The Ministry of Health has registered a new drug for HIV treatment
The Russian Ministry of Health registered Rucobia (INN fostemsavir) for the treatment of HIV infection. In the USA, the drug from ViiV Healthcare was approved in 2020.ViiV Healthcare received a registration certificate from the Russian Ministry of Health for Rucobia for the treatment of HIV infection. It is indicated for use in combination with other antiviral drugs in patients who have stopped responding to standard antiretroviral therapy. The information in the State Register of Medicines was brought to the attention of Pharmaceutical Gazette.
The drug is available in prolonged-release tablets in a dosage of 600 mg. The manufacturer is the Italian GlaxoSmithKlein Manufacturing S.p.A.
Fostemsavir is a first-in-class human immunodeficiency virus fusion inhibitor. In the body it is metabolized into the active form - temsavir, which is able to block the viral protein gp120. This prevents HIV from forming a bond with the CD4-receptor of the cell and penetrating into it. Thus the drug reduces the viral load in the body.
It is forbidden to take fostemsavir simultaneously with some anticonvulsants, cancer drugs, as well as with rifampicin for the treatment of tuberculosis, it is stated in the instructions for medical use. "Rucobia is used one tablet twice a day. It is not known if Rucobia is safe for children, breastfeeding and pregnant women.
The instructions also list the most common adverse reactions. These include nausea, vomiting, diarrhea, and several others.
The US Food and Drug Administration (FDA) approved fostemsavir in 2020. The rationale was based on data from a clinical trial (NCT02362503) involving adults with HIV-1 infection who had previously received therapy.
In 2019, ViiV Healthcare announced positive 96-week results from the Phase III BRIGHTE study of fostemsavir in intensively treated adults with HIV-1 infection. In the randomized cohort, virologic suppression and immunologic response rates increased from week 48 to week 96 in the multidrug-resistant population.
ViiV Healthcare was established in 2009 as a joint venture between Pfizer and GlaxoSmithKline focused on developing treatments for HIV infection. Japan's Shionogi joined the company in 2012. GlaxoSmithKline currently holds 76.5% in ViiV Healthcare, Pfizer owns 13.5% and Shionogi 10%.