РЕЗУЛЬТАТЫ ИССЛЕДОВАНИЯ ЭФФЕКТИВНОСТИ И БЕЗОПАСНОСТИ НОВОГО ОТЕЧЕСТВЕННОГО ПРЕПАРАТА 6НР В СОСТАВЕ СХЕМЫ АНТИРЕТРОВИРУСНОЙ ТЕРАПИИ БОЛЬНЫХ ВИЧ-ИНФЕКЦИЕЙ

The aim of the study was to assess the efficacy and safety of ART regimens that included different doses of the drug 6НР with the reception of QD, in comparison with the scheme of ART, containing, PhAZT, to select the daily dose 6НР in conducting phase III clinical trials.Patients and methods. 125 patients were randomized to 25 people in 4 groups, depending on the daily dose of the drug 6НР (600, 800, 1000, 1200 mg), and in the comparison group (phosphazide). For a daily dose of the drug 6НР the study was blind. All patients, in addition to the studied drugs were receiving 3TC and EFV. The effectiveness of ART regimens was assessed by the proportion of patients with HIV RNA <50 copies/ml and CD4+lymphocyte increase after 24 weeks of therapy. Results. The use of ART scheme, which included 6НР + 3TС + EFV, was highly effective regardless of the daily dose of the drug 6НР, and is comparable to the effectiveness of the comparison mode (PhAZT+3TC+EFV). More than 95.5% of patients receiving 600 mg and 800 mg of the drug 6НР QD, after 24 weeks of therapy, the level of HIV RNA was < 50 copies/ml (in the comparison group – 87.5%). In patients of all groups there was a significant increase in the median CD4+lymphocytes. The maximum result of increasing the median CD4 + lymphocyte count (164 cells/µl) was observed in patients receiving the drug 6НР – 600 mg/day. All the studied modes was safe because of the 24-week study made up 94% of the patients receiving 6НР, and 96% of receiving PhAZT. Only 1 patient (1%) receiving the maximum daily dose 6НР (1200 mg), marked AES possibly related to study medication, and which led to the cancellation of the treatment.Conclusions. The effectiveness and safety of all modes of ART did not depend on the daily dose of the drug 6НР and was comparable to the comparison scheme, which included PhAZT. The maximum virological and immunological response after 24 weeks of therapy was achieved in patients receiving the drug 6НР at a dose of 600 mg QD in the ART scheme. The drug 6HP is recommended for phase III study in a daily dose of 600 mg in the ART.Цель: оценка эффективности и безопасности схем АРТ, включавших различные дозировки препарата 6НР с приемом 1 раз в сутки, по сравнению со схемой АРТ, содержавшей ФАЗТ, для выбора суточной дозы 6НР при проведении III фазы клинических исследований.Пациенты и методы.125 пациентов были рандомизированны по 25 человек в 4 группы в зависимости от суточной дозы препарата 6НР (600, 800, 1000, 1200 мг) и в группу сравнения (фосфазид). По суточной дозе препарата 6НР исследование было слепым. Все пациенты, помимо исследуемых препаратов, получали 3ТС и EFV. Эффективность схем АРТ оценивали по доле пациентов с уровнем РНК ВИЧ <50 копий/мл и приросту количества CD4+лимфоцитов через 24 недели терапии. Результаты. Применение схемы АРТ, включавшей 6НР + 3ТС + EFV, было высокоэффективно вне зависи-мости от суточной дозы препарата 6НР, и сопоставимо с эффективностью режима сравнения (ФАЗТ + 3ТС + EFV). Более чем у 95,5% пациентов, получавших 600 мг и 800 мг препарата 6НР в сутки, через 24 недели терапии уровень РНК ВИЧ был < 50 копий/мл (в группе сравнения – 87,5%). У пациентов всех групп отмечено существенное увеличение медианы количества CD4+лимфоцитов. Максимальный результат увеличения медианы количества CD4+лимфоцитов (164 клетки/мкл) был отмечен у пациентов, получавших препарат 6НР, – 600 мг/сут. Все исследуемые режимы были безопасны, поскольку 24 недели исследования завершили 94% больных, получавших 6НР, и 96% – получавших ФАЗТ. Лишь у 1 больного (1%), получавшего максимальную суточную дозу 6НР (1200 мг), отмечено НЯ, возможно, связанное с исследуемым препаратом, и приведшее к отмене лечения.Заключение. Эффективность и безопасность всех режимов АРТ не зависела от суточной дозы препарата 6НР и была сопоставима со схемой сравнения, включавшей ФАЗТ. Максимальный вирусологический и иммунологический ответ через 24 недели терапии был достигнут у пациентов, получавших препарат 6НР в дозе 600 мг/сут в составе схемы АРТ. Препарат 6НР рекомендуется для проведения исследования III фазы в суточной дозе 600 мг в составе схемы АРТ

