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

Abstract Background The plasma concentration of patients treated with efavirenz (EFV) 600 mg was found to exceed the upper limit of the proposed therapeutic window in most Chinese HIV-infected individuals; thus, dosage reduction of EFV to 400 mg daily warranted consideration. This study aimed to assess the pharmacodynamics of EFV 400 mg for HIV-1-infected patients in China. Method Twenty cART-naïve individuals were enrolled in this study. EFV 400 mg combined with tenofovir (TDF) and lamivudine (3TC) as an initial antiretroviral regimen was administered for 48 weeks. EFV concentration and T cell subsets as well as HIV RNA load were evaluated at baseline and at 4, 12, 24, and 48 weeks. Moreover, neuropsychiatric adverse effects were also assessed by the Hamilton depression (HAMD) scale and Pittsburgh sleep quality index (PSQI). Results Eighteen males and two females whose median age was 26 (interquartile range [IQR]: 23–32) years completed 48 weeks of follow-up. The median EFV concentrations were 1.88 (IQR: 1.54–2.42), 1.74 (IQR: 1.36–1.93), 1.93 (IQR: 1.66–2.22), and 1.85 (IQR: 1.54–2.14) mg/L at weeks 4, 12, 24, and 48, respectively. The viral load was 4.59 (IQR: 4.10–5.19) log10 copies/mL at baseline, and it decreased by 4.6 (IQR: 3.98–5.18) log10 copies/mL from baseline to week 48. Three of 20 (15%), 10 of 20 (50.0%), 17 of 20 (85%), and 18 of 19 (95%) participants had a plasma viral load less than 50 copies/mL at weeks 4, 12, 24, and 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 HAMD score was 5 (IQR: 3–9.8) and 3 (IQR: 2.25–4) at baseline and 48 weeks, respectively. The PSQI score was 4 (IQR: 2–5.8) and 3 (IQR: 2–4) at baseline and 48 weeks, respectively. Dizziness was the most common event, occurring in 70% of patients within the first 2 weeks of treatment. Conclusion Patients prescribed with EFV 400 mg-containing agents demonstrated favourable virological and immunological responses. And the plasma EFV concentration was within the recommended therapeutic range, with fewer adverse reactions than with EFV 600 mg. EFV 400 mg was effective and safe in Chinese HIV-infected patients. Trial registration NCT04596488; Registered 21 October, 2020; Retrospectively registered.

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

10.21203/rs.3.rs-100711/v1 ◽

2020 ◽

Author(s):

Ling Xu ◽

Wenxiu Peng ◽

Xiaojing Song ◽

Yanling Li ◽

Yang Han ◽

...

Keyword(s):

Viral Load ◽

T Cell Subsets ◽

Therapeutic Window ◽

Cd4 Cell Count ◽

Immunological Responses ◽

Hiv Rna ◽

Hamd Score ◽

Treatment Naïve ◽

Neuropsychiatric Adverse Effects ◽

Cd4 Cell

Abstract Background: The plasma concentration of patients treated with efavirenz (EFV) 600 mg was found to exceed the upper limit of the proposed therapeutic window in most Chinese HIV-infected individuals; thus, dosage reduction of EFV to 400 mg daily warranted consideration. This study aimed to assess the pharmacodynamics of EFV 400 mg for HIV-1-infected patients in China.Method: Twenty cART-naïve individuals were enrolled in this study. EFV 400 mg combined with tenofovir (TDF) and lamivudine (3TC) as an initial antiretroviral regimen was administered for 48 weeks. EFV concentration and T cell subsets as well as HIV RNA load were evaluated at baseline and at 4, 12, 24, and 48 weeks. Moreover, neuropsychiatric adverse effects were also assessed by the Hamilton depression (HAMD) scale and Pittsburgh sleep quality index (PSQI).Results: Eighteen males and two females whose median age was 26 (interquartile range [IQR]: 23-32) years completed 48 weeks of follow-up. The median EFV concentrations were 1.88 (IQR: 1.54-2.42), 1.74 (IQR: 1.36-1.93), 1.93 (IQR: 1.66-2.22), and 1.85 (IQR: 1.54-2.14) mg/L at weeks 4, 12, 24, and 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 week 48. Three of 20 (15%), 10 of 20 (50.0%), 17 of 20 (85%), and 18 of 19 (95%) participants had a plasma viral load less than 50 copies/mL at weeks 4, 12, 24, and 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 HAMD score was 5 (IQR: 3-9.8) and 3 (IQR: 2.25-4) at baseline and 48 weeks, respectively. The PSQI score was 4 (IQR: 2-5.8) and 3 (IQR: 2-4) at baseline and 48 weeks, respectively. Dizziness was the most common event, occurring in 70% of patients within the first two weeks of treatment.Conclusion: Patients prescribed EFV 400 mg-containing agents demonstrated favourable virological and immunological responses. The plasma EFV concentration was within the recommended therapeutic range, with fewer adverse reactions than with EFV 600 mg. EFV 400 mg was effective and safe in Chinese HIV-infected patients.Trial registration: NCT04596488; Registered 21 October, 2020; Retrospectively registered

