Unplanned pregnancies and social and partner support during pregnancy in Spanish women living with HIV.

OBJECTIVES: To describe prevalence and factors associated with unplanned pregnancies, and social and partner support during pregnancy among women from the Cohort of the Spanish HIV/AIDS Research Network (CoRIS). METHODS: We included all women recruited in CoRIS from 2004 to 2019, aged 18-50 years at recruitment who were pregnant during 2020. We designed a questionnaire, organized into the following domains: sociodemographic characteristics, tobacco and alcohol consumption, pregnancy and reproductive health, and social and partner support. The information was gathered via telephone interviews conducted from June to December 2021. We calculated prevalence of unplanned pregnancies as well as odds ratios (ORs) of association and 95% confidence intervals (CIs) according to sociodemographic, clinical and reproductive characteristics. RESULTS: Among 53 women who were pregnant during 2020, 38 (71.7%) answered the questionnaire. Median age at pregnancy was 36 years [interquartile range (IQR) 31-39], 27 (71.1%) women were born outside of Spain, mainly in sub-Saharan Africa (39.5%) and 17 (44.7%) were employed. Thirty-four (89.5%) women had been through previous pregnancies and 32 (84.2%) had experienced previous abortions/miscarriages. Seventeen (44.7%) women had shared with their clinician their desire to get pregnant. Thirty-four (89.5%) pregnancies were natural and four used assisted reproductive techniques (in vitro fertilizations; one additionally used oocyte donation). Of 34 women with natural pregnancies, pregnancy was unplanned in 21 (61.8%) and 25 (73.5%) had information on how to become pregnant avoiding HIV transmission to the baby and partner. Women who did not seek advice from their physician about becoming pregnant had a significantly increased risk of unplanned pregnancy (OR = 71.25, 95% CI: 8.96-566.67). Overall, 14 (36.8%) women reported having low social support during pregnancy and 27 (71.0%) had good/very good support by their partner. CONCLUSIONS: Most pregnancies were natural and unplanned and very few women had talked with their clinician about their desire to become pregnant. A high proportion of women reported low social support during pregnancy.

Estimates of mpox effective reproduction number in Spain, April-August 2022.

We analysed the transmission of the human mpox virus in Spain by estimating the effective reproduction number of the disease from official surveillance data. Our computations show that this decreased steadily after an initial burst phase, dropping below 1 on July 12, and thus the outbreak was expected to reduce in the following weeks. Differences in trends were found across geographical regions of the country and across MSM and heterosexual populations.

Self-rated health among people living with HIV in Spain in 2019: a cross-sectional study.

BACKGROUND: HIV infection has become a chronic disease and well-being of people living with HIV (PLHIV) is now of particular concern. The objectives of this paper were to describe self-rated health among PLHIV, on ART and on ART virally suppressed and to analyse its determinants. METHODS: Data were obtained from a second-generation surveillance system based on a cross-sectional one-day survey in public hospitals. Epidemiological and clinical data were collected among HIV-infected inpatients and outpatients receiving HIV-related care the day of the survey in 86 hospitals in 2019. Self-rated health was measured using a question included in the National Health Survey: "In the last 12 months, how would you rate your health status?" an ordinal variable with five categories (very good, good, moderate, bad and very bad). For the analysis, these responses were dichotomized into two categories: 1 = very good/good and 0 = moderate, bad or very bad health status. Factors associated with very good/good self-rated health were estimated using logistic regression. RESULTS: Of 800 PLHIV, 67.5% perceived their health as very good/good, 68.4% among PLHIV on ART and 71.7% of those virally suppressed. Having university education (adjusted odds ratio (aOR):2.1), being unemployed (aOR:0.3) or retired (aOR:0.2), ever being diagnosed of AIDS (aOR:0.6), comorbidities (aOR:0.3), less than 2 year since HIV diagnosis (aOR:0.3) and not receiving ART (aOR:0.3) were associated with good self-rated health. Moreover, among PLHIV on ART, viral load less than 200 copies (aOR:3.2) were related to better perceived health. Bad adherence was inversely associated with good self-rated health among PLHIV on ART (aOR:0.5) and of those virally suppressed (aOR:0.4). CONCLUSIONS: Nearly seven in 10 PLHIV in Spain considered their health status as very good/good, being higher among virally suppressed PLHIV. Both demographic and clinical determinants affect quality of life.

