Pub Date : 2017-02-17DOI: 10.1080/15284336.2017.1287536
J. Davila, C. Hartman, Jeffrey A. Cully, M. Stanley, K. Amico, E. Soriano, Sophie G. Minick, S. May, T. Giordano
Background: The hospital setting provides an opportunity to re-engage people living with HIV (PLWH) in HIV care. We developed and implemented a protocol to identify PLWH in a hospital setting. The aim of the current study was to report on our strategy to recruit hospitalized HIV patients into an intervention study, and to report on lessons learned for future studies. Methods: Our protocol was developed based on experience of our research staff in recruiting HIV patients as well as clinical input from providers and administrators on delivering care in hospitalized settings. We identified hospitalized PLWH between 2010 and 2013 who were potentially eligible for an intervention study. Patients were identified by review of electronic medical records and clinician referral, followed by in-person screening to confirm eligibility. We examined factors related to identifying and enrolling hospitalized patients, and documented lessons learned. Results: Key strategies included systematic medical record review followed by in-person screening, collaboration with staff, and flexibility in recruitment logistics. We identified 1801 PLWH hospitalized during the 3-year study period. Eighty-four percent (n = 1514) met the met the inclusion criteria based on medical record review. Of these, 48% (n = 733) were ineligible. Among eligible patients, 59% (n = 460) were enrolled. Only 3% (n = 23) of eligible patients declined; 84% (n = 321) were not enrolled because they were discharged before enrollment. Lessons learned included (1) needing to identify patients and deliver the intervention before hospital discharge, (2) limiting the complexity of the intervention, and (3) having research staff available on weekends and after hours. Conclusions: Targeted recruitment of hospitalized populations is a feasible and productive approach for finding and engaging PLWH who are newly diagnosed or out of routine care.
{"title":"Feasibility of identifying out of care HIV-positive patients in a hospital setting and enrolling them in a retention intervention","authors":"J. Davila, C. Hartman, Jeffrey A. Cully, M. Stanley, K. Amico, E. Soriano, Sophie G. Minick, S. May, T. Giordano","doi":"10.1080/15284336.2017.1287536","DOIUrl":"https://doi.org/10.1080/15284336.2017.1287536","url":null,"abstract":"Background: The hospital setting provides an opportunity to re-engage people living with HIV (PLWH) in HIV care. We developed and implemented a protocol to identify PLWH in a hospital setting. The aim of the current study was to report on our strategy to recruit hospitalized HIV patients into an intervention study, and to report on lessons learned for future studies. Methods: Our protocol was developed based on experience of our research staff in recruiting HIV patients as well as clinical input from providers and administrators on delivering care in hospitalized settings. We identified hospitalized PLWH between 2010 and 2013 who were potentially eligible for an intervention study. Patients were identified by review of electronic medical records and clinician referral, followed by in-person screening to confirm eligibility. We examined factors related to identifying and enrolling hospitalized patients, and documented lessons learned. Results: Key strategies included systematic medical record review followed by in-person screening, collaboration with staff, and flexibility in recruitment logistics. We identified 1801 PLWH hospitalized during the 3-year study period. Eighty-four percent (n = 1514) met the met the inclusion criteria based on medical record review. Of these, 48% (n = 733) were ineligible. Among eligible patients, 59% (n = 460) were enrolled. Only 3% (n = 23) of eligible patients declined; 84% (n = 321) were not enrolled because they were discharged before enrollment. Lessons learned included (1) needing to identify patients and deliver the intervention before hospital discharge, (2) limiting the complexity of the intervention, and (3) having research staff available on weekends and after hours. Conclusions: Targeted recruitment of hospitalized populations is a feasible and productive approach for finding and engaging PLWH who are newly diagnosed or out of routine care.","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"18 1","pages":"75 - 82"},"PeriodicalIF":0.0,"publicationDate":"2017-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15284336.2017.1287536","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48585213","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-01-30DOI: 10.1080/15284336.2017.1282578
M. Karris, Sonia Jain, Tyler R. C. Day, Josué Pérez-Santiago, M. Goicoechea, M. Dubé, Xiaoying Sun, C. Spina, E. Daar, R. Haubrich, Sheldon Morris
Background: Nucleos(t)ide reverse transcriptase inhibitor (NRTI)-sparing regimens may potentially minimize antiretroviral (ART) toxicities, but demonstrate mixed efficacy and toxicity results. The impact of an integrase strand transfer inhibitor (INSTI) and protease inhibitor (PI) regimen on HIV viral dynamics and T cell kinetics remains underdescribed. Objective: To compare the effect of raltegravir + ritonavir boosted lopinavir (RAL + LPV/r) to efavirenz/tenofovir disoproxil fumarate/emtricitabine (EFV/TDF/FTC) on HIV kinetics and T cell dynamics. Methods: Fifty participants naïve to ART underwent HIV viral kinetic sampling evaluated using biexponential mixed effects modeling. A subset of 28 subjects (with complete viral suppression) underwent flow cytometry and evaluation of soluble markers of inflammation at weeks 0, 4, and 48 of ART. Results: RAL + LPV/r compared to EFV/TDF/FTC resulted in a prolonged first phase viral decay rate (18 vs. 13 days p < 0.01). From weeks 0 to 4, RAL + LPV/r was associated with a trend toward greater decreases in activated CD4+ T cells (−3.81 vs. −1.18 p = 0.09) and less decreases in activated effector memory CD4+ T cells (−0.63 vs. −2.69 p-0.07). These trends did not persist to week 48. No differences were noted at any time point for soluble markers of immune activation. Conclusions: The prolonged first phase viral decay observed with RAL + LPV/r in persons starting ART did not result in differences in viral suppression at week 48. We also observed trends in declines in certain cellular markers of immune activation but it remains unclear if this could translate to long-term immunologic benefits in persons on an INSTI + PI.
