- |||||||||| dolutegravir/lamivudine/tenofovir disoproxil fumarate / Cipla, Laurus Labs, Aurobindo, Viatris, Hetero, Macleods, Dovato (dolutegravir/lamivudine) / ViiV Healthcare
A comparative study evaluating renal outcomes after switching from TDF+FTC+EFV To TDF/3TC/DTG (TLD) versus DTG+3TC in virologically suppressed Thai PWH (Poster board: 079) - May 2, 2024 - Abstract #AIDS2024AIDS_1286;
The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
- |||||||||| HIV acquisition intra PrEP: do we need to change the existing diagnostic algorithms? (Poster board: 047) - May 2, 2024 - Abstract #AIDS2024AIDS_1167;
The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Evaluation of viremic people living with HIV presenting with dolutegravir resistance in Western Kenya (Poster board: 135) - May 2, 2024 - Abstract #AIDS2024AIDS_1139;
The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
- |||||||||| dolutegravir/lamivudine/tenofovir disoproxil fumarate / Cipla, Laurus Labs, Aurobindo, Viatris, Hetero, Macleods
SAT025 Lesson learned from the "DTG story" (Room 14a/Channel 9) - May 2, 2024 - Abstract #AIDS2024AIDS_515;
This means that as of 2023, over 90% of people on antiretroviral treatment in these countries are estimated to be on DTG-based regimens.The licence agreements have played a foundational role, enabling widespread access to TLD, (Tenofovir, Lamivudine, Dolutegravir - a WHO-preferred treatment for adults and adolescents), and in the development and availability of age-appropriate DTG-based treatment options for children and infants, addressing a key gap as children are disproportionately affected by HIV. As a result of the DTG paediatric licence, as well as a novel public-private partnership between ViiV, the Clinton Health Access Initiative (CHAI) and Unitaid providing technology transfer and regulatory support, generic dispersible tablet formulations of DTG have now been supplied to 95 LMICs for children weighing at least 3kg.This session, hosted by MPP and Unitaid, unpacks key moments and lessons learned, and their relevance to emerging treatment and prevention therapies.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Analysis of dolutegravir scaleup and HIV-1 treatment outcomes in Uganda from 2021-2023 (Room 1/Channel 2) - May 2, 2024 - Abstract #AIDS2024AIDS_247;
The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
- |||||||||| dolutegravir/lamivudine/tenofovir disoproxil fumarate / Cipla, Laurus Labs, Aurobindo, Viatris, Hetero, Macleods, Tivicay (dolutegravir) / ViiV Healthcare
Observational data, Journal, Adverse drug reaction: Adverse Drug Reactions and Prescription Patterns of Antiretroviral Drugs: A Longitudinal Observational Study From a Tertiary Care Hospital in Western India. (Pubmed Central) - Apr 19, 2024
The most prescribed concomitant medication was cotrimoxazole (15%, n=312)...However, it has also led to an increase in dolutegravir-associated ADRs like increased alkaline phosphatase, dyslipidaemia, and nephrotoxicity. Continuous monitoring of prescriptions and ADRs can add to our knowledge regarding their use and ADRs.
- |||||||||| Cimduo (lamivudine/tenofovir disoproxil fumarate) / Cipla, Celltrion, Macleods, Viatris, Sun Pharma, Aurobindo, Hetero
Enrollment open, HEOR: PrIMO: UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study (clinicaltrials.gov) - Apr 18, 2024
P=N/A, N=621, Recruiting,
Continuous monitoring of prescriptions and ADRs can add to our knowledge regarding their use and ADRs. Not yet recruiting --> Recruiting
- |||||||||| Cimduo (lamivudine/tenofovir disoproxil fumarate) / Cipla, Celltrion, Macleods, Viatris, Sun Pharma, Aurobindo, Hetero
Trial initiation date, HEOR: PrIMO: UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study (clinicaltrials.gov) - Mar 25, 2024
P=N/A, N=621, Not yet recruiting,
Specific tools for monitoring this risk are needed to institute appropriate preventive interventions. Initiation date: Jan 2024 --> Apr 2024
- |||||||||| dolutegravir/lamivudine/tenofovir disoproxil fumarate / Cipla, Laurus Labs, Aurobindo, Viatris, Hetero, Macleods
ACTG 5381: Virologic and Resistance Outcomes After Switch to TLD for Failing 1st- or 2nd-Line ART (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_1334;
Viral suppression was lower in participants switching from 2nd-line PI-based regimens than from failing 1st-line NNRTI-based regimens. Infrequent emergence of DTG mutations and lower TFV-DP concentrations in unsuppressed vs suppressed suggest that incomplete adherence to TLD was the major mechanism for failure to suppress viremia.
