Prospective plasma efavirenz concentration assessment in Chinese HIV‐infected adults enrolled in a large multicentre study

Guo, Fengjin; Cheng, Xinqi; Hsieh, Evelyn; Du, Xin; Fu, Qin; Peng, Wenxiu; Y, Li; Song, Xiaojing; Routy, Jean‐Pierre; T, Li

doi:10.1111/hiv.12607

Cited by 15 publications

(20 citation statements)

References 50 publications

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“…As EFV use increased after inclusion in the NFATP, a growing number of patients reported moderate to severe neuropsychiatric symptoms with the standard 600 mg daily dose of EFV, including dizziness, insomnia, nightmares, and depression, as has been reported internationally. The multi-national ENCORE1 studies published in 2014 and 2015 first suggested the non-inferiority of EFV 400 mg to EFV 600 mg daily [9,10], and in a prospective study by the CACT, plasma EFV levels measured in 455 treatment-naïve HIV patients initiated on an EFV-containing regimen showed that 34.2% and 43.8% of participants had plasma EFV concentrations above the upper limit of the proposed therapeutic window at 24 and 48 weeks, respectively, especially in those with low body weight (< 60 kg) [11]. Based on these collective findings, the 2018 Chinese National Guidelines for the Diagnosis and Treatment of HIV/AIDS suggested a dose adjustment for individuals with low body weight [12], and a prospective open-label randomized CACT trial of EFV 400 mg versus 600 mg aimed at collecting real-world evidence among Chinese patients with HIV has just completed enrollment.…”

Section: Optimizing Haart For Chinese Patients With Hivmentioning

confidence: 99%

Optimizing Treatment for Adults with HIV/AIDS in China: Successes over Two Decades and Remaining Challenges

Cao

Hsieh

2020

Curr HIV/AIDS Rep

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Purpose of Review The introduction of the National Free Antiretroviral Therapy Program (NFATP) in 2003 by the China National Center for AIDS/STD Control and Prevention has led to dramatic increases in antiretroviral therapy (ART) coverage among HIV-infected Chinese patients. Despite limitations in the number of available free antiretroviral drugs, the overall mortality associated with HIV/AIDS has dropped from 39.3 per 100 person-years in 2002 to 3.1 in 2014. In this review, we summarize the challenges, responses, and achievements of antiretroviral therapy (ART) in China over the past 20 years. Recent Findings Continuous optimization of the Chinese National Guidelines for HIV/AIDS Diagnosis and Treatment has been guided by data from serial domestic multi-center studies aimed at evaluating efficacy and toxicity of available ART regimens among Chinese patients with HIV, with the goal of maximizing adherence, access, and efficacy. In addition, increasing attention has been focused on the importance of continuity in the HIV care cascade to promote linkage to care, and address the multidisciplinary chronic care needs HIV/AIDS patients on lifelong ART. Summary Great progress has been achieved in the past 20 years in terms of access to and optimization of antiretroviral treatment in China. As the number of patients receiving long-term ART continues to grow, the focus of HIV/AIDS treatment has gradually transitioned from urgent care to the management of non-AIDS-related chronic complications and control of chronic inflammation.

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Section: Optimizing Haart For Chinese Patients With Hivmentioning

confidence: 99%

Optimizing Treatment for Adults with HIV/AIDS in China: Successes over Two Decades and Remaining Challenges

Cao

Hsieh

2020

Curr HIV/AIDS Rep

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“…The studies were carried out by the China AIDS Clinical Trial Network in 11 different municipalities/ provinces in China, including Beijing, Fujian, Guangdong, Guangxi, Henan, Hunan, Liaoning, Shanghai, Shanxi, Sichuan, and Yunnan provinces. The inclusion and exclusion criteria and study-related procedures of these clinical trials have been previously described in detail [18][19][20].…”

Section: Subjectsmentioning

confidence: 99%

HIV-1 CRF01_AE subtype and HIV-1 DNA level among patients with chronic HIV-1 infection: a correlation study

