Antiretroviral Concentrations in Hair Strongly Predict Virologic Response in a Large Human Immunodeficiency Virus Treatment-naive Clinical Trial

Gandhi, Monica; Bacchetti, Peter; Ofokotun, Igho; Jin, Chengshi; Ribaudo, Heather J.; Haas, David W.; Sheth, Anandi N.; Horng, Howard; Phung, Nhi; Kuncze, Karen; Okochi, Hideaki; Landovitz, Raphael J.; Lennox, Jeffrey L.; Currier, Judith S.

doi:10.1093/cid/ciy764

Cited by 22 publications

(23 citation statements)

References 13 publications

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“…Further work to analyze the relationship between hair levels analyzed by both labs as a predictor of future virologic suppression will be conducted as the study progresses to ensure that the new method yields predictive utility for virologic suppression similar to that seen in previous studies using hair levels. [6][7][8][9][10][11][12][13][14][15] Of note, with increasing roll out of integrase inhibitors worldwide, such as dolutegravir (DTG), and the availability of a DTG hair assay in the HAL, 38 translating the DTG assay to RLS will be similarly important‥…”

Section: 27-31mentioning

confidence: 99%

“…The use of hair concentrations of antiretrovirals (ARVs) as objective metrics of adherence has some advantages in RLS, including that hair is collected noninvasively and can be stored and shipped without a cold chain or biohazardous precautions. 5 Our group has shown that hair ART concentrations are associated with virologic outcomes in multiple cohorts [6][7][8][9][10][11][12][13][14] and in a clinical trial 15 demonstrating the pharmacodynamic relevance of hair ARV monitoring. However, adherence monitoring via hair concentrations has never been examined in India, despite a massive scale-up in ART access across the country.…”

Section: Introductionmentioning

confidence: 99%

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Measuring Adherence to Antiretroviral Therapy via Hair Concentrations in India

Gandhi

Devi

Bacchetti

et al. 2019

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Background: Objective adherence measures are of increasing interest in antiretroviral treatment (ART) monitoring. Hair ART levels predict virologic suppression and hair is easy to collect and store. No prior study has examined hair levels in an India-based cohort or laboratory. Methods: Small hair samples were collected from HIV-positive participants on either efavirenzbased or nevirapine-based ART in a South India-based study. Hair samples were split and analyzed for efavirenz or nevirapine in the UCSF-based Hair Analytical Laboratory (HAL) and the Division of Nutrition-analytic lab based at St. John's Research Institute (SJRI), Bangalore, India using liquid chromatography/tandem-mass-spectrometry. Agreement (using Bland-Altman methods) and rank correlation between the two laboratories' hair levels were calculated. Rank correlation between self-reported adherence (SRA) over the prior month using a visual analog scale and hair ART levels was calculated. Results: Among 75 participants (38 on nevirapine; 37 on efavirenz), the correlation between nevirapine levels generated by the two laboratories was 0.66 (p <0.0001) and between efavirenz levels was 0.87 (p <0.0001). Measurements from SJRI were usually within 20% of those from the

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Section: 27-31mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Measuring Adherence to Antiretroviral Therapy via Hair Concentrations in India

Gandhi

Devi

Bacchetti

et al. 2019

JAIDS Journal of Acquired Immune Deficiency Syndromes

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“…Examination of the effects of the intervention on objective metrics of ART adherence (e.g. via hair or urine metrics) would strengthen the scientific rigor of future RCTs . Further clinical research is also needed to examine the potential benefits of augmenting this integrative, behavioural intervention with promising medications for methamphetamine users such as mirtazapine .…”

