Validation study of a conventional enzyme immunoassay to detect HIV antibodies in oral fluid.

OBJECTIVES: The aim of our study was to validate the Genscreen HIV ½ version 2 (BIO-RAD) for detecting HIV antibodies in oral fluid specimens (OF). BACKGROUND: The advantage of assays to detect HIV infection in OF lies in the on-site easy access and noninvasive sample collection. METHODS: Paired serum and OF were collected from 496 subjects (263 HIV-positive and 233 HIV-negative) using the Oracol test kit (Oracle Diagnostics, Inc). The quality of OF was verified by measuring total IgGs using the Human IgG ELISA Quantitation Kit (Bethyl Lab.inc). All reactive OF samples were retested by Western blot HIV1/2 BLOT 2.2 (MP Biomedical, Singapore, China). RESULTS: Of 263 OF samples from participants with blood-based HIV-positive results, 259 were positive by Genscreen HIV ½ version 2 (98.48% sensitivity, 95% CI; 96.2-99.6). The 233 individuals who had a non-reactive HIV blood test were found negative on testing their OF by Genscreen HIV ½ version 2 (100% specificity, 95% CI; 98.4-100). NPV and PPV of the assay were 98.31% (95% CI; 95.74-99.34) and 100%, (95% CI; 98.53-100.00), respectively. CONCLUSION: Genscreen HIV ½ version 2 (Bio-Rad) is a prospective method for HIV surveillance studies in hard-to-reach populations with high risk behavior using non-invasive OF collection (Tab. 1, Fig. 1, Ref. 16).

Prevalence of resistance-associated mutations in newly diagnosed HIV-1 patients in Greece.

The prevalence of HIV-1 drug resistance mutations in naïve patients has been previously shown to differ greatly with the geographic origin. The purpose of this study was to prospectively estimate the prevalence of HIV-1 drug resistance in Greece by analyzing a representative sample of newly HIV-1 diagnosed patients, as part of the SPREAD collaborative study. Protease (PR) and partial reverse transcriptase (RT) sequences were determined from 101 newly diagnosed HIV-1 patients, in Greece, during the period September 2002--August 2003, representing one-third of the total newly diagnosed HIV-1 patients in the same time period. The prevalence of HIV-1 drug resistance was estimated according to the IAS-USA mutation table taking into account all mutations in RT and only major mutations in PR region. The overall prevalence of resistance was 9% [95% confidence interval (CI): 4.2--16.2%]. The prevalence of mutations associated with resistance to NRTIs was 5% (95% CI: 1.6--11.2%), for NNRTIs was 4% (95% CI: 1.1--9.8%), while no major resistance mutations were found in PR. No multi-class resistance was detected in the study population. The prevalence of resistant mutations in the recent seroconverters was 22%. For two individuals, there was clear evidence for transmitted resistance based on epidemiological information for a known source of HIV-1 transmission. The prevalence of the HIV-1 non-B subtypes and recombinants was 52%.

Low-dose IFN-alpha monotherapy in treatment-naive individuals with HIV-1 infection: evidence of potent suppression of viral replication.

To evaluate the safety and antiviral action of interferon-alpha (IFN-alpha) in HIV-1 infection, we undertook a proof of concept study in 27 treatment-naive patients. Eligible patients comprised two groups: the IFN-alphaT group (n = 17), which received 5 MIU IFN-alpha s.c. daily for 32 consecutive days, and the IFN-alphaNT group (n = 10), which did not receive IFN-alpha prior to highly active antiretroviral therapy (HAART), which was commenced on day 28 in both groups. IFN-alphaTreatment was well tolerated in 14 of the 17 patients of the IFN-alphaT group who completed the study. The mean HIV RNA reduction in the IFN-alphaT group on day 14 was 1.1 log(10). Viral load suppression was inversely associated with baseline viral load (p = 0.031). Four weeks after initiation of HAART, IFN-alphaT and IFN-alphaNT group patients had 2.40 and 1.82 log(10) HIV RNA reduction from baseline, respectively (p < 0.001). There was no evidence of cross-resistance with existing antiretrovirals in patients with HIV-RNA rebound after initial plasma viral load decline > or = 1 log(10) during IFN-alpha monotherapy. Thus, low daily IFN-alpha exhibits potent anti-HIV-1 activity in vivo without serious adverse effects. These properties render IFN-alpha an attractive candidate for further assessment as a constituent of HAART.

The impact of new antiretroic therapeutic schemes on the cost for AIDS treatment in Greece.

The paper attempts to evaluate the clinical and economic benefits between the administration of the dual and triple antiretroic schemes for the treatment of the HIV disease. Clinical and economic data are derived from patients hospitalized in 1996 and 1997 at the University Department of Dermatology and Venereology of Andreas Sygros Hospital. Methodology is based on the comparison of patients' nosological profile and direct annual cost before and after the administration of the triple treatment. The results of the study present that the triple combination therapy yields superior health outcomes, (decrease in the days of hospitalization and in the opportunistic disease events as well as fewer deaths and loss of production). Cost comparison presents a small decrease in the annual patient's cost, where all cost components are diminished, except the medication cost. A substitution of hospital care by drug therapy is revealed and a great change is taken place in the composition of the drugs' cost. Patient cost for antiretroic drugs has more than doubled from 1996 to 1997.