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Half of the people living with HIV (PLWH) with hepatitis C virus (HCV) remain untreated for HCV. We examined predictors of HCV linkage to care among PLWH and the impact of HIV lost to care.We conducted a retrospective review of PLWH/HCV from our HIV clinics between 2014 and 2017, and examined predictors of HCV linkage to care. We used the Kaplan-Meier method to estimate the probability of HIV retention and HCV linkage over time.Of 615 PLWH/HCV, 34% linked to HCV care and 21% were cured. Higher odds of linkage to HCV care were among blacks (adjusted odds ratio [aOR]: 2.95, 95% confidence interval [CI]: 1.59, 5.47), prior injection drug users (IDUs; aOR: 2.89, 95% CI: 1.39, 6.01), Medicare (aOR: 3.09, 95% CI: 1.56, 6.11), and cirrhotics (aOR: 2.80, 95% CI: 1.52, 5.14). Reduced odds for linkage were in active IDU (aOR: 0.16, 95% CI: 0.05, 0.45) and those seen by an advanced practice provider (aOR: 0.53, 95% CI: 0.30, 0.92). The main reason for failure to link to HCV care was lost to HIV care. At 3 years, the overall probability of being retained in HIV care was 53%; among those who had an HCV evaluation visit, it was 75% vs. 41% with no HCV evaluation visit. Accounting for loss to follow-up, PLWH/HCV had a 65% probability of having an HCV evaluation at 3 years.

The article presents a description of amendments of the Russian Federation Government Decree No. 871 from August 28, 2014 (with amendments from November 20, 2018). The authors analyzed the historical development of approaches for complex drug assessment in Russia, also criteria for its evaluation were under investigation. The changes affecting both the order and the procedure of forming the lists of medical drugs for medical use are reviewed. The particularities of the current procedure for the formation of lists of drugs for medical use are described in detail. In reliance on the analysis, further direction for improvement/development of the system of formation the lists of medical drugs for medical use are educed (List of Vital and Essential Medicines, List of Medical Drugs for Certain Categories of Citizens, List of High-Cost Medical Drugs).

Since generics and biosimilars have entered the Russian market of medications, there are new trends in the general picture of drug prices and consumption. In the present study, we analyze these trends to enable the prediction of possible savings or redistribution of funds in the area of anticancer drug supply, with a special view on highly expensive medications. The aim of this study is to identify changes in the market prices and consumption of medications for the treatment of solid tumors. Materials and methods . We analyzed the dynamics of prices and consumption rates of eight international non-proprietary names (INN) of anticancer drugs, whose generics or biosimilars entered the Russian pharmaceutical market in 2010-2018. Results. With an overall downward trend in prices, differences between individual drugs become apparent with time of joint circulation in the market. The rates of increase/decrease in the prices of the reference drugs that circulate together with generics/biosimilars for at least 4 years, have changed from -50 to +22%; for the respective generics/biosimilars, the figures ranged from -35 to -69%. After generics/biosimilars have entered the market in the Russian Federations, the consumption of the INNs have been increasing, but again with different paces for different drugs. Conclusion . With a general downward trend in prices and an increase in consumption of anticancer medications, there are significant differences in this dynamics as far as individual INNs are concerned. Additional studies are needed to identify factors having an impact on the prices and drug consumption of INNs after their generics/biosimilars have become available. For example, the number of original drugs with expired patent protection may be important. Without a good understanding of such factors, it is difficult to predict the size of savings and the possibility of their redistribution within the budget framework.

