ABSTRACT
A retrospective study was conducted by reviewing 459 medical records of adult treatment naive HIV patients who received a fixed dose combination of GPO-VIR-S (stavudine, lamivudine and nevirapine) or GPO-VIR-Z (zidovudine, lamivudine and nevirapine) at Ramathibodi Hospital in Bangkok, Thailand during 2002-2009 following Thai National Treatment Guideline for adults with HIV. The aim of this study was to assess the association between the baseline CD4 cell count and outcome. The median CD4 cell count at baseline, 6, 12 and 102 months were 102 cells/microl, 213 cells/microl, 274 cells/microl and 423 cells/microl. The virologic response (p=0.327), virologic rebound (p=0.626), adverse effects of anti-retroviral therapy (ART) (p=0.976), switching to other ART (p=0.245), occurrence of immune reconstitution inflammatory syndrome (IRIS) (p>0.05) and occurrence of drug resistance (p=0.952) were not significantly associated with baseline CD4 count. The Kaplan-Meier estimate showed the median time (95% CI) to achieve virologic response was 10.4 (9.8-11.0) months and the median time to achieve virologic rebound was 30.0 (21.6-38.4) months after initiation of ART. Analysis showed the median time to achieved virologic response (p=0.401) and virologic rebound (p=0.562) were not significantly associated with the baseline CD4 count. This study shows the outcome after onset of ART did not vary by baseline CD4 cell count.
Subject(s)
Anti-HIV Agents/therapeutic use , HIV Infections/blood , HIV Infections/drug therapy , Lamivudine/therapeutic use , Nevirapine/therapeutic use , Stavudine/therapeutic use , Zidovudine/therapeutic use , Adult , Anti-HIV Agents/administration & dosage , Anti-HIV Agents/adverse effects , CD4 Lymphocyte Count , Female , HIV Infections/epidemiology , Hematologic Tests , Humans , Immune Reconstitution Inflammatory Syndrome/epidemiology , Kaplan-Meier Estimate , Lamivudine/administration & dosage , Lamivudine/adverse effects , Male , Middle Aged , Nevirapine/administration & dosage , Nevirapine/adverse effects , Retrospective Studies , Stavudine/administration & dosage , Stavudine/adverse effects , Thailand/epidemiology , Treatment Outcome , Viral Load , Zidovudine/administration & dosage , Zidovudine/adverse effectsABSTRACT
Generic fixed dose combination stavudine (d4T), lamivudine (3TC) and nevirapine (NVP), named GPO-VIR is recommended in the HIV treatment guidelines for Thailand. The long term effectiveness and adverse effects of this drug combination for the treatment of HIV were evaluated in an ambispective study at Bamrasnaradura Infectious Diseases Institute, Nonthaburi Province, Thailand from March 2002 to January 2006. A total of 152 adult treatment naive HIV patients who had received at least 12 months of GPO-VIR were enrolled. The median (IQR) CD4 cell count increased from 23 (8-94) cells/microl at baseline to 126 (38-180), 136 (98-189), 199 (141-255) and 334 (243-414) cells/microl at 3, 6, 12 and 24 months (p < 0.001), respectively. The median (IQR) percentage of body weights increased from baseline by 3.0% (0.3-6.3), 6.2% (2.2-9.3), 7.3% (3.9-10.9) and 8.1% (3.4-11.9) at 3, 6, 12 and 24 months, respectively and then remained at a plateau until the end of the 3-year study. The occurrence of new opportunistic infections decreased significantly (p < 0.001) with GPO-VIR treatment. Drug resistance occurred in 5 cases (3.3%) with a median (IQR) time of 18.0 (16.5-32.5) months to occurrence. Adverse effects included hypercholesterolemia (43.2%), lipodystrophy (35.5%), hypertriglyceridemia (25%), hypertension (13.1%), peripheral neuropathy (11.9%), hyperlactatemia (2.6%) and lactic acidosis (1.3%). Thirty-six patients (27%) switched from GPO-VIR to other anti-retroviral drugs regimens due to lipodystrophy. This study showed GPO-VIR had clinical and immunological benefits, but one-third of patients had adverse effects.