{"title":"HIV viral kinetics and T cell dynamics in antiretroviral naïve persons starting an integrase strand transfer inhibitor and protease inhibitor regimen","authors":"M. Karris, Sonia Jain, Tyler R. C. Day, Josué Pérez-Santiago, M. Goicoechea, M. Dubé, Xiaoying Sun, C. Spina, E. Daar, R. Haubrich, Sheldon Morris","doi":"10.1080/15284336.2017.1282578","DOIUrl":"https://doi.org/10.1080/15284336.2017.1282578","url":null,"abstract":"Background: Nucleos(t)ide reverse transcriptase inhibitor (NRTI)-sparing regimens may potentially minimize antiretroviral (ART) toxicities, but demonstrate mixed efficacy and toxicity results. The impact of an integrase strand transfer inhibitor (INSTI) and protease inhibitor (PI) regimen on HIV viral dynamics and T cell kinetics remains underdescribed. Objective: To compare the effect of raltegravir + ritonavir boosted lopinavir (RAL + LPV/r) to efavirenz/tenofovir disoproxil fumarate/emtricitabine (EFV/TDF/FTC) on HIV kinetics and T cell dynamics. Methods: Fifty participants naïve to ART underwent HIV viral kinetic sampling evaluated using biexponential mixed effects modeling. A subset of 28 subjects (with complete viral suppression) underwent flow cytometry and evaluation of soluble markers of inflammation at weeks 0, 4, and 48 of ART. Results: RAL + LPV/r compared to EFV/TDF/FTC resulted in a prolonged first phase viral decay rate (18 vs. 13 days p < 0.01). From weeks 0 to 4, RAL + LPV/r was associated with a trend toward greater decreases in activated CD4+ T cells (−3.81 vs. −1.18 p = 0.09) and less decreases in activated effector memory CD4+ T cells (−0.63 vs. −2.69 p-0.07). These trends did not persist to week 48. No differences were noted at any time point for soluble markers of immune activation. Conclusions: The prolonged first phase viral decay observed with RAL + LPV/r in persons starting ART did not result in differences in viral suppression at week 48. We also observed trends in declines in certain cellular markers of immune activation but it remains unclear if this could translate to long-term immunologic benefits in persons on an INSTI + PI.","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"18 1","pages":"67 - 74"},"PeriodicalIF":0.0,"publicationDate":"2017-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15284336.2017.1282578","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44473288","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-01-12DOI: 10.1080/15284336.2016.1275425
M. Saumoy, J. Tiraboschi, J. Ordóñez‐Llanos, E. Ribera, P. Domingo, J. Mallolas, J. Curto, J. Gatell, D. Podzamczer
Background: The objective of this study was to determine the impact of tenofovir or abacavir discontinuation on low-density lipoprotein (LDL) phenotype and lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in HIV-infected patients treated with lopinavir/ritonavir plus 2 nucleos(t)ide reverse transcriptase inhibitors (NRTI). Methods: Multicenter, open-label study. Patients were randomized to continue with lopinavir/ritonavir plus 2 NRTI (triple therapy) or to switch to lopinavir/ritonavir plus lamivudine (dual therapy). LDL phenotype (by gradient gel electrophoresis) and Lp-PLA2 (by 2-thio-PAF) were determined at baseline and week 48. Results: Forty-four patients included (triple therapy n = 19, dual therapy n = 25): men 63.6%, age 41.5 years (25–61), Framingham score 4.9% (0.2–22). Tenofovir was part of the regimen in 28 (63.6%) patients. Dual therapy patients were younger (p = 0.013) and had lower baseline apolipoprotein A1 (p = 0.029). At week 48, there were no changes in standard lipid measurements, except ApoA1/Apo B, which increased in dual therapy (p = 0.038) with no differences between arms. At week 48, no change in LDL phenotype was found in either arm. No changes in total Lp-PLA2 activity or the relative distribution of LDL and HDL particles were found at week 48 in either arm. Conclusions: Discontinuing the third nucleos(t)ide, mainly tenofovir and abacavir, in a lopinavir/ritonavir-containing regimen was not associated with a deleterious effect on LDL phenotype nor in Lp-PLA2 activity.