- |||||||||| dolutegravir/lamivudine/tenofovir disoproxil fumarate / Cipla, Laurus Labs, Aurobindo, Viatris, Hetero, Macleods
Pharmaco-Virological Outcome and Resistance Profiles Among Togolese Adolescents Transitioning to DTG (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_1332;
Background: Very few data are available regarding efficacy of the transition to tenofovir-lamivudine-dolutegravir (TLD) among adolescents living with HIV (ALHIV) in West Africa...In this large study of 272 ALHIV carried out in Togo, we showed a high level of virological response to TLD with high level of adherence, and a rate of DTG resistance mutations emergence of 9.4% in case of virological failure. These first findings on a large series of adolescents in LMIC advocate the need of VL monitoring and to survey HIV drug resistance to DTG in the context of transitioning to TLD with a limited access to VL monitoring.
- |||||||||| dolutegravir/lamivudine/tenofovir disoproxil fumarate / Cipla, Laurus Labs, Aurobindo, Viatris, Hetero, Macleods
Changes in Body Composition During Pregnancy in South African Women Living With HIV on ART (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_1298;
Reductions in FFM accrual are similar by duration of TLD exposure but FM accrual appears most restricted in women recently initiated on ART. The long-term consequences of these differences for maternal and child metabolic health require urgent attention.
- |||||||||| dolutegravir/lamivudine/tenofovir disoproxil fumarate / Cipla, Laurus Labs, Aurobindo, Viatris, Hetero, Macleods, Dovato (dolutegravir/lamivudine) / ViiV Healthcare
Liver Steatosis Is Not Associated With Endothelial Function or Hormone Use in Transgender Women (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_1280;
Changes in arterial diameter and GAHT exposure were not associated with liver steatosis. Our findings reinforce the need of including traditional factors of liver steatosis for TGW's clinical assessment.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
A Target Trial of Preconception Switch From Nevirapine- to Dolutegravir-Based ART on Birth Outcomes (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_1259;
Switching from legacy NVP-based regimens to DTG/TDF/XTC prior to pregnancy may reduce the risk of low maternal weight in early pregnancy and fetal growth restriction. This study provides further evidence that specific regimens impact birth outcomes, and that switching from legacy regimens prior to conception can improve birth outcomes.
- |||||||||| dolutegravir/lamivudine/tenofovir disoproxil fumarate / Cipla, Laurus Labs, Aurobindo, Viatris, Hetero, Macleods
High Rates of Viral Suppression in Pregnancy Drop Postpartum in South African Women on TLD () - Mar 16, 2024 - Abstract #CROI2024CROI_1191;
Background: The global transition to 1st-line antiretroviral treatment (ART) with tenofovir+lamivudine+dolutegravir (TLD) has shown high rates of viral suppression (VS) in adults and children but little is known about pregnant and postpartum women.Pregnant women with HIV (PWH) already on TLD (Continuers, PWHc) or starting TLD <14 days prior to enrollment (Initiators, PWHi), were enrolled in ORCHID, an observational study of metabolic health, in Cape Town, South Africa, Sept 2021-Sept 2023...This is among the first reports of VL in pregnant and postpartum women on TLD. We found high rates of VS in pregnant women, but postpartum viremia remains a pressing concern, particularly for younger women and those initiating ART during pregnancy.
- |||||||||| dolutegravir/lamivudine/tenofovir disoproxil fumarate / Cipla, Laurus Labs, Aurobindo, Viatris, Hetero, Macleods
Virologic Outcomes With Tenofovir-Lamivudine-Dolutegravir for PI-Based Second-Line ART Failure () - Mar 16, 2024 - Abstract #CROI2024CROI_903;
Safety, PK, and virologic response data support the use of this regimen in PWH and TB. Background: Patients failing protease inhibitor (PI)-based 2nd-line antiretroviral therapy (ART) in the South African ART programme qualify for genotypic antiretroviral resistance testing (GART)
- |||||||||| dolutegravir/lamivudine/tenofovir disoproxil fumarate / Cipla, Laurus Labs, Aurobindo, Viatris, Hetero, Macleods, dolutegravir/emtricitabine/tenofovir alafenamide (DTG/FTC/TAF) / Viatris, Tivicay (dolutegravir) / ViiV Healthcare
Higher Risks of Hypertension With Use of DTG Versus PI/r in the VISEND Trial (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_847;
In VISEND, risks of Grade 1 HTN and changes in systolic BP were higher for TAF/3TC/DTG and TDF/FTC/DTG versus ZDV/3TC/ATV/r or ZDV/3TC/LPV/r. Results were not consistent when comparing TAF/3TC/DTG and TDF/FTC/DTG, where there were no significant differences for change in systolic BP, but there were differences when comparing the risk of Grade 1 HTN.
