Publications by authors named "Ignacio de Los Santos Gil"

22 Publications

  • Page 1 of 1

ENGLISH: Evolution of HCV associated Porphyria Cutanea Tarda after HCV Sustained Virologic Response by Direct Acting Antivirals.

Gastroenterol Hepatol 2021 Sep 22. Epub 2021 Sep 22.

Service of Infectious Diseases and Internal Medicine. Hospital Universitario de la Princesa. Madrid. IIP. Universidad Autónoma de Madrid, Spain.

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.
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http://dx.doi.org/10.1016/j.gastrohep.2021.09.001DOI Listing
September 2021

Dynamics of creatinine estimated glomerular filtration rate using one or more antiretrovirals that inhibit creatinine tubular secretion.

J Antimicrob Chemother 2021 03;76(4):1046-1050

Hospital Clinic de Barcelona, Barcelona, Spain.

Background: Cobicistat, dolutegravir and rilpivirine are all modest inhibitors of proximal tubular creatinine secretion (IPTCrS) and hence a moderate and early non-progressive creatinine estimated glomerular filtration rate (Cr-eGFR) reduction has been observed in clinical trials. Data regarding the impact of combination of those drugs on Cr-eGFR, in the clinical practice, are scarcely known.

Methods: Changes in Cr-eGFR after starting darunavir/cobicistat alone or in combination with dolutegravir and/or rilpivirine were studied in a nationwide retrospective cohort study of consecutive HIV-infected patients initiating darunavir/cobicistat. The relationship between Cr-eGFR changes over time and the use of darunavir/cobicistat alone or darunavir/cobicistat plus dolutegravir and/or rilpivirine adjusted by different HIV patient's characteristics, socio-demographics, HIV severity and use of tenofovir concomitant medication other than antiretrovirals was explored through univariate and multivariate analyses.

Results: The analysis included 725 patients. At 48 weeks, the combination of two or more IPTCrS (darunavir/cobicistat with rilpivirine and/or dolutegravir) was associated with higher decreases in Cr-eGFR [adjusted median difference (±SD) -3.5 ± 1.6 (95% CI -6.6 to -0.3), P = 0.047], and a decrease up to or higher than 15 mL/min/1.73 m2 was more frequent [adjusted OR 3.233 (95% CI 1.343-7.782), P = 0.009], with respect to darunavir/cobicistat alone. The Cr-eGFR changes between darunavir/cobicistat and darunavir/cobicistat with rilpivirine and/or dolutegravir showed more significant decreases in patients taking two or more IPTCrS at 12, 24 and 48 weeks. (ClinicalTrials.gov: NCT03042390).

Conclusions: Concomitant use of darunavir/cobicistat plus IPTCrS dolutegravir, rilpivirine, or both produced an additive effect in the expected Cr-eGFR decrease.
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http://dx.doi.org/10.1093/jac/dkaa547DOI Listing
March 2021

Ambulatory Blood Pressure Monitoring in HIV-Infected Patients: Usefulness for Cardiovascular Risk Assessment.

J Int Assoc Provid AIDS Care 2020 Jan-Dec;19:2325958220935693

16517Hospital Universitario de La Princesa, Madrid, Spain.

Background: There is a lack of consensus regarding the risk of hypertension in HIV-infected patients compared to the general population. Ambulatory blood pressure monitoring (ABPM) is the most accurate method for the hypertension diagnosis. Nevertheless, it is rarely used in HIV clinical care.

Materials And Methods: All HIV-infected patients who underwent 24 hours ABPM were included. The agreement between office blood pressure (BP) readings and ABPM was analyzed. The rate of patients with masked hypertension (MH), isolated clinical hypertension, and nocturnal hypertension was obtained. Furthermore, it was analyzed if the differences between both methods may affect the cardiovascular risk (CVR) assessment.

Results: A total of 116 patients were included. The κ coefficient between office BP and ABPM was 0.248. Over a quarter of the cohort was diagnosed with MH-25.8% (CI 95% 17.7%-34.0%), and 12% (CI 95%: 6.1%-16.1%) was diagnosed with ICH. Moreover, 19% of patients had hypertension exclusively during the night. The patients classified as low risk according to the CVR scores had a different diagnosis with ABPM than with office BP ( < .001).

Conclusions: The agreement between office BP and ABPM was low in HIV-infected patients. Ambulatory BP monitoring is useful in HIV-infected patients as a hypertension diagnosis method, especially among patients classified as low risk.
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http://dx.doi.org/10.1177/2325958220935693DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7444154PMC
July 2021

Higher relapse rate among HIV/HCV-coinfected patients receiving sofosbuvir/ledipasvir for 8 vs 12 weeks.

J Infect 2019 07 14;79(1):30-35. Epub 2019 May 14.

Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain.