{"title":"Atherogenic properties of LDL particles after switching from Truvada or Kivexa plus lopinavir/r to lamivudine plus lopinavir/r: OLE-MET substudy","authors":"M. Saumoy, J. Tiraboschi, J. Ordóñez‐Llanos, E. Ribera, P. Domingo, J. Mallolas, J. Curto, J. Gatell, D. Podzamczer","doi":"10.1080/15284336.2016.1275425","DOIUrl":"https://doi.org/10.1080/15284336.2016.1275425","url":null,"abstract":"Background: The objective of this study was to determine the impact of tenofovir or abacavir discontinuation on low-density lipoprotein (LDL) phenotype and lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in HIV-infected patients treated with lopinavir/ritonavir plus 2 nucleos(t)ide reverse transcriptase inhibitors (NRTI). Methods: Multicenter, open-label study. Patients were randomized to continue with lopinavir/ritonavir plus 2 NRTI (triple therapy) or to switch to lopinavir/ritonavir plus lamivudine (dual therapy). LDL phenotype (by gradient gel electrophoresis) and Lp-PLA2 (by 2-thio-PAF) were determined at baseline and week 48. Results: Forty-four patients included (triple therapy n = 19, dual therapy n = 25): men 63.6%, age 41.5 years (25–61), Framingham score 4.9% (0.2–22). Tenofovir was part of the regimen in 28 (63.6%) patients. Dual therapy patients were younger (p = 0.013) and had lower baseline apolipoprotein A1 (p = 0.029). At week 48, there were no changes in standard lipid measurements, except ApoA1/Apo B, which increased in dual therapy (p = 0.038) with no differences between arms. At week 48, no change in LDL phenotype was found in either arm. No changes in total Lp-PLA2 activity or the relative distribution of LDL and HDL particles were found at week 48 in either arm. Conclusions: Discontinuing the third nucleos(t)ide, mainly tenofovir and abacavir, in a lopinavir/ritonavir-containing regimen was not associated with a deleterious effect on LDL phenotype nor in Lp-PLA2 activity.","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"18 1","pages":"49 - 53"},"PeriodicalIF":0.0,"publicationDate":"2017-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15284336.2016.1275425","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47899066","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-01-09DOI: 10.1080/15284336.2016.1276312
M. Floridia, G. Masuelli, E. Tamburrini, A. Spinillo, G. Simonazzi, G. Guaraldi, A. D. Degli Antoni, P. Martinelli, V. Portelli, S. Dalzero, M. Ravizza
Objective: To evaluate the impact of Hepatitis B virus (HBV) coinfection on response to antiretroviral treatment in pregnant women with HIV. Methods: Retrospective analysis of a large case series of pregnant women with HIV in Italy; outcome measures were CD4 changes, HIV viral load, and main pregnancy outcomes (preterm delivery, low birthweight, intrauterine growth restriction, mode of delivery, and major birth defects). Results: Rate of HBV coinfection among 1462 pregnancies was 12.0%. Compared to the HBV-uninfected, HBV-coinfected women had a significantly lower median CD4 cell gain between first and third trimester (26.5 vs. 60 cells/mm3, p = 0.034), with similar rate of undetectable (<50 copies/ml) HIV-RNA at third trimester (70.5% vs. 65.2%, p = 0.229), and no differences in all the main maternal and infant outcomes. A multivariable linear regression analysis identified four variables significantly and independently associated with a lower CD4 response in pregnancy: HBV coinfection (–35 cells/mm3), being on antiretroviral treatment at conception (–59.7 cells/mm3), AIDS status (–59.8 cells/mm3) and higher first CD4 levels in pregnancy (–0.24 cells per unitary CD4 increase). Conclusions: HBV coinfection had no adverse influence on the main pregnancy outcomes or on HIV viral load suppression in late pregnancy but was associated with a significantly reduced CD4 response in pregnancy. This effect might have clinical relevance, particularly in women with advanced immune deterioration.
目的:评价乙型肝炎病毒(HBV)合并感染对HIV孕妇抗逆转录病毒治疗疗效的影响。方法:对意大利一大批HIV感染孕妇进行回顾性分析;结果测量是CD4变化、HIV病毒载量和主要妊娠结局(早产、低出生体重、宫内生长受限、分娩方式和主要出生缺陷)。结果:1462例妊娠中HBV合并感染率为12.0%。与未感染乙肝病毒的妇女相比，合并感染乙肝病毒的妇女在妊娠早期和晚期的CD4细胞增加中位数显著降低(26.5 vs. 60个细胞/mm3, p = 0.034)，在妊娠晚期的HIV-RNA检测不到率相似(<50拷贝/ml) (70.5% vs. 65.2%， p = 0.229)，并且在所有主要的母婴结局中没有差异。一项多变量线性回归分析确定了与妊娠期较低CD4应答显著且独立相关的四个变量:HBV合并感染(-35个细胞/mm3)、妊娠期接受抗逆转录病毒治疗(-59.7个细胞/mm3)、艾滋病状态(-59.8个细胞/mm3)和妊娠期较高的首次CD4水平(每单位CD4增加-0.24个细胞)。结论:HBV合并感染对妊娠后期的主要妊娠结局或HIV病毒载量抑制无不良影响，但与妊娠期CD4应答显著降低相关。这种效果可能具有临床意义，特别是对晚期免疫功能恶化的妇女。
{"title":"HBV coinfection is associated with reduced CD4 response to antiretroviral treatment in pregnancy","authors":"M. Floridia, G. Masuelli, E. Tamburrini, A. Spinillo, G. Simonazzi, G. Guaraldi, A. D. Degli Antoni, P. Martinelli, V. Portelli, S. Dalzero, M. Ravizza","doi":"10.1080/15284336.2016.1276312","DOIUrl":"https://doi.org/10.1080/15284336.2016.1276312","url":null,"abstract":"Objective: To evaluate the impact of Hepatitis B virus (HBV) coinfection on response to antiretroviral treatment in pregnant women with HIV. Methods: Retrospective analysis of a large case series of pregnant women with HIV in Italy; outcome measures were CD4 changes, HIV viral load, and main pregnancy outcomes (preterm delivery, low birthweight, intrauterine growth restriction, mode of delivery, and major birth defects). Results: Rate of HBV coinfection among 1462 pregnancies was 12.0%. Compared to the HBV-uninfected, HBV-coinfected women had a significantly lower median CD4 cell gain between first and third trimester (26.5 vs. 60 cells/mm3, p = 0.034), with similar rate of undetectable (<50 copies/ml) HIV-RNA at third trimester (70.5% vs. 65.2%, p = 0.229), and no differences in all the main maternal and infant outcomes. A multivariable linear regression analysis identified four variables significantly and independently associated with a lower CD4 response in pregnancy: HBV coinfection (–35 cells/mm3), being on antiretroviral treatment at conception (–59.7 cells/mm3), AIDS status (–59.8 cells/mm3) and higher first CD4 levels in pregnancy (–0.24 cells per unitary CD4 increase). Conclusions: HBV coinfection had no adverse influence on the main pregnancy outcomes or on HIV viral load suppression in late pregnancy but was associated with a significantly reduced CD4 response in pregnancy. This effect might have clinical relevance, particularly in women with advanced immune deterioration.","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"18 1","pages":"54 - 59"},"PeriodicalIF":0.0,"publicationDate":"2017-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15284336.2016.1276312","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48921518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-01-02DOI: 10.1080/15284336.2016.1261073
