Different Kinetics of Immunologic Recovery Using Nelfinavir or Lopinavir/Ritonavir-Based Regimens in Children with Perinatal HIV-1 Infection

2005 ◽  
Vol 18 (4) ◽  
pp. 729-735 ◽  
Author(s):  
M. De Luca ◽  
G. Miccinesi ◽  
E. Chiappini ◽  
M. Zappa ◽  
L. Galli ◽  
...  
Keyword(s):  
Viral Load ◽  
T Lymphocyte ◽  
Highly Active Antiretroviral Therapy ◽  
Lymphocyte Count ◽  
Virologic Failure ◽  
Undetectable Viral Load ◽  
Baseline Viral Load ◽  
Perinatal Hiv ◽  
Significant Difference ◽  
Hiv 1

The choice to include the optimal protease inhibitor (PI) in highly active antiretroviral therapy (HAART) regimens in children with perinatal HIV-1 infection is still under debate. Virologic and immunologic outcomes of three different regimens in an observational paediatric cohort were compared. Data from 12 saquinavir-, 18 nelfinavir-, and 10 lopinavir/ritonavir-treated children were analyzed after 4 and 24 weeks of therapy. Immunologic and virologic outcomes were compared using multivariate analysis adjusting the results for age, baseline CD4+ T-lymphocyte count and baseline viral load. Saquinavir-treated children displayed significant reduction in viral load at week 24 (but not at week 4) and no increase in CD4+ T-lymphocyte count, indicating a poor advantage in using this drug. Lopinavir/ritonavir-treated children presented lower viral loads than nelfinavir-treated children at week 4 (P=0.020) and week 24 (p<0.0001). Virologic failure occurred in 6/18 (33.3%) nelfinavir-treated children but in no child receiving lopinavir/ritonavir (P=0.013). An undetectable viral load was achieved in 9/10 (90.0%) lopinavir/ritonavir- vs. 3/18 (16.6%) nelfinavir-treated children (p<0.0001). No significant difference in CD4+ T-lymphocyte count was observed between lopinavir/ritonavir- and nelfinavir-treated children at weeks 4 and 24. However, a different kinetic of the immunologic recovery was observed. Lopinavir/ritonavir-treated children displayed higher CD4+ T-lymphocyte counts than saquinavir-treated children since the first month of therapy (week 4: P=0.042; week 24: P= 0.029) while nelfinavir-treated children took 24 weeks to reach such an outcome (P=0.034). Since lopinavir/ritonavir-based regimen controls viral replication more efficiently and restores CD4+ T-lymphocyte count more quickly than saquinavir- or nelfinavir-based HAART, it may be considered when a salvage therapy or a rapid increase in CD4+ T-lymphocytes is necessary.

GBV-C/HIV-1 coinfection is associated with low HIV-1 viral load and high CD4+ T lymphocyte count

2017 ◽  
Vol 162 (11) ◽  
pp. 3431-3438 ◽  
Author(s):  
Bárbara Katharine Barbosa de Miranda ◽  
Keyla Santos Guedes de Sá ◽  
Andrea Nazaré Rangel da Silva ◽  
Rosimar Neris Martins Feitosa ◽  
Izaura Maria Vieira Cayres-Vallinoto ◽  
...  
Keyword(s):  
Viral Load ◽  
T Lymphocyte ◽  
Lymphocyte Count ◽  
Hiv 1

scholarly journals High Rate of Non-detectable HIV-1 RNA among Antiretroviral Drug Naive HIV Positive Individuals in Nigeria

2013 ◽  
Vol 4 ◽  
pp. VRT.S12677 ◽  
Author(s):  
Georgina N. Odaibo ◽  
Isaac F. Adewole ◽  
David O. Olaleye
Keyword(s):  
Viral Load ◽  
Undetectable Viral Load ◽  
Antiretroviral Drugs ◽  
High Rate ◽  
Baseline Viral Load ◽  
Hiv Positive ◽  
Detectable Viral Load ◽  
Cell Counts ◽  
Drug Naïve ◽  
Hiv 1