Objectives: To compare the efficacy of sofosbuvir/ledipasvir (SOF/LDV) for 8 weeks (SL8) versus a 12-week course of SOF/LDV (SL12) among HIV/HCV-coinfected patients in clinical practice. In addition we compared sustained virological response (SVR) rates achieved with SL8 in HCV-monoinfected and HIV/HCV-coinfected patients in a real life setting.

Methods: HCV-infected patients were retrospectively selected from the HEPAVIR-DAA and GEHEP-MONO real-life prospective cohorts if they fulfilled the following criteria: 1) Infected with genotype 1; 2) Treatment with SL8 or SL12; 3) Treatment naïve prior to receiving SL8 or SL12; 4) Absence of cirrhosis; 5) Baseline HCV RNA<6 × 10 IU/mL; 6) Reached the scheduled time-point for SVR (SVR12) assessment. SVR12 and relapse rates of HCV-monoinfected and HIV/HCV-coinfected patients were compared on an intention to treat basis. The responses with SL8 and SL12 were also compared.

Results: In the SL8 group, 107 (51%) HCV-monoinfected and 102 (49%) HIV/HCV-coinfected patients were included. One hundred and sixty-four (43%) HCV-monoinfected subjects and 220 (57%) HIV/HCV-coinfected patients received SL12. SVR12 rates for HIV/HCV-coinfected patients treated with SL8 vs SL12 were SVR12 92.2% vs. 97.3% (p = 0.044) and the respective relapse rates were 4.9% vs. 0.5% (p = 0.013). SVR12 rates for SL8 among HCV-monoinfected and HIV/HCV-coinfected patients were: 96.3% vs. 92.2% (p = 0.243), respectively. The corresponding relapse rates were 0.9% vs. 4.9% (p = 0.112).

Conclusion: HIV/HCV-coinfected patients reach high rates of SVR12 with SL8, although lower than with SL12, mainly due to a higher probability of relapse. SVR12 rates with SL8 are numerically lower and the proportion of relapses higher in HIV/HCVcoinfected patients than in HCV-monoinfected subjects.
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http://dx.doi.org/10.1016/j.jinf.2019.05.005DOI Listing
July 2019

[Prevalence of undiagnosed human immunodeficiency virus infection in an emergency department and the characteristics of newly diagnosed patients].

Emergencias 2016 10;28(5):313-319

Servicio de Urgencias, Hospital Universitario de La Princesa, Madrid, España.

Objectives: To estimate the prevalence of undiagnosed human immunodeficiency virus (HIV) infection detected by routine testing of patients seeking care in an emergency department and to describe the characteristics associated with new HIV-infection diagnosis.

Material And Methods: Walk-in patients between the ages of 15 and 75 years who required a blood test were included. Routine fourth-generation enzyme-linked immunoassays were performed to detect HIV infection in all samples extracted. Patients with positive results were referred to the infectious diseases department for monitoring and treatment.

Results: Blood samples for 1722 patients were analyzed. Twenty-one patients (1.2%) refused to allow their samples to be tested; 19 more samples (1.1%) could not be tested. The prevalence of undiagnosed HIV infection among the remaining 1682 remaining patients was 0.6% (95% CI, 0.23%-0.96%). The prevalence tended to be nonsignificantly higher among patients born outside Spain (0.97% [95% CI, 0.3%-2.20%]) and in 36-50-year-olds (1.46% [95% CI, 0.4%-2.5%]). Characteristics associated with undiagnosed HIV infection were male sex (odds ratio [OR], 5.78 [95% CI, 1.0-31.4]), presenting with a chief complaint that suggested infection (OR, 8.14 [95% CI, 1.6-41.4]), and a history of hepatitis (OR, 5.53 [95% CI, 1.1-27.7]).

Conclusion: The prevalence of undiagnosed HIV infection in our emergency department was high at 0.6%. The rate of patient acceptance of routine HIV testing was high. Strategies that target improving the detection of undiagnosed HIV infection are advisable.
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October 2016

HIV-coinfected patients respond worse to direct-acting antiviral-based therapy against chronic hepatitis C in real life than HCV-monoinfected individuals: a prospective cohort study.

HIV Clin Trials 2017 05;18(3):126-134

a Unit of Infectious Diseases and Microbiology , Hospital Universitario de Valme , Seville , Spain.

Objective: HIV/HCV-coinfected patients and hepatitis C virus (HCV) monoinfected subjects are thought to respond equally to direct-acting antiviral (DAA)-based therapy despite the lack of data derived from clinical trials. This study is aimed to evaluate the impact of HIV coinfection on the response to DAA-based treatment against HCV infection in the clinical practice.

Patients And Methods: In a prospective multicohort study, patients who initiated DAA-based therapy at the Infectious Disease Units of 33 hospitals throughout Spain were included. The primary efficacy outcome variables were the achievement of sustained virologic response 12 weeks after the scheduled end of therapy date (SVR12).

