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).
Discovery and development of nucleoside and nucleotide reverse-transcriptase inhibitors began in the 1980s when the AIDS epidemic hit Western societies. 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.
Absorption. Commonly reported adverse events observed were diarrhea, nausea, and headache. Peak … 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. Drug-resistant viruses are an inevitable consequence of prolonged exposure of HIV-1 to anti-HIV drugs.Cn1c(n[nH]c1=O)Cn2ccc(c(c2=O)Oc3cc(cc(c3)Cl)C#N)C(F)(F)FInChI=1S/C17H11ClF3N5O3/c1-25-13(23-24-16(25)28)8-26-3-2-12(17(19,20)21)14(15(26)27)29-11-5-9(7-22)4-10(18)6-11/h2-6H,8H2,1H3,(H,24,28) Similarly, 294 (80.8%) of the 364 patients in the EFV arm achieved the primary efficacy endpoint. Johnson M, Kumar P, Molina J-M, et al. 12.4 Microbiology 13 NONCLINICAL TOXICOLOGY . In August 2018, the FDA approved doravirine under the product name Pifeltro, and in a combination tablet, doravirine… Islatravir, the first nucleoside reverse transcriptase translocation inhibitor, plus the recently approved non-nucleoside reverse transcriptase inhibitor doravirine (Pifeltro) may offer a potent and well-tolerated … DRIVE-AHEAD evaluated the virologic efficacy of DOR versus efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor, in treatment-naïve patients living with HIV-1. The study results showed that DOR was non-inferior compared to EFV and DRV/r based on HIV-1 RNA viral load reduction. The primary efficacy endpoint was identical to the DRIVE-FORWARD trial. 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. Global Statistics.
Onset: 4-8 hr. Whitehouse Station, NJ: Merck Sharp & Dohme Corp; 2018.Molina J-M, Squires K, Sax PE, et al. Sax PE, Wohl D, Yin MT, et al. Albuvirtide has a similar mechanism of action to enfuvirtide. HIV.gov. Accessed April 28, 2019.PIFELTRO [package insert]. Switching to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintain HIV-1 Virologic Suppression Through 48 Weeks. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate is Non-inferior to Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-naive Adults With Human Immunodeficiency Virus–1 Infection: Week 48 Results of the DRIVE-AHEAD Trial.
Orkin C, Squires KE, Molina J-M, et al. In the DOR arm, of the 383 participants, 21 (5%) experienced diarrhea, 25 (7%) experienced nausea, and 23 (6%) experienced headache.
Doravirine (DOR), a novel NNRTI, was approved by the FDA in August 2018 as an option for the treatment of HIV in patients with no prior ART history, based off of the results of 2 large phase III clinical trials.The DRIVE-FORWARD trial is a phase III, randomized, double-blind, multicenter, non-inferiority study assessing the efficacy of doravirine versus ritonavir-boosted darunavir (DRV/r) in patients living with HIV who had Patients were randomized to receive either DOR or DRV/r with a backbone combination regimen of emtricitabine (FTC) with tenofovir disoproxil fumarate (TDF) or abacavir (ABC) with lamivudine (3TC).The primary endpoint evaluated was the proportion of patients with a HIV-1 RNA viral load ≤ 50 copies per mL by week 48. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES . New ARTs have been approved with new mechanisms of action and/or with higher genetic barriers to overcome drug resistance. The first NRTI was zidovudine, approved by the U.S. Food and Drug Administration (FDA) in 1987, which was the first step towards treatment of HIV. Published January 10, 2019.
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