Guidelines for antiretroviral therapy in HIV-1 infected adults and adolescents: the recommendations of the Thai AIDS Society (TAS) 2008.

BACKGROUND: More than 100,000 patients have been treated, since the implementation of the National Universal Coverage for antiretroviral therapy (ART) in Thailand Although there are several comprehensive guidelines available internationally, there is a need to have guidelines that can be implemented in Thailand. MATERIAL AND METHOD: The guidelines were developed by a panel of 17 members who are the experts on HIV research and/or HIV patient care and appointed without incentive by the Thai AIDS Society (TAS). The recommendations were based on evidences from the published studies and availability of antiretroviral agents. Published studies that are relevant and applicable to Thailand in particular have been taken into consideration. RESULTS: The recommendations include: when to start ART; what to start; how to monitor the therapy; adverse effects and its management; diagnosis of treatment failure; and antiretroviral treatment options in patients with treatment failure. ART in special circumstances, i.e., patients with co-infection of tuberculosis or hepatitis B virus, is also included Appropriate level of CD4+ T-cell count to start ART among Thai patients has been considered carefully. The authors recommend to start ART at CD4+ T-cell count < 200 cells/mm3. CONCLUSION: ART should be initiated in adults and adolescents HIV-1 infected patients with a history of HIV-related illness or AIDS or with a CD4+ T-cell count <200 cells/mm3. For treatment-naive patients, the preferred initial therapy is a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen. CD4' T-cell count and viral load should be monitored for at least twice and once a year, respectively. Proper management of antiretroviral-related toxicity and enhancement of adherence are crucial for the long-term success of ART.

Invasive aspergillosis in a tertiary-care hospital in Thailand.

BACKGROUND: Invasive aspergillosis (1A) is one of the most common and serious fungal infections in immuno-compromised host. Available data regarding IA among Asian patients are limited. OBJECTIVE: To determine patients' characteristics, clinical presentation, treatment, and outcomes of patients with IA in a Tertiary-care Hospital in Thailand. MATERIAL AND METHOD: The authors retrospectively reviewed medical and laboratory records of adult patients with IA from January 2000 to December 2005. RESULTS: Ninety-four patients were identified and classified as proven (n = 35), probable (n = 10), and possible IA (n = 49) according to the criteria designed for cancer patients (EORTC/MSG). Mean +/- SD age was 48 +/- 19 (range, 17-89) years old and 54 patients (57%) were male. Acute leukemia was the most common underlying condition (30%). Major predisposing factors were neutropenia (39%), chemotherapy (34%), and receiving corticosteroid therapy (25%). Common sites of infection were lungs (68%), sinus (17%), and eyes (8%). Aspergillus fumigatus (67%) was the most frequently isolated species. Amphotericin B followed by itraconazole was the mainstay of treatment. Thirty-six patients (38%) had complete or partial response to therapy whereas 44 patients (47%) died due to aspergillosis. Multivariate analysis showed that corticosteroid therapy [hazard ratio (HR) 10.65; 95% confidence interval (CI) 1.03-110.15, p = 0.047] and pulmonary infection [HR 18.06; 95% CI 4.28-76.17, p < 0.001] were significant predictive factors of death. CONCLUSIONS: Epidemiology and outcomes of IA among Thai patients were comparable to those in Western countries. Early diagnosis of lA in patients at risk is still essentially required in order to offer appropriate therapy, decrease morbidity, and mortality rate.

Lipodystrophy and dyslipidemia in human immunodeficiency virus-infected Thai patients receiving antiretroviral therapy.

BACKGROUND: Lipodystrophy and dyslipidemia are increasing problems in HIV-infected patients receiving antiretroviral therapy (ART). OBJECTIVE: Determine the prevalence and predicting factors for lipodystrophy and dyslipidemia in these patients. MATERIAL AND METHOD: A cross-sectional study was performed on HIV-infected patients receiving ART in January 2006. Clinical assessment for lipodystrophy and blood tests for lipid profile were obtained. RESULTS: There were 56 patients with a mean age of 42.3 years and 71.4% were male. Lipodystrophy was detected in 66.1%. Baseline characteristics between patients with and without lipodystrophy were similar except for age, history of receiving d4T and undetectable HIV-RNA (p < 0. 05). There was a high prevalence of dyslipidemia (53.6%). By logistic regression, undetectable HIV-RNA (odds ratio (OR) 6.4, p = 0.016) and receiving d4T (OR 7.4, p = 0.022) are predicting factors for lipodystrophy. CONCLUSION: Lipodystrophy and dyslipidemia in HIV-infected Thai patients receiving ART are common. Clinical monitoring for these abnormalities during ART is highly recommended.

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.

Efficacy of a generic fixed-dose combination of stavudine, lamivudine and nevirapine (GPO-VIR) in Thai HIV-infected patients.

BACKGROUND: GPO-VIR, fixed-dose combination of stavudine 30/40 mg, lamivudine 150 mg, and nevirapine 200 mg are widely used in Thailand. OBJECTIVE: Determine the efficacy and tolerability of GPO-VIR in naive HIV-infected patients. MATERIAL AND METHOD: Primary outcome was the time of initiation to achieve the goal of therapy, which was HIV RNA < 50 copies/mL or 50% increased of CD4 cell count. Ninety patients were eligible for the present study. Mean +/- SD age was 35 +/- 7 years and 51% were male. Median baseline CD4 and HIV RNA were 52 cells/ mm3 and 280,000 (5.4 log10) copies/mL, respectively. Sixty-two (69%) patients had previous opportunistic infections. RESULTS: In a median follow-up period of 15 weeks, 49 (54%) patients achieved the goal of therapy. The probability of goal achievement showed that 12-, 24-, 36- and 48- weeks success rates were 8.5% [95% confidence interval (CI): 3.9-18.0%], 62.7% (95% CI: 50.8-74.6%), 80.0% (95% CI: 67.3-90.1%), and 93.3% (95% CI: 76.3-99.4%), respectively. The median success time to achieve the goal was 21 weeks. Eleven (12%) patients needed to discontinue GPO-VIR because of adverse drugs reaction. CONCLUSION: GPO-VIR may be one of the antiretroviral regimens for HIV-infected patients in Thailand and other resource-limited countries. Its efficacy is good in patients with advanced HIV infection.

