Discontinuation due to neuropsychiatric adverse events with efavirenz- and dolutegravir-based antiretroviral therapy: a comparative real-life study

Obervational study[Abstract] Objectives: Despite the high efficacy of antiretroviral treatment, no drug is free from adverse events (AEs). Efavirenz (EFV) and dolutegravir (DTG) are antiretroviral drugs for which neuropsychiatric adverse events (NPAEs) have been described. This study evaluated the safety and tolerability of DTG-based and EFV-based antiretroviral regimens in HIV-infected patients. Methods: A retrospective observational study was carried out in HIV-infected patients who started DTG- or EFV-based antiretroviral treatment from January 2008 to December 2018 at a reference hospital in north-western Spain. Epidemiological, clinical and immunovirological data were recorded. A statistical analysis was performed with SPSS software. Results: A total of 282 DTG- and 148 EFV-based therapies were initiated. During follow-up, statistically significant differences have been found between the rate of patients who discontinued DTG and EFV due to AEs (12.1% vs 35.8%, p<0.001) and the main AEs in both groups, NPAEs (8.2% vs 25.0%, p<0.001). Female gender (OR 2.610 (95% CI 1.327 to 5.133), p=0.005) was associated with discontinuations due to AEs. Patients with documented psychiatric disorders were at higher risk of discontinuation due to NPAEs (OR 4.782 (95% CI 1.190 to 19.220), p=0.027). The multivariate analysis showed a 61.2% risk reduction in benzodiazepine prescriptions in patients treated with DTG. In both groups, patients needed consultation and follow-up in the psychiatry unit (16.9% in the EFV group and 8.9% in the DTG group, p=0.021). Conclusions: We found a high rate of discontinuations due to AEs and NPAEs, prescription of benzodiazepines and a requirement for consultation in a psychiatric unit in both treatment groups, especially with EFV

Renal profile of patients treated with elvitegravir/ cobicistat/emtricitabine/tenofovir alafenamide fumarate and dolutegravir/abacavir/lamivudine: 120-week results from a real-world cohort

[Abstract] Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate (EVG/c/FTC/TAF) and dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) are currently available for HIV patients. Objectives: This study evaluated modifications in the renal safety profile in a large real-world cohort of patients who had received EVG/c/FTC/TAF or DTG/ABC/3TC. Methods: A retrospective observational study of HIV-infected patients who received EVG/c/FTC/TAF or DTG/ABC/3TC between March 2015 and June 2019 at a reference hospital in north-western Spain was conducted. Epidemiological, clinical, immunovirological data and information regarding antiretroviral therapy were recorded. The statistical differences between treatments were calculated. Results: A total of 457 patients were evaluated, 266 using EVG/c/FTC/TAF and 191 using DTG/ABC/3TC. Up to week 120, serum creatinine improved in both study groups among experienced patients (EVG/c/FTC/TAF 1.01±0.24 vs 0.91±0.19, p<0.001; DTG/ABC/3TC 1.08±0.24 vs 1.02±0.31, p<0.001), while in naïve patients serum creatinine remained stable compared with baseline. Statistically significant differences were found in serum creatinine when comparing both treatments at week 48 in experienced (0.94±0.21 vs 1.09±0.28, p<0.001) and naïve patients (0.89±0.16 vs 1.06±0.20, p=0.001), and among experienced patients at week 120 (0.91±0.19 vs 1.02±0.31, p=0.015) for the EVG/c/FTC/TAF and DTG/ABC/3TC groups, respectively. During the follow-up, 39 patients in EVG/c/FTC/TAF and 33 in DTG/ABC/3TC (p=0.449) discontinued treatment. The main reason for stopping treatment was adverse events, which were similar in both groups. Conclusions: During the follow-up, patients experienced changes that were not clinically relevant in both treatment groups. Differences in renal events were not found

Prevalencia de VIH, hepatitis, sífilis y tuberculosis en la población inmigrante del área sanitaria de A Coruña sometida a un examen de salud