Hannah Ewald, Marília Santini-Oliveira, Julian-Emanuel Bühler, D. Vuichard, S. Schandelmaier, M. Stöckle, M. Briel, H. Bucher, L. Hemkens
Background: Antiretroviral therapy (ART) regimens for HIV infection are frequently changed. We conducted a systematic review of randomized trials (RCTs) on the benefits and harms of switching to tenofovir disoproxil fumarate (TDF)-based regimens in ART-experienced patients. Methods: We included RCTs in HIV-infected adults comparing switching to a TDF-containing regimen with maintaining or switching to another regimen. We searched MEDLINE, EMBASE, CENTRAL, LILACS, SCI, and the WHO Global Health Library. We assessed bias with the Cochrane tool and synthesized data using random-effects meta-analyses and Peto’s approach. For further analyses, we added data from a previous systematic review in treatment-naïve patients. Results: 17 RCTs with 2210 patients were included. All but one study had a high risk of bias. There was no significant association of switching to TDF-based regimens with mortality, fractures, CD4-cell count, body fat, virological failure, LDL-, and HDL-cholesterol. TDF-based regimens decreased total cholesterol (mean difference −12.05 mg/dL; 95% CI −20.76 to −3.34), trigylcerides (−14.33 mg/dL; −23.73 to −4.93), and bone mineral density (BMD; hip: −2.46%; −3.9 to −1.03; lumbar spine −1.52%; −2.69 to −0.34). Effects on estimated glomerular filtration (eGFR) were inconsistent and depended on the measurement. Adding 22 RCTs from 8297 treatment-naïve patients gave consistent results with then significant reductions of LDL (−7.57 mg/dL; −10.37 to −4.78), HDL (−2.38 mg/dL; −3.83 to −0.93), and eGFR (−3.49 ml/min; −5.56 to −1.43). Conclusions: Switching to TDF-based regimens is associated with reductions of BMD and lipid levels and possibly lowered kidney function. The evidence is limited by the high risk of bias.
{"title":"Comparative effectiveness of tenofovir in HIV-infected treatment-experienced patients: systematic review and meta-analysis","authors":"Hannah Ewald, Marília Santini-Oliveira, Julian-Emanuel Bühler, D. Vuichard, S. Schandelmaier, M. Stöckle, M. Briel, H. Bucher, L. Hemkens","doi":"10.1080/15284336.2016.1261073","DOIUrl":"https://doi.org/10.1080/15284336.2016.1261073","url":null,"abstract":"Background: Antiretroviral therapy (ART) regimens for HIV infection are frequently changed. We conducted a systematic review of randomized trials (RCTs) on the benefits and harms of switching to tenofovir disoproxil fumarate (TDF)-based regimens in ART-experienced patients. Methods: We included RCTs in HIV-infected adults comparing switching to a TDF-containing regimen with maintaining or switching to another regimen. We searched MEDLINE, EMBASE, CENTRAL, LILACS, SCI, and the WHO Global Health Library. We assessed bias with the Cochrane tool and synthesized data using random-effects meta-analyses and Peto’s approach. For further analyses, we added data from a previous systematic review in treatment-naïve patients. Results: 17 RCTs with 2210 patients were included. All but one study had a high risk of bias. There was no significant association of switching to TDF-based regimens with mortality, fractures, CD4-cell count, body fat, virological failure, LDL-, and HDL-cholesterol. TDF-based regimens decreased total cholesterol (mean difference −12.05 mg/dL; 95% CI −20.76 to −3.34), trigylcerides (−14.33 mg/dL; −23.73 to −4.93), and bone mineral density (BMD; hip: −2.46%; −3.9 to −1.03; lumbar spine −1.52%; −2.69 to −0.34). Effects on estimated glomerular filtration (eGFR) were inconsistent and depended on the measurement. Adding 22 RCTs from 8297 treatment-naïve patients gave consistent results with then significant reductions of LDL (−7.57 mg/dL; −10.37 to −4.78), HDL (−2.38 mg/dL; −3.83 to −0.93), and eGFR (−3.49 ml/min; −5.56 to −1.43). Conclusions: Switching to TDF-based regimens is associated with reductions of BMD and lipid levels and possibly lowered kidney function. The evidence is limited by the high risk of bias.","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"18 1","pages":"17 - 27"},"PeriodicalIF":0.0,"publicationDate":"2017-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15284336.2016.1261073","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46407140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-01-02DOI: 10.1080/15284336.2016.1266074
D. Tan, J. Raboud, L. Szadkowski, É. Szabó, Hanxian Hu, Q. Wong, A. Cheung, S. Walmsley
Background: HIV-infected adults have increased fracture risk. Objectives: To generate pilot data comparing bone density, structure, and strength between HIV-infected adults with and without a prior fracture. Methods: Adults with and without a prior fracture after their HIV diagnosis were matched 1:1 based on age, sex, race, and smoking history. Participants underwent dual-energy X-ray absorptiometry (DXA), trabecular bone score (TBS), hip structural analyses (HSA), vertebral fracture assessment (VFA), high-resolution peripheral quantitative tomography (HR-pQCT) and measurement of bone turnover markers. Results were compared between cases and controls, with differences expressed as percentages of control group values. Results: 23 pairs were included. On DXA, cases had lower areal bone mineral density (aBMD) at the total hip (median difference in T-score −0.25, p = 0.04), but not the lumbar spine (median difference in T-score 0.10, p = 0.68). Cases had greater abnormalities in HSA and most HR-pQCT and HSA measures, by up to 15%. VFA revealed two subclinical fractures among cases but none among controls. TBS, CTX, and P1NP levels were similar between groups, with differences of 1.9% (p = 0.90), 9.7% (p = 0.55), and 10.0% (p = 0.24), respectively. For each parameter, we report the median and interquartile range for the absolute and relative difference between cases and controls, the correlation between cases and controls, and our recruitment rates, to inform the design of future studies. Conclusions: These pilot data suggest potential differences in bone structure, estimated bone strength, and asymptomatic vertebral fractures among HIV-infected adults with and without fracture, warranting further study as markers of fracture risk in HIV.