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

10.21203/rs.3.rs-85398/v1 ◽

2020 ◽

Author(s):

Ling Xu ◽

Wenxiu Peng ◽

Xiaojing Song ◽

Yanling Li ◽

Yang Han ◽

...

Keyword(s):

Viral Load ◽

Depression Scale ◽

T Cell Subsets ◽

Therapeutic Window ◽

Hamilton Depression Scale ◽

Cd4 Cell Count ◽

Immunological Responses ◽

600Mg Dose ◽

Treatment Naïve ◽

Cd4 Cell

Abstract 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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HCV RNA viral load is independent from CD4 cell count and plasma HIV RNA viral load in immunocompetent HIV-HCV co-infected patients: A 3-years follow-up study

Digestive and Liver Disease ◽

10.1016/j.dld.2014.01.106 ◽

2014 ◽

Vol 46 ◽

pp. e48

Author(s):

M. Basso ◽

M. Franzetti ◽

R. Scaggiante ◽

A. Sattin ◽

C. Mengoli ◽

...

Keyword(s):

Viral Load ◽

Cell Count ◽

Hcv Rna ◽

Cd4 Cell Count ◽

Hiv Rna ◽

Follow Up Study ◽

Cd4 Cell

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HCV RNA viral load is independent from CD4 cell count and plasma HIV RNA viral load in immunocompetent HIV-HCV co-infected patients: a 3-years follow-up study

AIDS Research and Therapy ◽

10.1186/1742-6405-11-21 ◽

2014 ◽

Vol 11 (1) ◽

pp. 21 ◽

Cited By ~ 3

Author(s):

Monica Basso ◽

Marzia Franzetti ◽

Renzo Scaggiante ◽

Andrea Sattin ◽

Carlo Mengoli ◽

...

Keyword(s):

Viral Load ◽

Cell Count ◽

Hcv Rna ◽

Cd4 Cell Count ◽

Hiv Rna ◽

Follow Up Study ◽

Cd4 Cell

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Joint modelling of bivariate longitudinal data with informative dropout and left-censoring, with application to the evolution of CD4+ cell count and HIV RNA viral load in response to treatment of HIV infection

Statistics in Medicine ◽

10.1002/sim.1923 ◽

2004 ◽

Vol 24 (1) ◽

pp. 65-82 ◽

Cited By ~ 57

Author(s):

Rodolphe Thiébaut ◽

Hélène Jacqmin-Gadda ◽

Abdel Babiker ◽

Daniel Commenges ◽

Keyword(s):

Viral Load ◽

Longitudinal Data ◽

Hiv Infection ◽

Cell Count ◽

Response To Treatment ◽

Informative Dropout ◽

Joint Modelling ◽

Cd4 Cell Count ◽

Hiv Rna ◽

Cd4 Cell

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Estimation Of Serum Erythropoietin Levels in Anaemic HIV Infected Patients in Lagos, Nigeria

Blood ◽

10.1182/blood.v122.21.4656.4656 ◽

2013 ◽

Vol 122 (21) ◽

pp. 4656-4656

Author(s):

Adebola Olu-Taiwo ◽

Suleimon Akanmu ◽

Olatilewa Amusu ◽

Samuel Ogunro

Keyword(s):