Plasma HIV-1 RNA concentration, or viral load, is an indication of the magnitude of virus replication and largely correlates with disease progression in an infected person. It is a very useful guide for initiation of therapy and monitoring of response to antiretroviral drugs. Although the majority of patients who are not on antiretroviral therapy (ART) have a high viral load, a small proportion of ART naive patients are known to maintain low levels or even undetectable viral load levels. In this study, we determined the rate of undetectable HIV-1 RNA among ART naive HIV positive patients who presented for treatment at the University College Hospital (UCH), Ibadan, Nigeria from 2005 to 2011. Baseline viral load and CD4 lymphocyte cell counts of 14,662 HIV positive drug naive individuals were determined using the Roche Amplicor version 1.5 and Partec easy count kit, respectively. The detection limits of the viral load assay are 400 copies/mL and 750,000 copies/mL for lower and upper levels, respectively. A total of 1,399 of the 14,662 (9.5%) HIV-1 positive drug naive individuals had undetectable viral load during the study period. In addition, the rate of non-detectable viral load increased over the years. The mean CD4 counts among HIV-1 infected individuals with detectable viral load (266 cells/μL; range = 1 to 2,699 cells/μL) was lower than in patients with undetectable viral load (557 cells/μL; range = 1 to 3,102 cells/μL). About 10% of HIV-1 infected persons in our study population had undetectable viral load using the Roche Amplicor version 1.5.

scholarly journals Characterization of HIV-1 near Full-Length Proviral Genome Quasispecies from Patients with Undetectable Viral Load Undergoing First-Line HAART Therapy

2017 ◽  
Author(s):  
Brunna M. Alves ◽  
Juliana D. Siqueira ◽  
Marianne M. Garrido ◽  
Ornella M. Botelho ◽  
Isabel M. Prellwitz ◽  
...  
Keyword(s):  
Viral Load ◽  
Highly Active Antiretroviral Therapy ◽  
Treatment Success ◽  
Undetectable Viral Load ◽  
Hiv Treatment ◽  
Full Length ◽  
Resistance Mutations ◽  
First Line ◽  
Subtype B ◽  
Hiv 1

Increased access to highly active antiretroviral therapy (HAART) by HIV+ individuals has become a reality worldwide. In Brazil, ART currently reaches over half of the HIV-infected subjects. In the context of a remarkable HIV-1 genetic variability, highly related variants, called quasispecies, are generated. HIV quasispecies generated during infection can influence virus persistence and pathogenicity, representing a challenge to treatment. However, the clinical relevance of minority quasispecies is still uncertain. For this study, we have determined the archived proviral sequences, viral subtype and drug resistance mutations from a cohort of HIV+ patients with undetectable viral load undergoing HAART as first-line therapy using next-generation sequencing for near full-length virus genome (NFLG) assembly. HIV-1 consensus sequences representing NFLG were obtained for eleven patients, while for another twelve varying genome coverage rates were obtained. Phylogenetic analysis showed the predominance of subtype B (83%; 19/23). Considering the minority variants, 18 patients carried archived virus harboring at least one mutation conferring antiretroviral resistance; for six patients, the mutations correlated with the current ARVs used. These data highlight the importance of monitoring HIV minority drug resistant variants and their clinical impact, to guide future regimen switches and improve HIV treatment success.

scholarly journals Off-label use of combined antiretroviral therapy, analysis of data collected by The Italian Register for HIV-1 infection in Paediatrics in a large cohort of children.

2021 ◽  
Author(s):  
Elena Chiappini ◽  
Catiuscia Lisi ◽  
Vania Giacomet ◽  
Paola Erba ◽  
Stefania Bernardi ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
T Lymphocyte ◽  
Highly Active Antiretroviral Therapy ◽  
Safety Data ◽  
Undetectable Viral Load ◽  
Antiretroviral Drugs ◽  
Older Children ◽  
Off Label ◽  
Increased Risk ◽  
Hiv 1

Abstract BackgroundEarly start of highly active antiretroviral therapy (HAART) in perinatally HIV-1 infected children is the optimal strategy to prevent immunological and clinical deterioration. To date, according to EMA, only 35% of antiretroviral drugs are licenced in children < 2 years of age and 60% in those aged 2–12 years, due to the lack of adequate paediatric clinical studies on pharmacokinetics, pharmacodynamics and drug safety in children.MethodsAn observational retrospective study investigating the rate and the outcomes of off-label prescription of HAART was conducted on 225 perinatally HIV-1 infected children enrolled in the Italian Register for HIV Infection in Children and followed-up from 2001 to 2018.Results22.2% (50/225) of included children were receiving an off-label HAART regimen at last check. Only 26% (13/50) of off-label children had an undetectable viral load (VL) before the commencing of the regimen and the 52.0% (26/50) had a CD4 + T lymphocyte percentage > 25%. At last check, during the off label regimen, the 80% (40/50) of patients had an undetectable VL, and 90% (45/50) of them displayed CD4 + T lymphocyte percentage > 25%. The most widely used off-label drugs were: dolutegravir/abacavir/lamivudine (16%; 8/50), emtricitbine/tenofovir disoproxil (22%; 11/50), lopinavir/ritonavir (20%; 10/50) and elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (10%; 10/50). At logistic regression analysis, detectable VL before starting the current HAART regimen was a risk factor for receiving an off-label therapy (OR:2.41; 95%IC 1.13–5.19; P = 0.024). Moreover, children < 2 years of age were at increased risk for receiving off-label HAART with respect to older children (OR:3.24; 95%IC 1063 − 7.3; P = 0.001). Even if our safety data regarding off-label regimens where poor, no adverse event was reported.ConclusionThe prescription of an off-label HAART regimen in perinatally HIV-1 infected children was common, in particular in children with detectable VL despite previous HAART and in younger children, especially those receiving their first regimen. Our data suggest similar proportions of virological and immunological successes at last check among children receiving off-label or on-label HAART. Larger studies are needed to better clarify efficacy and safety of off-label HAART regimens in children, in order to allow the enlargement of on-label prescription in children.

