The quality of the production process of antiretroviral therapy drugs as an essential component of the quality of life of patients with HIV in the context of the domestic pharmaceutical market
Authors: Ermishin Aleksandr , V'yugina Irina , Fomina Anastasiya 
Published: September 2024

The article presents the results of a comprehensive scientific analysis, including an analysis of the Russian pharmaceutical market for antiretroviral therapy drugs, an analysis of the HIV status of the population in the Russian Federation over the past few years, and an analysis of the production of antiretroviral drugs using the example of «Ritonavir». It is the most commonly used and effective antiretroviral drug used with other drugs to treat HIV. At the present stage of pharmaceutical development, the intrinsic antiviral activity of this drug is rarely used, but it is still widely used as an enhancer for other HIV protease inhibitor drugs. The availability of antiretroviral drugs, their quality and safety will directly depend on the streamlined technological process and the stability of production. The scientific result of the work is that for the first time a comprehensive study was carried out that included 3 components: an analysis of the domestic pharmaceutical market for antiretroviral therapy drugs, the state of HIV infection among the population in Russia, and an analysis of the production of these drugs using the example of «Ritonavir». It is noted that the Russian pharmaceutical market is demonstrating dynamic development: over the past 20 years, market growth has amounted to 11.43 times, or by 2348 billion rubles, over 5 years – 56.89% (or by 933 billion rubles), over the last year – by 11.97% (or 275 billion rubles). In 2022, a significant reduction in the volume of hospital purchases was noted for drugs with a price in the range of 150-500 rubles – by 1.9% (to the level of 5.8%), preference was given to more expensive ones, including drugs active against HIV containing «Ritonavir». An analysis of the state of HIV incidence in Russia showed a decline in the number of detected cases (over the last 7 years – 1.8 times, to the level of 56,003 people), a positive trend in the number of patients receiving antiretroviral therapy was noted – up to 99.3% in the country. In 2022, mortality in Russia from HIV amounted to 15,804 people, which is 1,110 people less than last year (or 6.56%) and amounted to 0.8% of the total number of deaths this year and has been trending downward over the past five years. An analysis of the suitability and efficiency of the «Ritonavir» tableting process at one of the capital’s domestic pharmaceutical enterprises for the critical quality attribute «Height» showed that the process suitability index was 1.075, which indicates its theoretical reproducibility, and the efficiency index was 0.835, which indicates that the process is not centralized, and additional adjustment of the tableting process is necessary, since the risk of obtaining tablets with a large height is high, which, in turn, increases the risk of foil breakthrough at the blister packing stage and will affect the quality and safety of the drug. Ultimately, the quality of life of people living with HIV and undergoing therapy depends on this.