541. Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Treatment Naïve Patients: Week 48 Results in Subgroups Based on Baseline Viral Load, CD4+ Count, and WHO Clinical Staging

Background: Dolutegravir (DTG) plus lamivudine (2-DR) is suggested as an initial and switch option in HIV-1 treatment. Objective: To analyze the effectiveness, durability, and safety of 2-DR compared with DTG plus abacavir/lamivudine (3-DR). Methods: This was an observational, ambispective study that included all treatment-naïve (TN) and treatment-experienced (TE) patients who started 2-DR or 3-DR between July 1, 2018, and November 30, 2020. The primary end point was noninferiority, at 24 and 48 weeks, of 2-DR versus 3-DR regarding the percentage of patients with viral load (VL)≥50 and 200 copies/mL in TN (4% margin) and VL<50 and 200 copies/mL in TE (margin 12%). Durability of response, and safety were also measured. Results: 242 patients were included (53 TN and 189 TE). Two TN patients on 2-DR had VL≥50 copies/mL and 1 had VL≥200 copies/mL at week 24. In TE patients on 2-DR, 90.2% achieved VL<200 copies/mL at week 24 (difference: 3.8%; 95% CI = −6.3% to 14%) and 91.8% at week 48 (difference: 0.06%; 95% CI = −9% to 10%), meeting noninferiority criteria. Among the 53 TN patients, only 1 VF was observed in 2-DR. In TN patients, the risk of treatment discontinuation was similar between groups (hazard ratio [HR] = 0.37; P = 0.15); similar rates were also found in TE patients (HR = 0.94; P = 0.85). TE patients on 2-DR showed a better safety profile compared with 3-DR patients ( P<0.001). Conclusion and Relevance: Our results did not show noninferiority in terms of virological effectiveness. Nevertheless, all effectiveness measures support the use of 2-DR in a real-life cohort of TN and TE. Additionally, durability and safety of 2-DR were confirmed to be similar to that of 3-DR.

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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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EBV AND HHV-6 CIRCULATING SUBTYPES IN PEOPLE LIVING WITH HIV IN BURKINA FASO, IMPACT ON CD4 T CELL COUNT AND HIV VIRAL LOAD

Mediterranean Journal of Hematology and Infectious Diseases ◽

10.4084/mjhid.2017.049 ◽

2017 ◽

Vol 9 (1) ◽

pp. 2017049 ◽

Cited By ~ 2

Author(s):

Lassina TRAORE ◽

Ouéogo NIKIEMA ◽

Abdoul Karim OUATTARA ◽

Tegwindé Rébéca COMPAORE ◽

Serge Théophile SOUBEIGA ◽

...

Keyword(s):

Viral Load ◽

T Cell ◽

Cell Count ◽

Cd4 Count ◽

Cd4 T Cell ◽

People Living With Hiv ◽

Study Population ◽

Living With Hiv ◽

Hiv 1 ◽

Cd4 T Cell Count

Epstein Barr Virus (EBV) and Human Herpes Virus 6 (HHV-6) are responsible for severe diseases, particularly in immunocompromised persons. There are poor data on the infection with these opportunistic viruses in Burkina Faso.The purpose of this study is to characterize EBV and HHV-6 subtypes and to assess their impact on CD4 T cell count, HIV-1 viral load and antiretroviral treatment in people living with HIV-1.The study population consisted of 238 HIV-positive patients with information on CD4 count, HIV-1 viral load and HAART. Venous blood samples collected on EDTA tubes were used for EBV and HHV-6 Real Time PCR subtyping.An infection rate of 6.7% (16/238) and 7.1% (17/238) were found respectively for EBV and HHV-6 in the present study. Among EBV infections, similar prevalences were noted for both subtypes (3.9% [9/238] for EBV-1 vs 4.6% [11/238] for EBV-2) with 2.1% (5/238) of co-infection. HHV-6A infection represented 6.3% (15/238) of the study population against 5.0% (12/238) for HHV-6B. . EBV-2 infection was significantly higher in patients with CD4 count ≥ 500 compared to those with CD4 count less than 500 cells (1.65% vs 8.56%, p = 0,011). The prevalence of EBV and HHV-6 infections were almost similar in HAART-naive and HAART-experienced patients.The present study provides information on the prevalence of EBV and HHV-6 subtypes in people living with HIV-1 in Burkina Faso. The study also suggests that HAART treatment has no effect on infection with these opportunistic viruses in people living with HIV-1.

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Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients

AIDS ◽

10.1097/qad.0000000000002463 ◽

2020 ◽

Vol 34 (5) ◽

pp. 707-718 ◽

Cited By ~ 4

Author(s):

Chloe Orkin ◽

Joseph J. Eron ◽

Jürgen Rockstroh ◽

Daniel Podzamczer ◽

Stefan Esser ◽

...