Results: A total of 908 individuals had reached the SVR12 evaluation time-point, 426 (46.9%) were HIV/HCV-coinfected, and 472 (52%) received interferon (IFN)-free therapy. In an intention-to-treat analysis, SVR12 rates in subjects with and without HIV-coinfection were 55.3% (94/170 patients) versus 67.3% (179/266 subjects; p = 0.012) for IFN-based treatment and 86.3% (221/256 subjects) versus 94.9% (205/216 patients, p = 0.002) for IFN-free regimens. Relapse after end-of-treatment response to IFN-free therapy was observed in 3/208 (1.4%) HCV-monoinfected subjects and 10/231 (4.4%) HIV/HCV-coinfected individuals (p = 0.075). In a multivariate analysis adjusted for age, sex, transmission route, body-mass index, HCV genotype, and cirrhosis, the absence of HIV-coinfection (adjusted odds ratio: 3.367; 95% confidence interval: 1.15-9.854; p = 0.027) was independently associated with SVR12 to IFN-free therapy.

Conclusions: HIV-coinfection is associated with worse response to DAA-based therapy against HCV infection. In patients receiving IFN-free therapy, this fact seems to be mainly driven by a higher rate of relapses among HIV-coinfected subjects.
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http://dx.doi.org/10.1080/15284336.2017.1330801DOI Listing
May 2017

Boceprevir or Telaprevir Based Triple Therapy against Chronic Hepatitis C in HIV Coinfection: Real-Life Safety and Efficacy.

PLoS One 2015 29;10(4):e0125080. Epub 2015 Apr 29.

Unit of Infectious Diseases and Microbiology, Valme University Hospital and Seville Institute of Biomedicine (IBiS), Seville, Spain; RIS-HEP07 Study Group of the Spanish AIDS Research Network.

Background And Aims: Clinical trials of therapy against chronic hepatitis C virus (HCV) infection including boceprevir (BOC) or telaprevir (TVR) plus pegylated interferon and ribavirin (PR) have reported considerably higher response rates than those achieved with PR alone. This study sought to evaluate the efficacy and safety of triple therapy including BOC or TVR in combination with PR in HIV/HCV-coinfected patients under real-life conditions.

Methods: In a multicentre study conducted in 24 sites throughout five European countries, all HIV/HCV-coinfected patients who initiated a combination of BOC or TVR plus PR and who had at least 60 weeks of follow-up, were analyzed. Sustained virologic response 12 weeks after the scheduled end of therapy date (SVR12) and the rate of discontinuations due to adverse events (AE) were evaluated.

Results: Of the 159 subjects included, 127 (79.9%) were male, 45 (34.4%) were treatment-naïve for PR and 60 (45.4%) showed cirrhosis. SVR12 was observed in 31/46 (67.4%) patients treated with BOC and 69/113 (61.1%) patients treated with TVR. Overall discontinuations due to AE rates were 8.7% for BOC and 8% for TVR. Grade 3 or 4 hematological abnormalities were frequently observed; anemia 7%, thrombocytopenia 17.2% and neutropenia 16.4%.

Conclusion: The efficacy and safety of triple therapy including BOC or TVR plus PR under real-life conditions of use in the HIV/HCV-coinfected population was similar to what is observed in clinical trials. Hematological side effects are frequent but manageable.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0125080PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4414348PMC
January 2016

[Barriers to ART initiation in HIV infected subjects and with treatment indication in Spain. Why don't they start their treatment? Bridgap Study].

Enferm Infecc Microbiol Clin 2015 Jun-Jul;33(6):397-403. Epub 2015 Jan 7.

Unidad de Enfermedades Infecciosas, Hospital de la Santa Creu i Sant Pau, Barcelona, España. Electronic address:

Introduction: In Spain, HIV treatment guidelines are well known and generally followed. However, in some patients there are no plans to initiate ART despite having treatment indications. The current barriers to ART initiation are presented.

Methods: A cross-sectional survey including every HIV infected patient in care in 19 hospitals across Spain in 2012, with ≥1 indication to start ART according to 2011 national treatment guidelines, who had not been scheduled for ART initiation. Reasons for deferring treatment were categorized as follows (non-exclusive categories): a) The physician thinks the indication is not absolute and prefers to defer it; b) The patient does not want to start it; c) The physician thinks ART must be started, but there is some limitation to starting it, and d) The patient has undetectable viral load in absence of ART.

Results: A total of 256 patients, out of 784 originally planned, were included. The large majority (84%) were male, median age 39 years, 57% MSM, 24% heterosexuals, and 16% IDUs. Median time since HIV diagnosis was 3 years, median CD4 count, 501 cells/mm3, median viral load 4.4 log copies/ml. Main ART indications were: CD4 count <500 cells/mm(3), 48%; having an uninfected sexual partner, 28%, and hepatitis C coinfection, 23%. Barriers due to, the physician, 55%; the patient, 28%; other limitations, 23%; and undetectable viral load, 6%.

