- |||||||||| lamivudine/zidovudine/efavirenz / Mylan, Strides Pharma Science
Journal: Effects of Highly Active Antiretroviral Therapy on Albuminuria in HIV-infected Persons. (Pubmed Central) - Apr 17, 2021 Albuminuria and/microalbuminuria and eGFR improve concurrently on HAART (with/without tenofovir DF). Zidovudine-based HAART (ZDV/3TC/NVP) resolves microalbuminuria earlier, and without relapse, unlike Tenovofir-based regimen and zidovudine with efavirenz (ZDV/3TC/EFV).
- |||||||||| dolutegravir/emtricitabine/tenofovir alafenamide (DTG/FTC/TAF) / Mylan, Tivicay (dolutegravir) / ViiV Healthcare
[VIRTUAL] PREDICTED LONG-TERM ADVERSE BIRTH AND CHILD HEALTH OUTCOMES IN THE ADVANCE TRIAL () - Mar 18, 2021 - Abstract #CROI2021CROI_782; There are consistent associations between pre-pregnancy clinical obesity and higher risks of adverse maternal, infant and child health outcomes. For every 100 women becoming pregnant after three years of TAF/FTC+DTG treatment, this analysis predicted 18 additional adverse outcomes.
- |||||||||| efavirenz/emtricitabine/tenofovir disoproxil fumarate / Generic mfg., estradiol valerate / Generic mfg., spironolactone / Generic mfg.
[VIRTUAL] FEMINIZING THERAPY DECREASES D-DIMER BUT WORSENS INSULIN SENSITIVITY IN TRANS WOMEN () - Mar 18, 2021 - Abstract #CROI2021CROI_740; Because PrEP uptake and ART adherence were very low, these effects seem primarily due to FHT use. Further study is needed to better understand cardiometabolic changes in TW by HIV serostatus and to optimize uptake of, and adherence to, HIV prevention and treatment options.
- |||||||||| dolutegravir/emtricitabine/tenofovir alafenamide (DTG/FTC/TAF) / Mylan
[VIRTUAL] PREDICTED 10-YEAR RISKS OF CARDIOVASCULAR DISEASE AND DIABETES IN THE ADVANCE TRIAL () - Mar 18, 2021 - Abstract #CROI2021CROI_727; Treatment-emergent weight gain, particularly on TAF/FTC+DTG, increased participants' predicted 10-year risk of developing CVD and T2D. These results support WHO recommendations for TDF/FTC+DTG as 1st-line therapy, with TAF/FTC+DTG only used for patients with osteoporosis or renal impairment.
- |||||||||| dolutegravir/emtricitabine/tenofovir alafenamide (DTG/FTC/TAF) / Mylan
[VIRTUAL] SAFETY/EFFICACY OF DTG VS EFV, TDF VS TAF IN PREGNANCY/ POSTPARTUM: IMPAACT 2010 TRIAL () - Mar 18, 2021 - Abstract #CROI2021CROI_264; At week 50 PP, maternal and infant grade≥3 AEs from enrollment through week 50 PP were similar across arms; infant mortality was higher (though stillbirths somewhat less frequent) in those whose mothers were in the EFV/FTC/TDF arm. Maternal HIV RNA suppression was similarly high in the combined DTG vs the EFV arm, although more women stopped EFV due to virologic failure.
- |||||||||| dolutegravir/emtricitabine/tenofovir alafenamide (DTG/FTC/TAF) / Mylan
[VIRTUAL] ANTEPARTUM WEIGHT GAIN AND ADVERSE PREGNANCY OUTCOMES IN IMPAACT 2010 () - Mar 18, 2021 - Abstract #CROI2021CROI_263; Low (but not high) weight gain was associated with adverse pregnancy outcomes. Women starting DTG+FTC/TAF in pregnancy gained more weight antepartum than women starting DTG+FTC/TDF or EFV/FTC/TDF, while women starting EFV/FTC/TDF had the lowest weight gain.
- |||||||||| efavirenz/emtricitabine/tenofovir disoproxil fumarate / Generic mfg.
Clinical, Journal: Genomic Instability Decreases in HIV Patient by Complementary Therapy with Rosmarinus officinalis Extracts. (Pubmed Central) - Mar 6, 2021 The groups that received the pharmacological therapy with ATRIPLA and the complementary therapy with R. officinalis extracts showed a decrease in the number of cells with micronuclei and nuclear abnormalities compared with the group that only received ATRIPLA. The complementary therapy with R. officinalis decreased the genomic instability in HIV patients.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Journal: Participants on dolutegravir re-suppress HIV RNA after virologic failure: updated data from the ADVANCE trial. (Pubmed Central) - Feb 3, 2021 Following evidence of HIV RNA re-suppression on DTG-based regimens, we assess the re-suppressive capacity of ADVANCE participants on TAF/FTC+DTG, TDF/FTC+DTG and TDF/FTC/EFV. Viraemic participants were able to re-suppress within 3 follow-up visits of protocol-defined virological failure (PDVF) in 77/121(64%), 85/126(67%) and 44/138(32%) cases respectively (DTG regimens vs. TDF/FTC/EFV; p<0.001).
- |||||||||| efavirenz / Generic mfg.