{"title":"Novel imaging modalities for the comparison of bone microarchitecture among HIV+ patients with and without fractures: a pilot study","authors":"D. Tan, J. Raboud, L. Szadkowski, É. Szabó, Hanxian Hu, Q. Wong, A. Cheung, S. Walmsley","doi":"10.1080/15284336.2016.1266074","DOIUrl":"https://doi.org/10.1080/15284336.2016.1266074","url":null,"abstract":"Background: HIV-infected adults have increased fracture risk. Objectives: To generate pilot data comparing bone density, structure, and strength between HIV-infected adults with and without a prior fracture. Methods: Adults with and without a prior fracture after their HIV diagnosis were matched 1:1 based on age, sex, race, and smoking history. Participants underwent dual-energy X-ray absorptiometry (DXA), trabecular bone score (TBS), hip structural analyses (HSA), vertebral fracture assessment (VFA), high-resolution peripheral quantitative tomography (HR-pQCT) and measurement of bone turnover markers. Results were compared between cases and controls, with differences expressed as percentages of control group values. Results: 23 pairs were included. On DXA, cases had lower areal bone mineral density (aBMD) at the total hip (median difference in T-score −0.25, p = 0.04), but not the lumbar spine (median difference in T-score 0.10, p = 0.68). Cases had greater abnormalities in HSA and most HR-pQCT and HSA measures, by up to 15%. VFA revealed two subclinical fractures among cases but none among controls. TBS, CTX, and P1NP levels were similar between groups, with differences of 1.9% (p = 0.90), 9.7% (p = 0.55), and 10.0% (p = 0.24), respectively. For each parameter, we report the median and interquartile range for the absolute and relative difference between cases and controls, the correlation between cases and controls, and our recruitment rates, to inform the design of future studies. Conclusions: These pilot data suggest potential differences in bone structure, estimated bone strength, and asymptomatic vertebral fractures among HIV-infected adults with and without fracture, warranting further study as markers of fracture risk in HIV.","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"18 1","pages":"28 - 38"},"PeriodicalIF":0.0,"publicationDate":"2017-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15284336.2016.1266074","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43285071","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-01-02DOI: 10.1080/15284336.2016.1251030
B. Spire, L. Nait-Ighil, P. Puglièse, I. Poizot-Martin, V. Jullien, A. Marcelin, E. Billaud
Background: Good efficacy and safety of raltegravir in person living with HIV was demonstrated in clinical trials over five years, but real-life data, particularly about quality of life (QoL), are lacking. QoL was evaluated over time in adult patients first treated or switched to regimens containing raltegravir in an observational cohort study. Methods: Patient QoL was evaluated using the Fatigue Impact Scale (FIS) and the HIV Symptom Index (HSI). Data were collected at baseline and at 1, 3, 6, 12, 18, and 24 months. Baseline FIS and HSI subscores were compared with the scores at each visit using the paired Wilcoxon test. The impact of time, sociodemographic and medical variables upon patient-perceived fatigue and symptoms was also assessed using mixed multivariate models. Results: From baseline, all FIS and HSI subscores improved significantly after one month of treatment. In addition, psychosocial FIS subscores and both the frequency of bothersome symptoms and HSI subscores improved significantly at each visit. Physical FIS subscores also improved significantly, except at month 18, whereas both cognitive and total FIS subscores improved only after 6 months and 24 months, respectively. In multivariate analysis, employment was independently associated over time with improved improvement in both FIS and HSI subscores. Conclusion: Patient QoL improved significantly over a 24-month period of treatment with a raltegravir-containing regimen. FIS and HSI are sensitive tools to measure the impact of new antiretroviral combinations on a patient’s perception of QoL.
