Incidence and risk factors of nevirapine-associated severe hepatitis among HIV-infected patients with CD4 cell counts less than 250 cells/microL.

OBJECTIVES: To determine incidence and risk factors of nevirapine (NVP)-associated severe hepatitis that led to NVP discontinuation among HIV-infected patients with CD4 < 250 cells/microL. MATERIAL AND METHOD: A retrospective cohort study was conducted among antiretroviral-naïve HIV-infected patients who had baseline CD4 < 250 cells/microL and were initiated NVP-based antiretroviral therapy (ART) between January 2003 and October 2005. All patients were categorized to group A: occurred clinical hepatitis and group B: did not occur clinical hepatitis. All were followed until 6 months after ART. RESULTS: There were 910 patients with a mean age of 35.4 years, 57% were males and median (IQR) CD4 cell count was 27 (9-80) cells/microL; contributing 5,006 person-months of observations. Ten (1.1%) patients were in group A and 900 (98.9%) patients were in group B. Incidence of clinical hepatitis was 2 per 1,000 person-months. Probabilities of clinical hepatitis at 0.5, 1, 2, 3 and 6 months after ART were 0.2%, 0.5%, 0.7%, 0.8% and 1.1%, respectively. By Cox regression analysis, baseline AST > or = 1.5 times of upper limit was associated with higher incidence of clinical hepatitis (p = 0.019, HR = 5.83, 95% CI = 1.33-25.51). CONCLUSION: Incidence of NVP-associated severe hepatitis that lead to NVP discontinuation among HIV-infected patients with baseline CD4 < 250 cells/microL is low. The higher baseline AST is also associated with a higher risk of severe hepatitis.

Evaluation of HIV-1 viral load detection by modified a commercial real-time PCR reagent used for Light Cycler 1.2 instrument.

OBJECTIVE: Commercial TaqMan real-time PCR reagent was modified and applied on Light Cylcer 1.2 for quantifying HIV-1 RNA in plasma and compared with the reference method; COBAS AmpliPrep/COBAS Amplicor HIV-1 monitor test version 1.5. MATERIAL AND METHOD: Three hundred and eight frozen and fresh plasma samples were used for evaluation. Sequential specimens were also tested for follow-up cases. RESULTS: The correlation between HIV-1 RNA values obtained by reference and modified method with automated and manual sample preparation were significant with r = 0.916 and 0.908 (p < 0.001, p < 0.001) respectively with similar agreement log of mean bias (0.5 versus 0.48). High degree of correlation and agreement were observed between the assays in blind fresh plasma, r = 0.953 (p < 0.001) with 0.15 log difference in HIV-1 RNA level. Among follow-up samples, both methods gave 100% concordant results. CONCLUSION: This modified protocol provided evidence for using modified commercial real-time PCR reagent for HIV-1 RNA quantitative detection as a monitoring tool for HIV/AIDS patients in Thailand.

Plasma nevirapine levels and 24-week efficacy of a fixed-dose combination of stavudine, lamivudine and nevirapine (GPO-VIR) among Thai HIV-infected patients.

BACKGROUND: A fixed-dose combination of stavudine, lamivudine, and nevirapine (GPO-VIR) is the most affordable antiretroviral therapy (ART) regimen in Thailand. The data of nevirapine (NVP) level and efficacy of this fixed-dose combination is limited. MATERIAL AND METHOD: Patients who were initiated GPO-VIR in 2004 were enrolled NVP levels at 12 weeks were determined. Patients were followed for 24 weeks. RESULTS: Fifty-nine patients with a mean age of 36.4 years and 54% male were enrolled. Mean body weight was 54.7 kgs. Median baseline CD4 and HIV-RNA were 29 cells/mm3 and 270,000 (5.4 log10) copies/mL, respectively. Mean plasma NVP levels at 12 weeks was 6.4 mg/L. By linear regression, female gender (p = 0.042), and higher weight (p = 0.020) were associated with lower NVP levels. At 24 weeks, 78% achieved undetectable HIV-RNA and median CD4 was 156 cells/mm3. CONCLUSION: NVP levels and 24-week efficacy of GPO-VIR are favorable. According to the affordable cost, GPO-VIR should be an appropriate initial regimen for naïve HIV-infected patients in resource-limited settings.

Survival time of AIDS patients in Bamrasnaradura Institute.

A retrospective cohort study compared the survival time of AIDS patients, or HIV infected patients who had a CD4 count less than 200 cell/mm3, who had Thailands local triple anti-retroviral drugs regimen (GPO-VIR) with original triple anti-retroviral therapy without protease inhibitor in Bamrasnaradura Institute. The result proved that survival time in patients who had local anti-retroviral drugs was the same as patients who had original triple anti-retroviral therapy without protease inhibitor (log rank p-value = 0.9617). In conclusion, local anti-retroviral drugs can be used to prolong patients' survival time as much as original triple anti-retroviral therapy without protease inhibitor

Early containment of severe acute respiratory syndrome (SARS); experience from Bamrasnaradura Institute, Thailand.

BACKGROUND: On March 11, 2003, a World Health Organization (WHO) physician was admitted to Bamrasnaradura Institute, after alerting the world to the dangers of severe acute respiratory syndrome (SARS) in Vietnam and developing a fever himself. Specimens from the first day of his admission were among the first to demonstrate the novel coronavirus, by culture, reverse transcription-polymerase chain reaction (RT-PCR), and rising of specific antibody, but proper protective measures remained unknown. The authors instituted airborne, droplet and contact precautions from the time of admission, and reviewed the efficacy of these measures. MATERIAL AND METHOD: A specific unit was set up to care for the physician, beginning by roping off an isolated room and using a window fan to create negative pressure, and later by constructing a glass-walled antechamber, designated changing and decontamination areas, and adding high-efficiency particulate air (HEPA) filters. The use of personal protective equipment (PPE) was consistently enforced by nurse managers for all the staff and visitors, including a minimum of N95 respirators, goggles or face shields, double gowns, double gloves, full head and shoe covering, and full Powered Air Purifying Respirator (PAPR) for intubation. To assess the adherence to PPE and the possibility of transmission to exposed staff a structured questionnaire was administered and serum samples tested for SARS coronavirus by enzyme-linked immunosorbent assay (ELISA). Exposure was defined as presence on the SARS ward or contact with laboratory specimens, and close contact was presence in the patient's room. RESULTS: The WHO physician died from respiratory failure on day 19. 112 of 129 exposed staff completed questionnaires, and the 70 who entered the patient's room reported a mean of 42 minutes of exposure (range 6 minutes-23.5 hours). 100% reported consistent handwashing after exposure, 95% consistently used a fit-tested N95 or greater respirator, and 80% were fully compliant with strict institutional PPE protocol. No staff developed an illness consistent with SARS. Serum samples from 35 close contacts obtained after day 28 had a negative result for SARS coronavirus antibody. CONCLUSIONS: Hospitalization of one of the earliest SARS patients with documented coronavirus shedding provided multiple opportunities for spread to the hospital staff, but strict enforcement of conservative infection control recommendations throughout the hospitalization was associated with no transmission.