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26 Diseases |  |
58 Trials |
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58 Trials |  |
4692 News |  |
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- Tivicay (dolutegravir) / ViiV Healthcare
Pediatric dolutegravir is highly preferred by patients/caregivers in Nigeria and Uganda at 1 month after initiation () - Oct 4, 2022 - Abstract #HIVGlasgow2022HIV_Glasgow_165;
There is high self-reported acceptability to pDTG and preference over previous drug options due to better taste and easier administration and reduced nausea, which are anticipated to help improve health outcomes for children taking pDTG. This study will further evaluate the acceptability and health outcomes at 6-months follow-up to ascertain longer-term effects of pDTG.
- Trogarzo (ibalizumab IV) / Theratechnologies, TaiMed Biologics
Rescue therapy with ibalizumab in HIV multi-drug resistances (MDR) patient () - Oct 4, 2022 - Abstract #HIVGlasgow2022HIV_Glasgow_163;
Virological suppression was accompanied by good immunological recovery. The overall tolerability profile was good, despite the onset of hypertension after the first infusion of the drug.
- Tivicay (dolutegravir) / ViiV Healthcare
Pediatric dolutegravir introduction for children living with HIV (CLWHIV) in Zimbabwe: lessons from early adopter sites () - Oct 4, 2022 - Abstract #HIVGlasgow2022HIV_Glasgow_162;
The overall tolerability profile was good, despite the onset of hypertension after the first infusion of the drug. Active stakeholder collaboration and enhanced monitoring has been critical to pDTG introduction and rapid mitigation of unexpected transition bottlenecks, thus providing lessons at a smaller scale ahead of national rollout.
- Tivicay (dolutegravir) / ViiV Healthcare
Transplacental transfer of bictegravir versus dolutegravir in human placenta () - Oct 4, 2022 - Abstract #HIVGlasgow2022HIV_Glasgow_135;
DTG is available in combination with either FTC and TAF, or abacavir and lamivudine...In clinical trials, BIC/FTC/TAF had high safety and better tolerability and non-inferior viral suppression than the DTG-containing regimen [4]...The transfer of DTG at concentration 3000 ng/mL in one perfusion was slower than that of antipyrine and BTC. However, more perfusions will be performed to better understand the transfer of BIC and DTG.
- bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
Transfer of antiretroviral drugs into breastmilk: a prospective study from the Swiss Mother and Child HIV Cohort Study () - Oct 4, 2022 - Abstract #HIVGlasgow2022HIV_Glasgow_133;
Differential ARVs exposure was observed in infants with some ARVs being below or above their effective concentrations raising the concern of resistance development if HIV infection occurs. More data on this potential risk are warranted to better support breastfeeding in women living with HIV.
- Tivicay (dolutegravir) / ViiV Healthcare
Virological failure and HIV RNA re-suppression rates in four randomised trials of dolutegravir, efavirenz or protease inhibitor-based treatment in 3116 participants () - Oct 4, 2022 - Abstract #HIVGlasgow2022HIV_Glasgow_126;
Rates of VF were not significantly different between DTG and EFV in ADVANCE (DTG 12%, EFV 9%), DOLPHIN-2 (DTG 33%, EFV 30%), and NAMSAL trials (DTG 16%, EFV 15%) (Table 1). In VISEND, VF was significantly lower for DTG versus PI/r (DTG 16%, PI/r 24%, p = 0.0048).
- Tivicay (dolutegravir) / ViiV Healthcare
Impact of switch towards 3TC/dolutegravir on the intact and total viral reservoir in the Rumba study () - Oct 4, 2022 - Abstract #HIVGlasgow2022HIV_Glasgow_121;
Preliminary investigations of this first head-to-head study suggest that HIV-1 reservoir dynamics are similar between Dovato® and Biktarvy® and that switch towards 3TC/dolutegravir does not increase the total or intact HIV-1 viral reservoir. Adjusted analyses are on-going and will be presented.
- | Juluca (dolutegravir/rilpivirine) / ViiV Healthcare, J&J, Edurant (rilpivirine) / J&J, Tivicay (dolutegravir) / ViiV Healthcare
Journal: Two cases of drug induced hypersensitivity to dolutegravir-rilpivirine fixed-dose combination: A case report. (Pubmed Central) - Oct 4, 2022
Our case underscores the role of meticulous medication allergy history in differentiating true medication allergy from excipient allergy. This observation may be useful in the era of antiretroviral simplification to two-drug regimens.
