Journal Article > ResearchFull Text
J Acquir Immune Defic Syndr; JAIDS. 2019 September 1; Volume 82 (Issue 1); 96-104.; DOI: 10.1097/QAI.0000000000002101
Kerschberger B, Ntshalintshali N, Mpala Q, Uribe PAD, Maphalala G, et al.
J Acquir Immune Defic Syndr; JAIDS. 2019 September 1; Volume 82 (Issue 1); 96-104.; DOI: 10.1097/QAI.0000000000002101
BACKGROUND
Viral load (VL) testing is being scaled up in resource-limited settings. However, not all commercially available VL testing methods have been evaluated under field conditions. This study is one of a few to evaluate the Biocentric platform for VL quantification in routine practice in Sub-Saharan Africa.
METHODS
Venous blood specimens were obtained from patients eligible for VL testing at two health facilities in Swaziland from October 2016 to March 2017. Samples were centrifuged at two laboratories (LAB-1, LAB-2) to obtain paired plasma specimens for VL quantification with the national reference method and on the Biocentric platform. Agreement (correlation, Bland–Altman) and accuracy (sensitivity, specificity) indicators were calculated at the VL thresholds of 416 (2.62 log10) and 1000 (3.0 log10) copies/mL. Leftover samples from patients with discordant VL results were re-quantified and accuracy indicators recalculated. Logistic regression was used to compare laboratory performance.
RESULTS
A total of 364 paired plasma samples (LAB-1: n = 198; LAB-2: n = 166) were successfully tested using both methods. The correlation was high (R = 0.82, p < 0.01), and the Bland–Altman analysis showed a minimal mean difference (− 0.03 log10 copies/mL; 95% CI: -1.15 to 1.08). At the clinical threshold level of 3.0 log10 copies/mL, the sensitivity was 88.6% (95% CI: 78.7 to 94.9) and the specificity was 98.3% (95% CI: 96.1 to 99.4). Sensitivity was higher in LAB-1 (100%; 95% CI: 71.5 to 100) than in LAB-2 (86.4%; 95% CI: 75.0 to 94.0). Most upward (n = 8, 2.2%) and downward (n = 11, 3.0%) misclassifications occurred at the 2.62 log threshold, with LAB-2 having a 16 (95% CI: 2.26 to 113.27; p = 0.006) times higher odds of downward misclassification. After retesting of discordant leftover samples (n = 17), overall sensitivity increased to 93.5% (95% CI: 85.5 to 97.9) and 97.1% (95% CI: 90.1 to 99.7) at the 2.62 and 3.0 thresholds, and specificity increased to 98.6% (95% CI: 96.5 to 99.6) and 99.0% (95% CI: 97.0 to 99.8) respectively.
CONCLUSIONS
The test characteristics of the Biocentric platform were overall comparable to the national reference method for VL quantification. One laboratory tended to misclassify VL results downwards, likely owing to unmet training needs and lack of previous hands-on practice.
Viral load (VL) testing is being scaled up in resource-limited settings. However, not all commercially available VL testing methods have been evaluated under field conditions. This study is one of a few to evaluate the Biocentric platform for VL quantification in routine practice in Sub-Saharan Africa.
METHODS
Venous blood specimens were obtained from patients eligible for VL testing at two health facilities in Swaziland from October 2016 to March 2017. Samples were centrifuged at two laboratories (LAB-1, LAB-2) to obtain paired plasma specimens for VL quantification with the national reference method and on the Biocentric platform. Agreement (correlation, Bland–Altman) and accuracy (sensitivity, specificity) indicators were calculated at the VL thresholds of 416 (2.62 log10) and 1000 (3.0 log10) copies/mL. Leftover samples from patients with discordant VL results were re-quantified and accuracy indicators recalculated. Logistic regression was used to compare laboratory performance.
