Initiating the antiretroviral therapy in treatment-naïve patients (original) (raw)
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European journal of …, 2000
Objectives: To determine factors associated with beginning antiretroviral therapy and with the number of drugs used. Methods: Longitudinal study of 3169 HIV-infected individuals naõÈ ve from antiretroviral drugs at enrolment in 65 infectious disease clinics in Italy. Initiation of antiretroviral therapy and number of drugs used (i.e., <3 vs. P3 drugs) were the main outcome measures. Adjusted odds ratios were calculated by logistic models to establish cofactors of these two measures. Results: From January 1997 to December 1998, 1288 (40.6%) individuals started therapy, 58.0% of whom were given a triple combination regimen. This regimen became more frequent over time. By multivariate analysis, high levels of HIV-RNA and low CD4 counts were the most important independent predictors of starting any type of therapy. A signi®cant association was also found with HIV exposure category, reason for being antiretroviral-naõÈ ve, presence/absence of liver disease, presence/absence of a new AIDS-de®ning disease, and clinical centre. High levels of HIV-RNA and low CD4 counts were also the most important predictors of starting with P3 drugs, compared to <3 drugs, and men had an independent higher probability of starting with P3 drugs, compared to women. The probability of starting with P3 drugs signi®cantly increased with calendar time. Conclusions: CD4 and HIV-RNA were the main cofactors of initiating both any type of therapy and therapy with P3 drugs. The large variability among clinical centres suggests that clinicians are uncertain as to the exact timing of beginning therapy and the speci®c regimen, especially among women.
2000
Objectives: To determine factors associated with beginning antiretroviral therapy and with the number of drugs used. Methods: Longitudinal study of 3169 HIV-infected individuals naõÈ ve from antiretroviral drugs at enrolment in 65 infectious disease clinics in Italy. Initiation of antiretroviral therapy and number of drugs used (i.e., <3 vs. P3 drugs) were the main outcome measures. Adjusted odds ratios were calculated by logistic models to establish cofactors of these two measures. Results: From January 1997 to December 1998, 1288 (40.6%) individuals started therapy, 58.0% of whom were given a triple combination regimen. This regimen became more frequent over time. By multivariate analysis, high levels of HIV-RNA and low CD4 counts were the most important independent predictors of starting any type of therapy. A signi®cant association was also found with HIV exposure category, reason for being antiretroviral-naõÈ ve, presence/absence of liver disease, presence/absence of a new AIDS-de®ning disease, and clinical centre. High levels of HIV-RNA and low CD4 counts were also the most important predictors of starting with P3 drugs, compared to <3 drugs, and men had an independent higher probability of starting with P3 drugs, compared to women. The probability of starting with P3 drugs signi®cantly increased with calendar time. Conclusions: CD4 and HIV-RNA were the main cofactors of initiating both any type of therapy and therapy with P3 drugs. The large variability among clinical centres suggests that clinicians are uncertain as to the exact timing of beginning therapy and the speci®c regimen, especially among women.
2023
Introduction: HIV/AIDS progressively weakens immune system and make it susceptible to life threatening opportunistic infections, neurological disorders or certain unusual malignancies. Second-line ART is the next regimen used in sequence immediately after first-line therapy has failed. Hence, the criteria to switch to second line ART includes immunological and/or virological and/or clinical failure. Manipur is one of the high prevalence states for HIV infection in India. There is so far very little study and data regarding patients in the early phase of second line ART from this part of the country. The present study describes the clinical and immunological outcomes of PLHIV on PI-based second-line ART regimens in northeastern India thereby identifying the need of change to third line ART, at an early stage. In addition, it determined the WHO clinical staging, CD4 counts and plasma viral load of patients on second line ART at 0 and 6 months and to assess the adherence of patients on second line ART. Methods: This hospital based longitudinal study enrolled 73 HIV positive patients on second line ART, admitted in Medicine ward, attending Medicine OPD, Center of Excellence (Coe)ART Centre, Regional Institute of Medical Sciences (RIMS), Imphal, Manipur (RIMS) from January 2021 to October 2022. Blood samples were sent for CD4 count, and plasma viral load at baseline and after 6 months on second line ART. Results: The mean age group was 38.37±9.93 years, majority were males (n=56, 76%), the most common complaints were fever (27.40%), diarrhoea (20.55%) and the common source of infection was heterosexual and IVDU 38% and 32% respectively. The most common regime used was TDF+3TC+DTG (52%, 38). There was improvement in mean BMI {from 21.20(+1.69) to 22.3±1.58 kg/m 2 }, mean CD4 cell count (from 266 cells/mm 3 to 440 cells/mm 3), reduction in viral load from172, 892.7(+189,040.8) to 7349.65(+22,526.4), at end of 6 months. Viral components in