- | Vocabria (cabotegravir oral) / ViiV Healthcare
Journal: Genotypic correlates of resistance to the HIV-1 strand transfer integrase inhibitor cabotegravir. (Pubmed Central) - Oct 4, 2022
Cabotegravir (CAB) is an integrase strand transfer inhibitor (INSTI) formulated as a long-acting injectable drug approved for pre-exposure prophylaxis and use with a long acting rilpivirine formulation for therapy in patients with virological suppression...Although these DRMs are similar to those occurring in persons receiving the related INSTI dolutegravir, Q148R was more likely to occur with CAB while G118R and R263K were more likely to occur with dolutegravir...Careful patient screening is required to prevent CAB from being used during active virus replication. Close virological monitoring is required to minimize CAB exposure to active replication to prevent the emergence of DRMs associated with cross-resistance to other INSTIs.
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: High-level dolutegravir resistance can emerge rapidly from few variants and spread by recombination: implications for INSTI salvage therapy. (Pubmed Central) - Oct 1, 2022
Here, we conducted a detailed case study of one of these individuals and find that T97A-containing HIV emerged from a large replicating population from only a few (≤4) viral lineages. When combined with primary INSTI resistance mutations, T97A provides a strong selective advantage; the finding that T97A-containing variants spread by replication and recombination, and persisted for months after discontinuing dolutegravir, has important implications as dolutegravir is rolled out worldwide.
- || Vocabria (cabotegravir oral) / ViiV Healthcare, Apretude (cabotegravir extended-release injectable suspension) / ViiV Healthcare
Review, Journal: Long-Acting Injectable Cabotegravir for HIV Prevention: What Do We Know and Need to Know about the Risks and Consequences of Cabotegravir Resistance? (Pubmed Central) - Sep 29, 2022
Though CAB-LA was highly effective in preventing HIV, breakthrough infections did occur in trials of CAB-LA despite on-time injections, resulting in selection of single and combinations of INSTI resistance mutations. As CAB-LA is scaled-up, prompt HIV diagnosis to prevent resistance, and resistance monitoring could help preserve the effectiveness of INSTIs for both HIV treatment and prevention.
- | Phase classification: Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum (clinicaltrials.gov) - Sep 29, 2022
P=N/A, N=325, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
As CAB-LA is scaled-up, prompt HIV diagnosis to prevent resistance, and resistance monitoring could help preserve the effectiveness of INSTIs for both HIV treatment and prevention. Phase classification: P4 --> P=N/A
- || Tivicay (dolutegravir) / ViiV Healthcare
Trial completion date, Trial primary completion date: BMS02: Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana (clinicaltrials.gov) - Sep 27, 2022
P=N/A, N=200, Not yet recruiting, Sponsor: Duke University
Phase classification: P4 --> P=N/A Trial completion date: May 2023 --> May 2024 | Trial primary completion date: Sep 2022 --> Sep 2023
- | Journal: Changes in Quality of Sleep, Mood, and Other Neuropsychiatric Symptoms After Switching Dolutegravir/Lamivudine/Abacavir to Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in a Randomized Study of People With Human Immunodeficiency Virus With Poor Sleep Quality: GESIDA 10418. (Pubmed Central) - Sep 24, 2022
At weeks 4 and 8 after all participants switched to darunavir/cobicistat/emtricitabine/tenofovir alafenamide, we have observed significant improvements in PSQI and HAD scores and in NS. In patients reporting subclinical sleep disturbances without insomnia, switching from dolutegravir/lamivudine/abacavir to darunavir/cobicistat/emtricitabine/tenofovir alafenamide was associated with better sleep quality and improvements in mood and NS.
- || Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Point-Of-Care Tenofovir urine Testing for the Prediction of Treatment Failure and Drug Resistance During Initial Treatment for HIV-1 Infection. (Pubmed Central) - Sep 24, 2022
P3
In participants with rebound, urine-TFV testing predicted the selection of drug resistance. Objective adherence testing may be used to rapidly provide insight into adherence, suppression, and drug resistance during ART.
- | Vemlidy (tenofovir alafenamide) / Gilead
Journal: Weight gain and metabolic effects in persons with HIV who switch to ART regimens containing integrase inhibitors or tenofovir alafenamide. (Pubmed Central) - Sep 24, 2022
Among VS persons who switched ART, INSTI and TAF use were independently associated with BMI increases. During eight months post-switch, BMI changes were greatest and most associated with INSTI use; afterward, gradual BMI gain was largely TAF-associated.
- | Preclinical, Journal: Second-generation HIV integrase inhibitors induce differentiation dysregulation and exert toxic effects in human embryonic stem cell and mouse models. (Pubmed Central) - Sep 22, 2022
Exposure to some InSTIs, even at sub-therapeutic concentrations, can induce adverse effects in hESCs and pregnant mice. Given the increasingly prevalent use of second-generation InSTIs, including in women of reproductive age, it is imperative to further elucidate the effect of InSTIs on embryonic development, as well as their long-term safety following in utero exposure.