Ранний вирусологический ответ при использовании препарата цепэгинтерферона альфа-2b в комбинации с рибавирином в терапии хронического гепатита С

Algeron (cepeginterferon alfa-2b) is a new pegylated form of interferon alfa containing linear polyethylene glycol (molecular weight 20 kDa). Pharmacokinetic profile of Algeron allows once weekly administration. In phase II–III study 150 treatment-naive patients with compensated liver function were randomized into 3 groups: Algeron 1,5 μg/kg/week, Algeron 2,0 μg/kg/week, and a reference group of PegIntron 1.5 μg/kg/week in combination with ribavirin 800– 1400 mg/day. Comparative ITT -analysis of early virologic response (EVR) showed absence of differences between groups in frequency of EVR. In Algeron groups (regardless of a dose – 1,5 or 2,0 μg/kg) EVR was observed in 94%, in PegIntron group – – in 88% of patients. Complete EVR (HCV RNA≤15 I I U/mL) was recorded in 88% and 84% of patients receiving Algeron 1,5 and 2,0 μg/kg, respectively, in the reference group – – in 84% of patients. There were no statistically significant differences between groups where patients received Algeron in different doses and the reference group, with or without genotype stratification. Adverse events occurring during the treatment with Algeron are dose-dependent; however, their frequency is no more than in patients receiving standard doses of PegIntron. Based on the absence of differences in efficacy and more favorable safety profile of a lower dose of the study drug, the therapeutic dose of Algeron was selected to be 1,5 μg/kg/week.Альгерон (цепэгинтерферон альфа 2b) – инновационный препарат пегилированного интерферона-альфа, содержащий линейную ююмолекулу полиэтиленгликоля молекулярной массой 20 кДа. Фармакокинетический профиль Альгерона позволяет вводить препарат 1 раз в неделю. В рамках клинического исследования фазы 150 ранее не применявших препаратов интерферона пациентов с хроническим гепатитом С были рандомизированы в 3 группы терапии: Альгерон 1,5 мкг/кг/нед, Альгерон 2,0 мкг/кг/нед и группу сравнения – ПегИнтрон 1,5 мкг/кг/нед в комбинации с рибавирином 800– 1400 мг/сут. Сравнительный анализ продемонстрировал отсутствие различий в достижении раннего вирусологического ответа (РВО) между группами. В группах пациентов, получавших Альгерон (независимо от вводимой дозы – 1,5 или 2,0 мкг/кг), РВО наблюдался в 94% случаев, в группе ПегИнтрона – в 88% случаев. Полный РВО (HCV РНК ≤15 МЕ/мл) зарегистрирован у 88% и 84% пациентов, получавших Альгерон в дозах 1,5 и 2,0 мкг/кг соответственно, в группе сравнения – у 84% участников. Анализ частоты наличия РВО, в том числе в зависимости от генотипа вируса гепатита С, не выявил статистически значимых отличий между группами. Нежелательные явления, наблюдавшиеся в процессе лечения Альгероном, были дозозависимыми, однако их частота не превышала таковую при использовании стандартных доз ПегИнтрона. На основании отсутствия различий в эффективности при более благоприятном профиле безопасности низкой дозы исследуемого препарата была выбрана терапевтическая доза Альгерона, равная 1,5 мкг/кг/нед

