Antiretroviral pill count and clinical outcomes in treatment‐naïve patients with <scp>HIV</scp> infection

Young, Jim; Smith, Colette; Teira, Ramón; Reiss, Peter; Vera, Inmaculada Jarrín; Crane, Heidi; Miró, José M.; Monforte, Antonella d’Arminio; Saag, M; Zangerle, Robert; Bucher, Heiner C.

doi:10.1111/hiv.12562

Cited by 9 publications

(5 citation statements)

References 47 publications

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“…Another finding that indicates the difficult management of these patients is the high number of concomitant medications. Indeed, while in non-advanced naïve patients we still discuss on the role of a single tablet regimen compared to more pills, the picture in late presenters is completely different [29]. Moreover, this high number of co-medications and the complex clinical picture could explain the onset of side effects that are really difficult to ascribe to a single antiretroviral drug.…”

Section: Discussionmentioning

confidence: 99%

A prospective randomized trial on abacavir/lamivudine plus darunavir/ritonavir or raltegravir in HIV-positive drug-naïve patients with CD4<200 cells/uL (the PRADAR study)

et al. 2019

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BackgroundVery few data are available on treatment in HIV Late presenter population that still represents a clinical challenge.MethodsProspective, multicenter, randomized open-label, 2 arm, phase-3 trial comparing the 48-week virological response of two different regimens: abacavir/lamivudine + darunavir/r vs abacavir/lamivudine + raltegravir in antiretroviral naive with CD4+ counts < 200/mm3 and a viral load (VL)<500,000 copies/mL. The primary Endpoint was the proportion of patients with undetectable viremia (VL<50 copies/mL) after 48 weeks. The planned sample size for this trial was 350 patients.ResultsIn 3 years, 53 patients were screened and 46 enrolled: 22 randomized to raltegravir and 24 to darunavir/r; 7 patients were excluded, 4 because of a VL >500,000 copies/mL and 3 for HLAB5701 positivity. The snapshot analysis at 48 weeks showed a virologic success of 77.3% in raltegravir and 66.7% in darunavir/r. Time to starting treatment was 34.5 days in raltegravir and 53 days in darunavir/r. At the as treated analysis, the median CD4 counts at 48 weeks was 297 cells/μL in raltegravir and 239 cells/μL in darunavir/r. No difference in total cholesterol, while triglycerides were higher in the darunavir/r arm. No statistical analyses were performed due to the low number of patients enrolled.ConclusionsLate presenter patients are frequent but very difficult to enroll in clinical trials, especially in western countries. These regimens and the conditions of many patients could not allow the test and treat strategy. The rate of virologic success was higher than 65% in both arms with a median CD4 cell count >200/μL at week 48.Trial registrationEUDRACT number: 2011-005973-21

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Section: Discussionmentioning

confidence: 99%

A prospective randomized trial on abacavir/lamivudine plus darunavir/ritonavir or raltegravir in HIV-positive drug-naïve patients with CD4<200 cells/uL (the PRADAR study)

et al. 2019

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“…By comparison, in an observational study of treatment-naive patients, the estimated risk difference for virologic failure was 3.4% when taking a single tablet rather than a three-pill efavirenz-based regimen for one year. 34 In randomised trials in naïve patients or those simplifying ART, it has been difficult to show any advantage of STR over MTR with respect to virologic suppression. Since virologic failure rates are so low with all modern ART regimens, any differences are generally driven by tolerability of trial regimens.…”

Section: Discussionmentioning

confidence: 99%

Virological Outcomes After Switching to Abacavir/Lamivudine/Dolutegravir Combined with Adherence Support in People Living with HIV with Poor Adherence: A Phase IV, Multicentre Randomized Prospective Open Label Study (TriiADD-CTN 286)

Klein¹,

Young²,

Ortiz-Paredes³

et al. 2022

PPA

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Background Many people living with HIV struggle to consistently adhere to antiretroviral therapy, fail to achieve long-term virologic control and remain at risk for HIV-related disease progression, development of resistance and may transmit HIV infection to others. Objective To determine if switching from current multi-tablet (curART) to single-tablet antiretroviral therapy (abacavir/lamivudine/dolutegravir; ABC/3TC/DTG), both combined with individualized adherence support, would improve HIV suppression in non-adherent vulnerable populations. Methods TriiADD was an investigator-initiated randomized, multicentre, open label study. HIV+ adults with documented non-adherence on curART were randomized in a 1:1 ratio to immediately switch to ABC/3TC/DTG or to continue curART. Both arms received adherence support. The primary outcome was the proportion of participants in each arm with HIV RNA < 50 copies/mL 24 weeks after randomization. Results In total, 50 people were screened and 27 randomized from 11 sites across Canada before the trial was stopped early due to slow recruitment. Participants were predominantly from ethnocultural communities, Indigenous people and/or had a history of injection drug use. The proportion achieving HIV RNA < 50 copies/mL at week 24 was 4/12 (33%) in the curART arm vs 7/13 (54%) in the ABC/3TC/DTG arm; median Bayesian risk difference, 5% (95% CrI, −17 to 28%) higher for those randomized to ABC/3TC/DTG. We encountered difficulties with recruitment of participants without prior drug resistance, retention despite intensive support, reliably measuring adherence and in overcoming entrenched adherence barriers. Conclusion Results of our trial are consistent with a slight improvement in viral suppression in a vulnerable population when a single tablet regimen is combined with patient-level adherence support. Beyond treatment simplicity and tolerability, tailored interventions addressing stigma and social determinants of health are still needed. The numerous challenges we encountered illustrate how randomised trials may not be the best approach for assessing adherence interventions in vulnerable populations.