{"title":"Quality of life improvement in HIV-1 patients treated with raltegravir in a real-life observational study: RACING","authors":"B. Spire, L. Nait-Ighil, P. Puglièse, I. Poizot-Martin, V. Jullien, A. Marcelin, E. Billaud","doi":"10.1080/15284336.2016.1251030","DOIUrl":"https://doi.org/10.1080/15284336.2016.1251030","url":null,"abstract":"Background: Good efficacy and safety of raltegravir in person living with HIV was demonstrated in clinical trials over five years, but real-life data, particularly about quality of life (QoL), are lacking. QoL was evaluated over time in adult patients first treated or switched to regimens containing raltegravir in an observational cohort study. Methods: Patient QoL was evaluated using the Fatigue Impact Scale (FIS) and the HIV Symptom Index (HSI). Data were collected at baseline and at 1, 3, 6, 12, 18, and 24 months. Baseline FIS and HSI subscores were compared with the scores at each visit using the paired Wilcoxon test. The impact of time, sociodemographic and medical variables upon patient-perceived fatigue and symptoms was also assessed using mixed multivariate models. Results: From baseline, all FIS and HSI subscores improved significantly after one month of treatment. In addition, psychosocial FIS subscores and both the frequency of bothersome symptoms and HSI subscores improved significantly at each visit. Physical FIS subscores also improved significantly, except at month 18, whereas both cognitive and total FIS subscores improved only after 6 months and 24 months, respectively. In multivariate analysis, employment was independently associated over time with improved improvement in both FIS and HSI subscores. Conclusion: Patient QoL improved significantly over a 24-month period of treatment with a raltegravir-containing regimen. FIS and HSI are sensitive tools to measure the impact of new antiretroviral combinations on a patient’s perception of QoL.","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"18 1","pages":"1 - 16"},"PeriodicalIF":0.0,"publicationDate":"2017-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15284336.2016.1251030","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48080049","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-01-02DOI: 10.1080/15284336.2016.1271503
M. Harris, B. Ganase, B. Watson, M. Hull, S. Guillemi, Wendy W. Zhang, R. Saeedi, P. Harrigan
Objectives: To assess safety and efficacy of a switch to unboosted atazanavir (ATV) among HIV-infected adults receiving ATV/ritonavir (r) and tenofovir disoproxil fumarate (TDF). Methods: HIV-infected adults with viral load (VL) <40 copies/mL at screening and <150 copies/mL consistently for ≥3 months while receiving a regimen including ATV/r and TDF were randomized to continue ATV/r 300/100 mg daily (control) or change to ATV 400 mg daily (switch), while maintaining their TDF backbone. The primary outcome was proportion of subjects without treatment failure (regimen switch or VL > 200 copies/mL twice consecutively) at 48 weeks. Results: Fifty participants (46 male, median age 47 years) were randomized, 25 to each arm. At week 48, treatment success occurred in 76% in the control arm and 92% in the switch arm (ITT, p = 0.25). ATV trough levels at week 9 were higher in controls (median 438 ng/mL) than in the switch arm (median 124 ng/mL) (p = 0.003), as was total bilirubin at week 48 (median 38 μmol/L and 28 μmol/L, respectively; p = 0.02). Estimated glomerular filtration rate (eGFR) decreased in the control arm (p = 0.007), but did not change in the switch arm. At week 48, eGFR was higher in the switch arm (median 96 mL/min) than in the control arm (median 85 mL/min) (p = 0.035), but the arms were similar with respect to fasting glucose, C-reactive protein, and lipid parameters. Conclusions: Switching from ATV/r to unboosted ATV appears to be safe and effective in selected virologically suppressed patients receiving TDF-containing regimens, and may have favorable effects on bilirubin and renal function.
{"title":"Efficacy and safety of “unboosting” atazanavir in a randomized controlled trial among HIV-infected patients receiving tenofovir DF","authors":"M. Harris, B. Ganase, B. Watson, M. Hull, S. Guillemi, Wendy W. Zhang, R. Saeedi, P. Harrigan","doi":"10.1080/15284336.2016.1271503","DOIUrl":"https://doi.org/10.1080/15284336.2016.1271503","url":null,"abstract":"Objectives: To assess safety and efficacy of a switch to unboosted atazanavir (ATV) among HIV-infected adults receiving ATV/ritonavir (r) and tenofovir disoproxil fumarate (TDF). Methods: HIV-infected adults with viral load (VL) <40 copies/mL at screening and <150 copies/mL consistently for ≥3 months while receiving a regimen including ATV/r and TDF were randomized to continue ATV/r 300/100 mg daily (control) or change to ATV 400 mg daily (switch), while maintaining their TDF backbone. The primary outcome was proportion of subjects without treatment failure (regimen switch or VL > 200 copies/mL twice consecutively) at 48 weeks. Results: Fifty participants (46 male, median age 47 years) were randomized, 25 to each arm. At week 48, treatment success occurred in 76% in the control arm and 92% in the switch arm (ITT, p = 0.25). ATV trough levels at week 9 were higher in controls (median 438 ng/mL) than in the switch arm (median 124 ng/mL) (p = 0.003), as was total bilirubin at week 48 (median 38 μmol/L and 28 μmol/L, respectively; p = 0.02). Estimated glomerular filtration rate (eGFR) decreased in the control arm (p = 0.007), but did not change in the switch arm. At week 48, eGFR was higher in the switch arm (median 96 mL/min) than in the control arm (median 85 mL/min) (p = 0.035), but the arms were similar with respect to fasting glucose, C-reactive protein, and lipid parameters. Conclusions: Switching from ATV/r to unboosted ATV appears to be safe and effective in selected virologically suppressed patients receiving TDF-containing regimens, and may have favorable effects on bilirubin and renal function.","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"18 1","pages":"39 - 47"},"PeriodicalIF":0.0,"publicationDate":"2017-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15284336.2016.1271503","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42092045","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-11-01DOI: 10.1080/15284336.2016.1248624
A. Serris, J. Zoungrana, Mamadou Diallo, R. Toby, Mireille Mpoudi Ngolle, S. Le Gac, J. Coutherut, A. Cournil, P. De Beaudrap, S. Koulla‐Shiro, E. Delaporte, L. Ciaffi
Introduction: Pregnancy is an exclusion criteria in most clinical trials involving antiretroviral therapy (ART) and modern contraception methods are systematically proposed to women of childbearing age. Nevertheless pregnancies are often observed. Reproductive choices during clinical trials should be understood to adapt interventions to the level of risk for mother and baby safety. Our goal was to describe the reproductive behavior and pregnancy outcomes among HIV-infected women on second-line antiretroviral treatment enrolled in two clinical trials and to compare them with those of HIV-positive women in non-research settings. Methods: The number and outcomes of pregnancies were recorded among 281 non menopausal women enrolled in the ANRS 12169-2LADY and ANRS 12286-MOBIDIP clinical trials in Cameroon, Senegal and Burkina Faso. All participants had agreed to use a least one contraceptive method (barrier or non-barrier) which was provided for free during the study. Data were collected through revision of pregnancy notification forms and by data extraction from the study database, regularly updated and checked during the study. Results: Sixty-six women had 84 pregnancies between January 2010 and July 2015 resulting in a pregnancy rate of 8.0 per 100 women-years (WY) (95% CI 6.5–9.9) which is similar to the ones observed in cohort studies in Sub-Saharan Africa (varying from 2.5 to 9.4 pregnancies per 100 WY). Among 60 live births, 10 (16.6%) were born prematurely and 9 (15%) had a low birth weight. Sixteen miscarriages/stillbirths occurred (19.5%). This percentage is comparable to the one expected in the seronegative population which is reassuring for HIV-positive women considering pregnancy on ART. Only one minor birth defect was diagnosed. In univariate and multivariate analysis, miscarriages/stillbirths were not associated either with age, nadir of CD4 count, duration of ART, CD4 count, or viral load at the beginning of pregnancy. Conclusion: HIV-positive women participating in clinical trials conducted in Sub-Saharan Africa tend to get pregnant as often as seropositive women who received medical care in non-research settings. It is therefore essential to adopt a pragmatic approach by re-evaluating the relevance of the criteria for exclusion of pregnant women according to the risk associated with exposure and to seek more effective and innovating contraceptive strategies when using potentially teratogenic molecules.