Aim: Knowing the prevalence of viral hepatitis, HIV, tuberculosis and syphilis infection in a healthy immigrant community through a health examination. Methods: Prospective observational study from March 2005 to March 2009 in a healthy population of immigrants with less than 5 years living in Galicia through NGO Ecos do Sur (A Coruña). All were given the option to make the Mantoux test and analytical study: serology for hepatitis, syphilis and HIV. Results : 204 individuals were included (48% males). 54.4% of immigrants had an age range between 21-35 years. 76% came from Latin America. 49% lived in Galicia for less than a year. 2% were carriers of HBV, 1% of HCV, while 1.4% were infected with HIV. 31.9% had a positive Mantoux test. The serology was 7.1% compatible with latent or past syphilis. Conclusion: The immigrant population in our geographical area comes mainly from Latin American countries. The prevalence of positive markers for HBV, HBV, HIV and syphilis was low, with lower rates than other communities of the Mediterranean.OBJETIVOS: Conocer la prevalencia de las hepatitis víricas, infección por VIH, infección tuberculosa y sífilis en un colectivo de inmigrantes sanos a través de un examen de salud. MÉTODOS: Estudio observacional y prospectivo realizado en una población de inmigrantes sanos con menos de 5 años de residencia en Galicia y que acudieron voluntariamente a ONGd Ecos do Sur ( A Coruña ). A todos se les ofreció la posibilidad de realización de prueba de Mantoux y estudio analítico: serología de hepatitis y VIH en centro hospitalario de referencia. El periodo de estudio: desde marzo 2005 a marzo 2009. Resultados : Un total de 204 individuos fueron incluidos en el estudio (48% varones). El 54,4% de los inmigrantes tenía un rango de edad entre 21-35 años. El 76% procedían de Iberoamérica. El 49% residía en Galicia desde hacía menos de un año. El 2% eran portadores del VHB, el 1% lo eran del VHC, mientras que el 1,4% estaban infectados por el VIH. El 34,5% presentaron Mantoux positivo. El 7,1% presentaba una serología compatible con sífilis latente o pasada. Conclusiones: La población inmigrante de nuestra área geográfica procede fundamentalmente de los países iberoamericanos. La prevalencia de marcadores positivos para VHB, VHB, VIH y sífilis fue baja, en menor proporción que otras comunidades de la cuenca mediterráne

How do women living with HIV experience menopause? Menopausal symptoms, anxiety and depression according to reproductive age in a multicenter cohort

CatedresBackground: To estimate the prevalence and severity of menopausal symptoms and anxiety/depression and to assess the differences according to menopausal status among women living with HIV aged 45-60 years from the cohort of Spanish HIV/AIDS Research Network (CoRIS). Methods: Women were interviewed by phone between September 2017 and December 2018 to determine whether they had experienced menopausal symptoms and anxiety/depression. The Menopause Rating Scale was used to evaluate the prevalence and severity of symptoms related to menopause in three subscales: somatic, psychologic and urogenital; and the 4-item Patient Health Questionnaire was used for anxiety/depression. Logistic regression models were used to estimate odds ratios (ORs) of association between menopausal status, and other potential risk factors, the presence and severity of somatic, psychological and urogenital symptoms and of anxiety/depression. Results: Of 251 women included, 137 (54.6%) were post-, 70 (27.9%) peri- and 44 (17.5%) pre-menopausal, respectively. Median age of onset menopause was 48 years (IQR 45-50). The proportions of pre-, peri- and post-menopausal women who had experienced any menopausal symptoms were 45.5%, 60.0% and 66.4%, respectively. Both peri- and post-menopause were associated with a higher likelihood of having somatic symptoms (aOR 3.01; 95% CI 1.38-6.55 and 2.63; 1.44-4.81, respectively), while post-menopause increased the likelihood of having psychological (2.16; 1.13-4.14) and urogenital symptoms (2.54; 1.42-4.85). By other hand, post-menopausal women had a statistically significant five-fold increase in the likelihood of presenting severe urogenital symptoms than pre-menopausal women (4.90; 1.74-13.84). No significant differences by menopausal status were found for anxiety/depression. Joint/muscle problems, exhaustion and sleeping disorders were the most commonly reported symptoms among all women. Differences in the prevalences of vaginal dryness (p = 0.002), joint/muscle complaints (p = 0.032), and sweating/flush (p = 0.032) were found among the three groups. Conclusions: Women living with HIV experienced a wide variety of menopausal symptoms, some of them initiated before women had any menstrual irregularity. We found a higher likelihood of somatic symptoms in peri- and post-menopausal women, while a higher likelihood of psychological and urogenital symptoms was found in post-menopausal women. Most somatic symptoms were of low or moderate severity, probably due to the good clinical and immunological situation of these women