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Nationwide Cohort Study of Antiretroviral Therapy Timing: Treatment Dropout and Virological Failure in China, 2011-2015.

ABSTRACT: Background:People living with human immunodeficiency virus (PLWH) are still being diagnosed late, rendering the benefits of "early" antiretroviral therapy (ART) unattainable. Therefore, we aimed to evaluate the benefits of "immediate" ART. Methods:A nationwide cohort of PLWH in China who initiated ART January 1, 2011, to December 31, 2014 and had baseline CD4 results >200 cells/?L were censored at 12 months, dropout, or death, whichever came first. Treatment dropout and virological failure (viral load ?400 copies/mL) were measured. Determinants were assessed by Cox and log-binomial regression. Results:The cohort included 123605 PLWH. The ?30 days group had a significantly lower treatment dropout rate of 6.72%, compared to 8.91% for the 91-365 days group and to 12.64% for the >365 days group. The ?30 days group also had a significantly lower virological failure rate of 5.45% (31-90 days: 7.39%; 91-365 days: 9.64%; >365 days: 12.67%). Greater risk of dropout (91-365 days: adjusted hazard ratio [aHR] = 1.33, 95% confidence interval [CI] = 1.25-1.42; >365 days: aHR = 1.55, CI = 1.47-1.54), and virological failure (31-90 days: adjusted risk ratio [aRR] = 1.35, CI = 1.26-1.45; 91-365 days: aRR = 1.66, CI = 1.55-1.78; >365 days: aRR = 1.85, CI = 1.74-1.97) were observed for those who delayed treatment. Conclusions:ART within 30 days of HIV diagnosis was associated with significantly reduced risk of treatment failure, highlighting the need to implement test-and-immediately-treat policies.

SUBMITTER: Zhao Y

PROVIDER: S-EPMC6293037 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Nationwide Cohort Study of Antiretroviral Therapy Timing: Treatment Dropout and Virological Failure in China, 2011-2015.

Zhao Yan Y Wu Zunyou Z McGoogan Jennifer M JM Sha Yiyi Y Zhao Decai D Ma Ye Y Brookmeyer Ron R Detels Roger R Montaner Julio S G JSG

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20190101 1

<h4>Background</h4>People living with human immunodeficiency virus (PLWH) are still being diagnosed late, rendering the benefits of "early" antiretroviral therapy (ART) unattainable. Therefore, we aimed to evaluate the benefits of "immediate" ART.<h4>Methods</h4>A nationwide cohort of PLWH in China who initiated ART January 1, 2011, to December 31, 2014 and had baseline CD4 results >200 cells/μL were censored at 12 months, dropout, or death, whichever came first. Treatment dropout and virologica ...[more]

PMID: 29771296

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Project description:Stavudine (D4T), zidovudine (AZT), and tenofovir (TDF) along with lamivudine (3TC) are the most widely used HIV treatment regimens in China. China's National Free Antiretroviral Treatment Programme (NFATP) has replaced D4T with AZT or TDF in the standard first-line regimens since 2010. Few studies have evaluated the adherence, virological outcome, and drug resistance in HIV patients receiving first-line antiretroviral therapy (ART) from 2011 to 2015 due to changes in ART regimen.From 2011 to 2015, 2787 HIV patients were examined, with 364, 1453, and 970 patients having initiated D4T-, AZT-, and TDF-based first-line ART regimens, respectively. The Cochran-Armitage test was used to examine the trends in clinical and virological outcomes during 2011 to 2015. Logistic regression was used to examine the effects of different regimens after 9 to 24 months of ART.From 2011 to 2014-2015, adverse drug reactions decreased from 18.9% to 6.7%, missed doses decreased from 9.9% to 4.6%, virological failure decreased from 16.2% to 6.4%, and drug resistance rates also significantly decreased from 5.4% to 1.1%. These successes were strongly associated with the standardized use of TDF- or AZT-based regimens in place of the D4T-based regimen. Poor adherence decreased from 11.3% in patients who initiated D4T-based regimens to 4.9% in those who initiated TDF-based regimens, adverse drug reactions decreased from 32.4% to 6.7%, virological failure reduced from 18.7% to 8.6%, and drug resistance reduced from 5.8% to 2.9%. Compared with patients who initiated AZT-based regimens, patients who initiated TDF-based regiments showed significant reductions in adherence issues, adverse drug reactions, virological outcomes, and drug resistance. Significant differences were also observed between those who initiated D4T- and AZT-based regimens.The good control of HIV replication and drug resistance was attributed to the success of China's NFATP from 2011 to 2015. This study provided real world evidence for further scaling up ART and minimizing the emergence of drug resistance in the "Three 90" era.