Physicians' opinions on generic antiretroviral drugs and single-tablet regimen de-simplification for the treatment of HIV infection: a multicentre survey in Spain.

OBJECTIVES: To assess the attitudes and opinions about generic antiretroviral drugs (ARVs) and single-tablet regimen (STR) de-simplification among physicians prescribing HIV treatment in the cohort of the Spanish HIV/AIDS Research Network (CoRIS). METHODS: An online questionnaire with 27 structured questions was sent to all physicians (n=199) who prescribed ARVs among the 45 centres participating in the cohort. RESULTS: A total of 169 (84.9%) physicians answered the questionnaire. Only 4.1% of the physicians would never prescribe generic ARVs, but 53.3% would not prescribe them if the number of pills per day increased and 89.3% would not prescribe them if the number of doses per day increased. However, 84.0% of the physicians agreed to prescribe generic ARVs if doing so would decrease costs for the public healthcare system. The percentages of physicians stating that generic ARVs (compared with branded ones) would be associated with worse adherence, more adverse effects or more probability of virological failure, provided that the number of pills and doses per day would not change, were low: 0.6%, 7.7% and 3.6%, respectively. However, these percentages were much higher if the generic ARV entailed breaking an STR: 63.9%, 18.9% and 42.0%, respectively. Most physicians stated that they needed more information about the effectiveness and safety of generic ARVs and the price difference compared with their branded equivalents. CONCLUSIONS: Although most physicians were confident about prescribing generic ARVs, the majority had strong concerns about de-simplifying STR, and they also needed more information about generic drugs.

Effectiveness of the combination elvitegravir/cobicistat/tenofovir/emtricitabine (EVG/COB/TFV/FTC) plus darunavir among treatment-experienced patients in clinical practice: a multicentre cohort study.

BACKGROUND: The aim of this study was to investigate the effectiveness and tolerability of the combination elvitegravir/cobicistat/tenofovir/emtricitabine plus darunavir (EVG/COB/TFV/FTC + DRV) in treatment-experienced patients from the cohort of the Spanish HIV/AIDS Research Network (CoRIS). METHODS: Treatment-experienced patients starting treatment with EVG/COB/TFV/FTC + DRV during the years 2014-2018 and with more than 24 weeks of follow-up were included. TFV could be administered either as tenofovir disoproxil fumarate or tenofovir alafenamide. We evaluated virological response, defined as viral load (VL) < 50 copies/ml and < 200 copies/ml at 24 and 48 weeks after starting this regimen, stratified by baseline VL (< 50 or ≥ 50 copies/ml at the start of the regimen). RESULTS: We included 39 patients (12.8% women). At baseline, 10 (25.6%) patients had VL < 50 copies/ml and 29 (74.4%) had ≥ 50 copies/ml. Among patients with baseline VL < 50 copies/ml, 85.7% and 80.0% had VL < 50 copies/ml at 24 and 48 weeks, respectively, and 100% had VL < 200 copies/ml at 24 and 48 weeks. Among patients with baseline VL ≥ 50 copies/ml, 42.3% and 40.9% had VL < 50 copies/ml and 69.2% and 68.2% had VL < 200 copies/ml at 24 and 48 weeks. During the first 48 weeks, no patients changed their treatment due to toxicity, and 4 patients (all with baseline VL ≥ 50 copies/ml) changed due to virological failure. CONCLUSIONS: EVG/COB/TFV/FTC + DRV was well tolerated and effective in treatment-experienced patients with undetectable viral load as a simplification strategy, allowing once-daily, two-pill regimen with three antiretroviral drug classes. Effectiveness was low in patients with detectable viral loads.

[Impacto de la pandemia de la COVID-19 en los sistemas de vigilancia epidemiologica de la infección por vih en España.] / Impact of the COVID-19 pandemic on the epidemiological surveillance systems of hiv infection in Spain.

