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  1. Article ; Online: Clinical outcomes and prognostic factors after HCV clearance with DAA in HIV/HCV-coinfected patients with advanced fibrosis/cirrhosis.

    Berenguer, Juan / Aldámiz-Echevarría, Teresa / Hontañón, Víctor / Fanciulli, Chiara / Quereda, Carmen / Busca, Carmen / Domínguez, Lourdes / Hernández, Cristina / Vergas, Jorge / Gaspar, Gabriel / García-Fraile, Lucio J / Díez, Cristina / De Miguel, Marta / Bellón, José M / Bañares, Rafael / González-García, Juan

    Hepatology (Baltimore, Md.)

    2024  

    Abstract: Background and aims: We assessed long-term clinical outcomes and prognostic factors for liver disease progression after sustained viral response with direct-acting antivirals in patients coinfected with HIV/HCV with advanced fibrosis or cirrhosis.: ... ...

    Abstract Background and aims: We assessed long-term clinical outcomes and prognostic factors for liver disease progression after sustained viral response with direct-acting antivirals in patients coinfected with HIV/HCV with advanced fibrosis or cirrhosis.
    Approach and results: A total of 1300 patients who achieved sustained viral response with direct-acting antivirals from 2014 to 2017 in Spain were included: 1145 with compensated advanced chronic liver disease (384 advanced fibrosis and 761 compensated cirrhosis) and 155 with decompensated cirrhosis. The median follow-up was 40.9 months. Overall, 85 deaths occurred, 61 due to non-liver non-AIDS-related causes that were the leading cause of death across all stages of liver disease. The incidence (95% CI) of decompensation per 100 person-years (py) was 0 in patients with advanced fibrosis, 1.01 (0.68-1.51) in patients with compensated cirrhosis, and 8.35 (6.05-11.53) in patients with decompensated cirrhosis. The incidence (95% CI) of HCC per 100 py was 0.34 (0.13-0.91) in patients with advanced fibrosis, 0.73 (0.45-1.18) in patients with compensated cirrhosis, and 1.92 (1.00-3.70) per 100 py in patients with decompensated cirrhosis. Prognostic factors for decompensation in patients with compensated advanced chronic liver disease included serum albumin, liver stiffness measurement (LSM), and fibrosis 4. In this population, LSM and LSM-based posttreatment risk stratification models showed their predictive ability for decompensation and HCC.
    Conclusions: Non-liver non-AIDS-related events were the leading causes of morbidity and mortality after direct-acting antiviral cure among coinfected patients with advanced fibrosis/cirrhosis. Among those with compensated advanced chronic liver disease, baseline LSM and posttreatment LSM-based models helped to assess decompensation and HCC risk.
    Language English
    Publishing date 2024-03-07
    Publishing country United States
    Document type Journal Article
    ZDB-ID 604603-4
    ISSN 1527-3350 ; 0270-9139
    ISSN (online) 1527-3350
    ISSN 0270-9139
    DOI 10.1097/HEP.0000000000000838
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    Zs.A 1660: Show issues Location:
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  2. Article ; Online: Human IgM

    Vitallé, Joana / Zenarruzabeitia, Olatz / Merino-Pérez, Aitana / Terrén, Iñigo / Orrantia, Ane / Pacho de Lucas, Arantza / Iribarren, José A / García-Fraile, Lucio J / Balsalobre, Luz / Amo, Laura / de Andrés, Belén / Borrego, Francisco

    International journal of molecular sciences

    2023  Volume 24, Issue 18

    Abstract: CD300a is differentially expressed among B cell subsets, although its expression in immunoglobulin (Ig) ... ...

    Abstract CD300a is differentially expressed among B cell subsets, although its expression in immunoglobulin (Ig)M
    MeSH term(s) Humans ; Memory B Cells ; HIV Infections ; Streptococcus pneumoniae ; Pneumococcal Infections ; Adjuvants, Immunologic ; Complementarity Determining Regions ; Immunoglobulin M
    Chemical Substances Adjuvants, Immunologic ; Complementarity Determining Regions ; Immunoglobulin M
    Language English
    Publishing date 2023-09-06
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2019364-6
    ISSN 1422-0067 ; 1422-0067 ; 1661-6596
    ISSN (online) 1422-0067
    ISSN 1422-0067 ; 1661-6596
    DOI 10.3390/ijms241813754
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  3. Article: Evolution of HCV associated porphyria cutanea tarda after HCV sustained virologic response by direct acting antivirals.