Results of the assessment of methodological quality of economic evaluations (EE), submitted to justify the inclusion/exclusion of drugs in the lists of drugs for medical use (list of vital and essential drugs, additional medication supply list and expensive drug list), are given in the article. The study was conducted in 2018 in the FSBI “Center for healthcare quality assessment and control” of the Ministry of Health of the Russian Federation. Assessment was performed based on 12 criteria in accordance with the requirements to the methodological quality of economic evaluations, described in the draft Order of the Government of the Russian Federation, No. 871, and then were approved in the Order of the Government of the Russian Federation, No. 871, state on 20.11.2018. The distribution of EE based on the number of criteria they did not meet, and also the frequency of made mistakes for each criterion are presented. Main reasons for EE not meeting the requirements to methodological quality, prescribed by the Order of the Government of the Russian Federation, No. 871, are analyzed.

The article provides the results of the assessment of methodological quality of budget impact analysis (BIA) submitted as a justification for the inclusion/exclusion of drugs into the drugs lists for medical use (Vital and Essential Drug list, List of Drugs for Certain Categories of Citizens, List of High-Cost Drugs) in 2018.The assessment was performed by the Center of Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation according to the requirements, described in the Order of the Government of the Russian Federation, № 871 (version from 29.10.2018), which consist of 11 criteria. The information on distribution of BIA studies in regards to the number of criteria not meeting the requirements and proportion of mistakes on every criterion is presented. Besides, the authors analyzed main causes of non-meeting the requirements for methodological quality of BIA studies described in the Order of the Government of the Russian Federation, № 871.

The paper discusses the issues of normative and legal regulation for creation of drug lists (List of Vital and Essential Medicines, List of Medical Drugs for Certain Categories of Citizens, List of High-Cost Medical Drugs (Seven Nosologies list). It also considers historical aspects, current state and planned changes of these rules. The stages of expertise, evaluation criteria, and rules of decision making in the process of inclusion of medical drugs (MD) into the lists according to the RF Government Decree no. 871 on 28 August 2014 and the project on the amendment of this decree are thoroughly considered. The proposed changes address the terms of submission of proposals for the inclusion and exclusion of MDs into the lists, and the terms of expert procedures. Changes in expert procedures (complex evaluation) of MD are proposed; a new stage (analysis of methodological quality of pharmacoeconomic studies and budget impact analysis) is introduced. Integral scales of clinical and pharmacoeconomic evaluation of MD are substituted with complex evaluation scales. The requirements for ethodological quality of pharmacoeconomic studies and budget impact analysis are created. A further stage of the development of the rules for creating the lists can be the performance of complex evaluation within a single expert body with the participation of expert organizations and leading specialists.

The article describes the procedure for preparing reimbursement lists with the “Dossier” automated system at the regional level. Basic advantages and characteristics of the system, procedures for filling out the application form (dossier) for the inclusion of the drug into reimbursement lists, and the algorithm of expert evaluation are presented.

There was a clinical and economic study of ustekinumab (stelara) as compared to etanercept (enbrel), infliximab (remicade) and adalimumab (humira) for treating patients with severe psoriasis. The clinical efficacy and safety of the biological drugs were analyzed, and estimated costs for their application as well as cost/efficacy ratio and cost efficacy increment were calculated. Advantages of ustekinumab vs. etanercept were demonstrated: the costs per one patient with severe psoriasis turned out to be less with the achieved positive effect. When the cost/efficacy ratio was calculated, the economic advantages of ustekinumab vs. infliximab were established beginning with Weeks 24-28 of the therapy (according to the results of individual studies, as early as beginning with Week 10 of the therapy). The economic advantage of ustekinumab vs. adalimumab increases by Week 52 of the therapy. The calculations of the cost efficacy increment proved that ustekinumab was more efficient than infliximab both in the short (Weeks 10-12 of the therapy) and long run (Weeks 50-52) and more efficient than adalimumab in the long run (Week 52 of the therapy).

