Russians with HIV complain about interruptions in the provision of ARV therapy in FMBA institutions

The public movement “Patient Control” announced problems with providing therapy to patients with HIV in the institutions of the Federal Medical and Biological Agency of Russia. Due to the lack of drugs, doctors are forced to change regimens and return to treatment options that were previously discontinued due to serious side effects. The FMBA recognizes the shortage of medicines and expects assistance from the Russian Ministry of Health.

Representatives of the “Patient Control” movement (unites people affected by the problem of HIV/AIDS and other socially significant diseases) addressed the Minister of Health of the Russian Federation Mikhail Murashko and the head of the FMBA Veronika Skvortsova. The Pereboi.ru website, the letter says, regularly receives complaints about a shortage of drugs for the treatment of HIV infection in institutions run by the FMBA of Russia. Thus, from December 1, 2023, corresponding signals were received from patients who are undergoing treatment at the Federal State Budgetary Institution FNKTsRiO FMBA (Dimitrovgrad, Ulyanovsk Region), Federal State Budgetary Healthcare Institution Medical Unit No. 135 FMBA (Desnogorsk, Smolensk Region), Federal State Budgetary Institution Clinical Hospital No. 8 FMBA (Obninsk, Kaluga Region), Federal State Budgetary Institution Health Care Center No. No. 31 FMBA (Novouralsk, Sverdlovsk region).

Patients are reporting severe shortages of several antiretroviral (ARV) drugs. They receive refusals to dispense medications prescribed by their attending physician, and are faced with forced changes in ARV therapy without medical indications. “This includes prescribing ARV drugs that were previously discontinued for medical reasons or due to side effects. Patients also report refusals in timely tests necessary to determine the level of HIV viral load and indicators of immune status,” says Patient Control.

Social activists quote the appeal of a patient from Desnogorsk: “Alaget (abacavir + lamivudine) is not in the hospital. They replaced it with tenofovir, but I took it for two years, then they replaced it with abacavir. And today they “delighted” me: they say, it’s good that at least these exist… I recently found out that tenofovir has a bad effect on my joints, and they just started hurting when I took it.” “They didn’t give me Genvoya, which I took for three years and achieved an undetectable viral load and cell growth, all without side effects. They only offered a replacement kaletra, which I refused because it previously had a lot of side effects. There isn’t even lamivudine, they offer phosphazide instead,” writes a patient from Novouralsk. “This is the third month without Tivicay (dolutegravir). The first month I was given Kaletra, I had terrible side effects from it. In the second month they gave me a regast, it was even worse. They said that maybe Tivicai would appear after the New Year, but there would be very little of it,” complains a patient from Obninsk.

The appeal to the regulator states that this situation contradicts the clinical recommendations of the Ministry of Health: the goals of ARV therapy, in addition to virological and immunological effectiveness, are to maintain or improve the patient’s quality of life. Patient Control fears that this situation may provoke disease progression in many patients, the development of resistant forms of the virus, and the emergence of HIV-associated diseases. Mikhail Murashko and Veronika Skvortsova are asked to take the situation under personal control, and also to consider the issue of additional purchases of ARV drugs and diagnostic tools to provide them to medical institutions under the authority of the FMBA of Russia.

This is not the first time that interruptions in FMBA institutions have happened, says Yulia Vereshchagina from Patient Control. “Since 2020, the FMBA of Russia has been removed from the subordination of the Ministry of Health of the Russian Federation. This means that regional ministries of health cannot influence the drug supply of the department’s medical institutions located on the territory of their region,” she explains. “Patient Control” did not find information on how many Russians with HIV belong to FMBA institutions. In total, the agency serves over 3 million people.

Kommersant sent a request to the FMBA, but did not receive a response at the time of publication. The agency’s response to Patient Control (Kommersant has read it) states that the issue is being resolved in cooperation with the Ministry of Health of the Russian Federation – the agency sent an appeal to them about the provision of medicines. “Given the current situation, all patients on antiretroviral therapy were offered alternative first-line treatment regimens in accordance with clinical guidelines. Specialists from the departments for the prevention and treatment of HIV infection constantly monitor adverse drug reactions to antiretroviral therapy,” the FMBA stated.

Kommersant sent a request to the Ministry of Health, but at the time of publication also did not receive a response.

Development Director of the analytical company RNC Pharma, pharmaceutical market analyst Nikolai Bespalov notes that interruptions in the provision of ARV therapy affect not only FMBA institutions. “Last year, the budget for the purchase of the appropriate set of ARV drugs was exhausted, including by transferring patients from old and ineffective drugs to more expensive therapy,” the expert points out. “The problem was partly solved through the budget of specific health care facilities, regional programs, etc. further, but to solve it systematically, it is necessary to radically reconsider the amount of federal funding.”

The Zdravresurs expert group, Kommersant told Kommersant in February, calculated that out of 61 announced auctions for the purchase of drugs for HIV therapy at the beginning of 2024, 17 did not take place due to suppliers not attending the auction. As a result, at that time the Ministry of Health was unable to purchase 107 thousand annual courses of drugs totaling about 1 billion rubles. Activists cited the low starting price offered by the medical department as a likely reason. The Ministry of Health then assured Kommersant that the accumulated stocks of drugs for HIV therapy in Russia would be enough for three months, new purchases were underway, and the situation was “under constant monitoring.”

Natalia Kostarnova