Lower Pill Burden and Once-Daily Antiretroviral Treatment Regimens for HIV Infection: A Meta-Analysis of Randomized Controlled Trials

Nachega, Jean B.; Parienti, Jean Jacques; Uthman, Olalekan A.; Gross, Robert; Dowdy, David W.; Sax, Paul E.; Gallant, Joel E.; Mugavero, Michael J.; Mills, Edward J.; Giordano, Thomas P.

doi:10.1093/cid/ciu046

Cited by 294 publications

(250 citation statements)

References 76 publications

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“…Although once daily dose is the goal to improve adherence, it is not always superior to twice daily dosing in terms of virologic success. In fact Nachega et al evidenced that once daily therapy is associated with better adherence but not with better virologic results in a systematic review of 19 clinical trials [23]. Another recent study by Arroyo et al found no difference in adherence rates in patients receiving once or twice daily regimens [24].…”

Section: Discussionmentioning

confidence: 99%

Efficacy and tolerability of switching to a dual therapy with darunavir/ritonavir plus raltegravir in HIV-infected patients with HIV-1 RNA ≤50 cp/mL

et al. 2017

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raltegravir (RAL) while having a viral load (VL) ≤50 copies/mL in the clinical setting. Study design Treatment-experienced HIV 1-infected patients enrolled in the ICONA Foundation Study cohort were included if they switched their current regimen to DRV/r + RAL with a HIV-RNA ≤50 copies/mL. Different definitions of virological failure (VF) and treatment failure (TF) were employed. Kaplan-Meier curves and Cox regression models were performed to estimate time to event probability. Results We included 72 HIV-infected patients, 22 (31%) of these were female, 31 (43%) men who have sex with men (MSM) amd 15 (21%) had hepatitis co-infections. Median age was 44 (IQR: 35-50) years amd CD4 count was 389 (IQR 283-606) cells/mmc. Median follow-up time for TF was 24 (IQR 9-31) months. Twenty-five discontinuations occurred (60% simplifications); only 2 (8%) were toxicity-driven (lipid elevations). The probability of VF (confirmed VL >50 copies/mL) was estimated at 7% [95% confidence interval (CI) 1-13%] by 12 and 9% (95% CI 2-16%) by 24 months. When considering TF, we found a probability of stop/intensification/single VL > 200 copies/ mL of 13% (95% CI 1-17%) and 22% (95% CI 11-33%) by 12 and 24 months. Female gender (adjusted relative hazard, ARH = 0.10; 95% CI 0.01-0.74; p = 0.024) and older age (AHR = 0.50 per 10 years older; 95% CI 0.25-0.99; p = 0.045) were associated with a lower risk of TF. A previous PI failure was strongly associated with TF (AHR = 52.6, 95% CI 3.6-779; p = 0.004). Conclusions DRV/r + RAL is a valuable NRTI-sparing option, especially in female and older patients, with a relatively low risk of VF and good tolerability after 2 years since start in an ART-experienced population. However, previous PI-failure should be a limiting factor for this strategy. AbstractBackground Nucleos(t)ide reverse transcriptase inhibitors (NRTI) toxicity may represent a threat for long-term success of combined antiretroviral therapy. Some studies have suggested a possible improvement of NRTI-related toxicity after switching to NRTI-sparing regimens. Objectives We aimed to explore the efficacy and tolerability of switching to darunavir/ritonavir (DRV/r) plus

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Section: Discussionmentioning

confidence: 99%

Efficacy and tolerability of switching to a dual therapy with darunavir/ritonavir plus raltegravir in HIV-infected patients with HIV-1 RNA ≤50 cp/mL

et al. 2017

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“…oral versus gastrostomy). A recent meta‐analysis of RCTs in adults has highlighted that once‐daily regimens and lower pill burden are associated with better adherence, the latter also being associated with better virological suppression 97.…”