在大多数涉及抗逆转录病毒治疗(ART)的临床试验中，妊娠是一个排除标准，现代避孕方法被系统地推荐给育龄妇女。然而，怀孕是经常观察到的。应了解临床试验期间的生殖选择，以使干预措施适应母亲和婴儿安全的风险水平。我们的目的是描述两项临床试验中接受二线抗逆转录病毒治疗的艾滋病毒感染妇女的生殖行为和妊娠结局，并将其与非研究环境中艾滋病毒阳性妇女的生殖行为和妊娠结局进行比较。方法:记录在喀麦隆、塞内加尔和布基纳法索参加ANRS 12169-2LADY和ANRS 12286-MOBIDIP临床试验的281名非绝经期妇女的妊娠次数和结局。所有参与者都同意使用研究期间免费提供的至少一种避孕方法(屏障或非屏障)。通过修订妊娠通知表和从研究数据库中提取数据收集数据，并在研究期间定期更新和检查数据。结果:2010年1月至2015年7月期间，66名妇女怀孕84次，妊娠率为每100名妇女年(WY) 8.0次(95% CI 6.5-9.9)，这与撒哈拉以南非洲队列研究中观察到的妊娠率相似(每100名妇女年怀孕2.5至9.4次)。在60例活产婴儿中，10例早产(16.6%)，9例低出生体重(15%)。发生16例流产/死产(19.5%)。这一比例与血清阴性人群的预期比例相当，这对于考虑接受抗逆转录病毒治疗怀孕的艾滋病毒阳性妇女来说是令人放心的。只有一个轻微的先天缺陷被诊断出来。在单因素和多因素分析中，流产/死产与年龄、CD4计数最低点、抗逆转录病毒治疗持续时间、CD4计数或怀孕初期的病毒载量无关。结论:在撒哈拉以南非洲参加临床试验的艾滋病毒阳性妇女往往与在非研究环境中接受医疗护理的血清阳性妇女一样经常怀孕。因此，必须采取务实的做法，根据与接触有关的风险重新评估排除孕妇的标准的相关性，并在使用可能致畸的分子时寻求更有效和创新的避孕策略。
{"title":"Getting pregnant in HIV clinical trials: women’s choice and safety needs. The experience from the ANRS12169-2LADY and ANRS12286-MOBIDIP trials","authors":"A. Serris, J. Zoungrana, Mamadou Diallo, R. Toby, Mireille Mpoudi Ngolle, S. Le Gac, J. Coutherut, A. Cournil, P. De Beaudrap, S. Koulla‐Shiro, E. Delaporte, L. Ciaffi","doi":"10.1080/15284336.2016.1248624","DOIUrl":"https://doi.org/10.1080/15284336.2016.1248624","url":null,"abstract":"Introduction: Pregnancy is an exclusion criteria in most clinical trials involving antiretroviral therapy (ART) and modern contraception methods are systematically proposed to women of childbearing age. Nevertheless pregnancies are often observed. Reproductive choices during clinical trials should be understood to adapt interventions to the level of risk for mother and baby safety. Our goal was to describe the reproductive behavior and pregnancy outcomes among HIV-infected women on second-line antiretroviral treatment enrolled in two clinical trials and to compare them with those of HIV-positive women in non-research settings. Methods: The number and outcomes of pregnancies were recorded among 281 non menopausal women enrolled in the ANRS 12169-2LADY and ANRS 12286-MOBIDIP clinical trials in Cameroon, Senegal and Burkina Faso. All participants had agreed to use a least one contraceptive method (barrier or non-barrier) which was provided for free during the study. Data were collected through revision of pregnancy notification forms and by data extraction from the study database, regularly updated and checked during the study. Results: Sixty-six women had 84 pregnancies between January 2010 and July 2015 resulting in a pregnancy rate of 8.0 per 100 women-years (WY) (95% CI 6.5–9.9) which is similar to the ones observed in cohort studies in Sub-Saharan Africa (varying from 2.5 to 9.4 pregnancies per 100 WY). Among 60 live births, 10 (16.6%) were born prematurely and 9 (15%) had a low birth weight. Sixteen miscarriages/stillbirths occurred (19.5%). This percentage is comparable to the one expected in the seronegative population which is reassuring for HIV-positive women considering pregnancy on ART. Only one minor birth defect was diagnosed. In univariate and multivariate analysis, miscarriages/stillbirths were not associated either with age, nadir of CD4 count, duration of ART, CD4 count, or viral load at the beginning of pregnancy. Conclusion: HIV-positive women participating in clinical trials conducted in Sub-Saharan Africa tend to get pregnant as often as seropositive women who received medical care in non-research settings. It is therefore essential to adopt a pragmatic approach by re-evaluating the relevance of the criteria for exclusion of pregnant women according to the risk associated with exposure and to seek more effective and innovating contraceptive strategies when using potentially teratogenic molecules.","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"17 1","pages":"233 - 241"},"PeriodicalIF":0.0,"publicationDate":"2016-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15284336.2016.1248624","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"59913051","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-11-01DOI: 10.1080/15284336.2016.1248625
Tamara M Johnson, R. Sison, J. Fallon, Prerak Shukla, Sristi Bhattarai, Herbert Galang, R. Habeeb, J. Slim