СОПУТСТВУЮЩИЕ ЗАБОЛЕВАНИЯ И ФАКТОРЫ РИСКА ИХ РАЗВИТИЯ У БОЛЬНЫХ ВИЧ-ИНФЕКЦИЕЙ СТАРШЕ 40 ЛЕТ

Objective: Evaluation of CVD and their risk factors in Russian 40+ HIV-infected patients is a key objective of the study. Materials and Methods: A retrospective analysis of 1872 medical records of 40+ HIV-infected patients from 12 regions of Russia on HAART was performed, including assessment of CVD presence, their risk factors and 10-years CVD risk based on SCORE. All patients received ARV treatment; the average duration of admission was 5 years (1–2 years – 43%, 3–5 years – 29%, over 5 years – 28%). Results: High incidence of CVD was observed: hypertension – 48%, including cerebrovascular disease – 2%; CAD – 9%, including myocardial infarction – 6%. Analysis of cardiovascular risk factors showed that 19% were overweight, lipid metabolism disorders were detected in 30% of patients, diabetes in 5%. 51% of patients smoked, systematic intake of alcohol in 61% of patients. 69% of patients had a risk of fatal CVD within 10 years based on SCORE, 16% of patients had a high/very high risk. Analysis of metabolic parameters showed that 99,4% of patients needed lifestyle improvement measures, 85% needed lipid lowering medication. One third of patients were constantly taking cardiovascular medications. Conclusions: CVD and metabolic disorders are more common for 40+ HIV-infected patients than for general population. ART assessment in 40+ patients additionally to viral load and CD4 level, should include analysis of cardiovascular risk factors and comorbidities. In elder patients ART regimen choice is particularly important, considering the risks of development and/or progression of CVD and risk of drugdrug interactions development.Цель: оценка сопутствующих заболеваний (ССЗ) и факторов риска их развития в российской популяции ВИЧ-инфицированных пациентов старше 40 лет. Материалы и методы: выполнен ретроспективный анализ карт 1872 ВИЧ-инфицированных пациентов старше 40 лет из 12 регионов России, включая оценку ССЗ, факторов риска их развития и 10-летний риск ССЗ по шкале SCORE. Все пациенты получали АРТ; средняя продолжительность терапии составила 5 лет (1–2 года – 43%, 3–5 лет – 29%, более 5 лет – 28%). Результаты: наблюдалась высокая частота ССЗ: артериальная гипертензия – 48%, включая нарушения мозгового кровообращения – 2%; ИБС – 9%, включая инфакрт миокарда – 6%. Анализ сердечно-сосудистых факторов риска показал ожирение у 19% пациентов, нарушения липидного обмена у 30% пациентов, сахарный диабет у 5%. Курение было отмечено у 51% пациентов, систематическое употребление алкоголя у 61%. 69% имели риск смертельного ССЗ в течение 10 лет по шкале SCORE, у 16% пациентов наблюдался высокий/очень высокий риск. Анализ нарушений метаболизма показал, что 99,4% пациентов нуждаются в различных мерах по изменению образа жизни, 85% нуждаются в гиполипидемической терапии. Одна треть пациентов постоянно получали сердечно-сосудистую терапию. Заключение: в группе больных ВИЧ-инфекцией старше 40 лет чаще выявляются заболевания сердечно-сосудистой системы, нарушение обмена веществ, по сравнению с общей популяцией. Анализ эффективности антиретровирусной терапии (АРТ) пациентов старше 40 лет дополнительно к вирусной нагрузке и уровню CD4 клеток должен включать анализ сердечно-сосудистых факторов риска и сопутствующих заболеваний. Для пациентов старшего возраста выбор режима АРТ особенно важен, учитывая риск развития и/или прогрессирования ССЗ и риск возникновения лекарственных взаимодействий