Fluctuations in HIV-1 Viral Load Are Correlated to CD4+ T-Lymphocyte Count During the Natural Course of Infection

2000 ◽  
Vol 23 (5) ◽  
pp. 375-379 ◽  
Author(s):  
Joanna Masel ◽  
Ramy A. Arnaout ◽  
Thomas R. O'Brien ◽  
James J. Goedert ◽  
Alun L. Lloyd
Keyword(s):  
Viral Load ◽  
T Lymphocyte ◽  
Lymphocyte Count ◽  
Natural Course ◽  
Hiv 1

Fluctuations in HIV-1 Viral Load Are Correlated to CD4+ T-Lymphocyte Count During the Natural Course of Infection

2000 ◽  
Vol 23 (5) ◽  
pp. 375-379 ◽  
Author(s):  
Joanna Masel ◽  
Ramy A. Arnaout ◽  
Thomas R. O'Brien ◽  
James J. Goedert ◽  
Alun L. Lloyd
Keyword(s):  
Viral Load ◽  
T Lymphocyte ◽  
Lymphocyte Count ◽  
Natural Course ◽  
Hiv 1

Long-term safety, tolerability and antiviral activity of rilpivirine in antiretroviral-naïve adolescents living with HIV-1, aged 12 to less than 18 years: Week 240 findings of a phase 2, open-label study, PAINT

2021 ◽  
Author(s):  
Johan Lombaard ◽  
Francis Ssali ◽  
Puthanakit Thanyawee ◽  
Jan Fourie ◽  
Simon Vanveggel ◽  
...  
Keyword(s):  
Viral Load ◽  
Virologic Failure ◽  
Virologic Response ◽  
Baseline Viral Load ◽  
Phase 2 ◽  
Adequate Treatment ◽  
Living With Hiv ◽  
Hiv 1 ◽  
Extension Period

Introduction: This Phase-2 study investigated long-term safety and efficacy of rilpivirine (RPV)+two investigator-selected nucleos(t)ide reverse-transcriptase inhibitors (NRTIs), in HIV-1-infected antiviral therapy-naïve adolescents. Methods: Participants (≥12to <18 years) were treated with RPV 25mg qd+2 NRTIs who entered treatment extension period for up to 240 weeks with visits every 3 months. Long-term safety (analysis of adverse events [AEs], laboratory results), efficacy (virologic-response and outcome for patients with viral load <50 and <400 by time to loss of virologic-response (TLOVR) and FDA Snapshot methods, and CD4+ cell count), and adherence (by pill-count) for up to 240 weeks are presented. Results: 24 of 36 entered treatment extension period and 21 completed week 240. At week 240, viral load <50 copies/mL was achieved by 14/32 (43.8%) participants; virologic-response by TLOVR was higher in participants with baseline viral load≤100,000 copies/mL (48.0%) versus viral load >100,000 copies/mL (28.6%). By FDA Snapshot, viral load < 50 copies/mL at week 240 was 53.1% (17/32) in participants with baseline viral load ≤100,000 copies/mL. Higher response was observed in participants with adherence >95% and baseline viral load ≤100,000 copies/mL. Through week 240, 16/32 participants (50.0%) experienced virologic-failure, including seven who developed treatment-emergent RPV resistance-associated mutations (RAMs; frequently E138K); all 7 had ≥1 treatment-emergent NRTI RAM. No serious AEs after week 48, no discontinuations due to AEs between week 48 and week 240 and no new safety signals were observed. RPV did not affect pubertal development/adolescent growth. Conclusions: At the 5-year follow-up, efficacy was low in adolescents, particularly those with poor adherence and/or high baseline viral load >100,000 copies/mL. To limit the risk of virologic failure, Edurant is restricted to patients with a baseline VL ≤100,000 copies/mL in most countries. In addition, adequate treatment adherence to RPV treatment is imperative for long-term viral suppression and should be emphasized in the management of adolescents living with HIV. RPV exhibited favorable long-term safety profile for adolescents living with HIV-1 with adequate adherence. Clinical Trial Number: NCT00799864

scholarly journals Decreased Specificity of an Assay for Recent Infection in HIV-1-Infected Patients on Highly Active Antiretroviral Treatment: Implications for Incidence Estimates

