Mean Baseline CD4 Cell Count Research Articles

Prevalence and predictors of anemia among adults on highly active antiretroviral therapy in Northeast Ethiopia: A retrospective cohort study.

Although antiretroviral therapy has significantly altered the natural history of human immunodeficiency virus infection and improved the quality of life of patients, there are conflicting reports regarding its impact on hematological outcomes. Thus, this study aimed at investigating the prevalence and predictors of anemia among adults on antiretroviral therapy in Northeast Ethiopia. A retrospective cohort study was carried out among adults who began antiretroviral treatment between September 2005 and January 2019 at two governmental hospitals in Dessie town. Data were collected from patients' medical records using a pretested data extraction instrument. Anemia was the primary outcome variable of the study. It was defined based on WHO criteria after adjustment for altitude and smoking status of measured values. Data were entered and validated using EpiData Version 3.1 and then exported to SPSS Version 20.0 for analysis. Descriptive analysis was done for prevalence and binary logistic regression was carried out to assess whether covariates were associated with experiencing anemia. Statistical significance has been considered at p-value <0.05. Medical records of 392 patients (mean age: 35.58 ± 9.46 years) were reviewed. Of the total 392 patients, 218 (55.6%) were females, 261 (66.6%) were categorized under WHO clinical stage III/IV and 134 (34.2%) had a baseline CD4 cell count of <100 cells/mm3. The mean baseline CD4 cell count was 179 cells/mm3 (range: 2 to 853 cells) and 230 (58.7%) of the participants were on zidovudine-based regimen. Anemia was diagnosed among 162 (41.3%) patients. After adjustment for other confounding factors, risk of anemia was significantly associated with low baseline CD4 cell count (AOR 1.80, 95% CI 1.05-3.06) and tenofovir based regimen (AOR 2.05, 95% CI 1.31-3.21). On the other hand, being educated was found to be protective (AOR 0.40, 95% CI 0.21-0.78). In this research, the prevalence of anemia was relatively high. Low baseline CD4 cell count and tenofovir based regimen were independent predictors of anemia; while being educated was protective. Treatment programs should focus on early diagnosis and treatment of HIV as well as routine screening and proper treatment of anemia.

Does community-based point of care HIV testing reduce late HIV diagnosis? A retrospective study in England and Wales.

The objective of this study was to investigate if patients diagnosed in community clinics have higher baseline CD4 cell counts than those diagnosed in Genitourinary medicine (GUM)/HIV clinics. We undertook a retrospective review of baseline CD4 cell counts for patients receiving a reactive HIV test in community-testing clinics. Eleven local HIV clinics were contacted to determine the baseline CD4 cell counts of these patients. Baseline CD4 cell counts of those diagnosed in the community were compared with mean local GUM/HIV clinic and median national baseline CD4 cell count for their year of diagnosis. Clients diagnosed in community settings had a mean baseline CD4 cell count of 481 cells/mm3 (SD 236 cells/mm3) and median baseline of 483 cells/mm3 (interquartile range 311-657 cells/mm3). This was significantly higher than those diagnosed in the GUM/HIV clinic local to the community-testing site (mean baseline CD4 397 cells/mm3, p = 0.014) and the national median for that year (336 cells/mm3, p < 0.001). HIV testing in community settings identifies patients at an earlier stage of infection than testing in clinical settings.

Phenotype and Treatment of Breast Cancer in HIV-Positive and -Negative Women in Cape Town, South Africa

PurposeAn estimated 5.9 million people in South Africa are infected with HIV. Because antiretroviral therapy has made infection with HIV a treatable, chronic condition, HIV-infected individuals are now surviving to middle and older age. We investigated the implications of HIV status for breast cancer in South Africa.MethodsWe compared clinical and demographic characteristics of women newly diagnosed with a first primary breast cancer at Tygerberg Hospital, Cape Town, South Africa, from January 2010 to December 2011 by HIV status. We then compared HIV-positive patients with HIV-negative controls, matched 2:1 on age and ethnicity, with respect to chemotherapy regimens, toxicities, completion of systemic chemotherapy, and changes in CD4 cell count.ResultsOf 586 women with breast cancer, 31 (5.3%) were HIV positive, 420 (71.7%) were HIV negative, and 135 (23%) were untested for HIV. Women with HIV were younger than other women (P < .001). The groups did not differ in regard to stage at presentation, histologic subtype, tumor grade, nodal involvement, or hormone receptor positivity. More than 84% of patients who initiated systemic chemotherapy, regardless of HIV status, completed it without serious toxicity. Among HIV-positive patients receiving chemotherapy, the mean baseline CD4 cell count was 477 cells/µL (standard deviation, 160 cells/µL), and the mean nadir was 333 cells/µL (standard deviation, 166 cells/µL).ConclusionHIV-infected women were younger at breast cancer diagnosis than HIV-negative women but otherwise similar in phenotype and completion of chemotherapy. Longer term follow-up is needed to evaluate the effects of HIV, antiretroviral therapy, and chemotherapy on the survival and quality of life of patients with breast cancer.