RESULTS
A total of 364 paired plasma samples (LAB-1: n = 198; LAB-2: n = 166) were successfully tested using both methods. The correlation was high (R = 0.82, p < 0.01), and the Bland–Altman analysis showed a minimal mean difference (− 0.03 log10 copies/mL; 95% CI: -1.15 to 1.08). At the clinical threshold level of 3.0 log10 copies/mL, the sensitivity was 88.6% (95% CI: 78.7 to 94.9) and the specificity was 98.3% (95% CI: 96.1 to 99.4). Sensitivity was higher in LAB-1 (100%; 95% CI: 71.5 to 100) than in LAB-2 (86.4%; 95% CI: 75.0 to 94.0). Most upward (n = 8, 2.2%) and downward (n = 11, 3.0%) misclassifications occurred at the 2.62 log threshold, with LAB-2 having a 16 (95% CI: 2.26 to 113.27; p = 0.006) times higher odds of downward misclassification. After retesting of discordant leftover samples (n = 17), overall sensitivity increased to 93.5% (95% CI: 85.5 to 97.9) and 97.1% (95% CI: 90.1 to 99.7) at the 2.62 and 3.0 thresholds, and specificity increased to 98.6% (95% CI: 96.5 to 99.6) and 99.0% (95% CI: 97.0 to 99.8) respectively.
CONCLUSIONS
The test characteristics of the Biocentric platform were overall comparable to the national reference method for VL quantification. One laboratory tended to misclassify VL results downwards, likely owing to unmet training needs and lack of previous hands-on practice.
Journal Article > ResearchAbstract Only
J Acquir Immune Defic Syndr; JAIDS. 2023 September 28; Online ahead of print; DOI:10.1097/QAI.0000000000003310
Ben Farhat J, Hessamfar M, Farbos S, Desclaux A, Dumondin G, et al.
J Acquir Immune Defic Syndr; JAIDS. 2023 September 28; Online ahead of print; DOI:10.1097/QAI.0000000000003310
OBJECTIVES
The Covid-19 pandemic’s impact on initiation and effectiveness of antiretroviral therapy (ART) in people diagnosed with HIV remains unclear. We evaluated critical delays in HIV care in people diagnosed before and during the pandemic in ex-Aquitaine, France.
METHODS
We considered adults diagnosed with HIV-1 in 2018-2021 and enrolled in the ANRS CO3 AQUIVIH-NA and followed them until 10/10/2022 for those diagnosed during the pandemic (1/4/2020 - 31/12/2021) and until 31/03/2020 for historical controls. We compared their characteristics at inclusion and the median time between diagnosis and ART initiation, ART initiation and viral suppression and diagnosis and virological suppression (effective management).
RESULTS
83 individuals were diagnosed during the pandemic versus 188 during the pre-pandemic period. Median follow-up was 549 (IQR: 329-713) days. Populations were similar in terms of sex, age, HIV transmission group, hospital type, and clinical characteristics at diagnosis, however, fewer were foreign-born during the pandemic (15.7% versus 33.5%, p=0.003). The probability of ART initiation, therapeutic success, effective management was higher in PLWH diagnosed during the pandemic in adjusted analyses (HR 2.0 95%CI. 1.5-2.7, HR 1.7 95%CI. 1.2-2.3, HR 1.8 95%CI. 1.3-2.6, respectively). Those diagnosed during the pandemic were 2.3 (95%CI: 1.2-4.1) times more likely to be virologically suppressed within 6 months of diagnosis compared to historical controls.
CONCLUSIONS
Pandemic-related reorganizations may have resulted in newly diagnosed PLWH being prioritized, however, the lower proportion of foreign-born PLWH diagnosed during the pandemic period, likely due to reduced migration and potential delays in diagnosis, may contribute to these preliminary findings.
The Covid-19 pandemic’s impact on initiation and effectiveness of antiretroviral therapy (ART) in people diagnosed with HIV remains unclear. We evaluated critical delays in HIV care in people diagnosed before and during the pandemic in ex-Aquitaine, France.
METHODS
We considered adults diagnosed with HIV-1 in 2018-2021 and enrolled in the ANRS CO3 AQUIVIH-NA and followed them until 10/10/2022 for those diagnosed during the pandemic (1/4/2020 - 31/12/2021) and until 31/03/2020 for historical controls. We compared their characteristics at inclusion and the median time between diagnosis and ART initiation, ART initiation and viral suppression and diagnosis and virological suppression (effective management).