OBJECTIVE: The COVID-19 pandemic indirectly affected other communicable diseases, such as human immunodeficiency virus (HIV) infection. The aim of this paper was to evaluate the impact of the COVID-19 pandemic on the epidemiological surveillance of HIV through epidemiological indicators. METHODS: Data collected in the New HIV Diagnosis Information System (SINIVIH, acronym in Spanish) in the period 2013-2021 was analyzed. The epidemiological indicators analyzed were: 1) Reporting delay of new diagnoses; 2) Under diagnosis of cases, calculated per month of diagnosis and for each year of diagnosis; 3) Late diagnosis, cases diagnosed with less than 350 CD4 cell/mm3. RESULTS: Regarding the reporting delay of new diagnoses, in 2022 2,770 diagnoses were reported in 2020, 43.8% more than those reported in 2021 for that year. The cases diagnosed per month between 2016 and 2019 followed a constant trend. In 2020, a significant decrease in diagnoses was observed between March and May that was not recovered after correcting for reporting delay. When comparing the rates of cases diagnosed in 2013 with the successive years, a continuous decrease was interrupted in the last year of the study period. The percentage of cases with late diagnosis had remained stable in the study period (between 46% and 50%), and a decrease in this percentage was observed after correcting for reporting delay. CONCLUSIONS: The epidemiological surveillance of HIV suffered a significant reporting delay. A decrease in cases diagnosed is confirmed, partly due to lockdown and lack of access to the health system. Changes on late diagnosis is not observed.

OBJECTIVE: La pandemia de la COVID-19 afectó de forma indirecta a otras enfermedades transmisibles, como la infección por el virus de la inmunodeficiencia humana (VIH). El objetivo de este estudio fue evaluar el impacto de la pandemia de la COVID-19 en la vigilancia epidemiológica del VIH a través de indicadores epidemiológicos. METHODS: Se analizaron los datos recogidos en el Sistema de Información de Nuevos Diagnósticos de VIH (SINIVIH) en el periodo 2013-2021. Los indicadores epidemiológicos analizados fueron: 1) Retraso en la notificación de nuevos diagnósticos; 2) Infradiagnóstico de caso, calculado por mes y por cada año de diagnóstico; 3) Diagnóstico tardío, casos diagnosticados con menos de 350 células CD4/mm3. RESULTS: Respecto al retraso en la notificación de nuevos diagnósticos, en 2022 se notificaron 2.770 casos diagnosticados en 2020, un 43,8% más respecto a los notificados en 2021 para ese año. Los casos diagnosticados por mes entre 2016 y 2019 seguían una tendencia constante. En 2020 se observó un descenso importante de diagnósticos entre marzo y mayo que no se recuperó al corregir por retraso en la notificación. Al comparar las tasas de casos diagnosticados en 2013 con los años sucesivos, se observó un descenso continuo que se interrumpía en el último año del periodo de estudio. El porcentaje de casos con diagnóstico tardío se mantuvo estable en el periodo de estudio (entre el 46% y el 50%), observándose un descenso al corregir por retraso en la notificación. CONCLUSIONS: La vigilancia epidemiológica del VIH sufrió un importante retraso en la notificación. Se constata un descenso en los casos diagnosticados, en parte debido al confinamiento y la falta de acceso a pruebas diagnósticas. No se observan cambios en el diagnóstico tardío.

Vaccination trends in people with HIV infection participanting in the hospital-based survey of patients infected with HIV, 2006-2021.

OBJECTIVE: To assess the trend in hepatitis A, hepatitis B, pneumococcal, tetanus and seasonal influenza vaccination in people with HIV infection and to analyse associated factors. METHODS: The Hospital Survey of Patients with HIV, an annual cross-sectional study conducted on a fixed day (2006-2021), was used. Inpatients and outpatients were included. Trends in vaccination and associated factors were analysed using logistic regression. RESULTS: A total of 8643 participants were included. Vaccination rates increased to 65.3% for hepatitis A, 83.7% for hepatitis B, 49.3% for tetanus, 68.9% for pneumococcal and 74.5% for seasonal influenza in 2021. Factors positively associated with vaccination were older age for pneumococcal and influenza vaccination; higher educational level for hepatitis A and tetanus; living in a closed institutions or prison for tetanus, pneumococcal and influenza; and having acquired HIV through sex between men for hepatitis A, B and pneumococcal. In addition, being on antiretroviral treatment and having a high CD4 count were positively associated with vaccination for all these diseases. Factors inversely associated with vaccination were being older (hepatitis A, B and tetanus), being an immigrant (tetanus and seasonal influenza) and being an injection drug user/ex-user for hepatitis A and B. CONCLUSIONS: Vaccination in people with HIV has increased in the study period. The results are in line with the recommendations in this population, although there is still room to reach the established vaccination indicators.