- | Prezista (darunavir) / J&J, Tivicay (dolutegravir) / ViiV Healthcare
Journal: Inflammation and Intracellular Exposure of Dolutegravir, Darunavir, Tenofovir and Emtricitabine in People living with HIV. (Pubmed Central) - Sep 21, 2022
Given the increasingly prevalent use of second-generation InSTIs, including in women of reproductive age, it is imperative to further elucidate the effect of InSTIs on embryonic development, as well as their long-term safety following in utero exposure. Our preliminary data support the hypothesis of lower DRV and DTG IC concentrations and lower TFV plasma exposure in patients with higher plasma IM suggesting an interplay between HIV drug penetration and persistent inflammation in cART-treated HIV-positive patients.
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: No overall impact on body mass index for age change after dolutegravir initiation in a French paediatric cohort. (Pubmed Central) - Sep 20, 2022
We found no evidence of change in BMIz in French children initiating dolutegravir. These reassuring findings maintain the primary position of dolutegravir among paediatric therapeutic options.
- || Tivicay (dolutegravir) / ViiV Healthcare
Clinical data, Journal: Comparative Clinical Outcomes With Scale-up of Dolutegravir as First-Line Antiretroviral Therapy in Ukraine. (Pubmed Central) - Sep 20, 2022
Treatment retention was equally high in all 3 groups. This evidence from Ukraine supports the ART Optimization Initiative as a strategy to improve efficiency of the ART program without negatively affecting patient clinical outcomes.
- | Tivicay (dolutegravir) / ViiV Healthcare
Retrospective data, Journal, Real-world evidence: Effectiveness and Safety of Dolutegravir Versus Efavirenz-Based Antiviral Regimen in People Living With HIV-1 in Sichuan Province of China: A Real-World Study. (Pubmed Central) - Sep 20, 2022
The virologic suppression of the DTG group may be superior to that of the EFV group. DTG-based regimens might be the preferred treatment option for people with HIV for initial HIV treatment.
- | Tivicay (dolutegravir) / ViiV Healthcare
Observational data, Retrospective data, Journal: Performance of Creatinine- and Cystatin C-Based Equations for Glomerular Filtration Rate Estimation in HIV-1-Infected Individuals Receiving Dolutegravir + Tenofovir Disoproxil Fumarate + Lamivudine as Initial Antiretroviral Therapy: A Retrospective Observational Study. (Pubmed Central) - Sep 20, 2022
The modification of diet in renal disease equation may not be optimal for Chinese HIV-1-infected adults receiving DTG + TDF + 3 TC as the initial antiviral therapy. Clinicians must carefully choose the GFR equation for patients with HIV/hepatitis B virus coinfection.
- | Tivicay (dolutegravir) / ViiV Healthcare
Observational data, Retrospective data, Journal: Efficacy and Safety of a Simplified Lamivudine Plus Dolutegravir Dual Therapy in HIV-1-Infected Patients: A Multicenter Cohort Study in China. (Pubmed Central) - Sep 20, 2022
Clinicians must carefully choose the GFR equation for patients with HIV/hepatitis B virus coinfection. Thus, the 3TC + DTG dual therapy displayed an excellent virological efficacy against HIV-1 infections and had an acceptable safety profile, with predominantly mild adverse events in HIV-1-infected patients in China.
- |||||||||| Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
New P3 trial: IMPALA: Improving HIV-1 Control in Africa with Long Acting Antiretrovirals (clinicaltrials.gov) - Sep 19, 2022
P3b, N=540, Not yet recruiting, Sponsor: MRC/UVRI and LSHTM Uganda Research Unit
- |||| Tivicay (dolutegravir) / ViiV Healthcare
Dolutegravir-based antiretroviral therapy is the regimen of choice during pregnancy. These encouraging findings should lead to changes in U.S. perinatal guidelines, @CarlosdelRio7 writes. https://t.co/CrFQPhefD7 #HIV #IDTwitter #pregnancy (Twitter) - Sep 16, 2022
- ||||||| Tivicay (dolutegravir) / ViiV Healthcare
Trial completion, Head-to-Head: An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment na (clinicaltrials.gov) - Sep 16, 2022
P3, N=719, Completed, Sponsor: ViiV Healthcare
Thus, the 3TC + DTG dual therapy displayed an excellent virological efficacy against HIV-1 infections and had an acceptable safety profile, with predominantly mild adverse events in HIV-1-infected patients in China. Active, not recruiting --> Completed
- || Tivicay (dolutegravir) / ViiV Healthcare
Trial completion date, Trial primary completion date: D (clinicaltrials.gov) - Sep 15, 2022
P3b/4, N=813, Active, not recruiting, Sponsor: Kirby Institute
Active, not recruiting --> Completed Trial completion date: Jul 2024 --> Oct 2023 | Trial primary completion date: Jul 2023 --> Oct 2022
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: High-level resistance to non-nucleos(t)ide reverse transcriptase inhibitor based first-line antiretroviral therapy in Ghana; A 2017 study. (Pubmed Central) - Sep 14, 2022
This study reports high-level resistance to NNRTI-based antiretroviral therapy in PLWH in Ghana. However, the absence of major PI and INSTI associated-mutations is a good signal that the current WHO recommendation of Dolutegravir in combination with an NRTI backbone will yield maximum benefits as first-line regimen for PLWH in Ghana.
- || Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Viral load status before switching to dolutegravir-containing antiretroviral therapy and associations with HIV treatment outcomes in sub-Saharan Africa. (Pubmed Central) - Sep 14, 2022
A VL test before switching to dolutegravir may help identify patients who need additional clinical monitoring and/or adherence support. Further surveillance of patients who switched to dolutegravir with an unknown or unsuppressed VL is needed.
- | bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare, Vemlidy (tenofovir alafenamide) / Gilead
Journal: Current Antiretroviral Treatment Among People With Hiv In The Us: Findings From The Cnics Cohort. (Pubmed Central) - Sep 14, 2022
Among 14,049 people with HIV in care in 2019-2020, 96% were treated with antiretroviral therapy (ART). Current antiretroviral treatment patterns highlight high uptake of guideline-recommended ART regimens including second-generation integrase strand transfer inhibitors (dolutegravir, bictegravir) and tenofovir alafenamide, especially in ARV-naïve individuals initiating ART.
- || Descovy (emtricitabine/tenofovir alafenamide) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
Enrollment open: UNIVERSALRBA: Relative Bioavailability Study to Investigate a Potential Interaction Between DTG DT and F/TAF TOS. (clinicaltrials.gov) - Sep 14, 2022
P1, N=16, Recruiting, Sponsor: Radboud University Medical Center
Current antiretroviral treatment patterns highlight high uptake of guideline-recommended ART regimens including second-generation integrase strand transfer inhibitors (dolutegravir, bictegravir) and tenofovir alafenamide, especially in ARV-naïve individuals initiating ART. Not yet recruiting --> Recruiting
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: Dolutegravir for children with HIV-associated tuberculosis. (Pubmed Central) - Sep 10, 2022
Not yet recruiting --> Recruiting No abstract available
- || Tivicay (dolutegravir) / ViiV Healthcare
PK/PD data, Journal, Head-to-Head: Dolutegravir twice-daily dosing in children with HIV-associated tuberculosis: a pharmacokinetic and safety study within the open-label, multicentre, randomised, non-inferiority ODYSSEY trial. (Pubmed Central) - Sep 10, 2022
P2/3
No abstract available Twice-daily dolutegravir was shown to be safe and sufficient to overcome the rifampicin enzyme-inducing effect in children, and could provide a practical ART option for children with HIV-associated TB.
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: Dolutegravir in Pregnancy as Compared with Current HIV Regimens in the United States. (Pubmed Central) - Sep 10, 2022
No clear differences in adverse birth outcomes were observed with dolutegravir-based ART as compared with non-dolutegravir-based ART, although samples were small. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others.).
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: The promise of paediatric dolutegravir in Zimbabwe. (Pubmed Central) - Sep 10, 2022
(Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others.). No abstract available
- | Tivicay (dolutegravir) / ViiV Healthcare
Journal: Once-daily dolutegravir-based antiretroviral therapy in infants and children living with HIV from age 4 weeks: results from the below 14 kg cohort in the randomised ODYSSEY trial. (Pubmed Central) - Sep 10, 2022
P2/3
No abstract available Dolutegravir-based ART was superior to standard of care (mainly protease inhibitor-based) with a lower risk of treatment failure in infants and young children, providing support for global dispersible dolutegravir roll-out for younger children and allowing alignment of adult and paediatric treatment.