Conclusions: The majority of subjects with ART indication were on it. The most frequent barriers among those who did not receive it were physician-related, suggesting that the relevance of the conditions that indicate ART may need reinforcing.
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http://dx.doi.org/10.1016/j.eimc.2014.06.012DOI Listing
March 2017

Impact of IL28B genotype on first-week response to telaprevir-based therapy in HIV-HCV coinfection.

Antivir Ther 2015 3;20(4):407-13. Epub 2014 Dec 3.

Unit of Infectious Diseases and Microbiology, Valme University Hospital, Seville, Spain.

Background: IL28B genotype predicts response to treatment against HCV with pegylated interferon/ribavirin (PR) and impacts on the outcome of therapy including telaprevir (TVR). This study aimed to determine the influence of the favourable IL28B genotype on early viral kinetics during therapy with TVR/PR in HIV-HCV-coinfected patients.

Methods: All HIV-HCV genotype 1 coinfected subjects who received TVR/PR for at least 4 weeks were included from populations prospectively followed in 22 centres throughout Germany, Switzerland and Spain.

Results: Of the 129 subjects included, 38 (29.5%) presented with IL28B genotype CC and 94 (72.9%) were treatment-experienced. A total of 96 (73.8%) patients showed undetectable plasma HCV RNA at treatment week (W)4: 30 (78.9%) of the IL28B-CC carriers and 65 (71.4%) of the non-CC carriers (P=0.377). Among treatment-naive patients, proportions of undetectable HCV RNA among IL28B-CC versus non-CC carriers were 8/9 (88.9%) versus 3/9 (33.3%; P=0.016) and 14/17 (82.4%) versus 11/18 (61.1%; P=0.164) at W2 and W4. The decrease of HCV RNA at W2 and W4 was similar among the IL28B carriers.

Conclusions: IL28B genotype does not predict W4 response to TVR/PR in HIV-HCV-coinfected patients, regardless of their treatment history. However, there is evidence of an impact on response during the first weeks in treatment-naive patients.
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http://dx.doi.org/10.3851/IMP2921DOI Listing
April 2016

[Pharmacokinetic interactions].

Enferm Infecc Microbiol Clin 2013 Jun;31 Suppl 2:12-9

Servicio de Medicina Interna, Unidad de Enfermedades Infecciosas, Hospital Universitario Miguel Servet, Zaragoza, España. Electronic address:

Rilpivirine (RPV) is a nonnucleoside reverse transcriptase inhibitor (NNRTI) that has been approved for use in treatment-naïve patients and which has potent antiviral activity. Its adverse effects profile differs from that of first-generation NNRTs. The pharmacological interactions produced by RPV are due to its effects on the CYP450 system; RPV is a substrate and mild inducer of CYP3A4. Moreover, in vitro, RPV inhibits glycoprotein-P. RPV has clinically significant pharmacological interactions, especially with protease inhibitors (except boosted darunavir and lopinavir) and the NNRTIs efavirenz and nevirapine. Coadministration of RPV with drugs that increase gastric pH, such as omeprazole, or those inducing CYP3A4, such as rifampicin, can significantly reduce RPV concentrations and is contraindicated. The concomitant use of RPV with a CYP3A4 inhibitor (such as clarithromycin) can increase RPV concentrations. Administration of PRV with food is recommended to obtain better absorption and adequate plasma values.
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http://dx.doi.org/10.1016/S0213-005X(13)70138-1DOI Listing
June 2013

[Neurosensory loss hearing of syphilitic etiology in a patient with human immunodeficiency virus infection].

Enferm Infecc Microbiol Clin 2014 May 16;32(5):336-7. Epub 2013 Oct 16.

Servicio de Medicina Interna: Sección de Enfermedades Infecciosas, Hospital Universitario de La Princesa, Madrid, España.

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http://dx.doi.org/10.1016/j.eimc.2013.07.018DOI Listing
May 2014

Benefits from sustained virologic response to pegylated interferon plus ribavirin in HIV/hepatitis C virus-coinfected patients with compensated cirrhosis.

Clin Infect Dis 2013 Jun 19;56(11):1646-53. Epub 2013 Feb 19.

Unidad de Enfermedades Infecciosas y Microbiología Clínica, Hospital Universitario de Valme, Avenida de Bellavista s/n, 41014 Sevilla, Spain.

Background: The objective of this study was to determine the impact of sustained virologic response (SVR) to pegylated interferon (peg-IFN) plus ribavirin (RBV) on the incidence of liver-related complications and overall mortality in human immunodeficiency virus (HIV)-infected patients with compensated hepatitis C virus (HCV)-related cirrhosis.

Methods: We included in this prospective cohort study 166 coinfected patients with compensated cirrhosis, who received peg-IFN plus RBV, to assess the time from the starting date of HCV therapy to the first hepatic decompensation and death due to any cause.