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Section: Discussionmentioning

confidence: 99%

“…Owing to the special requirements for consistent compatibility and effectiveness of cART, a continuing controversy concerns the safety of a substance exchange even in the case of generics with identical active ingredients [50][51][52]. Some studies have described risks for sustainability of virological control by cART when the generic drug was associated with a higher number of pills [50,53]. Other studies found no difference in efficacy when switching to generic drugs [51] or considered concerns to be unfounded even against multiple exchanges, as long as the bioequivalence of the prescribed generic medicines was ensured [54].…”

Section: Discussionmentioning

confidence: 99%

Budget Impact Analysis Highlighting the Cost-Saving Potential of Generic Tenofovir Disoproxil Based Antiretroviral Therapy in Comparison with Tenofovir Alafenamide Based Treatment Regimens in the German Healthcare System

Stoll¹,

Balkin²,

Goldbach³

et al. 2017

J AIDS Clin Res

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Objective: The fixed dose combination (FDC) of tenofovir disoproxil (TD) fumarate/emtricitabine (FTC) has been the most widely used backbone treatment for HIV until recently. In 2016, tenofovir alafenamide (TAF)/FTC became available as FDC, which promises superior renal and bone safety. However, in November 2016, the German Federal Joint Committee concluded that there is no additional benefit to the use of TAF versus TD fumarate. The decision of choosing TD or TAF in FDC with FTC is of economic impact as cost-saving generics (Gx-TD/FTC) became available in Germany in August 2017. Methods:A budget impact analysis (BIA) was conducted to estimate the impact of Gx-TD/FTC on the German healthcare system for 5-years. The BIA compared a theoretical setting with and without introduction of Gx-TD/FTC; calculating the respective costs for antiretroviral treatment, monitoring, and adverse event management.Results: Based on the model assumptions, low and high values of year-wise savings with Gx-TD/FTC throughout 5 years were estimated. The scenario of Gx-TD/FTC use growing to 35% by year 5, deemed the most realistic scenario(switch from TDF/FTC to Gx-TD/FTC only), would result in a saving of €22.6 million in first year and a maximum saving of €31.8 million by second year. In a maximum patient share scenario (80%) for Gx-TD/FTC which includes switch from branded TD fumarate/FTC and TAF/FTC, savings increased from €22.6 million annually to a maximum of €62.1 million. Conclusion:The estimated savings are based on a conservative approach and will be higher with increasing generic price rebates. Additionally, this analysis makes cautious assumptions in favor of patient safety and care pathways. This analysis highlights the potential for substantial and sustainable cost savings by the use of Gx-TD/FTC for the German healthcare system which is most pronounced when patients from branded TD fumarate/FTC and TAF/ FTC are switched to this generic treatment.

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Antiretroviral pill count and clinical outcomes in treatment‐naïve patients with HIV infection

Abstract: This particular single-tablet regimen is associated with a modest decrease in the risk of AIDS or death relative to multiple-pill formulations.

Cited by 9 publications

References 47 publications

A prospective randomized trial on abacavir/lamivudine plus darunavir/ritonavir or raltegravir in HIV-positive drug-naïve patients with CD4<200 cells/uL (the PRADAR study)

A prospective randomized trial on abacavir/lamivudine plus darunavir/ritonavir or raltegravir in HIV-positive drug-naïve patients with CD4<200 cells/uL (the PRADAR study)

Virological Outcomes After Switching to Abacavir/Lamivudine/Dolutegravir Combined with Adherence Support in People Living with HIV with Poor Adherence: A Phase IV, Multicentre Randomized Prospective Open Label Study (TriiADD-CTN 286)

Budget Impact Analysis Highlighting the Cost-Saving Potential of Generic Tenofovir Disoproxil Based Antiretroviral Therapy in Comparison with Tenofovir Alafenamide Based Treatment Regimens in the German Healthcare System

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