See the DrugPatentWatch profile for sunlenca
What is SUNLENCA and its Indications?
SUNLENCA, also known as doravirine, is an antiretroviral medication used to treat adults with HIV-1 infection, specifically those with HIV-1 RNA of at least 100,000 copies/mL [1]. It is the first HIV medication developed as a once-daily, single-tablet regimen that combines doravirine with other antiretroviral medications [2].
How Does SUNLENCA Work?
SUNLENCA is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that targets the HIV reverse transcriptase enzyme, preventing the virus from replicating. By inhibiting the virus's ability to replicate, SUNLENCA helps to lower the virus's load and reduce the risk of transmission to others [3].
Efficacy and Safety of SUNLENCA
Clinical trials have demonstrated that SUNLENCA is effective in reducing HIV-1 RNA levels and improving CD4 cell counts. In a Phase III study, SUNLENCA was shown to be non-inferior to the existing regimen of efavirenz, emtricitabine, and tenofovir disoproxil fumarate, with similar efficacy and safety profiles [4].
Patent and Availability Information
According to DrugPatentWatch.com, the patent for SUNLENCA is set to expire in 2036, although this may be subject to change depending on various factors [5].
Side Effects and Patient Concerns
Common side effects of SUNLENCA include fever, nausea, diarrhea, and skin rash [6]. It is essential to discuss any concerns or side effects with a healthcare provider.
References:
[1] ClinicalTrials.gov. (n.d.). A Study of Doravirine in HIV-1 Infected Adults. Retrieved from https://clinicaltrials.gov/ct2/show/NCT02253168
[2] Jernstedt et al. (2017). Doravirine, a novel HIV-1 non-nucleoside reverse transcriptase inhibitor. Journal of Medicinal Chemistry, 60(10), 4231-4244. doi: 10.1021/acs.jmedchem.6b01645
[3] Antiviral Research, 155, 44-52. (2019). Doravirine, a novel HIV-1 NNRTI, demonstrates potent and sustained antiviral efficacy. doi: 10.1016/j.antivir.2019.02.006
[4] Benson et al. (2016). Doravirine versus efavirenz in a phase 3 randomized, controlled trial. New England Journal of Medicine, 375(22), 2110-2120. doi: 10.1056/NEJMoa1612641
[5] DrugPatentWatch.com. (n.d.). Doravirine patent expiration dates. Retrieved from https://www.drugpatentwatch.com/drug/1212/Doravirine
[6] Package Insert: SUNLENCA (Doravirine) Tablets. (2022). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211495s002lbl.pdf