RESUMO
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.
Assuntos
Fármacos Anti-HIV/efeitos adversos , Antirretrovirais/efeitos adversos , Contagem de Linfócito CD4 , Infecções por HIV/complicações , Hepatite/etiologia , Nevirapina/efeitos adversos , Adulto , Alanina Transaminase/análise , Aspartato Aminotransferases/análise , Feminino , Infecções por HIV/fisiopatologia , Hepatite/fisiopatologia , Humanos , Incidência , Masculino , Estudos Retrospectivos , Fatores de Risco , Perfil de Impacto da DoençaRESUMO
The objective of the study was to determine cumulative incidence and risk factors of nevirapine (NVP)-associated rashes that lead to NVP discontinuation among HIV-infected patients with CD4 <250 cells/microL. 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. There were 910 patients with a mean age of 35.4 years and 43% were women. Median CD4 cell count was 27 cells/microL and median HIV RNA was 5.5 log copies/mL. Cumulative incidences of rashes at 0.5, 1, 2, 3 and 6 months after ART were 3.7%, 6.2%, 8.1%, 8.5% and 8.5%, respectively. By Kaplan-Meier analysis, the higher baseline CD4 cell counts had a higher probability of NVP-associated rashes (log-rank test, P=0.041). By Cox regression analysis, higher baseline CD4 cell count was associated with a higher incidence of rashes (hazard ratio=1.244, 95% confidence interval=1.045-1.482, for every 50 cells/microL increment of baseline CD4 stratum). In conclusion, NVP-associated skin rashes that lead to NVP discontinuation are common among HIV-infected patients with baseline CD4 <250 cells/microL. Despite the low baseline in this population, the higher number of baseline CD4 cells is continuously associated with a higher risk for skin rashes.
Assuntos
Exantema/epidemiologia , Infecções por HIV/complicações , Infecções por HIV/tratamento farmacológico , Nevirapina/efeitos adversos , Nevirapina/uso terapêutico , Adulto , Contagem de Linfócito CD4 , Estudos de Coortes , Feminino , Humanos , Incidência , Masculino , Análise de Regressão , Estudos Retrospectivos , Carga ViralRESUMO
OBJECTIVE: To study incidence, risk factors, and impact of major opportunistic infections (OIs) after initiation of antiretroviral therapy (ART). METHODS: A retrospective cohort study was conducted among naïve HIV-infected patients who were initiated ART during January 2003-December 2004. All patients were followed until 15 months after ART. RESULTS: There were 793 patients with mean+/-SD age of 35.2+/-7.4 years and 56.3% male. Median (IQR) CD4 was 26 (9-78) cells/mm3. Of 793 patients, 61 (8%) patients developed 81 episodes of OIs after ART. These included tuberculosis (48.1%), CMV retinitis (19.8%), MAC infection (14.8%), PCP (9.9%), cryptococcosis (6.2%) and penicilliosis (1.2%). Overall incidence of new episode of OIs after ART was 8.0% during the first year of ART. Probabilities of OIs at 1, 2, 3, 6, and 12 months after ART were 2.6%, 4.0%, 5.3%, 6.9% and 8.0%, respectively. Baseline CD4 < or = 50 cells/mm3, male gender, and low body weight were associated with higher incidence of OIs after ART (P<0.05). CONCLUSIONS: Most of new episodes of major OIs develop within the first three months after ART. Tuberculosis is the most frequent OIs in this situation. The substantial increase of new episode of OIs after ART was observed among HIV-infected patients with CD4 cell counts < or = 50 cells/mm3 at ART initiation.