Keyword(s):

Phase 3 ◽

Treatment Naïve ◽

Tenofovir Alafenamide ◽

Hiv 1

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2509. Pooled Resistance Analyses of Darunavir (DRV) Once Daily (QD) Regimens and Formulations Across 10 Clinical Studies of Treatment-Naïve (TN) and Treatment-Experienced (TE) Patients with Human Immunodeficiency Virus (HIV)-1 Infection

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz360.2187 ◽

2019 ◽

Vol 6 (Supplement_2) ◽

pp. S870-S871 ◽

Cited By ~ 1

Author(s):

Erkki Lathouwers ◽

Sareh Seyedkazemi ◽

Donghan Luo ◽

Kimberley Brown ◽

Sandra De Meyer ◽

...

Keyword(s):

Clinical Studies ◽

Virologic Failure ◽

Transcriptase Inhibitor ◽

Resistance Testing ◽

Resistance Development ◽

Single Tablet Regimen ◽

Treatment Naïve ◽

Tenofovir Alafenamide ◽

Hiv 1 ◽

Phenotypic Susceptibility

Abstract Background DRV has demonstrated high efficacy and barrier to resistance development across diverse populations, from TN to heavily TE patients. We evaluated resistance data from 10 clinical studies of different DRV 800 mg QD–based antiretroviral regimens and formulations. Methods The analysis included patients from 10 phase 2/3 studies (48–192 weeks in duration) of ritonavir- and cobicistat-boosted DRV 800 mg QD–based regimens in TN and virologically failing or suppressed TE patients with HIV-1 (table). Three were phase 3 studies of the DRV/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg single-tablet regimen (STR). Post-baseline resistance was evaluated in patients experiencing protocol-defined virologic failure (PDVF); definitions and criteria for resistance testing varied slightly among studies. Resistance-associated mutations (RAMs) were based on respective International Antiviral Society–USA mutation lists over time. Results Of the 3,635 patients evaluated, 250 met PDVF criteria and 205 had post-baseline genotypes/phenotypes. Overall, 4 (0.1%) patients developed (or had identified [switch studies]) ≥1 DRV and/or primary protease inhibitor (PI) RAM (table), and only 1 (< 0.1%, ODIN) patient lost DRV phenotypic susceptibility; this TE patient had prior VF with lopinavir. Among those who used a nucleos(t)ide reverse transcriptase inhibitor (NRTI) backbone (mostly emtricitabine [FTC] + tenofovir [TFV]), 12 (0.4%) patients had ≥1 NRTI RAM, including 10 with M184I/V associated with FTC resistance. No TFV RAMs were observed. Among patients receiving D/C/F/TAF (n = 1,949), none had post-baseline DRV, primary PI, or TFV RAMs; only 2 (0.1%) patients developed an FTC RAM. Conclusion Across a large, diverse population using DRV 800 mg QD–based regimens and formulations, resistance development remains rare; 0.1% of patients had ≥1 DRV and/or primary PI RAM post-baseline. Among 3 trials of the D/C/F/TAF STR, no patients developed a DRV or primary PI RAM. After > 10 years of investigating DRV 800 mg QD–based regimens in clinical trials, loss of phenotypic susceptibility to DRV has never been observed in TN or TE virologically suppressed patients and was only once observed in a TE patient with prior VF on multiple antiretrovirals, including a PI. Disclosures All authors: No reported disclosures.

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Rilpivirine vs. efavirenz in HIV-1 patients with baseline viral load 100 000 copies/ml or less

AIDS ◽

10.1097/qad.0b013e32835e1554 ◽

2013 ◽

Vol 27 (6) ◽

pp. 889-897 ◽

Cited By ~ 20

Author(s):

Jean-Michel Molina ◽

Nathan Clumeck ◽

Karla Redant ◽

Laurence Rimsky ◽

Simon Vanveggel ◽

...

Keyword(s):

Viral Load ◽

Baseline Viral Load ◽

Hiv 1

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The importance of baseline viral load when assessing relative efficacy in treatment-naïve HBeAg-positive chronic hepatitis B: a systematic review and network meta-analysis

Systematic Reviews ◽

10.1186/2046-4053-3-21 ◽

2014 ◽

Vol 3 (1) ◽

Cited By ~ 4

Author(s):

Stuart Mealing ◽

Isabella Ghement ◽

Neil Hawkins ◽

David A Scott ◽

Benedicte Lescrauwaet ◽

...