- |||||||||| dolutegravir/lamivudine/tenofovir disoproxil fumarate / Cipla, Laurus Labs, Aurobindo, Viatris, Hetero, Macleods
Pharmacogenetics of Early Neuropsychiatric Adverse Events After Switching to DTG in Second-Line ART (Poster hall) - Mar 5, 2024 - Abstract #CROI2024CROI_514;
We characterised associations between genetic polymorphisms and early NPAEs in adults failing efavirenz-based antiretroviral therapy and switching to a dolutegravir-based regimen.We conducted a pharmacogenetic sub-study of participants enrolled into the ARTIST clinical trial, who were switched from tenofovir-emtricitabine-efavirenz to tenofovir-lamivudine-dolutegravir and randomised to supplementary dolutegravir 50 mg dose or placebo for the first 2 weeks...Among participants who switched from efavirenz to dolutegravir, early insomnia events were common, but these were not associated with known functional polymorphisms. CYP2B6 slow metaboliser genotype was associated with lower dolutegravir exposure, reflecting prolonged efavirenz induction effect.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
48-Week Outcomes After Programmatic Transition to Dolutegravir in South Africa (Poster hall) - Mar 5, 2024 - Abstract #CROI2024CROI_484;
However, using an observational cohort approach with intensive outcome monitoring, only 81% of participants were virally suppressed and in care at 48 weeks. Over half of those who did not achieve the primary endpoint were lost from care or deceased.
- |||||||||| ribavirin / Generic mfg., sofosbuvir/velpatasvir / Generic mfg.
Efficacy of Sofosbuvir, Velpatasvir and Ribavirin in prior DAA experienced patients in Myanmar (New Hall) - Jan 20, 2024 - Abstract #APASL2024APASL_2633;
Background: Treatment options for DAA experienced hepatitis C patients are limited in Myanmar as Sofosbuvir, Velpatasvir, Voxilaprevir regimen and Glecaprevir and Pibrentasvir regimens are not available...Seventeen patients received prior treatment with Sofosbuvir and Daclatasvir, one with Sofosbuvir and Ledipasvir and two with SOF/VEL regimen...One patient had HBV co-infection and three had HIV taking Tenofovir/Lamivudine/Dolutegravir... SOF/VEL/RBV regimen for 24 weeks is effective in difficult-to-treat DAA experienced patients and is a feasible option in a resource limited country like Myanmar.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Journal: Effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide in HIV late presenters. (Pubmed Central) - Jan 15, 2024
This study demonstrated that switching to a doravirine-based regimen, mostly DOR/TDF/3TC, was highly effective and generally well tolerated, with substantial cost savings. Our results suggest that BIC/FTC/TAF could be a preferred regimen as initial therapy in HIV late presenters because of its high effectiveness and good tolerability.
- |||||||||| dolutegravir/lamivudine/tenofovir disoproxil fumarate / Cipla, Laurus Labs, Aurobindo, Viatris, Hetero, Macleods, Tivicay (dolutegravir) / ViiV Healthcare
Journal: Preswitch Regimens Influence the Rate of Weight Gain After Switch to Tenofovir Disoproxil Fumarate, Lamivudine, and Dolutegravir (TLD): Study From an East African Cohort. (Pubmed Central) - Dec 13, 2023
The rate of weight gain for individuals switching from EFV-based regimens significantly increased from 0.57?kg/year preswitch to 1.11?kg/year postswitch but remained stable at 0.35?kg/year preswitch vs 0.32?kg/year postswitch for individuals switching from NVP-based regimens. Switching from NNRTI-based regimens to TLD is associated with a modest increase in the rate of weight gain, with the preswitch NNRTI being the key determinant of the amount of weight gain experienced postswitch.
- |||||||||| Cimduo (lamivudine/tenofovir disoproxil fumarate) / Cipla, Celltrion, Macleods, Viatris, Sun Pharma, Aurobindo, Hetero
New trial, HEOR: PrIMO: UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study (clinicaltrials.gov) - Dec 6, 2023
P=N/A, N=621, Not yet recruiting,
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Trial completion date, Trial primary completion date: Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis (clinicaltrials.gov) - Dec 5, 2023
P2, N=30, Not yet recruiting,
Switching from NNRTI-based regimens to TLD is associated with a modest increase in the rate of weight gain, with the preswitch NNRTI being the key determinant of the amount of weight gain experienced postswitch. Trial completion date: Jan 2025 --> May 2025 | Trial primary completion date: Jun 2024 --> Oct 2024
- |||||||||| dolutegravir/lamivudine/tenofovir disoproxil fumarate / Cipla, Laurus Labs, Aurobindo, Viatris, Hetero, Macleods
Journal: Prevalence of HIV drug resistance among adolescents receiving ART in Cameroon with low- or high-level viraemia. (Pubmed Central) - Dec 4, 2023
Trial completion date: Jan 2025 --> May 2025 | Trial primary completion date: Jun 2024 --> Oct 2024 Our findings show that the 1000?copies/mL threshold is not an indicator of virological success and we call for a revision of the current WHO definition of VF in resource-limited countries.
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