-based antiviral agents to control diseases caused by coronavirus and influenza virus.The development of highly effective antiviral agents has been a major objective in virology and pharmaceutics. Drug repositioning has emerged as a cost-effective and time-efficient alternative approach to traditional drug discovery and development. This new shift focuses on the repurposing of clinically approved drugs and promising preclinical drug candidates for the therapeutic development of host-based antiviral agents to control diseases caused by coronavirus and influenza virus. Host-based antiviral agents target host cellular machineries essential for viral infections or innate immune responses to interfere with viral pathogenesis. This review discusses current knowledge, prospective applications and challenges in the repurposing of clinically approved and preclinically studied drugs for newly indicated antiviral therapeutics.

show abstract

Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1

Cited by 183 publications

References 33 publications

Modern Human Immunodeficiency Virus Therapy: Progress and Prospects

Modern Human Immunodeficiency Virus Therapy: Progress and Prospects

Successful use of once‐daily high‐dose darunavir and dolutegravir in multidrug‐resistant HIV

Repurposing host-based therapeutics to control coronavirus and influenza virus

Contact Info

Product

Resources

About