Tivicay (dolutegravir) / ViiV Healthcare 
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  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Enrollment closed, Enrollment change, Trial completion date:  LoDoCA: Tolerability of Lopinavir Versus Dolutegravir for Children and Adolescents Living With HIV (clinicaltrials.gov) -  Nov 28, 2023   
    P=N/A,  N=266, Active, not recruiting, 
    Thus, implementing personalized HIV medicine in this vulnerable population would substantially improve ART response and the achievement of the 95-95-95 goals in these underserved populations. Recruiting --> Active, not recruiting | N=500 --> 266 | Trial completion date: Jan 2025 --> Feb 2026
  • ||||||||||  Pifeltro (doravirine) / Merck (MSD), Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  The DoDo experience: an alternative antiretroviral 2-drug regimen of doravirine and dolutegravir. (Pubmed Central) -  Nov 27, 2023   
    We recommend the design and implementation of high-impact interventions to prevent the increase of HIVDR, failure of dolutegravir and address the non-resistance factors in the study area. DOR?+?DTG as a 2DR proved to be a durable treatment option even in extensively pretreated individuals.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Role of Dysregulated Autophagy in HIV Tat, Cocaine, and cART Mediated NLRP3 Activation in Microglia. (Pubmed Central) -  Nov 27, 2023   
    We selected a combination of three commonly used cART regimens: tenofovir, emtricitabine, and dolutegravir...Silencing of NLRP3, however, failed to block HIV Tat, cocaine, and cART-mediated dysregulation of the autophagy-lysosomal axis; these in vitro phenomena were also validated in vivo using iTat mice administered cocaine and cART. This study thus underscores the cooperative effects of HIV Tat, cocaine, and cART in exacerbating microglial activation involving dysregulated autophagy and activation of the NLRP3 inflammasome signaling.
  • ||||||||||  FDA event, Journal:  Identification of Novel Signals Associated with US-FDA Approved Drugs (2013) Using Disproportionality Analysis. (Pubmed Central) -  Nov 22, 2023   
    The HIV antiretroviral DTG reversed the effect NIC had on decreasing PG-induced upregulation of EGR2, which is concerning because EGR2 has been implicated in HIV latency reversal, T-cell apoptosis, and neuroinflammation, a process that underlies the development of HIV-associated neurocognitive disorders. However, further causality assessment is required to confirm the association of these drugs with identified potential signals.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    PK/PD data, Journal:  Pharmacokinetics and safety of twice-daily ritonavir-boosted atazanavir with rifampicin. (Pubmed Central) -  Nov 20, 2023   
    P2/3
    However, further causality assessment is required to confirm the association of these drugs with identified potential signals. Twice daily atazanavir/ritonavir during rifampicin co-administration was well-tolerated and achieved plasma concentrations above the target.
  • ||||||||||  Pifeltro (doravirine) / Merck (MSD)
    Enrollment open:  DoraDO: Doravirine Dose Optimisation in Pregnancy (clinicaltrials.gov) -  Nov 14, 2023   
    P4,  N=76, Recruiting, 
    Our results suggest that simplification to DT does not negatively influence the HIV-1-specific T-cell response or the exhaustion phenotype after 96 weeks of follow-up. Not yet recruiting --> Recruiting
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Trial completion, Trial completion date:  DolPHIN-2: Dolutegravir in Pregnant HIV Mothers and Their Neonates (clinicaltrials.gov) -  Nov 13, 2023   
    P3,  N=268, Completed, 
    Recruiting --> Active, not recruiting Active, not recruiting --> Completed | Trial completion date: Jan 2023 --> Sep 2023
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Clinical consequences of weight gain during treatment for HIV infection. (Pubmed Central) -  Nov 7, 2023   
    Further investigation is necessary to evaluate the long-term effects of DTG-based regimens on LTFU and its impact on HIV mortality rates, and qualitative research, specifically tracing LTFU, is recommended. Careful analysis will be needed, as with the weight-gain signal, before assigning causation, especially as plausible physiological mechanisms for this rise in blood pressure are unclear.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Review, Journal:  Biktarvy for the treatment of HIV infection: Progress and prospects. (Pubmed Central) -  Nov 6, 2023   
    Close involvement of HIV and surgical specialists is recommended to manage ARV therapy in patients undergoing bariatric surgery. Based on the accumulated evidence from HIV clinical trials and real-world studies, the clinical effectiveness of BIC
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Neurodevelopment of children who are HIV-exposed and uninfected in Kenya. (Pubmed Central) -  Nov 4, 2023   
    Addressing IPV and food insecurity may provide benefits regardless of maternal HIV status. DTG use was associated with higher neurodevelopmental scores in CHEU, compared to EFV regimens, potentially contributing to a lack of neurodevelopmental difference between CHEU and CHUU.