Use of Generic Antiretroviral Drugs and Single-Tablet Regimen De-Simplification for the Treatment of HIV Infection in Spain.

The present study sought to describe the use of generic drugs and single-tablet regimen (STR) de-simplification for the treatment of human immunodeficiency virus (HIV) infection among 41 hospitals from the cohort of the Spanish HIV/AIDS Research Network (CoRIS). In June 2018, we collected information on when generic antiretroviral drugs (ARVs) were introduced in the different hospitals, how the decisions to use them were made, and how the information was provided to the patients. Most of the nine available generic ARVs in Spain by June 2018 had been introduced in at least 85% of the participating hospitals, except for zidovudine (AZT)/lamivudine (3TC) and AZT. The time difference between the effective marketing date of each generic ARV and its first dispensing date in the hospitals was much shorter for the more recently approved generic ARV since the year 2017. However, only up to 20% of the hospitals de-simplified efavirenz (EFV)/tenofovir disoproxil (TDF)/emtricitabine (FTC), dolutegravir (DTG)/abacavir (ABC)/3TC, and rilpivirine (RPV)/TDF/FTC (to generic EFV+TDF/FTC, DTG+generic ABC/3TC, and RPV+generic TDF/FTC, respectively), whereas the generic STR EFV/TDF/FTC was introduced in 87.8% of the centers. The median times between the date of effective marketing of generic TDF/FTC and the date of de-simplification of EFV/TDF/FTC and RPV/TDF/FTC were 723 [interquartile range (IQR): 369-1,119] and 234 (IQR: 142-264) days, respectively; this time was 155 (IQR: 28-287) days for de-simplification of DTG/ABC/3TC. In conclusion, despite the widespread use of generic ARVs, STRs de-simplification was only undertaken in <20% of the hospitals. There was wide variability in the timing of the introduction of each generic ARV after they were available in the market.

Temporal Trends and Geographic Variability in the Prescription of Antiretroviral Treatments in People Living with HIV in Spain, 2004-2020.

BACKGROUND: The purpose of this study was to describe temporal trends in the use of antiretroviral therapy (ART) among people living with HIV (PLWHIV) from the cohort of the Spanish HIV/AIDS research network (CoRIS), 2004-2020. METHODS: We described the yearly evolution of the proportion of patients receiving ART and the most frequently prescribed antiretroviral drugs among newly recruited treatment-naïve patients and among all patients with active follow-up. RESULTS: Of 15,539 patients included, 14,618 (94.1%) started ART during their follow-up. Regarding initial regimens, the use of 2NRTI plus 1NNRTI (which were the most frequently prescribed until 2014) and 2NRTI plus 1bPI decreased after 2014, being gradually replaced by INI-based triple therapies. Since 2019, other regimens started to be prescribed, mainly dual therapies. TDF/FTC/EFV was the single-tablet regimen (STR) most frequently prescribed as initial ART until 2012, decreasing thereafter as TDF/FTC/RPV, TDF/FTC/EVG/COBI, and ABC/3TC/DTG became available. TAF/FTC/BIC accounted for 53.6% of initial prescriptions in 2020, followed by DTG/3TC (24%). The percentage of patients on ART increased from 45.7% in 2004 to 98.2% in 2020. Among all patients receiving ART, regimens based on 2NRTI plus 1INI increased from 0.1% in 2007 to 53.3% in 2020. During 2007-2015, most patients were receiving TDF/FTC/EFV, which was replaced after 2017 by ABC/3TC/DTG. In 2020, 13.0% of patients were receiving dual therapies. CONCLUSIONS: Robust real-world data on ART use in PLWHIV over more than 15 years show historical trends in prescriptions with an unprecedented visualization of the contemporary treatment patterns.

Brief Report: Patients' Experiences and Opinions After Desimplification of Their Single-Tablet Regimens for the Treatment of HIV Infection: A Survey in a Multicentre Cohort.