Background: There is no known reason to suspect an adverse drug interaction between dolutegravir-based antiretroviral therapy and sofosbuvir, simeprevir, or ledipasvir. There is a paucity of clinical data for this combination. Methods: Prospective, open-label study of patients with HIV well controlled on dolutegravir, abacavir, and lamivudine, who were co-infected with HCV genotype 1, and required therapy with simeprevir plus sofosbuvir or sofosbuvir/ledipasvir single-tablet regimen (STR) for 12 weeks. The two primary endpoints were percentage of patients achieving sustained virologic response (SVR) at 12 weeks post-treatment and percentage of patients with a HIV-1 viral load <50 copies/ml at end of the combination therapy. Results: Twenty-eight subjects were enrolled from August 2014 to September 2015. Thirteen patients were treated with simprevir plus sofosbuvir, and 15 subjects were treated with sofosbuvir/ledipasvir. 23 genotype 1a, and 5 genotype 1b were included. Nineteen were treatment naïve, and 2 patients had compensated cirrhosis. The mean age was 59 years (95% CI 58.21–59.78 years). The mean age was 59 years (95% CI: 58.21–59.78 years), and 25 patients were black. Out of the 28 patients who completed this study, SVR 12 was achieved in 27 of 28 patients (96%, 95% CI 89.6–100.0%), and all patients had an HIV virus load <50 copies/ml at week 12 of therapy, for an intent-to-treat rate of 100%. No patients ended therapy secondary to adverse events. Conclusion: Our study suggests a good safety and efficacy for the combination of a dolutegravir, abacavir, and lamivudine with sofosbuvir-based DAA therapy.
背景:没有已知的理由怀疑以多替格雷韦为基础的抗逆转录病毒治疗与索非布韦、西莫普韦或雷地帕韦之间存在不良药物相互作用。这种联合用药的临床数据缺乏。方法:前瞻性、开放标签研究，在多替格雷韦、阿巴卡韦和拉米夫定控制良好的HIV患者中，同时感染HCV基因型为1，需要西莫普韦加索非布韦或索非布韦/雷地帕韦单片方案(STR)治疗12周。两个主要终点是在治疗后12周达到持续病毒学应答(SVR)的患者百分比，以及在联合治疗结束时HIV-1病毒载量<50拷贝/ml的患者百分比。结果:2014年8月至2015年9月入组28例受试者。13例患者采用simprevir + sofosbuvir治疗，15例患者采用sofosbuvir/ledipasvir治疗。其中基因1a型23例，基因1b型5例。19例患者接受治疗naïve, 2例患者出现代偿性肝硬化。平均年龄59岁(95% CI 58.21 ~ 59.78岁)。平均年龄59岁(95% CI: 58.21-59.78年)，25例为黑人。在完成本研究的28例患者中，28例患者中有27例达到SVR 12 (96%， 95% CI 89.6-100.0%)，并且所有患者在治疗第12周时HIV病毒载量<50拷贝/ml，意向治疗率为100%。没有患者因不良事件而终止治疗。结论:我们的研究表明，多替格拉韦、阿巴卡韦和拉米夫定联合索非布韦为基础的DAA治疗具有良好的安全性和有效性。
{"title":"Clinical experience with dolutegravir/abacavir/lamivudine in HIV–HCV co-infected patients treated with a sofosbuvir-based regimen—safety and efficacy","authors":"Tamara M Johnson, R. Sison, J. Fallon, Prerak Shukla, Sristi Bhattarai, Herbert Galang, R. Habeeb, J. Slim","doi":"10.1080/15284336.2016.1248625","DOIUrl":"https://doi.org/10.1080/15284336.2016.1248625","url":null,"abstract":"Background: There is no known reason to suspect an adverse drug interaction between dolutegravir-based antiretroviral therapy and sofosbuvir, simeprevir, or ledipasvir. There is a paucity of clinical data for this combination. Methods: Prospective, open-label study of patients with HIV well controlled on dolutegravir, abacavir, and lamivudine, who were co-infected with HCV genotype 1, and required therapy with simeprevir plus sofosbuvir or sofosbuvir/ledipasvir single-tablet regimen (STR) for 12 weeks. The two primary endpoints were percentage of patients achieving sustained virologic response (SVR) at 12 weeks post-treatment and percentage of patients with a HIV-1 viral load <50 copies/ml at end of the combination therapy. Results: Twenty-eight subjects were enrolled from August 2014 to September 2015. Thirteen patients were treated with simprevir plus sofosbuvir, and 15 subjects were treated with sofosbuvir/ledipasvir. 23 genotype 1a, and 5 genotype 1b were included. Nineteen were treatment naïve, and 2 patients had compensated cirrhosis. The mean age was 59 years (95% CI 58.21–59.78 years). The mean age was 59 years (95% CI: 58.21–59.78 years), and 25 patients were black. Out of the 28 patients who completed this study, SVR 12 was achieved in 27 of 28 patients (96%, 95% CI 89.6–100.0%), and all patients had an HIV virus load <50 copies/ml at week 12 of therapy, for an intent-to-treat rate of 100%. No patients ended therapy secondary to adverse events. Conclusion: Our study suggests a good safety and efficacy for the combination of a dolutegravir, abacavir, and lamivudine with sofosbuvir-based DAA therapy.","PeriodicalId":13216,"journal":{"name":"HIV Clinical Trials","volume":"17 1","pages":"242 - 245"},"PeriodicalIF":0.0,"publicationDate":"2016-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/15284336.2016.1248625","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"59913095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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