Keyword(s):

Systematic Review ◽

Chronic Hepatitis ◽

Viral Load ◽

Hepatitis B ◽

Chronic Hepatitis B ◽

Meta Analysis ◽

Baseline Viral Load ◽

Relative Efficacy ◽

Positive Chronic Hepatitis ◽

Treatment Naïve

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High Rate of Non-detectable HIV-1 RNA among Antiretroviral Drug Naive HIV Positive Individuals in Nigeria

Virology Research and Treatment ◽

10.4137/vrt.s12677 ◽

2013 ◽

Vol 4 ◽

pp. VRT.S12677 ◽

Cited By ~ 1

Author(s):

Georgina N. Odaibo ◽

Isaac F. Adewole ◽

David O. Olaleye

Keyword(s):

Viral Load ◽

Undetectable Viral Load ◽

Antiretroviral Drugs ◽

High Rate ◽

Baseline Viral Load ◽

Hiv Positive ◽

Detectable Viral Load ◽

Cell Counts ◽

Drug Naïve ◽

Hiv 1

Plasma HIV-1 RNA concentration, or viral load, is an indication of the magnitude of virus replication and largely correlates with disease progression in an infected person. It is a very useful guide for initiation of therapy and monitoring of response to antiretroviral drugs. Although the majority of patients who are not on antiretroviral therapy (ART) have a high viral load, a small proportion of ART naive patients are known to maintain low levels or even undetectable viral load levels. In this study, we determined the rate of undetectable HIV-1 RNA among ART naive HIV positive patients who presented for treatment at the University College Hospital (UCH), Ibadan, Nigeria from 2005 to 2011. Baseline viral load and CD4 lymphocyte cell counts of 14,662 HIV positive drug naive individuals were determined using the Roche Amplicor version 1.5 and Partec easy count kit, respectively. The detection limits of the viral load assay are 400 copies/mL and 750,000 copies/mL for lower and upper levels, respectively. A total of 1,399 of the 14,662 (9.5%) HIV-1 positive drug naive individuals had undetectable viral load during the study period. In addition, the rate of non-detectable viral load increased over the years. The mean CD4 counts among HIV-1 infected individuals with detectable viral load (266 cells/μL; range = 1 to 2,699 cells/μL) was lower than in patients with undetectable viral load (557 cells/μL; range = 1 to 3,102 cells/μL). About 10% of HIV-1 infected persons in our study population had undetectable viral load using the Roche Amplicor version 1.5.

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Mo1386 - Effectiveness of 8 vs. 12 Week Ledipasvir-Sofosbuvir (LDV/SOF) in Black, Treatment Naïve Patients with Non-Cirrhotic, Genotype 1 HCV and Baseline Viral Load <6MM IU/ML; Data from the Trio Network

Gastroenterology ◽

10.1016/s0016-5085(18)33934-9 ◽

2018 ◽

Vol 154 (6) ◽

pp. S-1190

Author(s):

Michael P. Curry ◽

Bruce Bacon ◽

Steven L. Flamm ◽

Angela Landen ◽

Scott Milligan ◽

...

Keyword(s):

Viral Load ◽

Baseline Viral Load ◽

Genotype 1 ◽

Treatment Naïve

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Influence of HLA-B*5701 on 20 year survival rate among patients living with HIV

PLoS ONE ◽

10.1371/journal.pone.0255834 ◽

2021 ◽

Vol 16 (8) ◽

pp. e0255834

Author(s):

Bogusz Jan Aksak-Wąs ◽

Miłosz Parczewski ◽

Anna Urbańska ◽

Małgorzata Hackiewicz ◽

Justyna D. Kowalska

Keyword(s):

Viral Load ◽

Cd4 Count ◽

Baseline Viral Load ◽

People Living With Hiv ◽

Hiv Viral Load ◽

Cross Sectional ◽

End Point ◽

Lower Baseline ◽

Route Of Transmission ◽

Living With Hiv

Background The life expectancy of people living with HIV (PLWH) remains shorter than that of the general population, despite significant improvement in the recent years. Mortality in HIV-infected individuals may be associated with a higher viral load at of diagnosis, a lower CD4 count, or clinical variables such as sex or route of transmission. This article investigated the role of the HLA-B*5701 varian on mortality among PLWH. Methods Material for the analysis consist of the data of 2,393 patients for whom the HLA-B*57 variant was known. Those patients were followed under the care of the Infectious Diseases Hospital in Warsaw (n = 1555) and the Clinic of Acquired Immunodeficiency of the Pomeranian Medical University in Szczecin (n = 838). Factors such as age, gender, date of HIV diagnosis, route of transmission, date of death, baseline HIV viral load and baseline CD4 counts, were collected, and end-point cross-sectional analyses were marked at 60, 120, 180 and 240 month of observation. Results HLA-B*5701 allele was found in 133 (5.5%) analyzed cases. Median age was notably higher for HLA-B*5701 positive patients [32.7 (28.3–41.3) vs. 31.6 (26.8–38.3)years p = 0.02]. HLA-B*5701 was associated with lower baseline viral load [4.21 (3.5–4.8) vs. 4.79 (4.2–5.3)log copies/ml p<0.001] and higher CD4count [448 (294.5–662) vs. 352 (176–514) cells/μl p<0.001]. There were no association between HLA-B*5701 and survival for any given end-point. Higher mortality was associated to male gender, intravenous drug users, lower CD4 count at baseline and higher baseline viral load. Conclusions In our study, the presence of HLA-B*5701 allel was not associated with mortality rate of HIV infected patients, irrespective of being associated with both higher baseline CD4 + cell count and lower baseline HIV viral load.

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