ЭФФЕКТИВНОСТЬ И БЕЗОПАСНОСТЬ НОВОГО РОССИЙСКОГО НЕНУКЛЕОЗИДНОГО ИНГИБИТОРА ОБРАТНОЙ ТРАНСКРИПТАЗЫ ЭЛСУЛЬФАВИРИНА В ПЕРВОЙ ЛИНИИ ЛЕЧЕНИЯ ВИЧ-ИНФЕКЦИИ В КОМБИНАЦИИ С ДВУМЯ НУКЛЕОЗИДНЫМИ/НУКЛЕОТИДНЫМИ ИНГИБИТОРАМИ ОБРАТНОЙ ТРАНСКРИПТАЗЫ – ИССЛЕДОВАНИЕ 96 НЕДЕЛЬ

A randomized multicenter 96-week study of an elsulfavirine (ESV),  non-nucleoside reverse transcriptase inhibitor (NNRTI) of novel  generation, in combination with 2 nucleoside/ nucleotide reverse  transcriptase inhibitors (NRTIs) was conducted in naive HIV adult  patients, divided by 2 parts: 1) partially blind comparative to  efavirenz (EFV) 48-week study, 2) open-label observational study  during additional 48 weeks. High virological and immunological  effectiveness maintained during the study: proportion of patients  with HIV RNA <50 copies/ml in 48 weeks achieved 81,6%, in 96  weeks – 83,9% (MITT-analysis) and 91% (if patients withdrawn from the study due to other reasons not related to treatment were excluded). No resistance mutations were found in patients with viral  replication blips (HIV RNA 50-1300 copies/ml). CD4+-lymphocytes  count was increased by 187,5 at week 48 and 251,0 cells/mcl at  week 96. Good tolerability and safety were confirmed during second year of treatment: no additional safety data which could influence  benefit/risk ratio were recorded as well as withdrawal from the  treatment due to adverse events. Serious adverse events, connected with treatment, allergic reactions were not registered during the whole 96-week study. Conclusion. Results of the 96-week study confirm earlier data from  48-week study on high efficacy and safety of ESV. Based on these  data ESV was included into “National recommendations on  dispensary follow-up and treatment of patients with HIV-infection” as the first-line ART regime in combination with 2 NRTIs.Проведено многоцентровое рандомизированное исследование элсульфавирина (ESV) –  ненуклеозидного ингибитора обратной транскриптазы (ННИОТ) нового поколения в  комбинации с 2 нуклеотидными/нуклеозидными ингибиторами обратной транскриптазы  (НИОТ) у взрослых пациентов с ВИЧ-инфекцией, ранее не получавших АРТ, длительностью  96 недель, состоявшее из 2 этапов: 1) частично слепое, сравнительное с эфавирензом (EFV) исследование – 48 недель, 2) открытое наблюдательное исследование – дополнительные 48 недель. Наблюдалась высокая вирусологическая и иммунологическая эффективность  лечения, устойчивая в течение 96 недель: доля пациентов с неопределяемым уровнем РНК  ВИЧ <50 копий/мл через 48 недель составила 81,6%, через 96 недель – 83,9% (MITT- анализ) и 91% (без учета пациентов, выбывших по не связанным с лечением причинам). Ни  в одном случае всплесков репликации вируса (РНК ВИЧ от 50 до 1300 копий/мл) не  выявлено мутаций резистентности ВИЧ к препаратам. Прирост медианы количества CD4+- лимфоцитов через 48 недель составил 187,5 клеток/мкл, через 96 недель – 251,0 клетку/ мкл. Подтверждена хорошая переносимость и безопасность лечения в течение второго года  исследования: не выявлено каких-либо новых значимых данных в отношении безопасности,  негативно влияющих на соотношение польза/риск, не зарегистрировано  случаев отмены лечения из-за нежелательных явлений. На протяжении 96 недель не  зарегистрированы серьезные нежелательные явления, связанные с приемом препарата,  аллергические реакции. Заключение. Результаты 96-недельного исследования подтверждают полученные ранее  (по итогам 48 недель применения) данные о высокой эффективности и безопасности  элсульфавирина. На основании полученных результатов элсульфавирин включен в «Национальные рекомендации по диспансерному наблюдению и лечению больных ВИЧ- инфекцией» в качестве режима первой линии АРТ в комбинации с 2 препаратами группы НИОТ