Project description:BackgroundHIV viral load (VL) is an important indicator to monitor treatment response in antiretroviral therapy (ART). Patients on ART may experience viral blips, with low-level elevations of VL between 50 and 999 copies/mL known as low-level viraemia (LLV), but not reaching the threshold for virological failure (≥1,000 copies/mL) defined by WHO guidelines. The objective was to investigate the long-term impact of LLV on virological failure.MethodsWe analyzed adults who were ART naïve at baseline. LLV was defined as having an VL of 51-999 copies/mL at least once. The subjects with LLV were grouped into three categories: 51-199, 200-399, and 400-999 copies/mL. Patients with multiple episodes of LLV were classified based on the highest VL result. The subjects with LLV were also grouped by the frequency of LLV, i.e., a single episode, two consecutive episodes, two intermittent episodes, more than two consecutive episodes, and more than two intermittent episodes. Multivariable Cox models were used to predict the association of LLV with virological failure.ResultsA total of 93,944 subjects were included. The median number of VL tests performed was 3. There were 21,203 LLV cases, with an overall incidence of 22.6%. Most of the LLV cases were found in subjects with LVs of 50-199 copies/mL, followed by 400-999 and 200-399 copies/mL. Most of the LLV cases experienced single episodes, and the numbers of LLV with two consecutive episodes, two intermittent episodes, more than two consecutive episodes and more than two intermittent episodes were decreased successively. The risk factors associated with virological failure include: intermediate-level (200-399 copies/mL) and high-level (400-999 copies/mL) LLV, single episodes of LLV and two or more than two consecutive episodes of LLV, which may put the subjects at a 1.28-2.26-fold higher risk for virological failure.ConclusionStrengthened immediate medical attention should be placed on patients with VL of 200-999 copies/mL. The patients having experienced LLV once should be targeted for case management and repeat VL testing within 24 weeks to determine persistent LLV and monitor virological failure.

Project description:BackgroundProgress toward the global target for 95% virological suppression among those on antiretroviral treatment (ART) is still suboptimal. We describe the viral load (VL) cascade, the incidence of virological failure and associated risk factors among people living with HIV receiving first-line ART in an HIV cohort in Myanmar treated by the Médecins Sans Frontières in collaboration with the Ministry of Health and Sports Myanmar.MethodsWe conducted a retrospective cohort study, including adult patients with at least one HIV viral load test result and having received of at least 6 months' standard first-line ART. The incidence rate of virological failure (HIV viral load ≥ 1000 copies/mL) was calculated. Multivariable Cox's regression was performed to identify risk factors for virological failure.ResultsWe included 25,260 patients with a median age of 33.1 years (interquartile range, IQR 28.0-39.1) and a median observation time of 5.4 years (IQR 3.7-7.9). Virological failure was documented in 3,579 (14.2%) participants, resulting in an overall incidence rate for failure of 2.5 per 100 person-years of follow-up. Among those who had a follow-up viral load result, 1,258 (57.1%) had confirmed virological failure, of which 836 (66.5%) were switched to second-line treatment. An increased hazard for failure was associated with age ≤ 19 years (adjusted hazard ratio, aHR 1.51; 95% confidence intervals, CI 1.20-1.89; p < 0.001), baseline tuberculosis (aHR 1.39; 95% CI 1.14-1.49; p < 0.001), a history of low-level viremia (aHR 1.60; 95% CI 1.42-1.81; p < 0.001), or a history of loss-to-follow-up (aHR 1.24; 95% CI 1.41-1.52; p = 0.041) and being on the same regimen (aHR 1.37; 95% CI 1.07-1.76; p < 0.001). Cumulative appointment delay was not significantly associated with failure after controlling for covariates.ConclusionsVL monitoring is an important tool to improve programme outcomes, however limited coverage of VL testing and acting on test results hampers its full potential. In our cohort children and adolescents, PLHIV with history of loss-to-follow-up or those with low-viremia are at the highest risk of virological failure and might require more frequent virological monitoring than is currently recommended.

Project description:BackgroundPeople with HIV-1 in low-income and middle-income countries increasingly need second-line regimens with boosted protease inhibitors. However, data are scarce for treatment response in patients with HIV-1 subtype C (HIV-1C), which is predominant in these regions. We aimed to examine factors associated with virological failure in patients in a standardised national health-care setting.MethodsWe analysed data for participants in InfCare HIV, a prospective national cohort that includes more than 99% of people with HIV in Sweden. We extracted data for the cohort from the InfCare HIV database on Jan 14, 2015. Baseline was initiation of antiretroviral therapy. We used logistic regression to assess factors associated with primary virological failure (failure to suppress HIV-1 within 9 months) in patients with HIV-1B and HIV-1C and calculated odds ratios (OR) for failure. We also used Cox regression models to calculate hazard ratios (HR) for time-to-secondary virological failure (detectable viral load after initial virological suppression). We did homology-based molecular modelling to assess docking.FindingsWe included 1077 patients with HIV-1B and 596 with HIV-1C. In multivariate regression analysis, pre-therapy higher viral load (OR 1·82, 95% CI 1·49-2·21; p<0·0001), subtype C infection (1·75, 1·06-2·88; p=0·028), and boosted protease inhibitor-based regimens (1·55, 1·45-2·11; p=0·004) were associated with increased risk of primary virological failure. Individuals with HIV-1C who were given therapy with boosted protease inhibitors had earlier time-to-secondary virological failure than did those with HIV-1B given similar regimens (adjusted HR 1·92, 95% CI 1·30-2·83; p=0·002). Molecular modelling suggested lower affinity for protease inhibitors to HIV-1C protease than to HIV-1B.InterpretationOur findings suggest an increased risk of virological failure in patients with HIV-1C, especially in those on boosted protease inhibitor-based regimens. Future studies should further dissect the biochemical and viral mechanisms of resistance to protease inhibitors in patients with non-B subtypes of HIV-1, including clinical studies to assess the efficacy of boosted protease inhibitor-based regimens in low-income and middle income countries.FundingKarolinska Institutet Research Foundation, Swedish Research Council, Stockholm County Council, Swedish Physicians against AIDS, US National Institutes of Health, University of Missouri.

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Nationwide Cohort Study of Antiretroviral Therapy Timing: Treatment Dropout and Virological Failure in China, 2011-2015.

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Nationwide Cohort Study of Antiretroviral Therapy Timing: Treatment Dropout and Virological Failure in China, 2011-2015.

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