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See the DrugPatentWatch profile for dovato
Who Makes Dovato, and What Sets It Apart? Dovato is a prescription medication developed by ViiV Healthcare. It is a combination of HIV-1 reverse transcriptase inhibitors, tenofovir alafenamide fumarate (TAF) and emtricitabine (FTC), and a nucleotide/nucleoside reverse transcriptase inhibitor, lamivudine (3TC) as a co-formulation with dolutegravir (DTG). [1] Why Are Healthcare Providers Considering Dovato for Newly Diagnosed HIV Patients? In March 2019, Dovato received FDA approval as a single tablet regimen for HIV-1 infection treatment in adults with no antiretroviral treatment (ART) experience. This dual co-formulation offers the convenience of a one-pill, once-daily dosing regimen for adults with HIV-1 infection, excluding those with a documented history of resistance [2][3], but is it the best option? What Benefits Does Dovato Offer, and How Does It Compare to Other Treatment Options? Dovato offers several benefits, including improved tolerability compared with other treatment options [1] and a reduced pill burden for patients on a one-pill regimen. However, the drug has not been directly compared to other available HIV treatments in a head-to-head study in newly diagnosed patients, so we still have much more to learn. How Long Will Dovato Remain Available to Patients? As of now, Dovato's exclusivity expires on November 15, 2027 [4]. Biosimilar entry to the market can occur even before exclusivity expires. Biosimilars, such as Biktarvy (DTG/FTC/TAF) have entered the same class of medications with significant savings, offering new treatment options to newly diagnosed patients. References [1] ViiV Healthcare. (2019). Dovato Prescribing Information. [2] https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210833s000lbl.pdf [3] http://www.fda.gov/downloads/Drugs/DrugSafety/UCM624445.pdf [4] DrugPatentWatch.com Sources: 1. ViiV Healthcare (2019) 2. U.S FDA (2019) 3. U.S FDA (2019) 4. DrugPatentWatch.com
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