Use in patients who are ART treatment-experienced has also been evaluated in switch studies. Whitehouse Station, NJ: Merck Sharp & Dohme Corp; 2018.Molina J-M, Squires K, Sax PE, et al. In the DOR arm, no genotypic mutations or phenotypic resistance associated with DOR were identified at week 48.
Its high barrier to resistance and limited adverse effect profile, make this NNRTI an option for treatment-naive patients in certain clinical situations.Its coformulation with 3TC and TDF as the single tablet regimen, Delstrigo, limits its widespread use as it is not recommended to be used in patients with a renal function of ≤ 50 mL/min., when compared with other single tablet regimens, may be a more affordable option for patients (Table 1).Table 1: Monthly cost of select single tablet regimens (Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate) (Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate)(Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)(Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide)UNAIDS.
The most notable secondary outcome assessed was the development of virologic resistance. 13,14 …
https://www.hiv.gov/hiv-basics/overview/data-and-trends/global-statistics. Advancements in HIV drug therapies, such as the development of integrase strand transfer inhibitors (INSTIs) and single tablet regimens, have reduced polypharmacy associated with the management of this viral infection. Current initial therapies for most people living with HIV consist of 2 …
In the DRV/r arm, 3 patients exhibited polymorphic mutations to darunavir that did not affect drug susceptibility at week 48.
Deirdre Kaan, Doctor of Pharmacy Candidate 2020, Temple University School of PharmacyPreceptor: Amy Min, PharmD, BCACP, AAHIVP, Clinical Assistant Professor,Department of Pharmacy Practice of Pharmacy at Temple UniversityIn 2017, over 36.9 million people worldwide were living with HIV; only 75% were aware that they were living with HIV and 59% were able to access antiretroviral therapy (ART).
Adult Subjects Pediatric … In DRIVE-SHIFT, an open-label, active-controlled, non-inferiority trial, patients switched from their baseline ART regimen of 2 NRTIs and either a boosted protease inhibitor, boosted elvitegravir, or an NNRTI, to a single tablet regimen of DOR/3TC/TDF or continued their baseline ART regimen for 24 weeks. Accessed April 28, 2019.PIFELTRO [package insert]. Patients on efavirenz-based regimens exhibited more sleep disturbances (25.2% compared to 12.1%) and altered sensorium (8.2% versus 4.4%) compared to the patients on a DOR-based regimen.The DRIVE-FORWARD and DRIVE-AHEAD are the clinical trials that drove the FDA approval of doravirine, a novel NNRTI for treatment-naive patients living with HIV. Absorption.
In the DOR arm, of the 383 participants, 21 (5%) experienced diarrhea, 25 (7%) experienced nausea, and 23 (6%) experienced headache. The NNRTI drug class, which has recently fallen out of favor due to the approval of INSTIs, still remains as a recommended option for patients in certain clinical situations. Additionally, patients in the DOR arm reported lower rates of dizziness (8.8% compared to 37.1%) than the EFV arm. The primary efficacy endpoint was identical to the DRIVE-FORWARD trial. Sax PE, Wohl D, Yin MT, et al. Orkin C, Squires KE, Molina J-M, et al. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES . Doravirine: A Novel NNRTI - Duration ... 23:30. ß-Lactams: Mechanisms of Action and Resistance - Duration: 7:23.
Therapeutic advancements have also reduced medication side effects, potential drug interactions, and toxicities impacting patient care. Current initial therapies for most people living with HIV consist of 2 nucleoside reverse transcriptase inhibitors (NRTIs) in combination with certain INSTIs including dolutegravir, bictegravir, and raltegravir. New ARTs have been approved with new mechanisms of action and/or with higher genetic barriers to overcome drug resistance. Similarly, 294 (80.8%) of the 364 patients in the EFV arm achieved the primary efficacy endpoint.
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