RESULTS
83 individuals were diagnosed during the pandemic versus 188 during the pre-pandemic period. Median follow-up was 549 (IQR: 329-713) days. Populations were similar in terms of sex, age, HIV transmission group, hospital type, and clinical characteristics at diagnosis, however, fewer were foreign-born during the pandemic (15.7% versus 33.5%, p=0.003). The probability of ART initiation, therapeutic success, effective management was higher in PLWH diagnosed during the pandemic in adjusted analyses (HR 2.0 95%CI. 1.5-2.7, HR 1.7 95%CI. 1.2-2.3, HR 1.8 95%CI. 1.3-2.6, respectively). Those diagnosed during the pandemic were 2.3 (95%CI: 1.2-4.1) times more likely to be virologically suppressed within 6 months of diagnosis compared to historical controls.
CONCLUSIONS
Pandemic-related reorganizations may have resulted in newly diagnosed PLWH being prioritized, however, the lower proportion of foreign-born PLWH diagnosed during the pandemic period, likely due to reduced migration and potential delays in diagnosis, may contribute to these preliminary findings.
Journal Article > ResearchFull Text
J Acquir Immune Defic Syndr; JAIDS. 2019 December 1; Volume 82 (Issue 4); 386-391.; DOI:10.1097/QAI.0000000000002148
Musinguzi N, Castillo-Mancilla JR, Morrow M, Byakwaga H, Mawhinney S, et al.
J Acquir Immune Defic Syndr; JAIDS. 2019 December 1; Volume 82 (Issue 4); 386-391.; DOI:10.1097/QAI.0000000000002148
BACKGROUND
Residual systemic inflammation, which is associated with non-AIDS clinical outcomes, may persist despite viral suppression. We assessed the effect of antiretroviral therapy (ART) adherence interruptions on systemic inflammation among Ugandans living with HIV who were virally suppressed.
SETTINGS
We evaluated adults initiating first-line ART at a regional referral hospital clinic in Mbarara, Uganda.
METHODS
Plasma concentrations of interleukin-6 (IL-6), D-dimer, soluble sCD14, sCD163, the kynurenine/tryptophan (K/T) ratio, and CD8+ T-cell activation (HLA-DR+/CD38+ coexpression) were measured at baseline and 6 months after ART initiation among participants who achieved viral suppression (<400 copies/mL) at 6 months. ART adherence was monitored electronically. Time spent in an adherence interruption was computed as the percentage of days when the running average adherence was ≤10%. We fit adjusted linear regressions to evaluate the effect of time spent in an interruption on the log-transformed plasma concentrations of the inflammation biomarkers.
RESULTS
Of 282 participants, 70% were women, and the median age was 34 years. At baseline, median CD4 and median log viral load were 135 cells per microliter and 5.1 copies per milliliter, respectively. In the adjusted analysis, a running average adherence of <10% was associated with higher sCD14 (+3%; P < 0.008), sCD163 (+5%; P = 0.002), D-dimer (+10%; P = 0.007), HLA-DR+/CD8+ (+3%; P < 0.025), IL-6 (+14%; P = 0.008), and K:T ratio (+5%; P = 0.002). These findings were largely robust to adjustment for average adherence, as well as higher thresholds of running average adherence, albeit with decreased statistical significance.
CONCLUSIONS
Increased time spent in adherence interruptions is associated with increased levels of inflammation, despite viral suppression above and beyond average adherence.
Residual systemic inflammation, which is associated with non-AIDS clinical outcomes, may persist despite viral suppression. We assessed the effect of antiretroviral therapy (ART) adherence interruptions on systemic inflammation among Ugandans living with HIV who were virally suppressed.
SETTINGS
We evaluated adults initiating first-line ART at a regional referral hospital clinic in Mbarara, Uganda.