ДИНАМИКА ПРОЯВЛЕНИЙ ЭПИДЕМИЧЕСКОГО ПРОЦЕССА ВИЧ-ИНФЕКЦИИ ВО ВЗАИМОСВЯЗИ С ЭПИДЕМИОЛОГИЧЕСКОЙ СИТУАЦИЕЙ ПО НАРКОМАНИИ (ПО МАТЕРИАЛАМ РЕСПУБЛИКИ ТАТАРСТАН)

The aim of the study is to characterize the trends in the development of the epidemic process of HIV infection in connection with the epidemiological situation of drug addiction in the Republic of Tatarstan.Materials and methods. The official statistical data on the incidence of HIV infection and drug addiction in the Republic of Tatarstan for the period 1987–2016, the data on the prevalence for 2001 and 2016 are analyzed.Results. Direct correlation of the prevalence of HIV infection and prevalence of drug addiction in the different territories of the Republic of Tatarstan were identified for 2001 data (r=0,81, p&lt;0,001) and for 2016 (r=0,82, p&lt;0,001). A statistically significant increase in the incidence of HIV infection in the population against the background of a decrease in the incidence of drug addiction was demonstrated. In the early stages of the epidemic in the region HIV infection spread mainly through injecting drug use and, in recent years, HIV has been sexually transmitted mainly through heterosexual contact.Conclusion. The output of infection outside the population of injecting drug users and the prevalence of sexual transmission of HIV in recent yearsare a reflection of adverse trends in the direction of generalization of the epidemic of HIV infection.Цель исследования: дать характеристику тенденций развития эпидемического процесса ВИЧ-инфекции во взаимосвязи с эпидемиологической ситуацией по наркомании на примере материалов Республики Татарстан.Материалы и методы. Проанализированы официальные статистические данные по заболеваемости ВИЧ-инфекцией и наркоманией в Республике Татарстан за период с 1987 по 2016 год, данные по распространенности за 2001 и 2016 годы.Результаты. Выявлена прямая связь показателей распространенности ВИЧ-инфекции и показателей распространенности наркомании на различных территориях Республики Татарстан как для данных 2001 года (r=0,81, p&lt;0,001), так и для 2016 года (r=0,82, p&lt;0,001). Продемонстрирован статистически значимый рост заболеваемости населения ВИЧ-инфекцией на фоне снижения заболеваемости наркоманией. На начальных этапах развития эпидемии в регионе ВИЧ-инфекция распространялась преимущественно при инъекционном введении наркотиков, а в последние годы — половым путем, преимущественно при гетеросексуальных контактах.Заключение. Выход инфекции за пределы популяции потребителей инъекционных наркотиков и преобладание в последние годы полового пути заражения являются отражением неблагоприятной тенденции в направлении генерализации эпидемии ВИЧ-инфекции.</p

THE RESULTS OF THE EFFICACY AND SAFETY OF THE NEW RUSSIAN DRUG 6НР IN THE ANTIRETROVIRAL THERAPY REGIMENS OF HIV-INFECTED PATIENTS

The aim of the study was to assess the efficacy and safety of ART regimens that included different doses of the drug 6НР with the reception of QD, in comparison with the scheme of ART, containing, PhAZT, to select the daily dose 6НР in conducting phase III clinical trials.Patients and methods. 125 patients were randomized to 25 people in 4 groups, depending on the daily dose of the drug 6НР (600, 800, 1000, 1200 mg), and in the comparison group (phosphazide). For a daily dose of the drug 6НР the study was blind. All patients, in addition to the studied drugs were receiving 3TC and EFV. The effectiveness of ART regimens was assessed by the proportion of patients with HIV RNA &lt;50 copies/ml and CD4+lymphocyte increase after 24 weeks of therapy. Results. The use of ART scheme, which included 6НР + 3TС + EFV, was highly effective regardless of the daily dose of the drug 6НР, and is comparable to the effectiveness of the comparison mode (PhAZT+3TC+EFV). More than 95.5% of patients receiving 600 mg and 800 mg of the drug 6НР QD, after 24 weeks of therapy, the level of HIV RNA was &lt; 50 copies/ml (in the comparison group – 87.5%). In patients of all groups there was a significant increase in the median CD4+lymphocytes. The maximum result of increasing the median CD4 + lymphocyte count (164 cells/µl) was observed in patients receiving the drug 6НР – 600 mg/day. All the studied modes was safe because of the 24-week study made up 94% of the patients receiving 6НР, and 96% of receiving PhAZT. Only 1 patient (1%) receiving the maximum daily dose 6НР (1200 mg), marked AES possibly related to study medication, and which led to the cancellation of the treatment.Conclusions. The effectiveness and safety of all modes of ART did not depend on the daily dose of the drug 6НР and was comparable to the comparison scheme, which included PhAZT. The maximum virological and immunological response after 24 weeks of therapy was achieved in patients receiving the drug 6НР at a dose of 600 mg QD in the ART scheme. The drug 6HP is recommended for phase III study in a daily dose of 600 mg in the ART