    García-Fraile, Lucio J / García-Buey, Luisa / Alonso Cerezo, Concepción / Sanz Sanz, Jesús / de Los Santos Gil, Ignacio

    Gastroenterologia y hepatologia

    2021  Volume 45, Issue 4, Page(s) 249–255

    Abstract: Objectives: Porphyria cutanea tarda (PCT) is common and usually associated with HCV chronic infection and HFE polymorphisms. Since DAA IFN-free regimens availability, SVR for HCV is nearly a constant and we wonder whether HCV SVR determine PCT evolution. ...

    Abstract Objectives: Porphyria cutanea tarda (PCT) is common and usually associated with HCV chronic infection and HFE polymorphisms. Since DAA IFN-free regimens availability, SVR for HCV is nearly a constant and we wonder whether HCV SVR determine PCT evolution.
    Methods: Retrospective observational study including patients with HCV associated PCT from the Gastroenterology and Infectious Diseases Departments at our Hospital, treated with DAA (Apr/2015-Apr/2017). Clinical variables of PCT were collected at PCT diagnosis, after PCT treatment, before DAA use and after SVR achievement. UROD activity and C282Y/H63D polymorphisms were registered. SPSS 22.0.
    Results: 13 HCV-PCT patients included: median age 52.5 years; 4 females; 8 HCV/HIV co-infected (all on undetectable viral load). Classical PCT factors: 12 smoked, 9 alcohol abuse, 6 former IDU. 10 type I PCT and 1 type II PCT. HFE polymorphism: 2 cases with C282Y/H63D; H63D polymorphism in 8. PCT manifestations resolved with PCT treatment in 4 patients, almost completely in 7 patients, 1 patient referred stabilization and one worsened. After DAA treatment all the residual lesions resolved, what always led to specific treatment interruption.
    Conclusions: Our series of cases of HCV-associated PCT shows that SVR after DAA treatment leads to PCT resolution. Porphyrin levels are not needed after ending PCT specific treatment interruption when there are no residual skin lesions in HCV-associated PCT.
    MeSH term(s) Antiviral Agents/therapeutic use ; Female ; Hepatitis C/complications ; Hepatitis C, Chronic/complications ; Hepatitis C, Chronic/drug therapy ; Humans ; Middle Aged ; Mutation ; Porphyria Cutanea Tarda/complications ; Porphyria Cutanea Tarda/etiology ; Sustained Virologic Response
    Chemical Substances Antiviral Agents
    Language Spanish
    Publishing date 2021-09-22
    Publishing country Spain
    Document type Journal Article ; Observational Study
    ZDB-ID 632502-6
    ISSN 0210-5705
    ISSN 0210-5705
    DOI 10.1016/j.gastrohep.2021.09.001
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    Zs.A 2044: Show issues Location:
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  4. Article ; Online: Metabolic-Related Outcomes After Switching From Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide in Adults With Human Immunodeficiency Virus (HIV): A Multicenter Prospective Cohort Study.

    Martínez-Sanz, Javier / Serrano-Villar, Sergio / Muriel, Alfonso / García Fraile, Lucio J / Orviz, Eva / Mena de Cea, Álvaro / Campins, Antoni A / Moreno, Santiago

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2022  Volume 76, Issue 3, Page(s) e652–e660

    Abstract: Background: Tenofovir alafenamide (TAF) has replaced tenofovir disoproxil fumarate (TDF) in many clinical settings. However, concerns remain about potential metabolic complications of TAF. We aimed to evaluate changes in weight, laboratory markers, and ... ...

