Approved Medications Research

Factors Associated with Health Care Providers’ Preference for Forgoing an Oral Lead-In Phase When Initiating Long-Acting Injectable Cabotegravir and Rilpivirine in the SOLAR Clinical Trial

Cabenuva / By

Cabotegravir and rilpivirine long-acting (LA) antiretroviral therapy (ART) demonstrated similar safety and efficacy in maintaining viral suppression among participants switching from daily oral to LA ART in the Extension Phase of the FLAIR trial. The Phase IIIb SOLAR study comparing efficacy and safety of daily oral versus LA ART every 2 months allowed participants and […]

Factors Associated with Health Care Providers’ Preference for Forgoing an Oral Lead-In Phase When Initiating Long-Acting Injectable Cabotegravir and Rilpivirine in the SOLAR Clinical Trial Read More »

Impact of rilpivirine cross-resistance on long-acting cabotegravir-rilpivirine in low and middle-income countries

Cabenuva / By

Baseline rilpivirine drug resistance mutations (DRMs) are a risk factor for virological failure in patients treated with long-acting cabotegravir and rilpivirine (CAB/RPV LA). We investigated rilpivirine cross-resistance in treatment-naive and experienced patients in South Africa. One in 10 treatment-naive patients and 74.5% of patients failing treatment presented with rilpivirine DRMs.

Impact of rilpivirine cross-resistance on long-acting cabotegravir-rilpivirine in low and middle-income countries Read More »

Injectable Long-Acting Cabotegravir–Rilpivirine Therapy for People Living With HIV/AIDS: Addressing Implementation Barriers From the Start

Cabenuva / By

Injectable cabotegravir and rilpivirine (CAB/RPV), administered bimonthly by a medical provider, is convenient and improves privacy and medication management. One year after approval, myriad implementation barriers threaten the access and sustainability of this life-saving innovation: (1) eligibility issues (viral suppression, drug resistance, and failed oral regimens); (2) injection requires medical provider and transportation to facility; (3) strict

Injectable Long-Acting Cabotegravir–Rilpivirine Therapy for People Living With HIV/AIDS: Addressing Implementation Barriers From the Start Read More »

Long-Acting Cabotegravir and Rilpivirine: Innovation, New Challenges, and Opportunities

Cabenuva / By

Cabotegravir (an integrase strand transfer inhibitor [INSTI] that is structurally similar to dolutegravir) and rilpivirine (a nonnucleoside reverse transcriptase inhibitor [NNRTI]) formulated as a nanoparticle suspension for intramuscular injection (CAB + RPV LA) are the first complete long-acting maintenance antiretroviral treatment (ART) approved for clinical use. To date, the drugs have not been coformulated, so

Long-Acting Cabotegravir and Rilpivirine: Innovation, New Challenges, and Opportunities Read More »

Management of Drug-Drug Interactions Between Long-Acting Cabotegravir and Rilpivirine and Comedications With Inducing Properties: A Modeling Study

Cabenuva / By

Long-acting (LA) intramuscular cabotegravir and rilpivirine are prone to drug-drug interactions (DDI). However, given the long dosing interval, the conduct of clinical DDIs studies with LA antiretrovirals is challenging. We performed virtual clinical DDI studies using physiologically based pharmacokinetic (PBPK) modeling to provide recommendations for the management of DDIs with strong or moderate inducers such

Management of Drug-Drug Interactions Between Long-Acting Cabotegravir and Rilpivirine and Comedications With Inducing Properties: A Modeling Study Read More »

HIV-1 bispecific antibody iMab-N6 exhibits enhanced breadth but not potency over its parental antibodies iMab and N6

Trogarzo / By

The recently published AMP trial (HVTN 703/HPTN 081 and HVTN704/HPTN 085) results have validated broad neutralising antibodies (bNAbs) as potential anti-HIV-1 agents. However, single bNAb preparations are unlikely to cope with the onslaught of existing and de novo resistance mutations, thus necessitating the use of bNAb combinations to achieve clinically relevant results. Specifically, engineered antibodies

HIV-1 bispecific antibody iMab-N6 exhibits enhanced breadth but not potency over its parental antibodies iMab and N6 Read More »

Design of a Bispecific HIV Entry Inhibitor Targeting the Cell Receptor CD4 and Viral Fusion Protein Gp41

Trogarzo / By

Given the high variability and drug-resistance problem by human immunodeficiency virus type 1 (HIV-1), the development of bispecific or multi-specific inhibitors targeting different steps of HIV entry is highly appreciated. We previously generated a very potent short-peptide-based HIV fusion inhibitor 2P23. In this study, we designed and characterized a bifunctional inhibitor termed 2P23-iMab by genetically

Design of a Bispecific HIV Entry Inhibitor Targeting the Cell Receptor CD4 and Viral Fusion Protein Gp41 Read More »

Quantitative PET imaging of the CD4 pool in nonhuman primates

Trogarzo / By

Previous SPECT and PET semi-quantitative in vivo imaging studies in monkeys have demonstrated specific uptake of radiolabeled rhesus recombinant anti-CD4 monoclonal antibody fragment CD4R1-F(ab΄)2 in the spleen and clusters of lymph nodes (LNs) but yielded conflicting results of imaging the gut CD4 + T-cell pool. Here, using PET dynamic imaging with kinetic analysis, we performed a fully quantitative

Quantitative PET imaging of the CD4 pool in nonhuman primates Read More »

Ibalizumab shows in-vitro activity against group A and group B HIV-2 clinical isolates

Trogarzo / By

Treatment of multidrug-resistant HIV-2 is an emerging issue, because of the rapid selection of mutations at time of virological failure and the low number of antiretrovirals active on HIV-2. The aim of this study was to determine the susceptibility of HIV-2 primary isolates to ibalizumab, a long-acting monoclonal antibody that binds to CD4 that is approved for the treatment of MDR

Ibalizumab shows in-vitro activity against group A and group B HIV-2 clinical isolates Read More »

Predicted effects of the introduction of long-acting injectable cabotegravir pre-exposure prophylaxis in sub-Saharan Africa: a modelling study

Apretude / By

Long-acting injectable cabotegravir pre-exposure prophylaxis (PrEP) is recommended by WHO as an additional option for HIV prevention in sub-Saharan Africa, but there is concern that its introduction could lead to an increase in integrase-inhibitor resistance undermining treatment programmes that rely on dolutegravir. We aimed to project the health benefits and risks of cabotegravir-PrEP introduction in

Predicted effects of the introduction of long-acting injectable cabotegravir pre-exposure prophylaxis in sub-Saharan Africa: a modelling study Read More »

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