Choice of Initial Combination Antiretroviral Therapy in Individuals With HIV Infection
Archives of Internal Medicine, 2012
Background: Current guidelines give recommendations for preferred combination antiretroviral therapy (cART). We investigated factors influencing the choice of initial cART in clinical practice and its outcome. Methods: We analyzed treatment-naive adults with human immunodeficiency virus (HIV) infection participating in the Swiss HIV Cohort Study and starting cART from January 1, 2005, through December 31, 2009. The primary end point was the choice of the initial antiretroviral regimen. Secondary end points were virologic suppression, the increase in CD4 cell counts from baseline, and treatment modification within 12 months after starting treatment. Results: A total of 1957 patients were analyzed. Tenofovir-emtricitabine (TDF-FTC)-efavirenz was the most frequently prescribed cART (29.9%), followed by TDF-FTC-lopinavir/r (16.9%), TDF-FTC-atazanavir/r (12.9%), zidovudine-lamivudine (ZDV-3TC)-lopinavir/r (12.8%), and abacavir/lamivudine (ABC-3TC)-efavirenz (5.7%). Differences in prescription were noted among different Swiss HIV Cohort Study sites (P Ͻ.001). In multivariate analysis, compared with TDF-FTC-efavirenz, starting TDF-FTC-lopinavir/r was associated with prior AIDS (relative risk ratio, 2.78; 95% CI, 1.78-4.35), HIV-RNA greater than 100 000 copies/mL (1.53; 1.07-2.18), and CD4 greater than 350 cells/µL (1.67; 1.04-2.70); TDF-FTC-atazanavir/r with a depressive disorder (1.77; 1.04-3.01), HIV-RNA greater than 100 000 copies/mL (1.54; 1.05-2.25), and an opiate substitution program (2.76; 1.09-7.00); and ZDV-3TC-lopinavir/r with female sex (3.89; 2.39-6.31) and CD4 cell counts greater than 350 cells/µL (4.50; 2.58-7.86). At 12 months, 1715 patients (87.6%) achieved viral load less than 50 copies/mL and CD4 cell counts increased by a median (interquartile range) of 173 (89-269) cells/µL. Virologic suppression was more likely with TDF-FTC-efavirenz, and CD4 increase was higher with ZDV-3TC-lopinavir/r. No differences in outcome were observed among Swiss HIV Cohort Study sites. Conclusions: Large differences in prescription but not in outcome were observed among study sites. A trend toward individualized cART was noted suggesting that initial cART is significantly influenced by physician's preference and patient characteristics. Our study highlights the need for evidence-based data for determining the best initial regimen for different HIV-infected persons.
Virologic outcomes in early antiretroviral treatment: HPTN 052
HIV clinical trials, 2017
The HIV Prevention Trials Network (HPTN) 052 trial demonstrated that early antiretroviral therapy (ART) prevented 93% of HIV transmission events in serodiscordant couples. Some linked infections were observed shortly after ART initiation or after virologic failure. To evaluate factors associated with time to viral suppression and virologic failure in participants who initiated ART in HPTN 052. 1566 participants who had a viral load (VL) > 400 copies/mL at enrollment were included in the analyses. This included 832 in the early ART arm (CD4 350-550 cells/mm(3) at ART initiation) and 734 in the delayed ART arm (204 with a CD4 < 250 cells/mm(3) at ART initiation; 530 with any CD4 at ART initiation). Viral suppression was defined as two consecutive VLs ≤ 400 copies/mL after ART initiation; virologic failure was defined as two consecutive VLs > 1000 copies/mL > 24 weeks after ART initiation. Overall, 93% of participants achieved viral suppression by 12 months. The annual inci...
AIDS, 2020
Objectives: Antiretroviral treatment (ART) during acute/recent HIV infection decreases transmission and optimizes immune recovery but the optimal ART-regimen in this setting is unknown. The objectives were to analyze the virological efficacy, immunological reconstitution and tolerability of different ART-regimens at 3 years after starting ART during acute/recent HIV infection. Design: Retrospective cohort study of consecutive acutely/recently infected patients who started ART within 6 months postinfection. Methods: We compared regimens based on protease-inhibitors (N ¼ 28), integrasestrand-transfer-inhibitors (InSTI, N ¼ 87) and nonnucleoside-reverse-transcriptase-inhibitors (N ¼ 22). Virological suppression (viral load <50 copies/ml), immune reconstitution (CD4 þ T-cell count >900 cells/ml and CD4 þ /CD8 þ ratio >1) and adverse events leading to ART discontinuation at 1 and 3 years were compared. Results: Baseline characteristics were comparable among groups. Overall viral suppression at 1 (96%) and 3 years (99%) was comparable in all ART regimens and, InSTI group, comparable for dolutegravir and elvitegravir within InSTIs. CD4 þ T-cell counts at 1 year were comparable in all ART regimens. Overall proportion of patients reaching CD4 þ cell count more than 900 cells/ml and CD4 þ /CD8 þ ratio more than 1 was 36% and 40% and 46% and 63% at 1 and 3 years, respectively with no differences among ART regimens. Starting ART during the earliest Fiebig stages (I-V vs. VI) was associated with higher rates of CD4 þ cell count more than 900 cells/ml at 3 years (P ¼ 0.027). Discontinuation due to adverse events was more frequent with nonnucleoside-reversetranscriptase-inhibitors compared with other ART classes.