Virological and immunological responses of efavirenz-based HAART regimen initiated in HIV-infected patients at CD4 < 100 versus CD4 > or = 100 cells/mm3.

OBJECTIVE: To compare virological and immunological responsiveness of efavirenz (EFV)-based highly active anti retroviral therapy (HAART) between patients with baseline CD4 < 100 and CD4 > or = 100 cells/mm3. MATERIAL AND METHOD: A prospective cohort study in antiretroviral-naive HIV-infected patients was conducted between February and April 2002. Donated HAART regimen, consisting of stavudine, didanosine, and EFV was initiated. The primary outcome was time to undetectable HIV RNA, < 50 copies/mL. Patients were followed up every 12 weeks until 48 weeks (the end of the study). RESULTS: Forty-six patients were included, 21 patients for CD4 < 100 cells/mm3 and 25 patients for CD4 > or = 100 cells/mm3. Median CD4 cell counts of these corresponding groups were 26.5 and 177 cells/mm3. Patients' characteristics were similar between the two groups except CD4. The probability of undetectable HIV RNA at 12, 24, 36, and 48 weeks were 57.1% (95% CI, 37.7-78.1%), 76.2% (95% CI, 56.9-91.3%), 80.9% (95% CI, 62.3-94.0%), and 90.5% (95% CI, 68.9-99.1%) for the former group; and 64.0% (95% CI, 45.8-81.8%), 92.0% (95% CI, 77.5-98.6%), 96.0% (95% CI, 83.0-99.7%), and 96.0%.(95% CI, 83.0-99.7%) for the latter group. Median time to undetectable HIV RNA was 12 weeks for both groups. Median CD4 change at 48 weeks was 171 and 132 cells/mm3, respectively (p = 0.232). The adverse events were similar between the two groups. CONCLUSION: Initiation of EFV-based HAART regimen in HIV-infected patients at CD4 < 100 and > or = 100 cells/ mm3 gains similar immunological and virological response.

Use of HIV Postexposure Prophylaxis in healthcare workers after occupational exposure: a Thai university hospital setting.

BACKGROUND: PostExposure Prophylaxis (PEP) is widely used after exposures to Human Immunodeficiency Virus (HIV) to reduce the risk of infection in the healthcare setting. Few data are available on the safety and tolerability of Anti Retro Viral drugs (ARV) among Health Care Workers (HCWs) who are prescribed prophylaxis. OBJECTIVE: To collect information about the safety and compliance of taking ARV for HIV PEP among HCWs. MATERIAL AND METHOD: Retrospective review on registry data regarding occupational HIV exposures, the PEP regimens used, and the adverse events associated with PEP was performed. RESULTS: During a five year-period, 820 episodes with occupational blood or body fluid exposures were reported Nurses (27%) were the largest group at risk. The most common type of exposure was percutaneous injuries (82%). Only 125 (15%) HCWs had occupational exposures to HIV, 64 HCWs were prescribed HIV PEP and 32 (50%) HCWs did not complete the PEP regimen as initially prescribed. The commonly prescribed ARV was zidovudine (38%), lamivudine (33%), and indinavir (11%). Overall, 18 (28%) HCWs reported symptoms while on PEP such as nausea (89%), vomiting (55%), and dizziness (39%). None of the HCWs had HIV seroconversion. CONCLUSIONS: Adverse effects from HIV PEP were very common. Clinicians prescribing HIV PEP need to discuss with HCWs about PEP efficacy and side effects. Education efforts aimed at occupational exposure prevention are still important issues.

Prevalence of hepatitis B virus and hepatitis C virus co-infection with human immunodeficiency virus in Thai patients: a tertiary-care-based study.

BACKGROUND: Hepatitis B virus (HBV), hepatitis C virus (HCV), and HIV share the route of transmission. HBV or HCV co-infection with HIV has been associated with a reduced survival rate, an increased risk of progression to severe liver disease, and an increased risk of hepatotoxicity associated with active antiretroviral therapy. Information regarding prevalence of HBV and HCV co-infection with HIV in Thailand is limited. PATIENTS AND METHOD: A cross-sectional study of prevalence and risk factors of HBV and HCV co-infection in HIV-infected patients was conducted. All HIV-infected patients who were cared for in March 2003 at Ramathibodi Hospital were included. RESULTS: There were 529 HIV-infected patients with a mean age of 36.7 years and 56.5% males. Of these, 58.8% lived in Bangkok, whereas, the others were from provincial areas. Heterosexual contact were the acquisition of HIV infection in 98.1% of all patients. The prevalence of HBV infection was 8.7%, and HCV infection was 7.8%. There was no difference between the prevalence of these infections in Bangkok and provincial areas (p = 0.115). History of intravenous drug use was associated with both HBV and HCV co-infection (p < 0.001). HCV co-infection group was also associated with male gender (p = 0.002) and elevated serum alanine transaminase (ALT) level (p = 0.0003). CONCLUSIONS: The prevalence of HBV and HCV co-infection with HIV in Thai patients is significant. In the author s resources-limited setting, history of intravenous drug use is a major indicator to screen for both HBV and HCV co-infection. Male gender and elevated serum ALT level are also suggestive of HCV co-infection.