2012 ◽  
Vol 19 (8) ◽  
pp. 1248-1253 ◽  
Author(s):  
Antoine Chaillon ◽  
Stéphane Le Vu ◽  
Sylvie Brunet ◽  
Guillaume Gras ◽  
Frédéric Bastides ◽  
...  
Keyword(s):  
Viral Load ◽  
Highly Active Antiretroviral Therapy ◽  
Demographic Data ◽  
Undetectable Viral Load ◽  
Antiretroviral Drugs ◽  
Recent Infection ◽  
Cross Sectional ◽  
Highly Active ◽  
The Impact ◽  
Hiv 1

ABSTRACTThe aim of this study was to estimate the rate of misclassification in treated HIV patients who initiated treatment at the chronic stage of HIV infection using an enzyme immunoassay (EIA) that discriminates between recent infection (RI; within 6 months) and established infection. The performance of EIA-RI was evaluated in 96 HIV-1 chronically infected patients on highly active antiretroviral therapy (HAART) with an undetectable viral load (VL) for at least 3 years. Demographic data, HIV-1 viral load, CD4+T-cell count, viral subtype, and treatment duration were collected. The subset of misclassified patients was further analyzed using samples collected annually. The impact on incidence estimates was evaluated by simulation. The specificity in treated patients was significantly lower (70.8 to 77.1%) than that observed in untreated patients (93.3 to 99.3%,P< 0.001). Patients falsely classified as recently infected had been treated for a longer period and had longer-term viral suppression than those correctly classified. The loss of specificity of the test due to treatment may have a dramatic impact on the accuracy of the incidence estimates, with a major impact when HIV prevalence is high. The cross-sectional studies intended to derive HIV incidence must collect information on treatment or, alternatively, should include detection of antiretroviral drugs in blood specimens to rule out treated patients from the calculations.

scholarly journals Off-label use of combined antiretroviral therapy, analysis of data collected by the Italian Register for HIV-1 infection in paediatrics in a large cohort of children

2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Elena Chiappini ◽  
Catiuscia Lisi ◽  
Vania Giacomet ◽  
Paola Erba ◽  
Stefania Bernardi ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
T Lymphocyte ◽  
Highly Active Antiretroviral Therapy ◽  
Safety Data ◽  
Undetectable Viral Load ◽  
Antiretroviral Drugs ◽  
Older Children ◽  
Off Label ◽  
Increased Risk ◽  
Hiv 1

Abstract Background Early start of highly active antiretroviral therapy (HAART) in perinatally HIV-1 infected children is the optimal strategy to prevent immunological and clinical deterioration. To date, according to EMA, only 35% of antiretroviral drugs are licenced in children < 2 years of age and 60% in those aged 2–12 years, due to the lack of adequate paediatric clinical studies on pharmacokinetics, pharmacodynamics and drug safety in children. Methods An observational retrospective study investigating the rate and the outcomes of off-label prescription of HAART was conducted on 225 perinatally HIV-1 infected children enrolled in the Italian Register for HIV Infection in Children and followed-up from 2001 to 2018. Results 22.2% (50/225) of included children were receiving an off-label HAART regimen at last check. Only 26% (13/50) of off-label children had an undetectable viral load (VL) before the commencing of the regimen and the 52.0% (26/50) had a CD4 + T lymphocyte percentage > 25%. At last check, during the off label regimen, the 80% (40/50) of patients had an undetectable VL, and 90% (45/50) of them displayed CD4 + T lymphocyte percentage > 25%. The most widely used off-label drugs were: dolutegravir/abacavir/lamivudine (16%; 8/50), emtricitbine/tenofovir disoproxil (22%; 11/50), lopinavir/ritonavir (20%; 10/50) and elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (10%; 10/50). At logistic regression analysis, detectable VL before starting the current HAART regimen was a risk factor for receiving an off-label therapy (OR: 2.41; 95% CI 1.13–5.19; p = 0.024). Moreover, children < 2 years of age were at increased risk for receiving off-label HAART with respect to older children (OR: 3.24; 95% CI 1063–7.3; p = 0.001). Even if our safety data regarding off-label regimens where poor, no adverse event was reported. Conclusion The prescription of an off-label HAART regimen in perinatally HIV-1 infected children was common, in particular in children with detectable VL despite previous HAART and in younger children, especially those receiving their first regimen. Our data suggest similar proportions of virological and immunological successes at last check among children receiving off-label or on-label HAART. Larger studies are needed to better clarify efficacy and safety of off-label HAART regimens in children, in order to allow the enlargement of on-label prescription in children.

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