  • ||||||||||  Pifeltro (doravirine) / Merck (MSD), Tivicay (dolutegravir) / ViiV Healthcare
    Enrollment open, Trial completion date, Trial primary completion date:  DORDOL: Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch (clinicaltrials.gov) -  Oct 25, 2023   
    P3,  N=150, Recruiting, 
    Dolutegravir twice-daily in infants receiving rifampicin-based TB-treatment resulted in adequate dolutegravir exposure, supporting this treatment approach for infants with HIV-TB coinfection. Not yet recruiting --> Recruiting | Trial completion date: Feb 2025 --> Nov 2027 | Trial primary completion date: Sep 2024 --> Nov 2026
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Trial completion:  DISCO: Population Effectiveness of Dolutegravir Implementation in Sub-Saharan Africa (clinicaltrials.gov) -  Oct 23, 2023   
    P=N/A,  N=1000, Completed, 
    Not yet recruiting --> Recruiting | Trial completion date: Feb 2025 --> Nov 2027 | Trial primary completion date: Sep 2024 --> Nov 2026 Active, not recruiting --> Completed
  • ||||||||||  Juluca (dolutegravir/rilpivirine) / ViiV Healthcare, J&J, Dovato (dolutegravir/lamivudine) / ViiV Healthcare, Tivicay (dolutegravir) / ViiV Healthcare
    Retrospective data, Journal:  Efficacy and tolerability of dolutegravir/lamivudine versus (Pubmed Central) -  Oct 12, 2023   
    Two study participants experienced virological failure in the DTG/3TC arm. We observed no significant difference in CD4 cell counts, lipid parameters, or renal function between the two groups at 48 weeks.
  • ||||||||||  Significant sex differences in antiretroviral treatment of young HIV patients  (ePosters area) -  Oct 8, 2023 - Abstract #EACS2023EACS_1576;    
    INI: Overall, INI were used significantly more frequently in men (p<0.0001); especially, dolutegravir and bictegravir were used less frequently in women (p<0.0001)...The delayed use of newer HIV drugs might put young women at disadvantage in treatment. Our data support the ongoing call to action to enable pregnant women to participate in clinical trials and thus move from protection from research to protection through research.
  • ||||||||||  Fast track rechallenge after skin rash in a HIV-1 heavily treatment experienced patient with no alternative therapeutic options left (ePosters) -  Oct 8, 2023 - Abstract #EACS2023EACS_1520;    
    1a) and a previous history of efavirenz allergy, virologically undetectable on darunavir boosted with cobicistat, tenofovir alafenamide, emtricitabine, maraviroc and dolutegravir, eventually presented with viral failure, with the appearance of class-wide integrase inhibitor resistance (Fig...ART was then modified to doravirine, lenacapavir, fostemsavir, darunavir boosted with cobicistat, tenofovir alafenamide and emtricitabine...Following a multidisciplinary evaluation (infectious diseases, dermatology, pharmacology), a fast track re-introduction of ART, by balancing virological outcomes and allergological risks was performed two weeks after the resolution of the skin rash.Darunavir boosted with cobicistat, tenofovir alafenamide, emtricitabine, fostemsavir and enfuvirtide were given for 1 week...The process was done under strict medical surveillance. The patient was successfully re-introduced on optimized ARV regimen without complications and virological control was achieved since then.Our case illustrates the benefits of a multi-disciplinary medical evaluation when confronted with heavily treatment experienced patients facing adverse reactions, finding a balance between the risk of HIV progression, accumulation of drug resistances and the risk of severe or even fatal allergic reaction.
  • ||||||||||  Fast track rechallenge after skin rash in a HIV-1 heavily treatment experienced patient with no alternative therapeutic options left (ePosters) -  Oct 8, 2023 - Abstract #EACS2023EACS_1519;    
    1a) and a previous history of efavirenz allergy, virologically undetectable on darunavir boosted with cobicistat, tenofovir alafenamide, emtricitabine, maraviroc and dolutegravir, eventually presented with viral failure, with the appearance of class-wide integrase inhibitor resistance (Fig...ART was then modified to doravirine, lenacapavir, fostemsavir, darunavir boosted with cobicistat, tenofovir alafenamide and emtricitabine...Following a multidisciplinary evaluation (infectious diseases, dermatology, pharmacology), a fast track re-introduction of ART, by balancing virological outcomes and allergological risks was performed two weeks after the resolution of the skin rash.Darunavir boosted with cobicistat, tenofovir alafenamide, emtricitabine, fostemsavir and enfuvirtide were given for 1 week...The process was done under strict medical surveillance. The patient was successfully re-introduced on optimized ARV regimen without complications and virological control was achieved since then.Our case illustrates the benefits of a multi-disciplinary medical evaluation when confronted with heavily treatment experienced patients facing adverse reactions, finding a balance between the risk of HIV progression, accumulation of drug resistances and the risk of severe or even fatal allergic reaction.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Predictors of retention in care among people living with HIV: an Egyptian cross-sectional study (ePosters) -  Oct 8, 2023 - Abstract #EACS2023EACS_1224;    
    Predictors of retention in care were: having undetectable VL (adjusted odds ratio [a OR]: 3.6; 95% CI: 1.49-8.47), access to CD4 testing (a OR: 2.6; 95% CI: 1.02-6.64), longer duration since HIV diagnosis (a OR: 1.025; 95% CI: 1.01-1.04), a history of HBV vaccination (a OR: 2.835; 95% CI: 1.07-7.48), and being on dolutegravir (DTG ) -based ART (a OR: 2.42; 95% CI: 1.06-5.537)...Fig. 1 * Significant p value Conclusions :
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Predictors of retention in care among people living with HIV: an Egyptian cross-sectional study (ePosters) -  Oct 8, 2023 - Abstract #EACS2023EACS_1223;    
    Predictors of retention in care were: having undetectable VL (adjusted odds ratio [a OR]: 3.6; 95% CI: 1.49-8.47), access to CD4 testing (a OR: 2.6; 95% CI: 1.02-6.64), longer duration since HIV diagnosis (a OR: 1.025; 95% CI: 1.01-1.04), a history of HBV vaccination (a OR: 2.835; 95% CI: 1.07-7.48), and being on dolutegravir (DTG ) -based ART (a OR: 2.42; 95% CI: 1.06-5.537)...Fig. 1 * Significant p value Conclusions :