METHODS
Plasma concentrations of interleukin-6 (IL-6), D-dimer, soluble sCD14, sCD163, the kynurenine/tryptophan (K/T) ratio, and CD8+ T-cell activation (HLA-DR+/CD38+ coexpression) were measured at baseline and 6 months after ART initiation among participants who achieved viral suppression (<400 copies/mL) at 6 months. ART adherence was monitored electronically. Time spent in an adherence interruption was computed as the percentage of days when the running average adherence was ≤10%. We fit adjusted linear regressions to evaluate the effect of time spent in an interruption on the log-transformed plasma concentrations of the inflammation biomarkers.
RESULTS
Of 282 participants, 70% were women, and the median age was 34 years. At baseline, median CD4 and median log viral load were 135 cells per microliter and 5.1 copies per milliliter, respectively. In the adjusted analysis, a running average adherence of <10% was associated with higher sCD14 (+3%; P < 0.008), sCD163 (+5%; P = 0.002), D-dimer (+10%; P = 0.007), HLA-DR+/CD8+ (+3%; P < 0.025), IL-6 (+14%; P = 0.008), and K:T ratio (+5%; P = 0.002). These findings were largely robust to adjustment for average adherence, as well as higher thresholds of running average adherence, albeit with decreased statistical significance.
CONCLUSIONS
Increased time spent in adherence interruptions is associated with increased levels of inflammation, despite viral suppression above and beyond average adherence.
Journal Article > ResearchFull Text
J Acquir Immune Defic Syndr; JAIDS. 2024 April 15; Volume 95 (Issue 5); 431-438.; DOI:10.1097/QAI.0000000000003379
Youngui BT, Atwine D, Otai D, Vasiliu A, Ssekyanzi B, et al.
J Acquir Immune Defic Syndr; JAIDS. 2024 April 15; Volume 95 (Issue 5); 431-438.; DOI:10.1097/QAI.0000000000003379
INTRODUCTION
People living with HIV are considered at higher risk of developing severe forms of tuberculosis (TB) disease. Providing HIV testing to TB-exposed people is therefore critical. We present the results of integrating HIV testing into a community-based intervention for household TB contact management in Cameroon and Uganda.
METHODS
Trained community health workers visited the households of index patients with TB identified in 3 urban/semiurban and 6 rural districts or subdistricts as part of a cluster-randomized trial and provided TB screening to all household contacts. Voluntary HIV counseling and testing were offered to contacts aged 5 years or older with unknown HIV status. We describe the cascade of care for HIV testing and the factors associated with the acceptance of HIV testing.
RESULTS
Overall, 1983 household contacts aged 5 years or older were screened for TB. Of these contacts, 1652 (83.3%) did not know their HIV status, 1457 (88.2%) accepted HIV testing, and 1439 (98.8%) received testing. HIV testing acceptance was lower among adults than children [adjusted odds ratio (aOR) = 0.35, 95% confidence interval (CI): 0.22 to 0.55], those living in household of an HIV-positive vs HIV-negative index case (aOR = 0.56, 95% CI: 0.38 to 0.83), and contacts requiring a reassessment visit after the initial TB screening visit vs asymptomatic contacts (aOR = 0.20, 95% CI: 0.06 to 0.67) and was higher if living in Uganda vs Cameroon (aOR = 4.54, 95% CI: 1.17 to 17.62) or if another contact of the same index case was tested for HIV (aOR = 9.22, 95% CI: 5.25 to 16.18).
CONCLUSION
HIV testing can be integrated into community-based household TB contact screening and is well-accepted.
People living with HIV are considered at higher risk of developing severe forms of tuberculosis (TB) disease. Providing HIV testing to TB-exposed people is therefore critical. We present the results of integrating HIV testing into a community-based intervention for household TB contact management in Cameroon and Uganda.
METHODS
Trained community health workers visited the households of index patients with TB identified in 3 urban/semiurban and 6 rural districts or subdistricts as part of a cluster-randomized trial and provided TB screening to all household contacts. Voluntary HIV counseling and testing were offered to contacts aged 5 years or older with unknown HIV status. We describe the cascade of care for HIV testing and the factors associated with the acceptance of HIV testing.