Efficacy of 400 mg efavirenz versus standard 600 mg dose in HIV-infected, antiretroviral-naive adults (ENCORE1): a randomised, double-blind, placebo-controlled, non-inferiority trial

The optimum dose of key antiretroviral drugs is often overlooked during product development. The ENCORE1 study compared the efficacy and safety of reduced dose efavirenz with standard dose efavirenz in combination with tenofovir and emtricitabine as first-line treatment for HIV infection. An effective and safe reduced dose could yield meaningful cost savings. ENCORE1 is a continuing non-inferiority trial in HIV-1-infected antiretroviral-naive adults in 38 clinical sites in 13 countries. Participants (plasma HIV-RNA >1000 log10 copies per mL, CD4 T-cell count 50-500 cells per μL) were randomly assigned by a computer-generated sequence with a blocking factor of four (stratified by clinical site and by screening viral load) to receive tenofovir plus emtricitabine with either a reduced daily dose (400 mg) or a standard dose (600 mg) of efavirenz. Participants, physicians, and all other trial staff were masked to treatment group. The primary endpoint was the difference in proportions of participants with plasma HIV-RNA of less than 200 copies per mL at 48 weeks. Treatment groups were regarded as non-inferior if the lower limit of the 95% CI for the difference in viral load was less than -10% by modified intention-to-treat analysis. Adverse events were summarised by treatment. This trial is registered with ClinicalTrials.gov, number NCT01011413. The modified intention-to-treat analysis consisted of 630 patients (efavirenz 400=321; efavirenz 600=309). 32% were women; 37% were African, 33% were Asian, and 30% were white. The mean baseline CD4 cell count was 273 cells per μL (SD 99) and median plasma HIV-RNA was 4·75 log10 copies per mL (IQR 0·88). The proportion of participants with a viral load below 200 copies per mL at week 48 was 94·1% for efavirenz 400 mg and 92·2% for 600 mg (difference 1·85%, 95% CI -2·1 to 5·79). CD4 T-cell counts at week 48 were significantly higher for the 400 mg group than for the 600 mg group (mean difference 25 cells per μL, 95% CI 6-44; p=0·01). We recorded no difference in grade or number of patients reporting adverse events (efavirenz 400=89·1%, efavirenz 600=88·4%; difference 0·75%, 95% CI -4·19 to 5·69; p=0·77). Study drug-related adverse events were significantly more frequent in the 600 mg group than in the 400 mg group (146% [47] vs 118 [37]), difference -10·5%, 95% CI -18·2 to -2·8; p=0·01) and significantly fewer patients with these events stopped treatment (400 mg=6 [2%], 600 mg=18 [6%], difference -3·96%, 95% CI -6·96 to -0·95; p=0·01). Our findings suggest that a reduced dose of 400 mg efavirenz is non-inferior to the standard dose of 600 mg, when combined with tenofovir and emtricitabine during 48 weeks in ART-naive adults with HIV-1 infection. Adverse events related to the study drug were more frequent with 600 mg efavirenz than with 400 mg. Lower dose efavirenz should be recommended as part of routine care. Bill & Melinda Gates Foundation, University of New South Wales.

Novel Kivexa‐based regimens in early courses of treatment for HIV infection

BackgroundAs the long‐term efficacy of antiretroviral therapy regimens is confirmed, we need to identify additional combinations with long‐term safety and potency, while also favoring simplicity of administration. In this light, we have undertaken a review of the use of abacavir/lamivudine (Kivexa, KVX)‐based regimens using integrase or CCR5 inhibitors as the third agent.MethodsA retrospective chart review was undertaken, with informed patient consent. We identified all the patients in whom KVX was prescribed (following appropriate HLA‐B5701 screening) with either raltegravir (RGV) or maraviroc (MVC) as initial therapy or as a switch from another regimen for reasons other than virologic failure. Virologic efficacy over 48 weeks was evaluated, along with specific drug‐associated toxicity, adherence, and regimen modifications.ResultsA total of 38 patients (5 women) were evaluated, 24 on KVX/RGV, 13 on KVX/MVC, 1 on KVX/RGV/MVC. This was used as initial therapy in drug‐naïve subjects in three cases, and was selected as a modification of previous (current or not) therapy in 35 cases. Switches included replacement of the third agent with RGV or MVC (n=13), replacement of the NRTI backbone with KVX (n=13) or both. In all cases, the change was implemented to address a current or previous medication‐associated toxicity, most commonly to address jaundice (n=8), diarrhea (n=5) or reduced renal function (n=5). Patients were predominantly MSMs (n=17) or IDUs (n=13) with a mean baseline CD4 cell count of 363 cells/mm3, and plasma viral load of 46407 copies/mL (20 with full suppression at time of study entry). At 48 weeks, 34/38 (89%) achieved or maintained full suppression, with a mean CD4 count of 553 cells/mm3. Virologic failure with the development of the M184V mutation was observed in 3/4 non‐suppressed patients, and a loss of CCR5 tropism and RGV resistance were observed in one case each, all in the context of reduced adherence. There were no treatment discontinuations for toxicity and no medication‐associated serious adverse events.ConclusionKVX‐based regimens are safe and effective alternatives to more commonly used regimens in clinical practice, and offer the benefit of good long‐term tolerability and little or no need to enhance follow‐up for laboratory‐based abnormalities. Consideration should be given to non‐NNRTI and non‐PI‐based regimens to address issues of toxicity and simplification without apparent loss of efficacy.