Shattered rim cracking, propagation of a subsurface crack parallel to the tread surface, is one of the dominant railroad wheel failure types observed in North America. This crack initiation and propagation life depends on several factors, such as wheel rim thickness, wheel load, residual stresses in the rim, and the size and location of material defects in the rim. This article investigates the effect of the above-mentioned parameters on shattered rim cracking, using finite element analysis and fracture mechanics. This cracking is modelled using a three-dimensional, multiresolution, elastic–plastic finite element model of a railroad wheel. Material defects are modelled as mathematically sharp cracks. Rolling contact loading is simulated by applying the wheel load on the tread surface over a Hertzian contact area. The equivalent stress intensity factor ranges at the subsurface crack tips are estimated using uni-modal stress intensity factors obtained from the finite element analysis and a mixed-mode crack growth model. The residual stress and wheel wear effects are also included in modelling shattered rim cracking. The analysis results show that the sensitive depth below the tread surface for shattered rim cracking ranges from 19.05 to 22.23 mm, which is in good agreement with field observations. The relationship of the equivalent stress intensity factor (Δ K eq) at the crack tip to the load magnitude is observed to be approximately linear. The analysis results show that the equivalent stress intensity factor (Δ K eq) at the crack tip depends significantly on the residual stress state in the wheel. Consideration of as-manufactured residual stresses decreases the Δ K eq at the crack tip by about 40 per cent compared to that of no residual stress state, whereas consideration of service-induced residual stresses increases the Δ K eq at the crack tip by about 50 per cent compared to that of as-manufactured residual stress state. In summary, the methodology developed in this article can help to predict whether a shattered rim crack will propagate for a given set of parameters, such as load magnitude, rim thickness, crack size, crack location, and residual stress state.

Russian Abstract: Авторами проведено клинико-экономическое моделирование внедрения системы амбулаторного лекарственного обеспечения пациентов трудоспособного возраста с артериальной гипертензией (АГ) с учетом приверженности к лечению в РФ, сформулированы предложения, позволяющие повысить эффективность программ лекарственного обеспечения при одновременном сдерживании затрат.Согласно результатам систематического обзора исследований, при условии обеспечения пациентов лекарствами в течение ≥80% дней периода лечения частота госпитализаций пациентов с сердечно-сосудистыми заболеваниями может сократиться в 1,43 раза. За счет снижения частоты госпитализаций сокращается бремя государства на ведение пациентов с АГ, включая затраты, связанные с госпитализацией, вызовами скорой медицинской помощи (прямые медицинские затраты), выплатой пособий по временной нетрудоспособности (прямые немедицинские затраты), а также потери валового внутреннего продукта (косвенные затраты). Несмотря на существенную экономию средств за счет снижения частоты госпитализаций – 4,5 млрд руб. в год на группу 5 млн человек (зарегистрированные больные трудоспособного возраста с АГ в РФ), необходимый объем дополнительных финансовых средств в случае внедрения программы амбулаторного лекарственного обеспечения составит от 3,3 млрд руб. до 22,8 млрд руб. в год. в зависимости от цен на лекарственные препараты и выбранной стратегии государственного финансирования. Вместе с тем в определенных сегментах пациентов (например, фармакотерапия больных трудоспособного возраста с I стадией АГ) внедрение механизмов покрытия расходов на лекарственную терапию за счет государства может быть экономически выгодными уже в краткосрочной перспективе (1 год). Дополнительная экономическая выгода от государственных вложений при этом составит от 91,7 млн руб. до 802,5 млн руб.English Abstract: The authors performed clinical and economic modeling of the introduction of outpatient drug supply of working age patients with arterial hypertension (AH) in view of adherence to treatment in the Russian Federation and made proposals that increase the efficiency of drug supply programs while containing costs.According to a systematic review of research, provided that patients medications for ≥80% of days treatment period, the frequency of hospitalizations in patients with cardiovascular disease can be reduced by 1.43 times. By reducing the frequency of hospitalizations reduced the burden on the state management of patients with hypertension, including costs associated with hospitalization, medical emergencies (direct medical costs), the payment of temporary disability benefits (direct non-medical costs), as well as the loss of gross domestic product (indirect costs). Despite significant cost savings by reducing the frequency of hospital admissions - 4.5 billion rubles per year for a group of 5 million people (registered patients of working age with hypertension in the Russian Federation), the necessary amount of additional funds in the case of implementation of the program of outpatient drug supply will be from 3.3 billion rubles to 22.8 billion rubles in year depending on the price of drugs and the chosen strategy of public funding. However, in certain segments of patients (eg, pharmacotherapy of patients of working age with stage I hypertension) introducing mechanisms to cover the costs of drug therapy by the state can be cost-effective in the short term (1 year). Additional economic benefits of public investment in this amount of 91.7 million rubles up to 802.5 million rubles.