RESULTS
Overall, 1983 household contacts aged 5 years or older were screened for TB. Of these contacts, 1652 (83.3%) did not know their HIV status, 1457 (88.2%) accepted HIV testing, and 1439 (98.8%) received testing. HIV testing acceptance was lower among adults than children [adjusted odds ratio (aOR) = 0.35, 95% confidence interval (CI): 0.22 to 0.55], those living in household of an HIV-positive vs HIV-negative index case (aOR = 0.56, 95% CI: 0.38 to 0.83), and contacts requiring a reassessment visit after the initial TB screening visit vs asymptomatic contacts (aOR = 0.20, 95% CI: 0.06 to 0.67) and was higher if living in Uganda vs Cameroon (aOR = 4.54, 95% CI: 1.17 to 17.62) or if another contact of the same index case was tested for HIV (aOR = 9.22, 95% CI: 5.25 to 16.18).
CONCLUSION
HIV testing can be integrated into community-based household TB contact screening and is well-accepted.
Journal Article > ResearchFull Text
J Acquir Immune Defic Syndr; JAIDS. 2024 March 1; Online ahead of print; DOI:10.1097/QAI.0000000000003404
Ben Farhat J, TiendrebeogoMD T, Malateste K, Poda A, Minga A, et al.
J Acquir Immune Defic Syndr; JAIDS. 2024 March 1; Online ahead of print; DOI:10.1097/QAI.0000000000003404
OBJECTIVES
Efforts to control the COVID-19 pandemic have potentially compromised the availability and/or quality of HIV services. We aimed to assess the pandemic’s impact on ART initiation and HIV viral load (VL) monitoring in three West African countries.
METHODS
We used routinely collected data from five clinics contributing to the IeDEA collaboration in Burkina Faso, Côte d'Ivoire and Nigeria. We included ART-naïve adults living with HIV (ALWH) initiating ART from 01/01/2018. We conducted regression discontinuity analysis to estimate changes in the number of ART initiations and VL measures per week, before and during the pandemic period in each country.
RESULTS
In clinics in Burkina Faso and Côte d’Ivoire, ART initiations per week remained constant throughout the studied periods (-0.24 points (p) of ART initiations/week 95%CI -5.5, 5.9, -0.9 p 95%CI -8.5,8.6, respectively), whereas in Nigeria’s clinic, they decreased significantly (-6.3 p, 95% CI -10.8, -1.7) after the beginning of the pandemic. The volume of VL tests performed decreased significantly in all three countries (-17.0 p 95%CI -25.3, -8.6 in Burkina Faso, -118.4 p 95%CI -171.1, -65.8 in Côte d’Ivoire and -169.1p 95%CI-282.6, -55.6 in Nigeria).
CONCLUSIONS
Access to ART was maintained for newly diagnosed ALWH despite pandemic-related physical/social distancing measures. However, VL monitoring was severely disrupted and did not return to pre-pandemic levels approximately one year after the beginning of the pandemic. While HIV services in West Africa appear rather resilient, the impact of disruptions in VL monitoring on virological and clinical outcomes should continue to be monitored.
Efforts to control the COVID-19 pandemic have potentially compromised the availability and/or quality of HIV services. We aimed to assess the pandemic’s impact on ART initiation and HIV viral load (VL) monitoring in three West African countries.
METHODS
We used routinely collected data from five clinics contributing to the IeDEA collaboration in Burkina Faso, Côte d'Ivoire and Nigeria. We included ART-naïve adults living with HIV (ALWH) initiating ART from 01/01/2018. We conducted regression discontinuity analysis to estimate changes in the number of ART initiations and VL measures per week, before and during the pandemic period in each country.