Section: Adherence and Hiv Knowledgementioning

confidence: 99%

Paediatric European Network for Treatment of AIDS (PENTA) guidelines for treatment of paediatric HIV‐1 infection 2015: optimizing health in preparation for adult life

et al. 2015

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The 2015 Paediatric European Network for Treatment of AIDS (PENTA) guidelines provide practical recommendations on the management of HIV‐1 infection in children in Europe and are an update to those published in 2009. Aims of treatment have progressed significantly over the last decade, moving far beyond limitation of short‐term morbidity and mortality to optimizing health status for adult life and minimizing the impact of chronic HIV infection on immune system development and health in general. Additionally, there is a greater need for increased awareness and minimization of long‐term drug toxicity. The main updates to the previous guidelines include: an increase in the number of indications for antiretroviral therapy (ART) at all ages (higher CD4 thresholds for consideration of ART initiation and additional clinical indications), revised guidance on first‐ and second‐line ART recommendations, including more recently available drug classes, expanded guidance on management of coinfections (including tuberculosis, hepatitis B and hepatitis C) and additional emphasis on the needs of adolescents as they approach transition to adult services. There is a new section on the current ART ‘pipeline’ of drug development, a comprehensive summary table of currently recommended ART with dosing recommendations. Differences between PENTA and current US and World Health Organization guidelines are highlighted and explained.

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“…Since the arrival of triple therapy, the challenge of sustained and complete viral suppression has been solved for the majority of patients [1]. The major limiting factors for improving the long-term success of ART are tolerability and convenient pill burden [2]. The latest class of the antiretroviral drugs developed was integrase inhibitors (INI).…”

Section: Introductionmentioning

confidence: 99%

Simultaneous Estimation of Lamivudine, Abacavir and Dolutegravir by Uplc Method

Dubey¹,

Duggirala²

2018

Int J App Pharm

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Objective: To develop a simple, rapid, sensitive and effective reverse phase ultra-performance liquid chromatographic method (RP-UPLC) for simultaneous quantification of lamivudine, abacavir and dolutegravir in pure and tablet dosage forms. Methods:Chromatographic separation was performed by using Waters-ACQUITY UPLC system equipped with auto sampler, photodiode array (PDA) detector, zodiac sil RP C18 (4.6 mm × 250 mm, 3.0 µm) column, phosphate buffer (pH 3.0) and methanol in the ratio of 30:70 %v/v have been delivered at a flow rate of 0.25 ml/min and the detection was carried out using a Ultraviolet (UV) detector at a wavelength of 260 nm at ambient column temperature. The mobile phase was used as diluent. Results:The retention time (Rt) for lamivudine, abacavir and dolutegravir were 1.763, 2.247 and 3.175 min respectively. A good linear response was obtained in the range of 15-75 µg/ml, 30-150 µg/ml and 2.5-12.5 µg/ml, respectively. The Limit of Detection (LOD) values were found to be 0.021, 0.330 and 0.038 µg/ml, respectively and the Limit of Quantitation (LOQ) values were 0.056, 1.320 and 0.095 µg/ml, respectively. Conclusion:It was concluded that the developed RP-UPLC method was effective, suitable and conducive for analyzing lamivudine, abacavir and dolutegravir in pharmaceutical formulations. The method was quantitatively evaluated in terms of precision, linearity, accuracy (recovery), selectivity and robustness in accordance with standard guidelines.

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Lower Pill Burden and Once-Daily Antiretroviral Treatment Regimens for HIV Infection: A Meta-Analysis of Randomized Controlled Trials

Cited by 294 publications

References 76 publications

Efficacy and tolerability of switching to a dual therapy with darunavir/ritonavir plus raltegravir in HIV-infected patients with HIV-1 RNA ≤50 cp/mL

Efficacy and tolerability of switching to a dual therapy with darunavir/ritonavir plus raltegravir in HIV-infected patients with HIV-1 RNA ≤50 cp/mL

Paediatric European Network for Treatment of AIDS (PENTA) guidelines for treatment of paediatric HIV‐1 infection 2015: optimizing health in preparation for adult life

Simultaneous Estimation of Lamivudine, Abacavir and Dolutegravir by Uplc Method

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