Exposure to dolutegravir in pregnant women living with HIV in Central and Eastern Europe and neighboring countries — data from the ECEE Network Group

Objectives: The purpose of this study was to investigate dolutegravir (DTG) use among women and exposure to DTG during pregnancy in real world in Central and Eastern Europe and neighboring countries. Material and methods: Centres from 20 countries included in the Euroguidelines in Central and Eastern Europe (ECEE) Network and Finland were asked to complete an on-line questionnaire. Results: Seven centres from Czech Republic, Finland, Greece, Poland, Slovakia, and Turkey provided detailed information. DTG exposure was reported in 415 women, of which 26 were during pregnancy. Of those, 22 were on DTG at the time of conception and 4 had started DTG during pregnancy. Few women had conventional risk factors. The data on folic acid usage was unknown for eight women; 14 were using and four were not using folic acid. Four pregnancies were ongoing at the time of the study and of those with an outcome, 77.3% resulted with term, 13.6% preterm delivery, 4.5% spontaneous and 4.5% medical abortion. Conclusions: The DTG signal report indicates the importance of safety research for drug use in pregnancy and highlights the urgent need for systematic surveillance of pregnancy outcomes and neonatal surveillance. Countries with low- or moderate HIV prevalence should be included in studies reviewing pregnancy outcomes and in any surveillance system to ensure the accuracy of drug safety revision

In a real-life setting, direct-acting antivirals to people who inject drugs with chronic hepatitis c in Turkey

Background: People who inject drugs (PWID) should be treated in order to eliminate hepatitis C virus in the world. The aim of this study was to compare direct-acting antivirals treatment of hepatitis C virus for PWID and non-PWID in a real-life setting. Methods: We performed a prospective, non-randomized, observational multicenter cohort study in 37 centers. All patients treated with direct-acting antivirals between April 1, 2017, and February 28, 2019, were included. In total, 2713 patients were included in the study among which 250 were PWID and 2463 were non-PWID. Besides patient characteristics, treatment response, follow-up, and side effects of treatment were also analyzed. Results: Genotype 1a and 3 were more prevalent in PWID-infected patients (20.4% vs 9.9% and 46.8% vs 5.3%). The number of naïve patients was higher in PWID (90.7% vs 60.0%), while the number of patients with cirrhosis was higher in non-PWID (14.1% vs 3.7%). The loss of follow-up was higher in PWID (29.6% vs 13.6%). There was no difference in the sustained virologic response at 12 weeks after treatment (98.3% vs 98.4%), but the end of treatment response was lower in PWID (96.2% vs 99.0%). In addition, the rate of treatment completion was lower in PWID (74% vs 94.4%). Conclusion: Direct-acting antivirals were safe and effective in PWID. Primary measures should be taken to prevent the loss of follow-up and poor adherence in PWID patients in order to achieve World Health Organization’s objective of eliminating viral hepatitis

Efficiency and safety of direct acting antivirals in chronic hepatitis C patients infected with genotype 2 and 3 in Turkey

International Liver Congress / 54th Annual Meeting of the European-Association-for-the-Study-of-the-Liver (EASL) -- APR 10-14, 2019 -- Vienna, AUSTRIAWOS: 000463481701006…European Assoc Study LiverGilead Sciences Ilac Ltd. Sti. (Istanbul, Turkey)This study was supported by Gilead Sciences Ilac Ltd. Sti. (Istanbul, Turkey). Company was not involved to the content of the study/publication; no involvement to the decision to submit for publication

Pregnancy and Neonatal Outcomes Among Women Living with HIV: A Multi-center, Descriptive Study in Turkey