RESULTS
In clinics in Burkina Faso and Côte d’Ivoire, ART initiations per week remained constant throughout the studied periods (-0.24 points (p) of ART initiations/week 95%CI -5.5, 5.9, -0.9 p 95%CI -8.5,8.6, respectively), whereas in Nigeria’s clinic, they decreased significantly (-6.3 p, 95% CI -10.8, -1.7) after the beginning of the pandemic. The volume of VL tests performed decreased significantly in all three countries (-17.0 p 95%CI -25.3, -8.6 in Burkina Faso, -118.4 p 95%CI -171.1, -65.8 in Côte d’Ivoire and -169.1p 95%CI-282.6, -55.6 in Nigeria).
CONCLUSIONS
Access to ART was maintained for newly diagnosed ALWH despite pandemic-related physical/social distancing measures. However, VL monitoring was severely disrupted and did not return to pre-pandemic levels approximately one year after the beginning of the pandemic. While HIV services in West Africa appear rather resilient, the impact of disruptions in VL monitoring on virological and clinical outcomes should continue to be monitored.
Journal Article > ResearchFull Text
J Acquir Immune Defic Syndr; JAIDS. 2011 March 1; Volume 56 (Issue 3); e75-e78.; DOI:10.1097/QAI.0b013e3182097505
Bygrave H, Ford NP, van Cutsem G, Hilderbrand K, Jouquet G, et al.
J Acquir Immune Defic Syndr; JAIDS. 2011 March 1; Volume 56 (Issue 3); e75-e78.; DOI:10.1097/QAI.0b013e3182097505
BACKGROUND
The latest World Health Organization guidelines recommend replacing stavudine with tenofovir or zidovudine in first-line antiretroviral therapy in resource-limited settings. We report on outcomes and toxicities among patients on these different regimens in a routine treatment cohort in Lesotho.
METHODS
All adult patients initiating antiretroviral therapy from January 1, 2008, to December 31, 2008, were included in the analysis and followed until December 31, 2009. Choice of regimen was determined by clinical criteria.
RESULTS
Of 1124 patient records analyzed, median age was 39 years, and the majority (67.7%) were women. Five hundred eighty-seven patients were started on tenofovir, 255 on zidovudine, and 282 on stavudine. Patients on zidovudine were more than twice as likely to experience a toxicity-driven regimen substitution compared with tenofovir (adjusted hazard ratio: 2.32, 95% confidence interval: 1.23 to 4.40); for patients on stavudine, the risk of a toxicity-driven regimen switch was almost 6 times higher than tenofovir (adjusted hazard ratio: 5.43, 95% confidence interval: 3.31 to 8.91).
CONCLUSIONS
Our findings support the latest World Health Organization Guidelines, in particular the adoption of tenofovir in first line, given the advantages in terms of tolerability and availability as a once-daily formulation.
The latest World Health Organization guidelines recommend replacing stavudine with tenofovir or zidovudine in first-line antiretroviral therapy in resource-limited settings. We report on outcomes and toxicities among patients on these different regimens in a routine treatment cohort in Lesotho.
METHODS
All adult patients initiating antiretroviral therapy from January 1, 2008, to December 31, 2008, were included in the analysis and followed until December 31, 2009. Choice of regimen was determined by clinical criteria.
RESULTS
Of 1124 patient records analyzed, median age was 39 years, and the majority (67.7%) were women. Five hundred eighty-seven patients were started on tenofovir, 255 on zidovudine, and 282 on stavudine. Patients on zidovudine were more than twice as likely to experience a toxicity-driven regimen substitution compared with tenofovir (adjusted hazard ratio: 2.32, 95% confidence interval: 1.23 to 4.40); for patients on stavudine, the risk of a toxicity-driven regimen switch was almost 6 times higher than tenofovir (adjusted hazard ratio: 5.43, 95% confidence interval: 3.31 to 8.91).
CONCLUSIONS
Our findings support the latest World Health Organization Guidelines, in particular the adoption of tenofovir in first line, given the advantages in terms of tolerability and availability as a once-daily formulation.
Journal Article > ResearchFull Text
J Acquir Immune Defic Syndr; JAIDS. 2021 December 15; Volume 88 (Issue 5); 506-517.; DOI:10.1097/QAI.0000000000002794
Kerschberger B, Aung A, Mpala Q, Ntshalintshali N, Mamba C, et al.