Early virologic response to сеpeginterferon alfa-2b in combination with ribavirin in treatment of patients with chronic hepatitis C

Algeron (cepeginterferon alfa-2b) is a new pegylated form of interferon alfa containing linear polyethylene glycol (molecular weight 20 kDa). Pharmacokinetic profile of Algeron allows once weekly administration. In phase II–III study 150 treatment-naive patients with compensated liver function were randomized into 3 groups: Algeron 1,5 μg/kg/week, Algeron 2,0 μg/kg/week, and a reference group of PegIntron 1.5 μg/kg/week in combination with ribavirin 800– 1400 mg/day. Comparative ITT -analysis of early virologic response (EVR) showed absence of differences between groups in frequency of EVR. In Algeron groups (regardless of a dose – 1,5 or 2,0 μg/kg) EVR was observed in 94%, in PegIntron group – – in 88% of patients. Complete EVR (HCV RNA≤15 I I U/mL) was recorded in 88% and 84% of patients receiving Algeron 1,5 and 2,0 μg/kg, respectively, in the reference group – – in 84% of patients. There were no statistically significant differences between groups where patients received Algeron in different doses and the reference group, with or without genotype stratification. Adverse events occurring during the treatment with Algeron are dose-dependent; however, their frequency is no more than in patients receiving standard doses of PegIntron. Based on the absence of differences in efficacy and more favorable safety profile of a lower dose of the study drug, the therapeutic dose of Algeron was selected to be 1,5 μg/kg/week

Efficacy and safety of novel russian non-nucleoside reverse transcriptase inhibitor elsulfavirine in combination with 2 nucleoside/nucleotide reverse transcriptase inhibitors in first-line HIV treatment – 96-week study

A randomized multicenter 96-week study of an elsulfavirine (ESV),  non-nucleoside reverse transcriptase inhibitor (NNRTI) of novel  generation, in combination with 2 nucleoside/ nucleotide reverse  transcriptase inhibitors (NRTIs) was conducted in naive HIV adult  patients, divided by 2 parts: 1) partially blind comparative to  efavirenz (EFV) 48-week study, 2) open-label observational study  during additional 48 weeks. High virological and immunological  effectiveness maintained during the study: proportion of patients  with HIV RNA &lt;50 copies/ml in 48 weeks achieved 81,6%, in 96  weeks – 83,9% (MITT-analysis) and 91% (if patients withdrawn from the study due to other reasons not related to treatment were excluded). No resistance mutations were found in patients with viral  replication blips (HIV RNA 50-1300 copies/ml). CD4+-lymphocytes  count was increased by 187,5 at week 48 and 251,0 cells/mcl at  week 96. Good tolerability and safety were confirmed during second year of treatment: no additional safety data which could influence  benefit/risk ratio were recorded as well as withdrawal from the  treatment due to adverse events. Serious adverse events, connected with treatment, allergic reactions were not registered during the whole 96-week study. Conclusion. Results of the 96-week study confirm earlier data from  48-week study on high efficacy and safety of ESV. Based on these  data ESV was included into “National recommendations on  dispensary follow-up and treatment of patients with HIV-infection” as the first-line ART regime in combination with 2 NRTIs