Diabetic nephropathy (NF) came first among all the specified causes of end-stage renal failure. Patients with type 1 diabetes mellitus (DM) make up more than half of all patients treated with chronic hemodialysis in the United States and Western Europe. Among patients with diabetes with terminal renal failure, 60% are people over 50 years old, so hemodialysis is not always prescribed. However, hemodialysis is increasingly used in elderly and senile patients; therefore, the proportion of patients with diabetes, especially type II diabetes, in hemodialysis centers will increase, significantly increasing the cost of treating diabetes. Currently, along with metabolic, hemodynamic and genetic theories, the role of immune disorders in the formation and progression of DNs is being discussed. The prerequisites for the formation of a hypothesis about the immune genesis of DNs were the frequent detection of increased levels of circulating immune complexes (CICs) and immunoglobulins in the blood, as well as deposits of immunoglobulins and complement in the kidney structures of patients with diabetes. However, among researchers there is no unanimity in the explanation of these facts. Many consider indisputably existing immune abnormalities inherent in DN as non-specific epiphenomes. The immune hypothesis of the pathogenesis of DN was formulated back in the 70s. The currently accumulated data suggest the participation of the immunocomplex mechanism in the development of DN. Immunofluorescence examination of the kidney tissue of patients with diabetes almost always reveals a luminescence of IgG, IgM, less often IgA, SZ and other complement fractions along the basal membranes of the glomeruli (BMC) and tubules of focal granular and linear in nature.

To elucidate the role of some renal diseases, pyelonephritis in particular, in elderly patients with type 2 diabetes mellitus (DM).The trial included 150 patients with diabetes mellitus type 2 aged over 60 years with DM duration 16.6 +/- 7.8 years. All the patients underwent general clinical examination, Reberg-Tareev test, urine seeding, renal ultrasonography.The diagnoses associated with renal pathology were made in 75% of patients, the specific renal parenchymal damage (diabetic nephropathy-DN) proper was much less common (73 patients with type 2 DM). 16 of them were found to have chronic renal failure. The concurrent abnormalities included pyelonephritis (21%), urolithiasis (14%), renal cysts (19%), their combination (43%). Concomitant pyelonephritis had the most significant impact on renal function. Essential hypertension occurred in 65% of patients.In old age, renal damage specific for DM develops in the presence of pyelonephritis, cystic degeneration of the parenchyma, involutional processes, atherosclerotic and hypertensive arteriolosclerosis.

The authors have conducted an epidemiological study for multiple myeloma morbidity and mortality among 80,000 patients of the Medical Center examined in 1988-1995. Myeloma was diagnosed in 65 cases. Standard incidence rate was 4.09, 3.18 and 3.5 per 100,000 for myeloma in males, females and both sexes, respectively. Standard mortality was 2.76 and 1.73 per 100,000 for males and females, respectively. The above rates do not differ much from those of other countries. In terminal myeloma renal insufficiency occurred in 39 of 41 cases. In 8 cases chronic pyelonephritis was an independent course of renal failure thus indicating the importance of its persistent treatment.