Objective: Most new confirmed cases in our country consist of young people in the 20-35 age group, which corresponds to the reproductive age in women. This study evaluated the impact of diagnosing and treating human immunodeficiency virus (HIV) during pregnancy on vertical transmission and birth outcomes. Methods: This multicentred descriptive study assessed the pregnancy and delivery process, prevention and treatment practices, breastfeeding and perinatal transmission rate. Results: Of the 55 pregnancies in women living with HIV, only 58.2% had HIV status, 81.2% were under antiretroviral therapy, and 46.2% needed treatment change. Lamivudine/zidovudine + lopinavir/ritonavir (32.7%) and tenofovir/emtricitabine + lopinavir/ritonavir (24.5%) were the two most used regiments. The mean duration of treatment in women starting the treatment during pregnancy was 19.5±7.9 weeks. Viral suppression at the delivery was similar among women who initiated treatment before and during pregnancy (p=0.659). Additionally, 89.1% of women were undetectable status (50 copies/mL); however, 2% of them had >400 copies/mL at the delivery, and three newborns (5.5%) had HIV infections. None of the newborns had congenital anomalies. Conclusion: Our study findings revealed that addressing HIV status within routine pregnancy follow-ups and providing effective treatment before or starting from the early stage of the pregnancy have a crucial effect on protecting from the vertical transmission

Distribution of the Prevalence of Human Leukocyte Antigen (HLA)-B*57:01 Positivity in HIV-1 Infected Individuals and Its Effects on Treatment: Türkiye Map-Buhasder Working Group HIV-1 Enfekte Bireylerde İnsan Lökosit Antijeni (HLA)-B*57:01 Pozitifliği Prevalansının Dağılımı ve Tedavi Üzerine Etkileri: Türkiye Haritası-BUHASDER Çalışma Grubu

Human immunodeficiency virus (HIV)/acquired immundeficiency syndrome (AIDS) is a critical global public health problem that significantly affects both life expectancy and the overall quality of life of individuals in all age groups. The landscape of HIV infection has changed significantly in recent years due to the introduction of effective combination antiretroviral therapies (ART). A key component of first-line ART regimens for HIV treatment is abacavir, a nucleoside HIV reverse transcriptase inhibitor. Although abacavir is effective in suppressing viral replication and managing disease, its clinical utility is overshadowed by the potential for life-threatening hypersensitivity reactions in HLA-B*57:01-positive patients. In our country, local data obtained from various centers regarding the prevalence of HLA-B*57:01 in HIV-1-infected patients are available. In this study, it was aimed to determine the prevalence of the HLA-B*57:01 genotype in HIV-infected patients who were followed up and treated in many regions of our country. This retrospective study consists of the data of the patients aged 18 years and over diagnosed with HIV-1 infection between 01.01.2019 and 31.07.2022. Age, gender, place of birth, mode of transmission of the disease, death status, CD4+ T cell count and HIV RNA levels at the first clinical presentation, HLA-B*57:01 positivity, and the method used, clinical stage of the disease, virological response time with the treatment they received were recorded from the patient files. Data were collected from 16 centers and each center used different methods to detect HLA-B*57:01. These methods were sequence-specific oligonucleotide probe hybridization (SSOP), DNA sequence-based typing (SBT), single-specific primer-polymerase chain reaction (SSP-PCR), allele-specific PCR (AS-PCR) and quantitative PCR (Q-PCR). A total of 608 HIV-infected individuals, 523 males (86%) and 85 females (14%), were included in the study. The mean age of the patients was 36.9 ± 11.9 (18-73) years. The prevalence of HLA-B*57:01 allele was found to be 3.6% (22 patients). The number of CD4+ T lymphocytes in HLA-B*57:01 allele-positive patients was > 500/ mm3 in 10 patients (45.5%), while the number of CD4+ T lymphocytes in HLA-B*57:01 negative patients was > 500/mm3 in 216 patients (36.9%) (p> 0.05). Viral load at the time of diagnosis was found to be lower in patients with positive HLA-B*57:01 allele but it was not statistically significant (p> 0.05). Although different treatment algorithms were used in the centers following the patients, it was observed that the duration of virological response was shorter in HLA-B*57:01 positive patients (p= 0.006). Although the presence of the HLA-B*57:01 allele has a negative impact due to its association with hypersensitivity, it is likely to continue to attract interest due to its association with slower progression of HIV infection and reduced risk of developing AIDS. In addition, although the answer to the question of whether it is cost-effective to screen patients for HLA-B*57:01 before starting an abacavir-containing ART regimen for the treatment of HIV infection is being sought, it seems that HIV treatment guidelines will continue to recommend screening to identify patients at risk in this regard