Trial completion, Trial completion date: Pharmacologic Strategies to Use the Levonorgestrel Implant in HIV-infected Women (clinicaltrials.gov) - Jan 22, 2021 P2, N=28, Completed, Normal pituitary function and appropriate TSH suppression while on LT4 ruled out central hypothyroidism. Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Mar 2020
- |||||||||| Pifeltro (doravirine) / Merck (MSD)
Clinical, Journal: Once-Daily Doravirine in HIV-1-Infected, Antiretroviral-Naive Adults: An Integrated Efficacy Analysis. (Pubmed Central) - Jan 8, 2021 P3 Active, not recruiting --> Completed DOR, as a single entity (in combination with other antiretroviral agents) and as a fixed-dose combination (DOR/3TC/TDF), demonstrated noninferior efficacy to DRV+r and EFV as assessed by the proportion of HIV-1-infected, treatment-naïve adults with HIV-1 RNA <50 copies/mL.
- |||||||||| Trial completion: REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment (clinicaltrials.gov) - Jan 7, 2021
P4, N=851, Completed, DOR, as a single entity (in combination with other antiretroviral agents) and as a fixed-dose combination (DOR/3TC/TDF), demonstrated noninferior efficacy to DRV+r and EFV as assessed by the proportion of HIV-1-infected, treatment-naïve adults with HIV-1 RNA <50 copies/mL. Active, not recruiting --> Completed
- |||||||||| bictegravir (GS-9883) / Gilead, Pifeltro (doravirine) / Merck (MSD), Tivicay (dolutegravir) / ViiV Healthcare
[VIRTUAL] Dolutegravir/Doravirine: A dual-therapy, nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) sparing HIV antiretroviral regimen in a patient with declining renal function () - Dec 26, 2020 - Abstract #ASHP2020ASHP_2590; The patient was prescribed a regimen of efavirenz/tenofovir DF/emtricitabine (Atripla) upon referral to the specialty clinic. On his first visit he was initiated on bictegravir/tenofovir alafenamide/emtricitabine (Biktarvy) but was switched to a regimen consisting of doravirine 100mg, dolutegravir 50mg, and lamivudine 50mg in January of 2019 because of his declining kidney function...The patient was on esomeprazole, a PPI, for management of severe GERD with esophageal damage (Schatzki’s ring), thus ruling out Juluca as an option...As of February 2020, his CD4 count was 707 and as of June 2020, the patient’s viral loads have remained consistently suppressed at 12 months on a two-drug combination of doravirine and dolutegravir.
- |||||||||| Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD)
Trial completion date: DRIVE-AHEAD: Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A) and ATRIPLA (clinicaltrials.gov) - Dec 23, 2020 P3, N=734, Active, not recruiting, On his first visit he was initiated on bictegravir/tenofovir alafenamide/emtricitabine (Biktarvy) but was switched to a regimen consisting of doravirine 100mg, dolutegravir 50mg, and lamivudine 50mg in January of 2019 because of his declining kidney function...The patient was on esomeprazole, a PPI, for management of severe GERD with esophageal damage (Schatzki’s ring), thus ruling out Juluca as an option...As of February 2020, his CD4 count was 707 and as of June 2020, the patient’s viral loads have remained consistently suppressed at 12 months on a two-drug combination of doravirine and dolutegravir. Trial completion date: Nov 2021 --> Nov 2023
- |||||||||| [VIRTUAL] The NNRTI-Based Single-Tablet Regimens for the Antiretroviral Treatment of Naive Adults Living with HIV-1 in Russia - Cost-Minimization Analysis () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_688;
METHODS Indirect treatment comparison (ITC) by Bucher`s method was performed based on DRIVE-AHEAD and STaR trial data, using FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate as common comparator to assess the relative clinical effectiveness of compared STRs...When compared to RPV/TDF/FTC, one-year therapy with DOR/TDF/3TC was associated with lower costs and saves an average €1,323 (31.4%) per patient. CONCLUSIONS STR DOR/TDF/3TC provides significant cost-savings to the Russian health care system with non-inferior efficacy to RPV/FTC/TDF in treatment-naive HIV-patients with initial viral load (VL) <100 000 copies/mL.
- |||||||||| Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD)
Trial completion date: Effects of Switching From ATRIPLA (clinicaltrials.gov) - Jul 2, 2020 P2b, N=86, Active, not recruiting, Doravirine Phase 2 and Phase 3 Trials in Treatment-Naïve Adults Trial completion date: May 2022 --> Mar 2024
- |||||||||| Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) / Gilead, BMS, Merck (MSD)
Clinical, Journal: Lipidomics Reveals Reduced Inflammatory Lipid Species and Storage Lipids after Switching from EFV/FTC/TDF to RPV/FTC/TDF: A Randomized Open-Label Trial. (Pubmed Central) - Apr 30, 2020 Patients ≥ 18 years old on EFV co-formulated with emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) with HIV-RNA < 50 copies/mL for ≥6 months were randomized to continue EFV/FTC/TDF (n = 14) or switch to RPV/FTC/TDF (n =15)...Patients on RPV/FTC/TDF showed a decrease in the global amount of storage lipids (-0.137 log [fold-change] EFV vs. 0.059 log [fold-change] RPV) but an increase in lysophosphatidylcholines (LPCs) and total steroids. Compared with EFV, RPV increased metabolites with anti-inflammatory properties and reduced the repository of specific lipotoxic lipids.
- |||||||||| Tybost (cobicistat) / Gilead, Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco
Trial completion: Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants (clinicaltrials.gov) - Apr 29, 2020 P3, N=1443, Completed, Compared with EFV, RPV increased metabolites with anti-inflammatory properties and reduced the repository of specific lipotoxic lipids. Active, not recruiting --> Completed
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion date, Trial primary completion date: B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults (clinicaltrials.gov) - Apr 19, 2020 P4, N=200, Recruiting, Active, not recruiting --> Completed Trial completion date: Jan 2020 --> Oct 2021 | Trial primary completion date: Dec 2019 --> Sep 2021
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