et al. 2020

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Background: The impact of HIV-1 subtype (CRF01_AE and non-CRF01_AE) on HIV-1 DNA levels in HIV-1 chronically infected patients with suppressive antiretroviral therapy (ART) remains poorly understood. To evaluate the correlation of HIV-1 subtype with DNA level, and identify baseline predictors of HIV-1 DNA decay. Methods: ART-naïve HIV-1-infected patients from two large multi-center studies in China were classified into CRF01_AE and non-CRF01_AE subtype groups. Peripheral blood samples were collected at baseline and week 12, 24, 48 and 96 after ART initiation and total HIV-1 DNA levels were quantified by real-time PCR. HIV-1 DNA levels at week 96 were categorized into high, moderate, and low levels, reflecting HIV-1 DNA ≥ 3, 2-3, ≤ 2 log 10 copies/10 6 PBMCs, respectively, and the corresponding proportion of CRF01_AE and non-CRF01_AE subtype were compared. The baseline predictors of low HIV-1 total DNA levels (≤ 2 log 10 copies/10 6 PBMCs) at week 96 were evaluated using a logistic regression model. Results: Compared to the non-CRF01_AE subtypes (n = 185), patients with CRF01_AE subtype (n = 188) harboured a higher level of HIV-1 DNA (median: 3.19 vs. 2.95 log 10 copies/10 6 PBMCs, P < 0.001) prior to treatment. After 96 weeks of ART, HIV-1 DNA levels remained higher in the CRF01_AE subtype group (median: 2.63 vs. 2.39 log 10 copies/10 6 PBMCs, P = 0.002). There was no significant difference in the proportion of patients achieving high (22.3% vs. 14.6%, P = 0.054), moderate (59.6% vs. 60.5%, P = 0.849) and low levels (18.1% vs 24.9%, P = 0.111) between CRF01_AE and non-CRF01_AE groups. In the multivariable analysis, baseline HIV-1 DNA level and CD4 + T cell count but not the subtype were independent risk factors for achieving HIV-1 DNA level ≤ 2 log 10 copies/10 6 PBMCs. Conclusion: HIV-1 CRF01_AE subtype is neither correlated with HIV-1 DNA reservoir decline nor a prognostic factor for achieving lower HIV-1 DNA levels (≤ 2 log 10 copies/10 6 PBMCs) after ART. However, higher HIV-1 DNA level in HIV-1 CRF01_AE patients should be aroused much attention and strengthen surveillance during ART.

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“…Previous literatures also showed that weight > 60 kg was associated with lower EFV concentrations in HIV-infected patients [8,14] . In our study, weight of patients at baseline ranged from 47 to 67 kg.…”

Section: Discussionmentioning

confidence: 74%

“…Patients with EFV concentration > 4 mg/L experienced three times more frequent of CNS adverse events [7] . Moreover, our previous multicenter study showed that median plasma EFV concentration increasing gradually over 48 weeks and 43.8% patients had EFV concentration > 4 mg/L in China [8] . This meaned that HIV-infected Chinese adults were more likely to suffer from neuropsychiatric symptoms.…”

Section: Introductionmentioning

confidence: 94%

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Pharmacodynamics of efavirenz 400mg in treatment-naïve Chinese HIV-infected patients in a prospective cohort study

Peng

Song

et al. 2020

Preprint

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BackgroundThe plasma concentration of efavirenz (EFV) 600mg dose was found to exceed the upper limit of proposed therapeutic window in most Chinese HIV-infected individuals, thus dosage reduction of EFV to 400mg daily warrant consideration. This study aimed at assessing the pharmacodynamics of EFV 400mg for HIV-infected patients in China. MethodTwenty cART-naïve individuals were enrolled in this study. EFV 400mg combined with tenofovir (TDF) and lamivudine (3TC) as initial antiretroviral regimens were administered for 48 weeks. EFV concentration and T-cell subsets as well as HIV RNA load were evaluated at baseline, 4, 12, 24, 48 weeks. Moreover, the neuropsychiatric adverse effects were also assessed by Hamilton depression scale (HAMD) and Pittsburgh sleep quality index (PSQI).ResultsEighteen males and two females whose median age was 26 (interquartile range [IQR]: 23-32) years completed 48 weeks of follow-up. The median EFV concentration was 1.88 (IQR: 1.54-2.42), 1.74 (IQR: 1.36-1.93), 1.93 (IQR: 1.66-2.22), 1.85 (IQR: 1.54-2.14) mg/L at week 4, 12, 24, 48, respectively. The viral load was 4.59 (IQR: 4.10-5.19) lg copies/mL at baseline and it decreased by 4.6 (IQR: 3.98-5.18) lg copies/mL from baseline to weeks 48. 3 of 20 (15%), 10 of 20 (50.0%), 17 of 20 (85%), 18 of 19 (95%) participants had a plasma viral load less than 50 copies/mL at weeks 4, 12, 24, 48 respectively. The median CD4 cell count was 330 (IQR: 237-410) cells/µL at baseline and it increased to 473 (IQR: 344-574) cells/µL at 48 weeks. The score of HAMD was 5 (IQR: 3-9.8), 3 (IQR: 2.25-4) at baseline and 48 weeks. And the score of PSQI was 4 (IQR: 2-5.8), 3 (IQR: 2-4) at baseline and 48 weeks. Dizziness was the most common event, occurring in 70% patients within the first two weeks of treatment. ConclusionPatients prescribed with EFV 400mg-containing agents demonstrated favorable virological and immunological responses. And the plasma EFV concentration was within the recommended therapeutic range with less adverse reactions. EFV 400mg was effective and safe in Chinese HIV-infected patients.

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Prospective plasma efavirenz concentration assessment in Chinese HIV‐infected adults enrolled in a large multicentre study

Cited by 15 publications

References 50 publications

Optimizing Treatment for Adults with HIV/AIDS in China: Successes over Two Decades and Remaining Challenges

Optimizing Treatment for Adults with HIV/AIDS in China: Successes over Two Decades and Remaining Challenges

HIV-1 CRF01_AE subtype and HIV-1 DNA level among patients with chronic HIV-1 infection: a correlation study

Pharmacodynamics of efavirenz 400mg in treatment-naïve Chinese HIV-infected patients in a prospective cohort study

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