J Acquir Immune Defic Syndr; JAIDS. 2021 December 15; Volume 88 (Issue 5); 506-517.; DOI:10.1097/QAI.0000000000002794
BACKGROUND
The lack of acute and early HIV infection (AEHI) diagnosis and care contributes to high HIV incidence in resource-limited settings. We aimed to assess the yield, predict and diagnose AEHI, and describe AEHI care outcomes in a public sector setting in Eswatini.
SETTING
This study was conducted in Nhlangano outpatient department, from March 2019 to March 2020.
METHODS
Adults at risk of AEHI underwent diagnostic testing for AEHI with the quantitative Xpert HIV-1 viral load (VL) assay. AEHI was defined as the detection of HIV-1 VL on Xpert and either a HIV-seronegative/HIV-serodiscordant third-generation antibody-based rapid-diagnostic test (RDT) result. First, the cross-sectional analysis obtained the yield of AEHI and established a predictor risk score (PRS) for the prediction of AEHI using Lasso logistic regression. Second, diagnostic accuracy statistics described the ability of the fourth-generation antibody/p24 antigen-based Alere™HIV-Combo RDT to diagnose AEHI (vs Xpert VL testing). Third, we described AHI care outcomes of AEHI-positive patients using survival analysis.
RESULTS
Of 795 HIV-seronegative/HIV-serodiscordant outpatients recruited, 30 (3.8%, 95%CI 2.6-5.3%) had AEHI. The PRS contained several factors (HIV-serodiscordant RDT, women, feeling at risk of HIV, swollen glands, fatigue) and had a sensitivity and specificity of 83.3% and 65.8% to predict AEHI. The HIV-Combo RDT had a sensitivity and specificity of 86.2% and 99.9% to diagnose AEHI. Of 30 AEHI-positive patients, the 1-month cumulative treatment initiation was 74% (95%CI 57-88%), and the 3-month viral suppression (<1000 copies/mL) was 87% (67-98%).
CONCLUSION
AEHI diagnosis and care appears possible in resource-limited settings.
The lack of acute and early HIV infection (AEHI) diagnosis and care contributes to high HIV incidence in resource-limited settings. We aimed to assess the yield, predict and diagnose AEHI, and describe AEHI care outcomes in a public sector setting in Eswatini.
SETTING
This study was conducted in Nhlangano outpatient department, from March 2019 to March 2020.
METHODS
Adults at risk of AEHI underwent diagnostic testing for AEHI with the quantitative Xpert HIV-1 viral load (VL) assay. AEHI was defined as the detection of HIV-1 VL on Xpert and either a HIV-seronegative/HIV-serodiscordant third-generation antibody-based rapid-diagnostic test (RDT) result. First, the cross-sectional analysis obtained the yield of AEHI and established a predictor risk score (PRS) for the prediction of AEHI using Lasso logistic regression. Second, diagnostic accuracy statistics described the ability of the fourth-generation antibody/p24 antigen-based Alere™HIV-Combo RDT to diagnose AEHI (vs Xpert VL testing). Third, we described AHI care outcomes of AEHI-positive patients using survival analysis.
RESULTS
Of 795 HIV-seronegative/HIV-serodiscordant outpatients recruited, 30 (3.8%, 95%CI 2.6-5.3%) had AEHI. The PRS contained several factors (HIV-serodiscordant RDT, women, feeling at risk of HIV, swollen glands, fatigue) and had a sensitivity and specificity of 83.3% and 65.8% to predict AEHI. The HIV-Combo RDT had a sensitivity and specificity of 86.2% and 99.9% to diagnose AEHI. Of 30 AEHI-positive patients, the 1-month cumulative treatment initiation was 74% (95%CI 57-88%), and the 3-month viral suppression (<1000 copies/mL) was 87% (67-98%).
CONCLUSION
AEHI diagnosis and care appears possible in resource-limited settings.
