Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial

Choopanya, Kachit; Martin, Michael; Suntharasamai, Pravan; Sangkum, Udomsak; Mock, Philip A.; Leethochawalit, Manoj; Chiamwongpaet, Sithisat; Kitisin, Praphan; Natrujirote, Pitinan; Kittimunkong, Somyot; Chuachoowong, Rutt; Gvetadze, Roman; McNicholl, Janet M.; Paxton, Lynn A.; Curlin, Marcel E.; Hendrix, Craig W.; Vanichseni, Suphak

doi:10.1016/s0140-6736(13)61127-7

Cited by 1,258 publications

(953 citation statements)

References 25 publications

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“…40,41 A Phase III study of daily oral TDF among IDUs in Thailand demonstrated an overall 49% effectiveness in the modified intention-to-treat analysis. 42,43 Efficacy was also highly dependent on adherence. It increased from 46% to 74% when the analysis was limited to participants with detectable TDF concentrations.…”

Section: Antiretroviral Prep For Hiv-uninfected Individualsmentioning

confidence: 99%

Challenges and potential barriers to the uptake of antiretroviral-based prevention in Asia and the Pacific region

Kato²,

Phanuphak

et al. 2014

Sex. Health

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Abstract. Evidence has emerged over the past few years on the effectiveness of antiretroviral-based prevention technologies to prevent (i) HIV transmission while decreasing morbidity and mortality in HIV-infected persons, and (ii) HIV acquisition in HIV-uninfected individuals through pre-exposure prophylaxis (PrEP). Only few of the planned studies on treatment as prevention (TasP) are conducted in Asia. TasP might be more feasible and effective in concentrated rather than in generalised epidemics, as resources for HIV testing and antiretroviral treatment could focus on confined and much smaller populations than in the generalised epidemics observed in sub-Saharan Africa. Several countries such as Cambodia, China, Thailand and Vietnam, are now paving the way to success. Similar challenges arise for both TasP and PrEP. However, the operational issues for PrEP are amplified by the need for frequent retesting and ensuring adherence. This paper describes challenges for the implementation of antiretroviral-based prevention and makes the case that TasP and PrEP implementation research in Asia is much needed to provide insights into the feasibility of these interventions in populations where firm evidence of 'real world' effectiveness is still lacking.

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Section: Antiretroviral Prep For Hiv-uninfected Individualsmentioning

confidence: 99%

Challenges and potential barriers to the uptake of antiretroviral-based prevention in Asia and the Pacific region

Kato²,

Phanuphak

et al. 2014

Sex. Health

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“…[1][2][3][4] On the basis of these observations, in July 2012 the Food and Drug Administration approved daily treatment with Truvada for the prevention of HIV-1 acquisition, and the Centers for Disease Control and Prevention has issued guidelines for its use. 5 However, Truvada was found to be ineffective in preventing HIV-1 acquisition among women in the Preexposure Prophylaxis Trial for HIV Prevention among African Women (FEM-PrEP), whose rate of adherence, as assessed on the basis of plasma tenofovir (TFV) levels, was less than 40%.…”

mentioning

confidence: 99%

Tenofovir-Based Preexposure Prophylaxis for HIV Infection Among African Women

Marrazzo

Ramjee

Richardson

et al. 2015

Obstetrical &Amp; Gynecological Survey

210

348

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“…Although plasma measures of TFV and/or FTC have been most commonly analyzed in PrEP trials [1,2,[4][5][6][7], drug concentrations in plasma represent recent drug ingestion (eg, yes/ no for taking drug or not). However, TFV and its moieties exhibit long half-lives in various matrices, enabling assessment of longer-term measures of cumulative drug exposure, such as those in DBS [10] and hair, that may be more relevant for PrEP monitoring.…”

Section: Discussionmentioning

confidence: 99%

“…Plasma or PBMC concentrations of tenofovir (TFV)/FTC or their phosphorylated forms have been most frequently incorporated into PrEP trials as pharmacologic measures [1,2,7]. Measurements of plasma antiretroviral concentrations represent more recent dosing (eg, 1-14 preceding days, depending on assay sensitivity) [6] and may be susceptible to "white-coat effects," wherein adherence improves transiently before visits [8].…”

mentioning

confidence: 99%

Strong Correlation Between Concentrations of Tenofovir (TFV) Emtricitabine (FTC) in Hair and TFV Diphosphate and FTC Triphosphate in Dried Blood Spots in the iPrEx Open Label Extension: Implications for Pre-exposure Prophylaxis Adherence Monitoring

Gandhi¹,

Glidden²,

Liu³

et al. 2015

J Infect Dis.

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Self-reported adherence to pre-exposure prophylaxis (PrEP) has limitations, raising interest in pharmacologic monitoring. Drug concentrations in hair and dried blood spots (DBS) are used to assess long-term-exposure; hair shipment/storage occurs at room temperature. The iPrEx Open Label Extension collected DBS routinely, with opt-in hair collection; concentrations were measured with liquid chromatography/tandem mass spectrometry. In 806 hair-DBS pairs, tenofovir (TFV) hair levels and TFV diphosphate (DP) in DBS were strongly correlated (Spearman coefficient r = 0.734; P < .001), as were hair TFV/DBS emtricitabine (FTC) triphosphate (TP) (r = 0.781; P < .001); hair FTC/DBS TFV-DP (r = 0.74; P < .001); hair FTC/DBS FTC-TP (r = 0.587; P < .001). Drug detectability was generally concordant by matrix. Hair TFV/FTC concentrations correlate strongly with DBS levels, which are predictive of PrEP outcomes.

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Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial

Cited by 1,258 publications

References 25 publications

Challenges and potential barriers to the uptake of antiretroviral-based prevention in Asia and the Pacific region

Challenges and potential barriers to the uptake of antiretroviral-based prevention in Asia and the Pacific region

Tenofovir-Based Preexposure Prophylaxis for HIV Infection Among African Women

Strong Correlation Between Concentrations of Tenofovir (TFV) Emtricitabine (FTC) in Hair and TFV Diphosphate and FTC Triphosphate in Dried Blood Spots in the iPrEx Open Label Extension: Implications for Pre-exposure Prophylaxis Adherence Monitoring

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