OBJECTIVES: The aims of this study were to describe patients' experiences after single-tablet regimen (STR) desimplification and its impact on self-reported treatment adherence and quality of life. METHODS: We performed a survey among all patients from the multicenter cohort of the Spanish HIV/AIDS Network who had desimplified the STRs dolutegravir/abacavir/lamivudine (DGT/ABC/3TC) or rilpivirine/tenofovir disoproxil fumarate/emtricitabine to their separate components (DTG + generic ABC/3TC or RPV + generic TDF/FTC) between December 2016 and November 2018. RESULTS: Among 216 patients who fulfilled inclusion criteria, 138 (63.9%) completed the questionnaire. Most of the patients (78.3%) knew what generic drugs are, only 8.7% believed that treatment with 2 pills is less effective than treatment with an STR, and 67.4% agreed that it is reasonable to take 2 pills instead of 1 for HIV treatment to decrease costs for the health care system. After desimplification, 13.0% of the patients stated they had more secondary effects, 8.0% had forgotten one or more doses more frequently than before, and 10.9% had sometimes forgotten to take 1 pill, but not the other. A proportion of 30.4% reported not being happy to take more pills a day, and 10.1% experienced a worse quality of life after the treatment desimplification. CONCLUSIONS: After STR desimplification, most of the patients had a fair knowledge about generic antiretrovirals, and they agreed to desimplify their STR to decrease costs. Although almost a third of the respondents were not happy to take 2 pills a day, only a minority reported worse adherence or quality of life.

Effectiveness and tolerability of dolutegravir and abacavir/lamivudine administered as two separate pills compared to their equivalent single-tablet regimen in a multicentre cohort in Spain.

INTRODUCTION: We aimed to assess the effectiveness and tolerability of dolutegravir (DTG), abacavir (ABC) and lamivudine (3TC) administered as branded STR (DTG/ABC/3TC) or as two separate pills (DTG and either branded ABC/3TC [DTG+(ABC/3TC)b] or generic ABC/3TC [DTG+(ABC/3TC)g]). METHODS: We included individuals from the multicentre cohort of the Spanish HIV/AIDS Research Network (CoRIS) who received DTG/ABC/3TC, DTG+(ABC/3TC)b or DTG+(ABC/3TC)g during 2015 to 2018. We used multivariable logistic regression to compare the proportion of antiretroviral-naïve individuals who achieved viral suppression (VS) (viral load ≤50 copies/mL) at 24 weeks of initiating with DTG+(ABC/3TC)b or DTG+(ABC/3TC)g versus DTG/ABC/3TC. We also calculated the proportion of virologically suppressed individuals who maintained VS at 24 weeks after switching from DTG/ABC/3TC to DTG+(ABC/3TC)g. RESULTS: During the study period, 829, 68 and 47 treatment-naïve individuals started treatment with DTG/ABC/3TC, DTG+(ABC/3TC)b or DTG+(ABC/3TC)g respectively. The proportions of individuals who changed their regimens due to side effects during the first 24 weeks were 3.7%, 4.4% and 6.4% respectively (p = 0.646). We did not find significant differences in VS at 24 weeks among individuals starting with DTG+(ABC/3TC)b or DTG+(ABC/3TC)g compared to those initiating with DTG/ABC/3TC. Among 177 virologically suppressed individuals who switched from DTG/ABC/3TC to DTG+(ABC/3TC)g, 170 (96.0%) maintained VS at 24 weeks. CONCLUSIONS: In naïve individuals, the effectiveness and tolerability at 24 weeks of DTG plus ABC/3TC administered as two separate pills, either as branded or generic ABC/3TC, was similar to the STR DTG/ABC/3TC. Switching the STR DTG/ABC/3TC to its separate components DTG+(ABC/3TC)g in virologically suppressed individuals did not seem to impair its effectiveness.

Lymphogranuloma venereum in Spain, 2005-2015: A literature review. / Linfogranuloma venéreo en España, 2005-2015: revisión de la bibliografía.

Lymphogranuloma venereum (LGV) was an unusual disease in Europe until 2003, when several outbreaks among men who have sex with men (MSM) emerged. Since 2015, LGV has been included notifiable disease in Spain. Our aim is to review LGV cases published in Spain from 2005 to 2015. Fourteen studies met the inclusion criteria describing cases in 7autonomous regions. Most cases were MSM, Spaniards, aged between 30-45, with anorectal syndrome. L2 was the predominant serotype isolated. More than 60% of the cases among MSM were co-infected with HIV and nearly half of those reported another concurrent STI. Since the first LGV case published more than 10years ago, this disease has spread across Spain. Epidemiological and clinical characteristics of cases are similar to cases described in Europe. Implementation of national surveillance will improve information about LGV's magnitude and its evolution, key elements for its control.