28 patients treated by programmed hemodialysis (PH) were followed up from 1985 to 1991. All the patients were over 60 years old. 16 patients died within month 1-60 since PH initiation. Overall PH duration for the whole group reached 24.6 +/- 3.58 months. Pretreatment urea and creatinine in plasma of senile patients were significantly lower than in young patients not resulting, though, in uremia reduction. The findings show that it is not valid to consider creatinine a determinant for starting hemodialysis in senile patients. Despite multimorbidity, more rapid progression of atherosclerosis and complicated establishment of the vascular approach, senile patients successfully adapt to PH regimen, need less numerous weekly PH hours. By anemia manifestations, incidence of hyperparathyroidism and polyneuropathy, senile patients did not differ much from their younger counterparts.

Impairment of parenchymatous organs, primarily kidneys, responsible for their dysfunction in crush syndrome results in many respects from disseminated intravascular coagulation (DIC). It is also associated with hemorrhagic complications. It is demonstrated that treatment modalities aimed at arrest of DIC syndrome (plasmapheresis, heparin, dysaggregation drugs, transfusions of large amounts of fresh frozen plasma) stopped bleeding and septic shock in 12 patients with crush syndrome following the earthquake in Armenia (1988).

The incidence of podagric nephropathy in different age groups was studied on a large populational material (41,452 persons over 30 years). The number of patients suffering from podagra was shown to increase with each decade of life. In 122 patients with podagric nephropathy, deviations in urinalyses were recorded in 80 cases (65.5%). Of these, 53 patients (72.6%) were ot 60 years of age and older. In patients over 60, derangement of nitrogen-excretory renal function was seen more frequently (in 64.4%) than in other age groups. The greater incidence of podagra and podagric nephropathy over the recent decade may be related not to the changes in the nutrition pattern and hypodynamia but also, and possibly to a larger measure, with deterioration of the environmental conditions and alterations in radiation background.

Eighteen patients with senile pyelonephritis and nephrogenic arterial hypertension were examined for the effect of trental monotherapy (600 mg/day) on intrarenal hemodynamics, the rate of glomerular filtration (effective renal blood flow, the intensity of blood flow in the medullary layer of the kidney), activity of the renin-angiotensin-aldosterone system (plasma renin activity, plasma and urine aldosterone), prostaglandin synthetic capacity of the kidneys (PGE and PGF2 alpha), water-electrolyte balance (circulating blood volume, sodium content in the serum and its excretion with urine), and on arterial pressure and general vascular peripheral resistance. Prolonged administration of the drug (from 3 weeks to 6 months) led to a significant improvement of the medullary blood flow, increase (p less than or equal to 0.05) of excretion of natriuretic PGE [correction of RGE] and lowering (p less than or equal to 0.05) of diurnal excretion of PGF2 alpha, which was accompanied by a rise of natriuresis (p less than or equal to 0.05) and diuresis.

A study was made of the content of lymphocyte subpopulations and activation marker expression on peripheral blood mononuclear cells. There were 15 patients with diabetic nephropathy (DN) in the pre-nephrotic stage and 19 patients with lingering diabetes mellitus (DM) not complicated by DN. Indirect immunofluorescence and monoclonal antibodies to leukocytic differentiated antigens CD3, CD4, CD8, CD22, CD25, CD71 and HLA-DR were used. Radioimmunoassay was employed simultaneously to measure the content of neopterin (a marker of cellular immunity activation) in the serum. It has been demonstrated that the pre-nephrotic stage of DN is marked by the normal content of the main subpopulations of peripheral lymphocytes (CD3, CD4, CD8 and CD22-positive). At the same time DN is associated with hyper-expression of activation markers (CD25, HLA-DR) on peripheral blood mononuclear cells and with an increase of serum neopterin concentration. The pathogenetic role of activated lymphocytes in DN may be related to the production by them of endoglycosidase, an enzyme splitting heparan sulfate of the subendothelial basal membranes of the glomeruli, thereby interfering with the negative charge of the glomerular filter and the local anticoagulation potential.