- |||||||||| clarithromycin / Generic mfg.
Not the Common Cause of Chronic Diarrhea: A Case of Disseminated Mycobacterium Avium Complex Infection (Shoreline Exhibit Hall) - Sep 8, 2021 - Abstract #ACG2021ACG_2371; Case Description/ A 35-year-old woman with HIV on bictegravir, emtricitabine & tenofovir alafenamide, last CD4 count of 29, presented to the emergency department for 5 weeks of watery diarrhea with mild diffuse abdominal pain...Clarithromycin, ethambutol, Rifabutin, and intravenous Amikacin were started in the hospital...B. AFB stain showed innumerable acid-fast bacteria (Mycobacterium avium intracellulare complex) within clustered histiocytes in the colon
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Clinical, P2/3 data, Clinical Trial,Phase III, Journal: Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide in adolescents and children with HIV: week 48 results of a single-arm, open-label, multicentre, phase 2/3 trial. (Pubmed Central) - Sep 8, 2021 P2/3 Our data support the treatment of HIV in adolescents and children with this single-tablet regimen. At present, the single-tablet regimen is recommended as first-line treatment in the USA for adolescents and as an alternative regimen in children and has the potential to represent an important regimen in the paediatric population.
- |||||||||| bictegravir (GS-9883) / Gilead
Journal: Weight gain following antiretroviral therapy (ART) initiation in ART-naïve people living with HIV in the current treatment era. (Pubmed Central) - Sep 1, 2021 At present, the single-tablet regimen is recommended as first-line treatment in the USA for adolescents and as an alternative regimen in children and has the potential to represent an important regimen in the paediatric population. There is heterogeneity between regimens in weight gain following ART initiation among previously ART-naïve PLWH; we observed greater gain among PLWH taking newer INSTIs (DTG, BIC) and DRV-based regimens.
- |||||||||| Dovato (dolutegravir/lamivudine) / ViiV Healthcare, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Journal: Simulating HIV Breakthrough and Resistance Development During Variable Adherence to Antiretroviral Treatment. (Pubmed Central) - Aug 28, 2021 There is heterogeneity between regimens in weight gain following ART initiation among previously ART-naïve PLWH; we observed greater gain among PLWH taking newer INSTIs (DTG, BIC) and DRV-based regimens. These in vitro viral breakthrough results suggest that the high potency, long half-lives, and antiviral synergy provided by the BIC/FTC/TAF triple therapy regimen may protect from viral rebound and resistance development after short term lapses in drug adherence.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion date, Trial primary completion date: Study to Evaluate the Pharmacokinetics (PK), Safety, and Efficacy of B/F/TAF in Human Immunodeficiency Virus (HIV)-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters (clinicaltrials.gov) - Aug 26, 2021 P1b, N=35, Recruiting, These in vitro viral breakthrough results suggest that the high potency, long half-lives, and antiviral synergy provided by the BIC/FTC/TAF triple therapy regimen may protect from viral rebound and resistance development after short term lapses in drug adherence. Trial completion date: Jun 2022 --> Feb 2023 | Trial primary completion date: Jun 2022 --> Jan 2023
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion date, Trial primary completion date, 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) - Aug 25, 2021 P=N/A, N=201, Active, not recruiting, Recruiting --> Active, not recruiting | Trial completion date: Jun 2021 --> Dec 2021 | Trial primary completion date: Jun 2021 --> Dec 2021 Trial completion date: Nov 2021 --> Sep 2024 | Trial primary completion date: Nov 2021 --> Sep 2024
- |||||||||| Journal: The Use of Integrase Strand Transfer Inhibitors to Treat HIV in Pregnancy. (Pubmed Central) - Aug 20, 2021
Here, we present the case of a pregnant woman with well-controlled HIV on a well-tolerated prepregnancy regimen of bictegravir, emtricitabine, and tenofovir alafenamide...In the second trimester, because of adverse effects from the new ART regimen and after a risk-benefit discussion, the patient restarted the original regimen. She was able to maintain viral suppression until giving birth.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion date, Trial initiation date, Trial primary completion date: INSIGHT: INSTI's For The Management of HIV-associated TB (clinicaltrials.gov) - Aug 18, 2021 P2b, N=120, Not yet recruiting, She was able to maintain viral suppression until giving birth. Trial completion date: Mar 2024 --> Oct 2024 | Initiation date: Mar 2021 --> Oct 2021 | Trial primary completion date: Mar 2023 --> Oct 2023
- |||||||||| Dovato (dolutegravir/lamivudine) / ViiV Healthcare, Tivicay (dolutegravir) / ViiV Healthcare
Enrollment closed: ALTAR: Reducing Antiretroviral Treatments (clinicaltrials.gov) - Aug 9, 2021 P3, N=360, Active, not recruiting, The presence of pre-existing resistance substitutions did not affect treatment outcomes, and there was no treatment-emergent resistance. Not yet recruiting --> Active, not recruiting
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Clinical, Journal: Acute HIV infection with presentations mimicking acalculous cholecystitis: A case report. (Pubmed Central) - Jul 31, 2021 Acalculous cholecystitis in combination with acute hepatitis could be manifestations of acute HIV infection. For individuals at risk of acquiring HIV infection who present with manifestations of acute acalculous cholecystitis, HIV testing should be considered.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion, Trial completion date, Trial primary completion date: SOLUBIC: Bioequivalence of Solid/Crushed/Dissolved Forms of Biktarvy (clinicaltrials.gov) - Jul 28, 2021 P1, N=18, Completed, Active, not recruiting --> Completed Recruiting --> Completed | Trial completion date: Dec 2021 --> May 2021 | Trial primary completion date: Dec 2021 --> Apr 2021
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Enrollment open: BIC-PHI: Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection (clinicaltrials.gov) - Jul 19, 2021 P2, N=66, Recruiting, Recruiting --> Completed | Trial completion date: Dec 2021 --> May 2021 | Trial primary completion date: Dec 2021 --> Apr 2021 Not yet recruiting --> Recruiting
- |||||||||| bersacapavir (JNJ-56136379) / J&J
Enrollment change, Trial withdrawal: A Study of JNJ-56136379 in Healthy Participants (clinicaltrials.gov) - Jul 14, 2021 P1, N=0, Withdrawn, Not yet recruiting --> Recruiting N=21 --> 0 | Recruiting --> Withdrawn
- |||||||||| Vocabria (cabotegravir oral) / ViiV Healthcare, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Enrollment closed, 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) - Jun 18, 2021 P3, N=654, Active, not recruiting, Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Clinical, Journal: Bictegravir/emtricitabine/tenofovir alafenamide-induced acute pancreatitis: a case report. (Pubmed Central) - Jun 10, 2021 A diagnosis of mild drug-related acute pancreatitis was made and BIC/FTC/TAF was immediately stopped. The association between the episode of acute pancreatitis and BIC/FTC/TAF was scored as probable according to the Naranjo causality scale.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Enrollment closed: Effects of Biktarvy on CFR in Stable HIV Patients (clinicaltrials.gov) - Jun 9, 2021 P3, N=25, Active, not recruiting, Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
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