CONCOMITANT DISEASES AND RISK FACTORS FOR THEIR DEVELOPMENT IN PATIENTS WITH HIV INFECTION OLDER THAN 40 YEARS

Objective: Evaluation of CVD and their risk factors in Russian 40+ HIV-infected patients is a key objective of the study. Materials and Methods: A retrospective analysis of 1872 medical records of 40+ HIV-infected patients from 12 regions of Russia on HAART was performed, including assessment of CVD presence, their risk factors and 10-years CVD risk based on SCORE. All patients received ARV treatment; the average duration of admission was 5 years (1–2 years – 43%, 3–5 years – 29%, over 5 years – 28%). Results: High incidence of CVD was observed: hypertension – 48%, including cerebrovascular disease – 2%; CAD – 9%, including myocardial infarction – 6%. Analysis of cardiovascular risk factors showed that 19% were overweight, lipid metabolism disorders were detected in 30% of patients, diabetes in 5%. 51% of patients smoked, systematic intake of alcohol in 61% of patients. 69% of patients had a risk of fatal CVD within 10 years based on SCORE, 16% of patients had a high/very high risk. Analysis of metabolic parameters showed that 99,4% of patients needed lifestyle improvement measures, 85% needed lipid lowering medication. One third of patients were constantly taking cardiovascular medications. Conclusions: CVD and metabolic disorders are more common for 40+ HIV-infected patients than for general population. ART assessment in 40+ patients additionally to viral load and CD4 level, should include analysis of cardiovascular risk factors and comorbidities. In elder patients ART regimen choice is particularly important, considering the risks of development and/or progression of CVD and risk of drugdrug interactions development

Switching to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintains HIV-1 Virologic Suppression Through 48 Weeks: Results of the DRIVE-SHIFT Trial

BACKGROUND: Doravirine is a novel, nonnucleoside reverse transcriptase inhibitor with demonstrated efficacy in treatment-naive adults with HIV-1. METHODS: In this open-label, active-controlled, noninferiority trial, adults with HIV-1 virologically suppressed for ≥6 months on 2 nucleoside reverse transcriptase inhibitors plus a boosted protease inhibitor, boosted elvitegravir, or a non-nucleoside reverse transcriptase inhibitor were randomized (2:1) to switch to once-daily, single-tablet doravirine 100 mg with lamivudine 300 mg and tenofovir disoproxil fumarate 300 mg (DOR/3TC/TDF) or to continue their current therapy (Baseline Regimen) for 24 weeks. The primary endpoint was the proportion of participants with HIV-1 RNA <50 copies/mL (defined by the FDA Snapshot approach), with the primary comparison between DOR/3TC/TDF at week 48 and Baseline Regimen at week 24 and a secondary comparison between the groups at week 24 (noninferiority margin, -8%). RESULTS: Six hundred seventy participants (447 DOR/3TC/TDF, 223 Baseline Regimen) were treated and included in the analyses. At week 24, 93.7% on DOR/3TC/TDF vs 94.6% on Baseline Regimen had HIV-1 RNA <50 copies/mL [difference -0.9 (-4.7 to 3.0)]. At week 48, 90.8% on DOR/3TC/TDF had HIV-1 RNA <50 copies/mL, demonstrating noninferiority vs Baseline Regimen at week 24 [difference -3.8 (-7.9 to 0.3)]. In participants on ritonavir-boosted protease inhibitor at entry, mean reductions in fasting LDL-C and non-HDL-C at week 24 were significantly greater for DOR/3TC/TDF vs Baseline Regimen (P < 0.0001). Adverse events occurred in 68.9% on DOR/3TC/TDF and 52.5% on Baseline Regimen by week 24, leading to treatment discontinuation in 2.5% and 0.4%, respectively. CONCLUSIONS: Switching to once-daily DOR/3TC/TDF is a generally well-tolerated option for maintaining viral suppression in patients considering a change in therapy. REGISTRATION: ClinicalTrials.gov NCT02397096.status: publishe