    Abstract Background: Tenofovir alafenamide (TAF) has replaced tenofovir disoproxil fumarate (TDF) in many clinical settings. However, concerns remain about potential metabolic complications of TAF. We aimed to evaluate changes in weight, laboratory markers, and metabolic-related clinical events after replacing TDF with TAF.
    Methods: Multicenter prospective cohort study in the Spanish CoRIS cohort. We included virologically suppressed adults with human immunodeficiency virus (HIV) receiving TDF for more than 12 months who either switched to TAF or maintained TDF, with no changes in the core agent. Participants were matched by propensity score. We fitted generalized equation models to assess changes in weight, blood lipids, and hepatic steatosis index, and to compare the incidence of diabetes, hypertension, and lipid-lowering drug use after 144 weeks.
    Results: In total, 1446 participants were matched in each group. Median age was 38 years, 85% were male, mean weight at baseline was 73 kg. Participants who switched to TAF had a mean weight increase of +0.5 kg at 144 weeks over those who maintained TDF, with no difference in the occurrence of overweight or obesity. Individuals who switched to TAF had a significant increase in total cholesterol (+7.9 mg/dL) and triglycerides (+11.2 mg/dL), with no differences in the total cholesterol-high-density lipoprotein (HDL) ratio. However, no increased incidence of diabetes, hypertension, or lipid-lowering drug use was observed after the follow-up period.
    Conclusions: Switching from TDF to TAF is associated with modest weight gain and increases in total cholesterol and triglycerides, without an impact on the incidence of obesity or metabolic-related clinical events, in this Spanish cohort with a majority White male population.
    MeSH term(s) Adult ; Male ; Humans ; Female ; Tenofovir/adverse effects ; Anti-HIV Agents/adverse effects ; HIV Infections/drug therapy ; Prospective Studies ; Adenine/adverse effects ; HIV-1 ; Lipids ; Cholesterol ; Triglycerides ; Obesity ; Hypertension
    Chemical Substances Tenofovir (99YXE507IL) ; Anti-HIV Agents ; Adenine (JAC85A2161) ; Lipids ; Cholesterol (97C5T2UQ7J) ; Triglycerides
    Language English
    Publishing date 2022-07-28
    Publishing country United States
    Document type Multicenter Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciac621
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    Zs.MO 480: Show issues

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  5. Article: DBP

    Resino, Salvador / Jiménez-Sousa, María Ángeles / Blanco, Julià / Pacheco, Yolanda M / Del Romero, Jorge / Peraire, Joaquim / Virseda-Berdices, Ana / Muñoz-Gómez, María José / Galera-Peñaranda, Carlos / García-Fraile, Lucio Jesus / Benito, José M / Rallón, Norma

    Frontiers in pharmacology

    2022  Volume 12, Page(s) 773848

    Abstract: Background: ...

    Abstract Background:
    Language English
    Publishing date 2022-01-18
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2587355-6
    ISSN 1663-9812
    ISSN 1663-9812
    DOI 10.3389/fphar.2021.773848
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  6. Article: Subcutaneous IL-6 Inhibitor Sarilumab vs. Standard Care in Hospitalized Patients With Moderate-To-Severe COVID-19: An Open Label Randomized Clinical Trial.

    García-Vicuña, Rosario / Rodriguez-García, Sebastián C / Abad-Santos, Francisco / Bautista Hernández, Azucena / García-Fraile, Lucio / Barrios Blandino, Ana / Gutiérrez Liarte, Angela / Alonso-Pérez, Tamara / Cardeñoso, Laura / Alfranca, Aránzazu / Mejía-Abril, Gina / Sanz Sanz, Jesús / González-Alvaro, Isidoro

    Frontiers in medicine

    2022  Volume 9, Page(s) 819621

    Abstract: Background: The use of IL-6 blockers in COVID-19 hospitalized patients has been associated with a reduction in mortality compared to standard care. However, many uncertainties remain pertaining to optimal intervention time, administration schedule, and ... ...