Safety Evaluation and Tolerability Overview of Favipiravir in the Management of COVID-19: A Real-Life Experience from Turkey

Introduction: Coronavirus diseases-2019 (COVID-19) have been ongoing for more than two years. Despite the scientific researchconducted in this process, there is still no widely accepted definitive treatment for the disease. For treating COVID-19, using antiviralagents previously used for the treatment of other RNA-virus infections has been seen as a fast way to a solution, and favipiravir is oneof the leading agents. This prospective, multicenter, observational study was designed to investigate the safety of favipiravir in 500patients treated with favipravir for favipravir.Methods: This study was conducted as a multicenter prospective study. Eight different sites from four cities participated, and 500patients were included in the study. Follow-up of laboratory parameters, adverse events (AEs), and amelioration of fever, dyspnea,and cough symptoms of the patients was recorded in a case report form.Results: A total of 475 patients from eight centers completed the study. A total of 401 AEs were reported in 206 (51.4%) patients, whichwere mild-to-moderate in the majority of cases. Serious AEs occurred in 5 patients and death occurred in 4 patients. From the first tothe last measurement, serum alanine aminotransferase levels (31.9±27.7 vs. 47.2±49.7 U/L, p&lt;0.001) increased, whereas C-reactiveprotein (39.9±66.4 vs. 15.2±30.5 mg/L, p&lt;0.001) and creatine kinase (101.7±187.7 vs. 71.9±43.5 U/L, p=0.018) levels decreased. Infollow-up parameters, oxygen saturation (SpO2; 96.2±2.7 vs. 97.5±2.1%, p&lt;0.001) and amelioration of fever (&gt;37.8 for 6.6% on day 3,3.2% on day 5, and 0.6% on day 10), dyspnea (for 56.4% on day 5, 62.4% on day 7, and 81.2% on day 10), and cough (46.0% on day 5,73.0% on day 7, and 87.3% on day 10) were noted in an increasingly higher percentage of patients with continued therapy.Conclusion: The current study provides real-life data of favipiravir, which is a unique option in Turkey for treating COVID-19 patients.The results revealed that favipiravir is a well-tolerated agent with a low side-effect profile. However, it needs to be evaluated withwell-designed, dose-compared, randomized controlled studies for the evaluation of efficacy</p

Efficacy and safety of direct-acting antivirals in elderly patients with chronic Hepatitis C: A nationwide real-life, observational, multicenter study from Turkey

Background: The number and proportion of elderly patients living with chronic hepatitis C are expected to increase in the coming years. We aimed to compare the real-world efficacy and safety of direct-acting antiviral treatment in elderly and younger Turkish adults infected with chronic hepatitis C. Methods: In this multicenter prospective study, 2629 eligible chronic hepatitis C patients treated with direct-acting antivirals between April 2017 and December 2019 from 37 Turkish referral centers were divided into 2 age groups: elderly (≥65 years) and younger adults (<65 years) and their safety was compared between 2 groups in evaluable population. Then, by matching the 2 age groups for demographics and pretreatment risk factors for a non-sustained virological response, a total of 1516 patients (758 in each group) and 1244 patients (622 in each group) from the modified evaluable population and per-protocol population were included in the efficacy analysis and the efficacy was compared between age groups. Results: The sustained virological response in the chronic hepatitis C patients was not affected by the age and the presence of cirrhosis both in the modified evaluable population and per-protocol population (P = .879, P = .508 for modified evaluable population and P = .058, P = .788 for per-protocol population, respectively). The results of the per-protocol analysis revealed that male gender, patients who had a prior history of hepatocellular carcinoma, patients infected with non-genotype 1 hepatitis C virus, and patients treated with sofosbuvir+ribavirin had a significantly lower sustained virological response 12 rates (P < .001, P = .047, P = .013, and P = .025, respectively). Conclusion: Direct-acting antivirals can be safely used to treat Turkish elderly chronic hepatitis C patients with similar favorable efficacy and safety as that in younger adults