The analysis of the availability of fixed-dose combinations in antiretroviral therapy for HIV infection in the Russian Federation

Abstract

To analyze the features of drugs provision for special groups of treatment-nave HIV-infected patients initiating antiretroviral treatment with fixed dose combination (FDC) for once-daily single-tablet regimen, in Russian healthcare setting. We studied the regulatory legal documents governing the provision of antiretroviral drugs in Russia and analyzed the Russian Program of State Guarantees to determine the inclusion of the investigated FDCs in the lists of regional benefits, as well as regional and federal procurement of these drugs in 2020 and 2021. We compared costs of first line therapy for special groups using FDCs regimens per year in case of regional purchases or centralized purchases. It was show that doravirin/tenofovir/lamivudine was the least expensive in 2020 and in 2021 among new FDCs form drugs. Worth 325.8 and 323.9 thousand rubles. per patient per year. The most expensive was bictegravir/tenofovir alafenamide/emtricitabine (401.6 and 439.9 thousand rubles, respectively). In case of Ministry of Health centralized purchases, the costs of new FDCs (doravirin/tenofovir/lamivudine and bictegravir/tenofovir alafenamide/emtricitabine), included in Vital and Essential drug list (VEDL) in 2022, will amount to 151,2 and 191.4 thousand rubles respectively, which is 52.9% and 40.4% lower than the cost per course of rilpivirine/tenofovir/emtricitabine. The inclusion of new effective and economical FDCs the whole scheme in one tablet once-daily in VEDL, expands the possibilities of simplify and effective first-line therapy for special groups of HIV-infected patients, as well as reduce the financial burden on the Program of State Guarantees budget and increases treatment coverage. All of this corresponds to the goals of the State Strategy to Combat the Spread of HIV in Russian Federation.