    Abstract Background: The use of IL-6 blockers in COVID-19 hospitalized patients has been associated with a reduction in mortality compared to standard care. However, many uncertainties remain pertaining to optimal intervention time, administration schedule, and predictors of response. To date, data on the use of subcutaneous sarilumab is limited and no randomized trial results are available.
    Methods: Open label randomized controlled trial at a single center in Spain. We included adult patients admitted with microbiology documented COVID-19 infection, imaging confirmed pneumonia, fever and/or laboratory evidence of inflammatory phenotype, and no need for invasive ventilation. Participants were randomly assigned to receive sarilumab, a single 400 mg dose in two 200 mg subcutaneous injections, added to standard care or standard care, in a 2:1 proportion. Primary endpoints included 30-day mortality, mean change in clinical status at day 7 scored in a 7-category ordinal scale ranging from death (category 1) to discharge (category 7), and duration of hospitalization. The primary efficacy analysis was conducted on the intention-to-treat population.
    Results: A total of 30 patients underwent randomization: 20 to sarilumab and 10 to standard care. Most patients were male (20/30, 67%) with a median (interquartile range) age of 61.5 years (56-72). At day 30, 2/20 (10%) patients died in the sarilumab arm vs. none (0/10) in standard care (Log HR 15.11, SE 22.64;
    Conclusions and relevance: Our pragmatic pilot study has failed to demonstrate the benefit of adding subcutaneous sarilumab to standard care for mortality by 30 days, functional status at day 7, or hospital stay. Findings herein do not exclude a potential effect of sarilumab in severe COVID-19 but adequately powered blinded randomized phase III trials are warranted to assess the impact of the subcutaneous route and a more selected target population.
    Trial registration: www.ClinicalTrials.gov, Identifier: NCT04357808.
    Language English
    Publishing date 2022-02-23
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2775999-4
    ISSN 2296-858X
    ISSN 2296-858X
    DOI 10.3389/fmed.2022.819621
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  7. Article ; Online: Impact of recent drug use on the efficacy of elbasvir/grazoprevir for HCV-infected people on opioid agonist therapy.

    Macías, Juan / Téllez, Francisco / de Los Santos, Ignacio / Morano, Luis E / Merino, Dolores / Granados, Rafael / Vera-Mendez, Francisco / González-Serna, Alejandro / Campo-Moneo, Esther / García-Fraile, Lucio / García, Federico / Real, Luis M / Pineda, Juan A

    Journal of viral hepatitis

    2021  Volume 28, Issue 6, Page(s) 878–886

    Abstract: Elbasvir/grazoprevir (EBR/GZR) use in drug users on opiate agonist therapy (OAT) is supported by the C-EDGE Co-STAR trial. SVR rates in this study were within those found in the rest of patients included by the EBR/GZR development programme. In clinical ... ...

    Abstract Elbasvir/grazoprevir (EBR/GZR) use in drug users on opiate agonist therapy (OAT) is supported by the C-EDGE Co-STAR trial. SVR rates in this study were within those found in the rest of patients included by the EBR/GZR development programme. In clinical practice, however, efficacy could theoretically be lower. Thus, we aimed at evaluating the SVR rates of EBR/GZR among people who injected drugs (PWID) with and without OAT in clinical practice. Patients starting EBR/GZR included in the HEPAVIR-DAA (NCT02057003), recruiting HIV/HCV-coinfected patients or the GEHEP-MONO (NCT02333292), including HCV-monoinfected individuals, prospective cohorts were analysed. Overall SVR12 (ITT), discontinuations due to adverse effects and drop-outs were evaluated. The same analysis was carried out for PWID with and without OAT. 336 patients had started EBR/GZR and reached the SVR12 evaluation date. 318 [95%, 95% confidence interval (95% CI): 92%-98%] patients achieved SVR12. SVR12 was 97% (95% CI: 93%-99%, n/N = 141/145) among people who never used injecting drugs, 94% (95% CI: 88%-97%, n/N = 117/125) among PWIDs without OAT and 91% (95% CI: 81%-97%, n/N = 60/66) among PWIDs with OAT (p = 0.134). Five (1.5%) patients showed relapses, and two (0.6%) individuals showed viral breakthrough. The SVR12 rate for recent drug users was 69% (n/N = 18/26) compared with 97% (n/N = 276/284) for individuals without recent drug use (in the prior year) (p < 0.001). Among recent drug users, three (12%) showed relapses, and five (19%) were lost-to-follow-up. The SVR rates achieved with EBR/GZR were high in real-world conditions of use. However, PWID with recent drug use reach suboptimal response rates with EBR/GZR.
    MeSH term(s) Amides ; Analgesics, Opioid ; Antiviral Agents/adverse effects ; Benzofurans ; Carbamates ; Cyclopropanes ; Drug Therapy, Combination ; Genotype ; Hepacivirus/genetics ; Hepatitis C/drug therapy ; Humans ; Imidazoles ; Pharmaceutical Preparations ; Prospective Studies ; Quinoxalines/adverse effects ; Sulfonamides
    Chemical Substances Amides ; Analgesics, Opioid ; Antiviral Agents ; Benzofurans ; Carbamates ; Cyclopropanes ; Imidazoles ; Pharmaceutical Preparations ; Quinoxalines ; Sulfonamides ; grazoprevir (4O2AB118LA) ; elbasvir (632L571YDK)
    Language English
    Publishing date 2021-04-15
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1212497-7
    ISSN 1365-2893 ; 1352-0504
    ISSN (online) 1365-2893
    ISSN 1352-0504
    DOI 10.1111/jvh.13496
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    Zs.A 4119: Show issues Location:
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  8. Article ; Online: Antiretroviral therapy duration and immunometabolic state determine efficacy of ex vivo dendritic cell-based treatment restoring functional HIV-specific CD8+ T cells in people living with HIV.

