- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, Cimduo (lamivudine/tenofovir disoproxil fumarate) / Mylan, Celltrion, Aurobindo, Cipla, Hetero, Sun Pharma, Macleods
3- B/F/TAF Like @PaulSaxMD & @Amit_Achhra mentioned, this should work Extrapolation of DAWNING, NADIA and VISEND studies (in the context of VF), & the 2DS study (suppressed PLWH+extensive NRTIs RAMs) No reason to believe BIC (+F/TAF) wouldn't perform as well as DTG (+TDF/3TC) (Twitter) - Dec 15, 2022
- |||||||||| Dovato (dolutegravir/lamivudine) / ViiV Healthcare, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Enrollment open: 2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial (clinicaltrials.gov) - Dec 6, 2022 P4, N=134, Recruiting, Given the findings concerning the effect of same-day ART prescription and AOIs on AR-related regimen discontinuation, individualized approaches to PLWAH are necessary. Active, not recruiting --> Recruiting
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Journal, Real-world evidence: Real World Data on Forgiveness to Uncomplete Adherence to Bictegravir/ Emtricitabine/Tenofovir Alafenamide. (Pubmed Central) - Nov 25, 2022 According to probit analysis adherence was not related to the possibility to maintain an HIV-RNA TND or < 50 copies/ml. Long-term success of ART needs effective regimens that are the least intrusive of the patient's lifestyle, an elevated forgiveness may be considered as an additional feature that can further improve long-term outcomes.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare, Vemlidy (tenofovir alafenamide) / Gilead
P3 data, Review, Journal: Comparison of the design and methodology of Phase 3 clinical trials of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and dolutegravir-based dual therapy (DTG) in HIV: a systematic review of the literature. (Pubmed Central) - Nov 19, 2022 The designs would not be comparable due to differences in pre-randomisation losses, blinding, patient recruitment, as well as differences in methodological quality, with the average score of the RCTs conducted with BIC/FTC/TAF, DTG/3TC and DTG/RPV being 4.2 (high quality), 3.0 (medium quality) and 3.0 (medium quality), respectively. Due to methodological differences between the BIC/FTC/TAF, DTG/3TC and DTG/RPV RCTs, the results of these are not comparable.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, GS-5894 / Gilead, GS-1720 / Gilead
Enrollment open: Study of Novel Antiretrovirals in Participants With HIV-1 (clinicaltrials.gov) - Nov 18, 2022 P1b, N=110, Recruiting, Despite emergence of K65N/R +/- M184V/I after virologic failures, BIC/FTC/TAF could be an option for simplification following viral suppression. Not yet recruiting --> Recruiting
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Journal, Real-world evidence: The effect of changing to Bictegravir on lipids using real world data: A brief report. (Pubmed Central) - Nov 4, 2022 We demonstrated that patients with the most adverse lipid profiles at baseline had significant improvements in lipid profiles. In addition, patient switching away from protease inhibitor therapy also had significant improvements in triglyceride.
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Enrollment closed, Trial primary completion date: Bictegravir in the Elderly Living With HIV (BICEP) (clinicaltrials.gov) - Nov 1, 2022 P=N/A, N=162, Active, not recruiting, These results confirm the robustness of this combination. Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2022 --> Jul 2023
- |||||||||| Vocabria (cabotegravir oral) / ViiV Healthcare, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Trial completion date, Head-to-Head: SOLAR: A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY (clinicaltrials.gov) - Oct 26, 2022 P3, N=688, Active, not recruiting, Since viremia raises inflammatory markers, differences in antiviral efficacy may make a difference in the suppression of chronic inflammation but in conclusion, we did not find any change in inflammatory markers by changing from 3DR to 2DR in daily clinical practice. Trial completion date: Jul 2023 --> Mar 2023
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Lupus-Like Glomerulonephritis as the First Presentation of AIDS () - Oct 15, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_4361; Biktarvy was initiated within 2 weeks of his HIV diagnosis...HAART with steroids +/- MMF therapy early in disease can stabilize renal function. HIV testing should be performed more frequently in patients presenting with acute GNs.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
A Case of Medullary Sponge Kidney Presented With Persistent Hypokalemia () - Oct 15, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_4335; Case Description A 33-year-old female with well-controlled HIV on Biktarvy (HIV-1 RNA < 20 copies/ml) presented with palpitations and tingling in the arms and legs for one day...Her kidneys from the CT scan 7 years ago did not show calcification or increased density of the pyramids but now she has a typical US finding of MSK. This case highlights that hypokalemia and distal RTA might be the first sign of MSK while structural changes were not prominent in the imaging.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
A Case of Collapsing Focal Segmental Glomerulosclerosis in Post-mRNA COVID-19 Vaccination (Exhibit Hall, Orange County Convention Center, West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_922; Case Description A 24-year-old male with history of well-controlled HIV on Biktarvy was referred to nephrology for acute kidney injury (AKI) with nephrotic-range proteinuria...Treatment was started with Methylprednisolone, Mycophenolate and Lisinopril...It is unclear of what mechanism attributed to FSGS, but it is possible to consider an inflammatory response against the spike protein as a ‘second hit’ phenomenon to susceptible individuals, such as African Americans with APOL-1 risk alleles or HIV. This is a potential adverse effect that must be considered after mRNA covid vaccination.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
Osteoporosis among older persons living with HIV in Kenya: baseline results from the BFTAF elderly switch study () - Oct 4, 2022 - Abstract #HIVGlasgow2022HIV_Glasgow_305; DXA is not readily available in Kenya, and risk calculation without BMD did not identify the majority of participants who qualify for treatment of osteoporosis. Additional data for this population are required on clinical implications of undiagnosed osteoporosis, ARV regimen selection to reduce osteoporosis risk, particularly in populations with widespread use of TDF, and on the impact of investment in osteoporosis screening and treatment, including population-specific risk calculators.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
New-onset diabetes in persons with HIV on BIC/FTC/TAF in real-world clinical practice () - Oct 4, 2022 - Abstract #HIVGlasgow2022HIV_Glasgow_291; A significant proportion of patients initiating BIC/FTC/TAF developed diabetes, although a causal relationship cannot be established. Since most patients progressed from prediabetes, information about previous prediabetes could be important in order to address the potential impact of each INSTI regimen influence on the onset of diabetes.
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