The biopharmaceutical company PROMOMED has completed the development cycle of one of the most modern HIV therapy regimens, previously unavailable in Russia. The drug combination includes tablet and injectable forms of cabotegravir and rilpivirine. All four drugs have already received registration certificates. The combination of cabotegravir and rilpivirine is included in the clinical recommendations of the Russian Ministry of Health "HIV infection in adults" as an option for optimizing antiretroviral therapy.

A unique technology for the production of long-acting suspensions was developed at the Biochemik plant in Saransk. For the first time in our country, it has become possible to release cabotegravir and rilpivirine, which are of crucial social importance. The decision to start commercial sale can be made by PROMMED solely taking into account the necessary legal conditions, in the presence of which the release will be organized according to the full cycle — from the production of the active pharmaceutical substance to the finished dosage form. In the near future, the Company will begin clinical trials of drugs to expand the evidence base for the effectiveness and safety of this approach.

The effectiveness of the injection regimen in the world has been confirmed by the results of large clinical trials of ATLAS, FLAIR and ATLAS-2M. According to the data obtained, therapy administered every four or eight weeks is comparable in effectiveness to daily use of antiretroviral drugs. More than 90% of patients retain undetectable levels of HIV RNA in their blood after switching to the injection regimen. The combination of cabotegravir and rilpivirine is a fundamentally new treatment format for HIV infection. The US Food and Drug Administration (FDA) has awarded cabotegravir the status of a breakthrough therapy. This method increases patient adherence to treatment.

The main condition for starting complex therapy with cabotegravir and rilpivirine is an undetectable viral load. "In other words, these drugs are indicated for patients who have already taken antiretroviral therapy. The level of HIV RNA in the blood should be less than 50 copies/ml. If a person has just learned the diagnosis and has not yet achieved suppression, therapy is not prescribed," explains Victoria Shcherbakova, Medical Director PROMOMED. — The transition to complex treatment with cabotegravir and rilpivirine takes place in two stages. During the first month, the patient takes medications in tablet form. This allows doctors to evaluate the tolerability of drugs and ensure that there are no serious side effects before switching to continuous injections."