Section: Discussionmentioning

confidence: 99%

Randomized controlled trial of a positive affect intervention to reduce HIV viral load among sexual minority men who use methamphetamine

et al. 2019

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Introduction In the era of HIV treatment as prevention (TasP), evidence‐based interventions that optimize viral suppression among people who use stimulants such as methamphetamine are needed to improve health outcomes and reduce onward transmission risk. We tested the efficacy of positive affect intervention delivered during community‐based contingency management (CM) for reducing viral load in sexual minority men living with HIV who use methamphetamine. Methods Conducted in San Francisco, this Phase II randomized controlled trial tested the efficacy of a positive affect intervention for boosting and extending the effectiveness of community‐based CM for stimulant abstinence to achieve more durable reductions in HIV viral load. From 2013 to 2017, 110 sexual minority men living with HIV who had biologically confirmed, recent methamphetamine use were randomized to receive a positive affect intervention (n = 55) or attention‐control condition (n = 55). All individual positive affect intervention and attention‐control sessions were delivered during three months of community‐based CM where participants received financial incentives for stimulant abstinence. The 5‐session positive affect intervention was designed to provide skills for managing stimulant withdrawal symptoms as well as sensitize individuals to natural sources of reward. The attention‐control condition consisted of neutral writing exercises and self‐report measures. Results Men randomized to the positive affect intervention displayed significantly lower log10 HIV viral load at six, twelve and fifteen months compared to those in the attention‐control condition. Men in the positive affect intervention also had significantly lower risk of at least one unsuppressed HIV RNA (≥200 copies/mL) over the 15‐month follow‐up. There were concurrent, statistically significant intervention‐related increases in positive affect as well as decreases in the self‐reported frequency of stimulant use at six and twelve months. Conclusions Delivering a positive affect intervention during community‐based CM with sexual minority men who use methamphetamine achieved durable and clinically meaningful reductions in HIV viral load that were paralleled by increases in positive affect and decreases in stimulant use. Further clinical research is needed to determine the effectiveness of integrative, behavioural interventions for optimizing the clinical and public health benefits of TasP in sexual minority men who use stimulants such as methamphetamine.

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“…Thus the concentrations of drugs in hair matrix resulting from passive diffusion of plasma species could be adopted as evaluation of long-term adherence to antiretroviral drugs [13,14]. Earlier studies have demonstrated that the concentration of antiretroviral drugs in hair is a reliable measure for assessment of long-term adherence to antiretroviral drugs [15][16][17][18][19][20][21].…”

Section: Introductionmentioning

confidence: 99%

LC-MS/MS Quantification of Nevirapine and Its Metabolites in Hair for Assessing Long-Term Adherence

Yang

Chu

et al. 2020

Molecules

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The adherence assessment based on the combination of nevirapine (NVP) and its two metabolites (2-hydroxynevirapine and 3-hydroxynevirapine) would more comprehensively and accurately reflect long-term adherence than that of a single prototype. This study aimed to develop a specific, sensitive and selective method for simultaneous detection of the three compounds in hair and explore whether there was consistency among the three compounds in assessing long-term adherence. Furthermore, 75 HIV-positive patients who were taking the NVP drug were randomly recruited and divided into two groups (high-and low-adherence group). All participants self-reported their days of oral drug administration per month and provided their hair strands closest to the scalp at the region of posterior vertex. The concentrations of three compounds in the hair were determined using a developed LC-MS/MS method in multiple reaction monitoring. This method showed good performances in limit of quantification and accuracy with the recoveries from 85 to 115% and in precision with the intra-day and inter-day coefficients of variation within 15% for the three compounds. The population analysis revealed that patients with high-adherence showed significantly higher concentrations than those with low-adherence for all three compounds. There were significantly moderate correlations of nevirapine with 2-hydroxynevirapine and 3-hydroxynevirapin and high correlation between 2-hydroxynevirapine and 3-hydroxynevirapin. The two NVP’s metabolites showed high consistency with NVP in evaluating long-term adherence.

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Antiretroviral Concentrations in Hair Strongly Predict Virologic Response in a Large Human Immunodeficiency Virus Treatment-naive Clinical Trial

Cited by 22 publications

References 13 publications

Measuring Adherence to Antiretroviral Therapy via Hair Concentrations in India

Measuring Adherence to Antiretroviral Therapy via Hair Concentrations in India

Randomized controlled trial of a positive affect intervention to reduce HIV viral load among sexual minority men who use methamphetamine

LC-MS/MS Quantification of Nevirapine and Its Metabolites in Hair for Assessing Long-Term Adherence

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