Journal Article > ResearchAbstract Only
J Acquir Immune Defic Syndr; JAIDS. 2024 March 1; Volume 95 (Issue 3); 260-267.; DOI:10.1097/QAI.0000000000003341
van Heerden JK, Meintjes G, Barr D, Zhao Y, Griesel R, et al.
J Acquir Immune Defic Syndr; JAIDS. 2024 March 1; Volume 95 (Issue 3); 260-267.; DOI:10.1097/QAI.0000000000003341
BACKGROUND
Tenofovir diphosphate (TFV-DP) concentration in dried blood spots is a marker of long-term adherence. We investigated the relationship between TFV-DP concentrations and virological outcomes in participants initiating tenofovir–lamivudine–dolutegravir (TLD) as first-line or second-line antiretroviral therapy.
SETTING
Three primary care clinics in Khayelitsha, Cape Town, South Africa.
METHODS
We conducted a post hoc analysis of 2 randomized controlled trials of participants initiating TLD. TFV-DP concentrations and viral loads were measured at 12, 24, and 48 weeks. Multivariable logistic regression was performed to assess the association with virological suppression (<50 copies/mL) per natural logarithm increase in TFV-DP concentration. Generalized estimating equations with logit link were used to assess associations with virological rebound. The Akaike Information Criterion and Quasi-likelihood Information Criteria were used to compare models built on continuous TFV-DP data to 4 previously defined concentration categories.
RESULTS
We included 294 participants in the analysis, 188 (64%) of whom initiated TLD as second-line therapy. Adjusted odds ratios (95% CIs) of virological suppression were 2.12 (1.23, 3.75), 3.11 (1.84, 5.65), and 4.69 (2.81, 8.68) per natural logarithm increase in TFV-DP concentration at weeks 12, 24, and 48, respectively. In participants with virological suppression at week 12, the adjusted odds ratio for remaining virologically suppressed was 3.63 (95% CI: 2.21 to 5.69) per natural logarithm increase in TFV-DP concentration. Models using continuous TFV-DP data had lower Akaike Information Criterion and Quasi-likelihood Information Criteria values than those using categorical data for predicting virological outcomes.
CONCLUSION
TFV-DP concentrations in dried blood spots exhibit a dose–response relationship with viral load. Analyzing TFV-DP concentrations as continuous variables rather than conventional categorization may be appropriate.
Tenofovir diphosphate (TFV-DP) concentration in dried blood spots is a marker of long-term adherence. We investigated the relationship between TFV-DP concentrations and virological outcomes in participants initiating tenofovir–lamivudine–dolutegravir (TLD) as first-line or second-line antiretroviral therapy.
SETTING
Three primary care clinics in Khayelitsha, Cape Town, South Africa.
METHODS
We conducted a post hoc analysis of 2 randomized controlled trials of participants initiating TLD. TFV-DP concentrations and viral loads were measured at 12, 24, and 48 weeks. Multivariable logistic regression was performed to assess the association with virological suppression (<50 copies/mL) per natural logarithm increase in TFV-DP concentration. Generalized estimating equations with logit link were used to assess associations with virological rebound. The Akaike Information Criterion and Quasi-likelihood Information Criteria were used to compare models built on continuous TFV-DP data to 4 previously defined concentration categories.
RESULTS
We included 294 participants in the analysis, 188 (64%) of whom initiated TLD as second-line therapy. Adjusted odds ratios (95% CIs) of virological suppression were 2.12 (1.23, 3.75), 3.11 (1.84, 5.65), and 4.69 (2.81, 8.68) per natural logarithm increase in TFV-DP concentration at weeks 12, 24, and 48, respectively. In participants with virological suppression at week 12, the adjusted odds ratio for remaining virologically suppressed was 3.63 (95% CI: 2.21 to 5.69) per natural logarithm increase in TFV-DP concentration. Models using continuous TFV-DP data had lower Akaike Information Criterion and Quasi-likelihood Information Criteria values than those using categorical data for predicting virological outcomes.
CONCLUSION
TFV-DP concentrations in dried blood spots exhibit a dose–response relationship with viral load. Analyzing TFV-DP concentrations as continuous variables rather than conventional categorization may be appropriate.