China's State Drug Administration Drug Review Center (CDE) recently announced that the two-drug HIV therapy submitted by GlaxoSmithKline (GSK) - Dotiravirpivirin tablets of the new drug market application to be included in the priority review, the formulation of adaptation: for treatment to receive stable antiretroviral treatment program to achieve Virological inhibition (HIV-1 RNA less than 50 copies/mL) for at least six months, no history of virological failure, and no known or suspected resistance to non-nucleoside retrovirus inhibitors or integrated enzyme inhibitors in adult human immunodeficiency virus type 1 (HIV-1) infection patients.
screenshot source: CDE's official website, Dotila Velipiverin, is a dual-drug HIV therapy launched by GSK's ViiV Healthcare.
the drug, which was approved in the U.S. in November 2017 to treat specific adult patients infected with HIV-1, is the first two-drug treatment approved for HIV-1 patients.
of these, dolutegravir, developed by ViiV Healthcare, is an HIV-1 integrated enzyme chain transfer inhibitor (INSTI) that prevents HIV from entering cells and can be used in a coalition with other antiretroviral drugs to treat adult patients infected with HIV-1.
, developed by Janssen Sciences Ireland UC, is a non-nucleoside retrovirase inhibitor (NNRTI).
, the global anti-HIV drugs mainly include CCR5 antagonists, fusion inhibitors, reverse transcriptase inhibitors, integrated enzyme inhibitors, protease inhibitors and so on.
To avoid drug resistance from a single drug, clinical treatment options are mostly combined with three or more drugs, while limiting the number of drugs in HIV treatment options can help reduce toxicity in patients.
there are currently a number of HIV two-drug compound preparations in China, this time dotiravelpivelin is to be included in the priority review, is expected to bring new treatment options for patients.
and effectiveness of dotiravelpiverin in the treatment of HIV-1 patients has previously been evaluated in two studies called SWORD 1 and WORD 2.
the two studies recruited 1,024 volunteers who were already effectively controlled for viral infection in current anti-HIV treatments.
the volunteers were randomly divided into two groups, one continuing to receive current anti-HIV therapy and the other using dotiravelpivirin.
studies have shown that doteravelipivirin is effective in suppressing HIV, comparable to the anti-HIV therapies used by these volunteers.
specifically, in the summary and separate analysis of the two studies, the Dotiravirpivirin programme achieved non-effective viral suppression at 48 weeks (HIV-1 RNA -lt;50 copy/ml) compared to the three- or four-drug solution.
inhibition rates were similar between the treatment groups.
the results of these studies may change the understanding of how HIV is managed, according to an earlier press release from ViiV Healthcare.
For more than 20 years, it has been thought that three or more drugs are needed to maintain virological inhibitions, but the WORD study provides compelling data that inhibition can be maintained through two drug treatments, Dotiravir and Lipivirin.
data mark an exciting first step toward making both drugs a reality for HIV treatment.
According to an earlier FDA press release, Dotiravelpivirin provides two-drug maintenance therapy for patients who have been inhibited by the virus, who benefit from this once-a-day nucleotide-free HIV retrovirase inhibitor (NRTI) program.
its approval could bring about a paradigm change in treatment for HIV-infected patients, limiting the number of drugs in HIV therapy could reduce toxicity to patients.
the use of antiviral "cocktail" therapy to treat HIV infection is one of the most important advances in medicine over the past 25 years.
there are already a variety of effective control of HIV-1 virus proliferation of single-piece combination treatment options, as long as patients adhere to daily medication, their life expectancy and healthy people are not significantly different.
congratulations on the inclusion in the priority review of the application for the listing of Dotiravelpivirin tablets in China, and hoped that the treatment would be approved at an early time, benefiting more hiv-infected patients.