- Mycobutin (rifabutin) / Pfizer, Lupin, Tivicay (dolutegravir) / ViiV Healthcare
Effect of rifabutin in dolutegravir dosing: a case series (Hall B + C) - Sep 8, 2022 - Abstract #IDWeek2022IDWEEK_2119;
- Infectious Morbidity and Mortality of HIV-Exposed, Uninfected Infants Compared with HIV-Unexposed Uninfected Infants in Botswana (Hall B + C) - Sep 8, 2022 - Abstract #IDWeek2022IDWEEK_2068;
- Disseminated histoplasmosis presenting with orocutaneous manifestations in a low-prevalence area (Hall B + C) - Sep 8, 2022 - Abstract #IDWeek2022IDWEEK_1897;
- Vemlidy (tenofovir alafenamide) / Gilead
Rifampicin and Tenofovir Alafenamide Containing Regimen Drug Interaction in People Living with HIV: Case Series Report (Hall B + C) - Sep 8, 2022 - Abstract #IDWeek2022IDWEEK_1831;
- HIV-1 Drug Resistance in Patients Failing Integrase Strand Transfer Inhibitor-Based Regimens in Rhode Island, USA (Hall B + C) - Sep 8, 2022 - Abstract #IDWeek2022IDWEEK_1821;
- HIV Drug Resistance and Viral Outcomes after 2nd-line Antiretroviral Failure in Kenya (Hall B + C) - Sep 8, 2022 - Abstract #IDWeek2022IDWEEK_1820;
- Tivicay (dolutegravir) / ViiV Healthcare
Effectiveness and Durability of Dolutegravir (DTG)-Based Regimens in Older People Living with HIV (PLWH) from the Veterans Aging Cohort Study (VACS) (Hall B + C) - Sep 8, 2022 - Abstract #IDWeek2022IDWEEK_1815;
- Tivicay (dolutegravir) / ViiV Healthcare
Dolutegravir Plus 3TC In Antiretroviral Experienced Adults: Immunovirological Outcomes In a Multicenter Retrospective Cohort In Spain (Hall B + C) - Sep 8, 2022 - Abstract #IDWeek2022IDWEEK_1812;
- bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
Bictegravir or Dolutegravir-Containing Antiretroviral Regimens in Solid Organ Transplantation: Single-Center Experience (Hall B + C) - Sep 8, 2022 - Abstract #IDWeek2022IDWEEK_1809;
- Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
5-year outcomes of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as initial treatment of HIV-1 in adults with high baseline HIV-1 RNA and/or low CD4 count in two Phase 3 randomized clinical trials (Hall B + C) - Sep 8, 2022 - Abstract #IDWeek2022IDWEEK_1801;
- Tivicay (dolutegravir) / ViiV Healthcare
More Than Skin Deep: Kaposi Sarcoma of the Gastrointestinal Tract (Crown Ballroom) - Sep 4, 2022 - Abstract #ACG2022ACG_3834;
He was also started on pantoprazole for grade D esophagitis and treated with penicillin G for late latent syphilis...On follow-up, patient has completed multiple cycles of paclitaxel...(B-C) Numerous purple lesions throughout gastric antrum. (D) Retroflexion with additional violaceous lesions at the gastric fundus.
- Mycobutin (rifabutin) / Pfizer, Lupin, Valcyte (valganciclovir) / Roche, Mitsubishi Tanabe, Tivicay (dolutegravir) / ViiV Healthcare
Enterocolitis Caused by Mycobacterium Avium Complex in an HIV-Infected Patient (Crown Ballroom) - Sep 4, 2022 - Abstract #ACG2022ACG_1559;
He also had cytomegalovirus (CMV) viremia treated with valganciclovir...His MAC treatment was changed to amikacin, linezolid, rifampin, and ethambutol with subsequent improvement in his diarrhea...Figure 1C. Ziehl-Neelsen stain of duodenal mucosa with acid-fast bacillus positive organisms consistent with Mycobacterium avium complex.
- Tivicay (dolutegravir) / ViiV Healthcare
Atypical Disseminated Mycobacterium Avium Complex: A Rare Case of Chronic Severe Diarrhea in a Patient with HIV (Crown Ballroom) - Sep 4, 2022 - Abstract #ACG2022ACG_1002;
So physicians must be familiar with the causes and utilize endoscopic interventions as needed for effective diagnosis and treatment in AIDS patients. Figure: Petechial lesions in the terminal ileum noted on endoscopy
- || Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal: Evaluating Diversity in Randomized Clinical Trials of Dolutegravir-Based Antiretroviral Therapy Regimens: Pooled 48-Week Analyses by Race, Sex, and Regional Subgroups. (Pubmed Central) - Sep 3, 2022
Achieving VS may vary by participant characteristics, highlighting the urgent need for enrollment to reflect the demographics of global HIV populations more accurately. Future studies should strive to support participants throughout the trial to ensure optimal representation, inclusion, and retention.