    Calvet-Mirabent, Marta / Sánchez-Cerrillo, Ildefonso / Martín-Cófreces, Noa / Martínez-Fleta, Pedro / de la Fuente, Hortensia / Tsukalov, Ilya / Delgado-Arévalo, Cristina / Calzada, María José / de Los Santos, Ignacio / Sanz, Jesús / García-Fraile, Lucio / Sánchez-Madrid, Francisco / Alfranca, Arantzazu / Muñoz-Fernández, María Ángeles / Buzón, Maria J / Martín-Gayo, Enrique

    EBioMedicine

    2022  Volume 81, Page(s) 104090

    Abstract: Background: Dysfunction of CD8: Methods: We studied association of restoration of functional HIV-1-specific CD8: Findings: HIV-1-specific CD8: Interpretation: Together, our study identifies specific immunometabolic parameters for different PLWH ...

    Abstract Background: Dysfunction of CD8
    Methods: We studied association of restoration of functional HIV-1-specific CD8
    Findings: HIV-1-specific CD8
    Interpretation: Together, our study identifies specific immunometabolic parameters for different PLWH subgroups potentially useful for future personalized DC-based HIV-1 vaccines.
    Funding: NIH (R21AI140930), MINECO/FEDER RETOS (RTI2018-097485-A-I00) and CIBERINF grants.
    MeSH term(s) Anti-Retroviral Agents/pharmacology ; Anti-Retroviral Agents/therapeutic use ; CD4-Positive T-Lymphocytes ; CD8-Positive T-Lymphocytes ; Dendritic Cells ; HIV Infections/drug therapy ; HIV-1 ; Humans
    Chemical Substances Anti-Retroviral Agents
    Language English
    Publishing date 2022-06-02
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 2851331-9
    ISSN 2352-3964
    ISSN (online) 2352-3964
    DOI 10.1016/j.ebiom.2022.104090
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  9. Article ; Online: Poly I:C and STING agonist-primed DC increase lymphoid tissue polyfunctional HIV-1-specific CD8

    Calvet-Mirabent, Marta / Claiborne, Daniel T / Deruaz, Maud / Tanno, Serah / Serra, Carla / Delgado-Arévalo, Cristina / Sánchez-Cerrillo, Ildefonso / de Los Santos, Ignacio / Sanz, Jesús / García-Fraile, Lucio / Sánchez-Madrid, Francisco / Alfranca, Arantzazu / Muñoz-Fernández, María Ángeles / Allen, Todd M / Buzón, Maria J / Balazs, Alejandro / Vrbanac, Vladimir / Martín-Gayo, Enrique

    European journal of immunology

    2022  Volume 52, Issue 3, Page(s) 447–461

    Abstract: Effective function of ... ...