The Prognosis of Pediatric AIDS in Serbia

To determine the outcome of HIV infection in children in a resource-limited setting, a retrospective analysis of a series of 51 pediatric cases from the Serbian cohort of HIV infected patients was performed. Twenty seven patients died in the pre-HAART era, but mono/dual antiretroviral treatment had significantly (p=0.046) prolonged survival. Of the total of 24 HAART-treated patients, 10 had clinical AIDS before HAART initiation. The mean baseline CD4 cell count was 193.9 +/- 170.0/mm(3). After a mean follow-up of 72.6 +/- 44 months, a favorable response was recorded in 62.5%, treatment failure (defined as non-achievement of undetectable viremia) in 20.8%, and a discrepant virological and immunological response (achievement of undetectable viremia but without a rise in CD4 cell counts adequate for age) in 16.7% patients. No patients died, and there were only three hospital admissions after commencing HAART. Five immune restoration inflammatory syndrome episodes were recorded, of which four were due to BCG-osis. Lipodystrophy and hyperlipidemia occurred in 18.2% and 26.3% patients, respectively. We conclude that even in suboptimal facilities, the prognosis of HIV disease among children on HAART may be rather good. The metabolic syndrome seems to emerge as an important issue among long-term surviving children on HAART.

CORRELATION BETWEEN BASELINE CD4+ T-LYMPHOCYTE COUNT AND PLASMA VIRAL LOAD IN AIDS PATIENTS AND THEIR EARLY CLINICAL AND IMMUNOLOGICAL RESPONSE TO HAART: A PRELIMINARY STUDY

The aim of this study was to determine the clinical, immunological and virological status of newly diagnosed AIDS cases and to monitor their clinical and immunological response to HAART after a minimum period of three months. Forty three drug naive AIDS patients were enrolled. The most common presenting complaints were weight loss (74.4%), cough (72.1%) and diarrhoea (67.4%). Mean baseline CD4 cell count was 112 ±60 cells/μL and mean baseline plasma viral load of 31 patients studied was 192,686 copies/mL. Baseline plasma viral load was higher among patients with lower baseline CD4 cell count. During follow-up, 80.8% patients showed clinical improvement, while a CD4 cell count increased by ≥50 cells/μL in 84.6% cases. Mean CD4 cell count increased from 126 ±16.6 cells/μL at baseline to 278 ±196.7 cells/μL.

Correlation between baseline CD4&lt;sup&gt; +&lt;/sup&gt; T-Lymphocyte count and plasma viral load in AIDS patients and their early clinical and immunological response to HAART: A preliminary study

The aim of this study was to determine the clinical, immunological and virological status of newly diagnosed AIDS cases and to monitor their clinical and immunological response to HAART after a minimum period of three months. Forty three drug naive AIDS patients were enrolled. The most common presenting complaints were weight loss (74.4%), cough (72.1%) and diarrhoea (67.4%). Mean baseline CD4 cell count was 112 +/- 60 cells/microL and mean baseline plasma viral load of 31 patients studied was 192,686 copies/mL. Baseline plasma viral load was higher among patients with lower baseline CD4 cell count. During follow-up, 80.8% patients showed clinical improvement, while a CD4 cell count increased by > or =50 cells/microL in 84.6% cases. Mean CD4 cell count increased from 126 +/- 16.6 cells/microL at baseline to 278 +/- 196.7 cells/microL.