Results: SVR was observed in 43 (25%) individuals. Two (4.6%) patients with SVR developed liver decompensation vs 33 (26.8%) individuals without SVR (P = .002). The incidence of liver-related complications was 0.89 cases per 100 person-years (95% confidence interval [CI], .11-3.1) in SVR patients and 6.4 cases per 100 person-years (95% CI, 4.5-8.9) in non-SVR patients. Factors independently associated with liver decompensation were non-SVR (hazard ratio [HR], 8.1; 95% CI, 1.08-61.5; P = .042) and MELD score ≥9 at baseline (HR, 2.9; 95% CI, 1.2-7.2; P = .016). Two (4.6%) patients with SVR died due to any cause compared with 22 (17.9%) individuals without SVR (P = .02). MELD score ≥9 (HR, 3.1; 95% CI, 1.3-7.7; P = .011) and non-SVR (HR, 8.0; 95% CI, 1.07-61; P = .043) were independently associated with overall mortality.

Conclusions: The achievement of SVR following peg-IFN plus RBV markedly reduces the incidence of liver-related decompensation and the overall mortality in HIV/HCV-coinfected patients with compensated cirrhosis.
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http://dx.doi.org/10.1093/cid/cit103DOI Listing
June 2013

Response to pegylated interferon plus ribavirin among HIV/hepatitis C virus-coinfected patients with compensated liver cirrhosis.

Clin Infect Dis 2012 Dec 5;55(12):1719-26. Epub 2012 Sep 5.

Unidad de Enfermedades Infecciosas y Microbiología Clínica, Spain.

Background: The objective of this study was to determine the efficacy of pegylated interferon (peg-IFN) plus ribavirin (RBV) in human immunodeficiency virus (HIV)-infected patients with hepatitis C virus (HCV)-related compensated liver cirrhosis, as well as the predictors of response in these individuals.

Methods: All subjects enrolled in a prospective cohort of 841 HIV/HCV-coinfected patients who received peg-IFN and RBV and who had a liver biopsy or a liver stiffness measurement within the year before starting peg-IFN plus RBV were included in this study. The sustained virologic response (SVR) rate and predictors of SVR response were analyzed.

Results: A total of 629 patients were included in this study; 175 (28%) had cirrhosis. In an intention-to-treat analysis, 44 (25%) patients with cirrhosis and 177 (39%) without cirrhosis achieved SVR (P = .001). Among patients with cirrhosis, SVR was observed in 14%, 47%, and 30% of individuals with HCV genotypes 1, 2-3, and 4, respectively. Discontinuation of therapy owing to adverse events was observed in 30 (17%) individuals with cirrhosis and 37 (8%) subjects without cirrhosis (P = .001).

Conclusions: The efficacy of peg-IFN plus RBV among HIV/HCV-coinfected patients with cirrhosis is lower than in those without cirrhosis, although this antiviral combination still leads to a substantial rate of SVR in those carrying HCV genotype 3. A higher rate of discontinuations of HCV therapy due to adverse events among cirrhotic patients could partially explain the differences in the SVR rate between both populations.
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http://dx.doi.org/10.1093/cid/cis779DOI Listing
December 2012

Hepatitis C virus genotype 4 responds better to pegylated interferon with ribavirin than genotype 1 in HIV-infected patients.

AIDS 2012 Aug;26(13):1721-4

Unidad de Enfermedades Infecciosas y Microbiología Clínica, Hospital Universitario de Valme, Seville, Spain.

We assess the efficacy of pegylated interferon (peg-IFN) with ribavirin (RBV) and the predictors of sustained virological response (SVR) among HIV/hepatitis C virus genotype 4 (HCV-4)-coinfected patients. Thirty-nine (31.5%) of 124 individuals with HCV-4 achieved SVR compared with 103 (22.7%) of 453 individuals with HCV genotype 1 (P=0.046). Only interleukin-28B (IL28B) genotype CC was independently associated with SVR in HIV/HCV-4-coinfected patients. The efficacy of peg-IFN with RBV in coinfected individuals with genotype 4 is significantly higher than in those with genotype 1. IL28B CC genotype is the main predictor of response in this population.
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http://dx.doi.org/10.1097/QAD.0b013e3283568884DOI Listing
August 2012

Liver toxicity associated with antiretroviral therapy including efavirenz or ritonavir-boosted protease inhibitors in a cohort of HIV/hepatitis C virus co-infected patients.

J Antimicrob Chemother 2011 Nov 7;66(11):2605-14. Epub 2011 Sep 7.

Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain.

Objectives: To compare the frequency of grade 3 or 4 transaminase elevations (TEs) in HIV/hepatitis C virus (HCV) co-infected patients who started a three-antiretroviral drug regimen including efavirenz or a ritonavir-boosted protease inhibitor (PI/r) and the influence of pre-existing significant hepatic fibrosis or cirrhosis.