Viral Load ◽

Cell Count ◽

Inflammatory Cytokines ◽

Serum Ferritin ◽

Full Blood Count ◽

Response Ratio ◽

Cd4 Cell Count ◽

Treatment Naïve ◽

Cd4 Cell ◽

Serum Erythropoietin

Background Erythropoietin(EPO) response to anaemia has been reported to be suboptimal in HIV infected anaemic patients. Objectives To assess the relationship between EPO levels and degree of anaemia, CD4+ cell count and viral load of HIV infected treatment naive subjects and if there is any association with inflammatory cytokines. Subjects and Methods A total of 120 subjects aged 18-66 years, comprises (1) HIV infected treatment naive subjects who had anaemia with Hb level <10g/dL. Control subjects were: (2) HIV infected non-anaemic, (3) non-HIV infected anaemic and (4) non-HIV infected non-anaemic individuals. Full blood count using automated counter; CD4+ cell count by semi-automated flow cytometer; and viral load were estimated. Serum erythropoietin levels, serum ferritin levels, CRP levels, TNF-α levels and IL-6 levels were estimated. Appropriateness of EPO response was determined by calculating EPO response ratio. Results Majority (72%) of the HIV infected anaemic patients had a normocytic hypochromic type of anaemia. A weak positive correlation between EPO levels and CD4+ cell count (r=0.075, p=0.572) was obtained. A significant negative correlation between EPO levels and haemoglobin levels (r=-0.268, p=0.003). Twenty-seven (71.05%) of the 38 HIV infected anaemic subjects had EPO response ratio less than 0.8. Serum ferritin level was significantly higher in HIV infected anaemic subjects compared to the controls (p=0.000). Serum interleukin-6 level was significantly higher in HIV infected anaemic subjects compared to HIV infected non-anaemic subjects (p=0.003). Serum C-reactive protein level was significantly higher in HIV infected anaemic subjects compared to non-HIV infected non-anaemic (p=0.004) and non-HIV infected anaemic subjects and(0.001). Serum tumour necrosis factor-α level was significantly higher in HIV infected anaemic subjects compared to other arms of the study population (p=0.000). Conclusion The present study revealed that HIV infected anaemic subjects had reduced serum EPO levels. However, serum inflammatory cytokines levels were raised in the same subjects. Disclosures: No relevant conflicts of interest to declare.

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Effect of early initiation of highly active antiretroviral therapy on CD4 cell count and HIV-RNA viral load trends within 24 months of the onset of acute retroviral syndrome

HIV Medicine ◽

10.1111/j.1468-1293.2008.00576.x ◽

2008 ◽

Vol 9 (6) ◽

pp. 440-444 ◽

Cited By ~ 5

Author(s):

N Voirin ◽

J-P Routy ◽

D Smith ◽

D Baratin ◽

C Trpo ◽

...

Keyword(s):

Viral Load ◽

Antiretroviral Therapy ◽

Cell Count ◽

Highly Active Antiretroviral Therapy ◽

Early Initiation ◽

Cd4 Cell Count ◽

Hiv Rna ◽

Highly Active ◽

Acute Retroviral Syndrome ◽

Cd4 Cell

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Frequency of Cytomegalovirus Viral Load in Iranian Human Immunodeficiency Virus-1-Infected Patients with CD4+ Counts <100 Cells/mm3

Intervirology ◽

10.1159/000514385 ◽

2021 ◽

pp. 1-5

Author(s):

Mohammad Reza Jabbari ◽

Hoorieh Soleimanjahi ◽

Somayeh Shatizadeh Malekshahi ◽

Mohammad Gholami ◽

Leila Sadeghi ◽

...

Keyword(s):

Human Immunodeficiency Virus ◽

Viral Load ◽

Cell Count ◽

Previous History ◽

Cd4 Count ◽

Cd4 Cell Count ◽

Cell Counts ◽

Immunodeficiency Virus ◽

Cd4 Cell ◽

Hiv 1

Objectives: The aim of present work was to assess cytomegalovirus (CMV) viremia in Iranian human immunodeficiency virus (HIV)-1-infected patients with a CD4+ count <100 cells/mm3 and to explore whether CMV DNA loads correlate with CD4+ cell counts or associated retinitis. Methods: This study was conducted at the AIDS research center in Iran on HIV-1-infected patients with CD4+ count <100 cells/mm3, antiretroviral therapy-naive, aged ≥18 years with no previous history of CMV end-organ disease (CMV-EOD). Results: Thirty-nine of 82 patients (47.56%) had detectable CMV viral load ranging from 66 to 485,500 IU/mL. CMV viral load in patients with retinitis ranges from 352 to 2,720 IU/mL, and it was undetectable in 2 patients. No significant associations between CMV viremia and CD4+ cell count was found (p value = 0.31), whereas significant association of CMV viremia in HIV-infected patients with retinitis was found (p < 0.02). Conclusions: We estimated the frequency of CMV viral load infection in Iranian HIV-1-infected patients with a CD4+ cell count <100 mm3/mL in the largest national referral center for HIV-1 infection in Iran. Further research is required on the relevance of CMV viral load in diagnostic and prognostic value of CMV-EOD.

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