Trends and predictors of quality of life among HIV-infected adults taking highly active antiretroviral therapy in rural Uganda

We examined trends and predictors of quality of life (QOL) over 12 months among a prospective cohort of 947 HIV-1-infected adults initiating highly active antiretroviral therapy (HAART) between May 2003 and May 2004 in rural Uganda. Participants provided clinical, demographic and psychosocial data at baseline and every three months thereafter. Outcome measures included physical and mental health summary scores based on the Medical Outcomes Study-HIV Health Survey (MOS-HIV). Generalised estimating equations were used to assess magnitude of change in summary scores and factors associated with QOL. Of 710 women and 237 men enroled, the mean age was 38.7 years and mean baseline CD4 cell count was 124.1 cells/µL. At enrolment, physical and mental health summary scores were 39.2 and 40, respectively. By 12 months of HAART, scores increased by 11.2 points (p <0.001) and 7.4 points (p <0.001), respectively. For both scores, most gains were achieved by the third month of therapy. While several clinical, psychosocial and sociodemographic factors predicted QOL at HAART initiation, financial dependence on others was the only remaining predictor after controlling for time on HAART. Interventions to enhance the economic and employment opportunities of patients taking HAART in rural Africa may help maximise gains in QOL.

Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) in a Northern Alberta Population

To describe the demographics and estimate the prevalence of hepatitis C virus (HCV) in a cohort of Human Immunodeficiency Virus (HIV) positive patients in Northern Alberta. A cross-sectional (prevalence) study was performed on a cohort of HIV-positive patients. HCV testing was not widely available until December 1989, and the more sensitive, second generation immunoassay was not available until 1992. To reduce the effect of testing bias, we restricted consideration of HCV status to patients first seen January 1, 1992 onward. Forty-four percent of patients in the whole cohort were tested for HCV (564/1,276) and 62% (505/809) of patients entered since January 1, 1992 were tested for HCV. During the period January 1, 1992-December 31, 1999, the prevalence of HCV in our cohort of northern Alberta HIV-positive patients was at least 37.9% (307/809) and was 60.8% (307/505) among those who were tested for HCV in 1992 or later. The mean age of the co-infected group was 33.6 years, 66.1% were male, 91.2% were injection drug users (IDUs), 56.8% were Caucasian, and 40.0% were Aboriginal. A statistically significant difference was found between the HCV-negative cohort, the HCV co-infected cohort, and the HCV-untested cohort for the following variables: risk behaviour, gender, ethnic status, death, occurrence of an AIDS-defining illness (p < 00.0001), and mean baseline CD4 cell count (p = 0.002). A high proportion of the HIV-infected IDUs was co-infected with HCV. Compared to the HCV-negative group, the co-infected group appears to have had less advanced HIV disease. This is likely a reflection of more recent HIV infection in the HCV co-infected group.

Induction and maintenance therapy with intermittent interleukin-2 in HIV-1 infection

AbstractStudies establishing that intermittent subcutaneous interleukin-2 (IL-2) therapy can lead to substantial CD4 cell increases in many HIV-infected patients have generally been of limited duration. We studied 77 patients participating in active longitudinal studies of subcutaneous IL-2 therapy at our center in order to determine the long-term feasibility of this approach. Following initial induction, patients in each trial were eligible to receive intermittent 5-day cycles of subcutaneous IL-2 treatment at individualized doses and frequencies capable of maintaining CD4 counts at postinduction levels. The mean duration of study participation to date is 5.9 years (range, 1.0-9.3 years). Mean baseline CD4 cell count and CD4 percent values of 0.521 × 109/L (521 cells/μL) and 27% have risen to 1.005 × 109/L (1005 cells/μL) and 38%, respectively, at 90 months. The mean number of subcutaneous IL-2 cycles required to achieve and maintain these increases was 10 cycles (range, 3-29 cycles), and the current mean interval of cycling required to maintain these elevations is 39 months (median, 35 months; range, 2-91 months). We conclude that subcutaneous IL-2 therapy is capable of maintaining CD4 cell increases for an extended period using a remarkably low frequency of intermittent cycling. These observations may contribute to patients' acceptance of subcutaneous IL-2 as a favorable long-term treatment strategy. (Blood. 2004;103:3282-3286)

Depression and CD4 Decline-Reply

<h3>In Reply.</h3> —We found depressive symptoms did not affect time to acquired immunodeficiency syndrome (AIDS) or time to death in HIV-infected homosexual men as did our San Francisco colleagues.¹In their present letter, Dr Barrett and colleagues assert we failed to observe, as they did, an effect of depression on CD4 decline because our participants had low baseline CD4 cell counts. We replicated their analysis splitting our cohort around the median baseline CD4 cell count reported in their letter (0.621×10⁹/L). Using this dichotomization, the "higher" baseline CD4 group had a mean baseline CD4 cell count of 0.870×10⁹/L. Mean annual CD4 decline was -0.068×10⁹/L for the 104 depressed respondents vs -0.072×10⁹/L for the 422 nondepressed subjects in this group (<i>P</i>=.57). The "lower" baseline CD4 group had a mean baseline CD4 cell count of 0.434×10⁹/L. The mean annual CD4 decline