- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, lamivudine / Generic Mfg., abacavir/lamivudine / Generic Mfg.
Long-term efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in ART-naïve adults (Exhibition hall) - Nov 15, 2019 - Abstract #EACS2019EACS_1701; Through 3 years of follow-up in ART-naïve adults, use of B/F/TAF resulted in high rates of virologic suppression through W144. B/F/TAF was well tolerated, had fewer drug-related adverse events compared with DTG/ABC/3TC, and no clinically relevant effect on bone and renal safety or fasting lipids.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, lamivudine / Generic Mfg., abacavir/lamivudine / Generic Mfg.
Long-term efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in ART-naïve adults (Exhibition hall) - Nov 15, 2019 - Abstract #EACS2019EACS_891; Through 3 years of follow-up in ART-naïve adults, use of B/F/TAF resulted in high rates of virologic suppression through W144. B/F/TAF was well tolerated, had fewer drug-related adverse events compared with DTG/ABC/3TC, and no clinically relevant effect on bone and renal safety or fasting lipids.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, lamivudine / Generic Mfg., abacavir/lamivudine / Generic Mfg.
Long-term efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in ART-naïve adults (Exhibition hall) - Nov 15, 2019 - Abstract #EACS2019EACS_143; Through 3 years of follow-up in ART-naïve adults, use of B/F/TAF resulted in high rates of virologic suppression through W144. B/F/TAF was well tolerated, had fewer drug-related adverse events compared with DTG/ABC/3TC, and no clinically relevant effect on bone and renal safety or fasting lipids.
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, NN1213 / Novo Nordisk
Trial completion date, Trial primary completion date: Early ART to Limit Infection and Establishment of Reservoir (clinicaltrials.gov) - Nov 11, 2019 P2, N=150, Recruiting, Active, not recruiting --> Completed Trial completion date: Jun 2020 --> May 2021 | Trial primary completion date: Dec 2019 --> Nov 2020
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Enrollment open, Trial primary completion date: EMTreatED: Empiric Treatment for Acute HIV in the ED (clinicaltrials.gov) - Oct 15, 2019 P4, N=40, Recruiting, Trial completion date: Jun 2020 --> May 2021 | Trial primary completion date: Dec 2019 --> Nov 2020 Not yet recruiting --> Recruiting | Trial primary completion date: Oct 2020 --> Apr 2021
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, NN1213 / Novo Nordisk
Trial primary completion date: Early ART to Limit Infection and Establishment of Reservoir (clinicaltrials.gov) - Sep 26, 2019 P2, N=150, Recruiting, No abstract available Trial primary completion date: Jul 2019 --> Dec 2019
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Trial primary completion date: EMTreatED: Empiric Treatment for Acute HIV in the ED (clinicaltrials.gov) - Sep 25, 2019 P4, N=40, Not yet recruiting, Trial primary completion date: Jul 2019 --> Dec 2019 Trial primary completion date: Nov 2019 --> Oct 2020
- |||||||||| Journal: Drug updates and approvals: 2018 in review. (Pubmed Central) - Sep 8, 2019
In 2018, the FDA approved several new drugs for use in primary care. This article highlights the following new drugs: bictegravir, emtricitabine, and tenofovir alafenamide (Biktarvy); doxylamine succinate and pyridoxine hydrochloride (Bonjesta); erenumab-aooe (Aimovig); lofexidine hydrochloride (Lucemyra); tezacaftor and ivacaftor (Symdeko); and tildrakizumab-asmn (Ilumya).
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Enrollment closed, HEOR, Adherence: BIC-STaR: Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide (clinicaltrials.gov) - Sep 3, 2019 P=N/A, N=200, Active, not recruiting, This article highlights the following new drugs: bictegravir, emtricitabine, and tenofovir alafenamide (Biktarvy); doxylamine succinate and pyridoxine hydrochloride (Bonjesta); erenumab-aooe (Aimovig); lofexidine hydrochloride (Lucemyra); tezacaftor and ivacaftor (Symdeko); and tildrakizumab-asmn (Ilumya). Recruiting --> Active, not recruiting
- |||||||||| bictegravir (GS-9883) / Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Adverse Events with Biktarvy: Post-Marketing Study () - Aug 26, 2019 - Abstract #IDWeek2019IDWeek_2895; VS rates were high throughout the evaluation period. Ongoing post-marketing evaluation is important for early recognition of unexpected adverse outcomes.
- |||||||||| Dovato (dolutegravir/lamivudine) / ViiV Healthcare, Tivicay (dolutegravir) / ViiV Healthcare
New P3 trial: ALTAR: Reducing Antiretroviral Treatments (clinicaltrials.gov) - Aug 8, 2019 P3, N=360, Not yet recruiting,
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
A Rare Case of Biktarvy-Induced HBV Flare (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_2078; Hepatotoxicity could be due to the variations of viral replication activating immune responses. Even though the flare ups of chronic HBV can be due to initiation of emtricitabine, it is recommended to continue the agent and monitor for down trending pattern of aminotransferases which was depicted in our case.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Journal: Bictegravir/Emtricitabine/Tenofovir Alafenamide: A Review in HIV-1 Infection. (Pubmed Central) - Aug 3, 2019 Bictegravir/emtricitabine/tenofovir AF is generally well tolerated, requires no prior HLA-B*5701 testing (making it more suitable for 'rapid start' treatment), fulfils the antiretroviral regimen requirement for patients with hepatitis B virus (HBV) co-infection (i.e. contains tenofovir AF and emtricitabine, both of which are active against HBV) and can be used in renally impaired patients with creatinine clearance (CR) ≥ 30 mL/min. Thus, although cost-effectiveness analyses would be beneficial, current data indicate that bictegravir/emtricitabine/tenofovir AF is a convenient initial and subsequent treatment option for adults with HIV-1 infection, including those co-infected with HBV, and provides the first non-pharmacologically boosted, INSTI-based, triple-combination STR suitable for patients with CR 30-50 mL/min.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion date: Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults (clinicaltrials.gov) - Jul 30, 2019 P3, N=631, Active, not recruiting, Thus, although cost-effectiveness analyses would be beneficial, current data indicate that bictegravir/emtricitabine/tenofovir AF is a convenient initial and subsequent treatment option for adults with HIV-1 infection, including those co-infected with HBV, and provides the first non-pharmacologically boosted, INSTI-based, triple-combination STR suitable for patients with CR 30-50 mL/min. Trial completion date: Aug 2021 --> May 2021
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