Regulator to update primary care standard for HIV infection

If the draft is adopted, the order of the Ministry of Health of the Russian Federation No. 483n of June 23, 2022 "On approval of the standard of primary health care for adults with HIV infection (diagnosis, treatment and dispensary observation)" will cease to be valid. The updated standard was developed in accordance with the clinical guidelines "HIV infection in adults".

As now, the therapy will be carried out on an outpatient basis, the average duration of treatment for a completed case will be 365 days, and the form of providing such medical care will be planned. At the same time, the regulator proposes to expand the list of nosologies, including six new diseases and conditions in accordance with ICD-10.

These include dementia in HIV disease (F02.4), laboratory detection of HIV (R75), special screening examination for infection with the virus (Z11.4), contact with and possibility of infection with the human immunodeficiency virus (Z20.6), counselling on issues related to the human immunodeficiency virus (Z71.7), and a family history of HIV disease (Z83.0).

The Ministry of Health also proposes adding one initial appointment with a therapist (general practitioner) and a single quantitative study to determine cytomegalovirus DNA using the PCR method in peripheral and umbilical cord blood to the diagnostics. The current regulations stipulate the need to conduct a study to determine antibodies to toxoplasma in the blood - this point is missing in the new document.

The approach to treating HIV patients will also change. The need for a single initial and repeat visit to a phthisiatrician will be added to doctor appointments, and the number of repeat appointments with an infectious disease specialist will be increased from three to four. The regulator has removed the determination of class M antibodies to the nuclear antigen (anti-HBc IgM) of the hepatitis B virus in the blood and the study of the acid-base balance and blood gases from laboratory research methods.

In the draft of the new standard, the Ministry of Health has shortened the list of drugs for patients, removing from it drugs with the INN fosamprenavir and combination drugs abacavir + lamivudine, doravirine + lamivudine + tenofovir, zidovudine + lamivudine, rilpivirine + tenofovir + emtricitabine. The updated list includes the non-nucleoside reverse transcriptase inhibitor nevirapine and integrase inhibitors - cabotegravir and raltegravir.

In December 2024, the Scientific Center for Expertise of Medical Products of the Ministry of Health of the Russian Federation issued a new type of pharmacopoeial standard sample (PSS) for lamivudine, which is used as part of combination therapy with other antiretroviral agents to treat HIV infection. Lamivudine is also included in the list of vital and essential drugs. The standard sample of lamivudine will be packaged in 150 mg. In total, 60 drugs for the treatment of HIV infection with only this active substance or in combination with lamivudine and other antiretroviral agents are registered in Russia.

In January 2025, the Moscow Department of Health changed the order on additional measures to improve HIV prevention in the city, expanding the list of areas in which specialized patients will be provided assistance. For example, pediatric oncology and hematology, combustiology, transplantology (except for complications), obstetrics and gynecology were added to the list.