    Abstract Effective function of CD8
    MeSH term(s) AIDS Vaccines/metabolism ; Adjuvants, Immunologic/pharmacology ; Animals ; CD4-Positive T-Lymphocytes ; CD8-Positive T-Lymphocytes ; Dendritic Cells ; HIV Core Protein p24/metabolism ; HIV-1 ; Lymphoid Tissue ; Mice ; Poly I-C/pharmacology
    Chemical Substances AIDS Vaccines ; Adjuvants, Immunologic ; HIV Core Protein p24 ; Poly I-C (O84C90HH2L)
    Language English
    Publishing date 2022-01-08
    Publishing country Germany
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 120108-6
    ISSN 1521-4141 ; 0014-2980
    ISSN (online) 1521-4141
    ISSN 0014-2980
    DOI 10.1002/eji.202149502
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  10. Article: Patterns of Sexualized Drug Use among Gay, Bisexual, and Other Men Who Have Sex with Men Living with HIV: Insights from a Comprehensive Study-The U-SEX-2 GESIDA 9416 Study.

    Ryan, Pablo / Dolengevich-Segal, Helen / Ramos-Ruperto, Luis / Cabello, Alfonso / Sanchez-Conde, Matilde / Vergas, Jorge / Valencia, Jorge / Cuevas, Guillermo / Sanz, José / Curto-Ramos, Javier / Pérez-Bootello, Javier / Naharro-Rodriguez, Jorge / Ollero, Mar J F / Garcia Fraile, Lucio / Pérez-Latorre, Leire / Bisbal, Otilia / De la Fuente, Sara / Losa, Juan Emilio / Cervero, Miguel /
    Estebanez, Miriam / Suarez-Garcia, Inés / Gimeno, Alejandra / Terrancle, Ignacio / Mican, Rafael / González-Baeza, Alicia

    Journal of clinical medicine

    2023  Volume 12, Issue 23

    Abstract: Background: Sexualized drug use (SDU) has become a public health concern in recent years. This study aimed to estimate the prevalence of SDU in gay, bisexual, and other men who have sex with men living with HIV (HIV + GBMSM) in Madrid during 2019/2020 ... ...

    Abstract Background: Sexualized drug use (SDU) has become a public health concern in recent years. This study aimed to estimate the prevalence of SDU in gay, bisexual, and other men who have sex with men living with HIV (HIV + GBMSM) in Madrid during 2019/2020 and compare it with data from 2016/2017 in order to detect changes in patterns.
    Methods: We analyzed the frequency of SDU in a sample of HIV + GBMSM attending HIV clinics, who participated in an anonymous online survey regarding sexual behavior and recreational drug use. The association between SDU, sexual risk behaviors, and STIs was evaluated.
    Results: This study included 424 HIV + GBMSM, with a mean age of 40 (10.43) years. Overall, 94% (396) reported being sexually active. Additionally, 33% (140) had been diagnosed with an STI within the previous year. Moreover, 54% (229) had used drugs in the last year, 25% (107) engaged in SDU, and 16% (17) reported engagement in slamsex. After adjusting for confounding factors, SDU was associated with STIs, fisting, unprotected anal intercourse, and having >24 sexual partners in the last year. According to the DUDIT test scores, 80% (81) probably had problematic drug use (≥6 points), and 8% (8) probable drug dependence (≥25 points). When comparing the U-SEX-1 (2016/2017) data with the U-SEX-2 (2019/2020) data, no significant differences were found in the proportion of participants practicing SDU or slamming.
    Conclusions: The prevalence of SDU among HIV + GBMSM has remained high in recent years and without significant changes. The risk of problematic drug use among those who practice SDU is high. We observed a clear association between SDU, high-risk sexual behaviors, and STIs.
    Language English
    Publishing date 2023-11-24
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2662592-1
    ISSN 2077-0383
    ISSN 2077-0383
    DOI 10.3390/jcm12237293
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