Patients And Methods: All pre-treated or treatment-naive HIV/HCV co-infected patients who started an antiretroviral regimen including two nucleos(t)ide reverse transcriptase inhibitors along with efavirenz or a PI/r in seven Spanish centres from January 2007 to December 2009 were included in this prospective study.

Results: Of 262 patients included in this study, 76 (29%) individuals began antiretroviral therapy (ART) including efavirenz and 186 (71%) a PI/r-based combination. The median (interquartile) follow-up was 14.0 (6.2-23.7) months. A total of 20 (7.6%) patients presented grade 3-4 TEs. Four (1.5%) subjects discontinued ART due to this adverse event. Grade 3-4 TEs were observed in 5 (6.6%) subjects receiving efavirenz and 15 (8.1%) treated with PI/r (P = 0.681). Three (6.5%) patients in the efavirenz group with significant fibrosis developed grade 3-4 TEs versus 2 (8.7%) without pre-existing significant fibrosis (P = 0.743). In the PI/r group, the corresponding figures were 10 (8.8%) and 5 (9.3%), respectively (P = 0.931).

Conclusions: The frequency of grade 3-4 TEs associated with efavirenz-based ART combinations under clinical practice conditions is low and similar to that found in patients receiving PI/r currently used in HIV/HCV co-infected patients. The baseline fibrosis stage does not have an impact on the development of TEs caused by these antiretroviral drugs in this population.
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http://dx.doi.org/10.1093/jac/dkr357DOI Listing
November 2011

[Etravirine in special populations].

Enferm Infecc Microbiol Clin 2009 Dec;27 Suppl 2:40-5

Hospital Universitario de la Princesa, Madrid, España.

The choice of antiretroviral treatment in comorbidities requires thorough knowledge of the interactions, pharmacokinetics and adverse effects of the drug to be used. Most drugs carry some risk in certain processes associated or not with HIV infection and drugs that can be used in these situations are of great interest. The development of etravirine, a new non-nucleoside reverse transcriptase inhibitor, will allow its use in these processes, with a lower risk of secondary effects and therefore of worsening the course of the disease and of treatment withdrawal. This is the case of patients coinfected with active hepatitis B and/or C virus and patients with a history of psychiatric disorders or receiving psychotropic drugs. The possible use of etravirine in women of fertile age is also of interest, due to the lower risk of teratogenicity if pregnancy occurs during treatment. Other collectives, such as patients with renal insufficiency or children and adolescents should not be forgotten; although these populations are less well studied, data are beginning to become available.
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http://dx.doi.org/10.1016/S0213-005X(09)73218-5DOI Listing
December 2009

Efficacy and safety of pegylated interferon plus ribavirin in HIV and hepatitis C virus-coinfected patients with advanced immunosuppression.

Clin Infect Dis 2009 Oct;49(8):e84-91

Unidad de Enfermedades Infecciosas, Servicio de Medicina Interna, Hospital Universitario de Valme, Hospital Universitario Virgen del Rocío, Sevilla, Spain.

Background: The aim of this study was to assess the efficacy and safety of pegylated interferon (IFN) plus ribavirin (RBV) in human immunodeficiency virus (HIV) and hepatitis C virus (HCV)-coinfected patients with severe immunodeficiency in a clinical cohort. BACKGROUND. A total of 542 HIV-infected patients receiving treatment with pegylated IFN plus RBV from June 2001 through April 2007 were included in this study. The outcome variables were sustained virologic response (SVR) rate and the emergence of AIDS-defining events during HCV infection therapy. SVR rates among patients with a CD4 cell count 250 cells/mm(3). The association between SVR and potential predictors was analyzed.

Results: Ten (26%) of 39 individuals with a baseline CD4 cell count 250 cells/mm(3) and 198 (39%) of 503 with baseline CD4 cell counts >or=250 CD4 cells/mm(3) achieved SVR (P = .09). In a nested case-control study with populations matched at a 1:2 ratio, the SVR rate was 26% in the CD4 cell count 250 cells/mm(3) group and 32% in the CD4 cell count >250 cells/mm(3) group (P = .5). Baseline CD4 cell count (250 cells/mm(3) vs >250 cells/mm(3)) was not associated with SVR in the multivariate analysis. Two (5%) individuals in the CD4 cell count 250 cells/mm(3) group experienced opportunistic events during follow-up. In the CD4 cell count 250 cells/mm(3) group, severe hematological toxicity and pegylated IFN or RBV dosage reductions occurred in 16 (41%) and 12 (31%) patients, respectively. In the CD4 cell count >250 cells/mm(3) group, severe hematological toxicity and pegylated IFN or RBV dosage reductions occurred in 29% (P = .1) and 20% (P = .1) of patients, respectively.