Comparative Effectiveness of Initial Antiretroviral Therapy Regimens
JAIDS Journal of Acquired Immune Deficiency Syndromes, 2011
Corresponding author: Michael J. Mugavero, MD, MHSc, CCB 142, 908 20 th St South, Background-The generalizability of antiretroviral therapy (ART) clinical trial efficacy findings to routine care settings is not well studied. We compared the relative effectiveness of initial ART regimens estimated in AIDS Clinical Trial Group (ACTG) randomized controlled trials with that among patients receiving ART at Antiretroviral Therapy Cohort Collaboration (ART-CC) study sites.
Journal of Antimicrobial Chemotherapy, 2020
ObjectivesWe compared 48 week effectiveness and safety of first-line antiretroviral regimens.MethodsWe analysed HIV treatment-naive adults from the Cohort of the Spanish HIV/AIDS Research Network (CoRIS) starting the most commonly used antiretroviral regimens from 2014 to 2018. We used multivariable regression models to assess the impact of initial regimen on: (i) viral suppression (VS) (viral load <50 copies/mL); (ii) change in CD4 cell count; (iii) CD4/CD8 normalization (>0.4 and >1); (iv) CD4 percentage normalization (>29%); (v) multiple T-cell marker recovery (MTMR: CD4 > 500 cells/mm3 plus CD4 percentage >29% plus CD4/CD8 > 1); (vi) lipid, creatinine and transaminase changes; and (vii) discontinuations due to adverse events (AE).ResultsAmong 3945 individuals analysed, the most frequently prescribed regimens were ABC/3TC/DTG (34.0%), TAF/FTC/EVG/CBT (17.2%), TDF/FTC + DTG (11.9%), TDF/FTC/EVG/CBT (11.7%), TDF/FTC/RPV (11.5%), TDF/FTC + bDRV (8.3%) and TDF/FT...
AIDS, 2003
Background: Antiretroviral Therapy(ART) remarkably reduced HIV-1 infection-related mortality in children. The efficacy and safety of different ART regimen in pediatric age groups remained issues of debates and available evidence were scarce especially among children taking the of one the two prototypes (NVP or EFV) Non-Nucleoside Reverse Transcriptase Inhibitor(NNRTI) as backbone of ART regimen. Therefore, the objective of this study was to compare clinical, immunological and virological responses of zidovudine-lamivudinenevirapine (AZT+3TC+ NVP) versus zidovudine-lamivudine-efavirenz (AZT+3TC+EFV) ART regimen among HIV-1 infected children. Methods: A retrospective cross-sectional study was done by reviewing medical records of the patients to evaluate clinical, immunological and virological outcomes of NVP+AZT+3TC versus EFV+AZT+3TC ART regimen among HIV-1 infected children. Data were entered into Epi-info version 7.2.2 for clean up and exported to SPSS version 17 for analysis. Paired and Independent t-tests were used to compare the CD4 cell count, weight and virologic level at six months with corresponding baseline value; and the mean weight, CD4 gain and viral suppression across the two ART regimens at six months of ART respectively. Results: Medical records of 122 patients from NVP-based regimen and 61 patients from EFV group were reviewed. After six months of NVP+AZT+3TC treatment, the mean CD4 cell count difference from baseline was 215(95% CI, 175.414-245.613, p<0.001). From EFV+AZT+3TC group, the mean CD4 cell count difference from baseline was 205(95% CI 155.404-235.623, p< 0.001). The mean CD4 count difference between the two regimens was comparable (p 0.145). Similarly, optimal viral suppression was achieved in 82% (100/122) of NVP+AZT+3TC regimen and 83% (44/61) of EFV+AZT+3TC regimen which was still comparable across the two groups. Conclusion: There was no difference in clinical, immunological and virological outcomes among patients taking NVP+AZT+3TC or EFV+AZT+3TC ART regimen.