Conclusions: The efficacy of pegylated IFN plus RBV in HIV-HCV-coinfected patients with advanced immunosuppression is substantial and not significantly different to that observed in the overall coinfected population. HCV therapy is generally safe in the population of coinfected patients with advanced immunosuppression.
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http://dx.doi.org/10.1086/605677DOI Listing
October 2009

Insulin resistance is not a relevant predictor of sustained virological response to pegylated interferon plus ribavirin in HIV/HCV co-infected patients.

J Hepatol 2009 Apr 29;50(4):684-92. Epub 2008 Dec 29.

Unidad de Enfermedades Infecciosas, Servicio de Medicina Interna, Hospital Universitario de Valme, Sevilla, Spain.

Background/aims: To evaluate the possible influence of baseline insulin resistance in sustained virological response.

Methods: One hundred and fifty-five consecutive individuals from a multicentric cohort of HIV/HCV co-infected patients who underwent therapy with pegylated interferon plus ribavirin were included. The main outcome variable was sustained virological response, defined as undetectable plasma HCV RNA at week 24 after the end of the therapy. Insulin resistance was determined using the HOMA method.

Results: Sustained virological response was achieved in 55 (36%) patients. Forty-two (38%) patients with a HOMA lower than 4 developed sustained virological response vs 13 (29%) of those with a HOMA above 4 (p=0.27). Analyses restricted to patients harbouring genotype 1 or 4 showed similar rates of sustained virological response among patients with a HOMA below and above 4 [19 (27%) vs 7 (24%); p=0.8]. In the multivariate analysis, genotype 3 [AOR 9.26; 95% CI 3.03-28.30; p<0.0001], a baseline HCV viral load below 600.000IU/mL [AOR 2.97; 95% CI 1.03-8.57; p=0.04] and baseline LDL cholesterol above 100mg/dL [AOR 6.62; 95% CI 1.97-22.19; p=0.002] were independently associated with sustained virological response.

Conclusions: Insulin resistance is not a relevant predictor of sustained virological response to pegylated interferon plus ribavirin in HIV/HCV co-infected patients.
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http://dx.doi.org/10.1016/j.jhep.2008.10.032DOI Listing
April 2009

[Management of renal toxicity in HIV-positive patients. What to measure, how to measure it and how frequently].

Enferm Infecc Microbiol Clin 2008 Jun;26 Suppl 8:55-61

Servicio de Nefrología, Hospital Universitario de la Princesa, Madrid, España.

Chronic kidney disease in patients with HIV is being recognized as one of the most frequent comorbidities of this disease and consequently much research is currently being performed in this area. The possible manifestations are highly varied and consequently a high index of suspicion is required. Appropriate investigations should be performed from the moment patients first seek care to rule out renal disease and to prevent worsening, with the diagnostic or therapeutic measures that may subsequently be required. One of the most common problems is nephrotoxicity caused by some drugs and cases associated with tenofovir are becoming more frequently described. However, there is wide clinical experience with this drug and renal toxicity associated with its use is uncommon both in clinical trials and in clinical practice. Familiarity with what may happen, the associated factors and appropriate patient management are essential.
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http://dx.doi.org/10.1157/13126272DOI Listing
June 2008

Efficacy of pegylated interferon plus ribavirin treatment in HIV/hepatitis C virus co-infected patients receiving abacavir plus lamivudine or tenofovir plus either lamivudine or emtricitabine as nucleoside analogue backbone.

J Antimicrob Chemother 2008 Dec 13;62(6):1365-73. Epub 2008 Oct 13.

Unidad de Enfermedades Infecciosas, Hospital Universitario de Valme, Sevilla, Spain.

Objectives: To compare the response to hepatitis C virus (HCV) therapy among human immunodeficiency virus (HIV)/HCV co-infected patients receiving a nucleos(t)ide reverse transcriptase inhibitor [N(t)RTI] backbone consisting of abacavir plus lamivudine with that observed in subjects who receive tenofovir plus lamivudine or emtricitabine.

Methods: A total of 256 subjects, enrolled in a cohort of 948 HIV-infected patients who received pegylated interferon and ribavirin from October 2001 to January 2006, were included in this study. All patients were taking one protease inhibitor or one non-nucleoside reverse transcriptase inhibitor and abacavir plus lamivudine or tenofovir plus lamivudine or emtricitabine as N(t)RTI backbone during HCV therapy. Sustained virological response (SVR) rates in both backbone groups were compared.

Results: In an intention-to-treat analysis, 20 out of 70 (29%) individuals under abacavir and 83 out of 186 (45%) under tenofovir showed SVR (P = 0.02). N(t)RTI backbone containing tenofovir was an independent predictor of SVR in the multivariate analysis [adjusted odds ratio (95% CI), 2.6 (1.05-6.9); P = 0.03]. The association between abacavir use and lower SVR was chiefly seen in patients with plasma HCV-RNA load higher than 600 000 IU/mL and genotype 1 or 4. Among patients treated with ribavirin dose <13.2 mg/kg/day, 3 (20%) of those under abacavir versus 22 (52%) under tenofovir reached SVR (P = 0.03), whereas the rates were 31% and 38% (P = 0.4), respectively, in those receiving >/=13.2 mg/kg/day.

Conclusions: HIV-infected patients who receive abacavir plus lamivudine respond worse to pegylated interferon plus ribavirin than those who are given tenofovir plus lamivudine or emtricitabine as N(t)RTI backbone, especially in those receiving lower ribavirin doses.
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http://dx.doi.org/10.1093/jac/dkn420DOI Listing
December 2008

Influence of concomitant antiretroviral therapy on the rate of sustained virological response to pegylated interferon plus ribavirin in hepatitis C virus/HIV-coinfected patients.

J Antimicrob Chemother 2007 Dec 14;60(6):1347-54. Epub 2007 Oct 14.

Unidad de Enfermedades Infecciosas, Hospital Universitario de Valme, Sevilla, Spain.

Objectives: To investigate whether concomitant antiretroviral therapy (ART) is a predictor of sustained virological response (SVR) in human immunodeficiency virus (HIV)/hepatitis C virus (HCV)-coinfected patients treated with pegylated interferon plus ribavirin.

Methods: Three hundred and ten HIV/HCV-coinfected patients on pegylated interferon plus ribavirin treatment, 258 of them with concurrent ART, were included in this retrospective multicentre study. The predictors of SVR were evaluated.

Results: SVR was shown by 114 (37%) subjects. HCV genotype 2 or 3, plasma HCV-RNA load lower than 600 000 IU/mL, an exposure to the therapy against HCV infection > or =80% of the planned dose and baseline CD4 cell counts higher than or equal to 300/mm(3) were predictors of SVR. Likewise, patients without ART and those receiving a combination including tenofovir or stavudine plus lamivudine plus a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI) showed a higher SVR rate than the subjects who were on other ART strategies at baseline [44%, 44% and 29%, respectively; adjusted odd ratio (95% CI) for no ART = 1.96 (1.07-4.76), P = 0.025, and for ART including tenofovir or stavudine plus lamivudine plus a PI or a NNRTI = 2.08 (1.16-3.70), P = 0.014].

Conclusions: The ART strategy on starting therapy with pegylated interferon plus ribavirin is a predictor of SVR in HIV/HCV-coinfected patients. Subjects without ART and those receiving combinations of a PI or a NNRTI with a nucleos(t)ide backbone of tenofovir or stavudine plus lamivudine respond better than those who receive other regimens.
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http://dx.doi.org/10.1093/jac/dkm373DOI Listing
December 2007

[Spanish cohort of naïve HIV-infected patients (CoRIS): rationale, organization and initial results].

Enferm Infecc Microbiol Clin 2007 Jan;25(1):23-31

Centro Nacional de Epidemiología, Instituto de Salud Carlos III, Madrid, Spain.

Objective: To describe the methodology and baseline results of the Spanish cohort of naïve HIV-infected patients included in the Research Network on HIV/AIDS (CoRIS).

Methods: CoRIS is a multicenter, hospital-based prospective cohort of HIV sero-prevalent, retroviral-naïve subjects, over 13 years old, and seen at 17 hospitals in 8 of the 17 Autonomous Regions in Spain from January 2004 to October 2005. The socio-demographic characteristics, as well as epidemiological, clinical, laboratory and treatment data were recorded, and biological samples were collected at baseline and during follow-up.

Results: A total of 1,591 subjects have been included in CoRIS; 24% are women, median age at cohort entry is 36 years, and 74% were diagnosed during 2004 or 2005. Twenty-seven percent came from countries other than Spain, mainly Latin-America (16%) and sub-Saharan Africa (5%). Thirty-two percent had completed secondary education and 16% university studies. The most frequent categories of transmission were men having sex with men (37%) and heterosexual sex (36%); only 21% were injection drug users. At cohort entry, median CD4 count was 317 cells/mm 3 and median viral load was 52,300 copies/mL; 18% were diagnosed with AIDS. Main AIDS-defining illnesses were Pneumocystis jiroveci pneumonia (6.1%), esophageal candidiasis (3.3%) and tuberculosis (extrapulmonary, 3.0% and pulmonary 2.7%). There were 35 deaths (2.2%). Thirty-three percent of patients gave a baseline sample to the BioBank.

Conclusions: CoRIS offers relevant information about the current epidemiological profile of HIV infection in Spain, where sexual transmission has become predominant. The type and amount of information obtained from clinical and epidemiological data collection together with biological samples demonstrate the viability of the project, which offers many possibilities for future research.
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http://dx.doi.org/10.1157/13096749DOI Listing
January 2007
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