BACKGROUND: The objective of the study is to assess the acceptance, compliance and side effects of antiretroviral therapy in relation to age, gender, risk group, HIV infection stage and type of treatment. METHODS: This is a cohort-observational study. Inclusion criteria were: consecutive non-selected IIV patients in which antiretroviral treatment was indicated on medical grounds. The study was carried out from February 1990 to February 1996. We measured: a) poor compliance, when suspicion (by medical history, analytical data and administered drug control by the hospital pharmacy) more than a 25% of prescribed treatment was not taken; b) adverse events that obliged to discontinued the drug; and c) long-term therapy, when treatment acceptance and compliance and regular follow-up was stated. Statistics methods: Ji-square and Student's t- test. RESULTS: 567 patients were included, with a median follow up of 609 days. Male 413, female 154. Mean age: 32.9 years. Average CD4+ cells: 0.260 x 10(9)/L. There was a history of intravenous drug use (IDU) in 60.4% of cases and CDC classification group C (1993) 34.2%. Antiretroviral treatment was refused by 16.6% of patients, more frequently IDU patients (21.3%, p < 0.0001). There was a drop-out rate of 17.3%, with no differences among different groups. Poor compliance was found in 23% of cases, more frequently in IDU and group-C patients. Adverse events were observed in 22.6% of cases, more frequently in female (33.8%, p < 0.0004) and group C patients (28.6%, p < 0.04). The treatments used (AZT monotherapy, DDI monotherapy, AZT DDI and AZT + DDC) had no influence on compliance or follow-up. Long-term follow-up and compliance was achieved in 47.6% of patients, with a lesser degree in IDU (42.4%, p < 0.002) and group C patients (39.7%, p < 0.006). CONCLUSIONS: HIV-infected patients treated with antiretroviral agents, not enrolled in clinical trials, had similar rates of compliance that patients with other chronic diseases. Treatment refusal and poor compliance were more frequent in IDU patients, while adverse events were more frequent in patients with more advanced HIV infection stage.
BACKGROUND: The objective of the study is to assess the acceptance, compliance and side effects of antiretroviral therapy in relation to age, gender, risk group, HIV infection stage and type of treatment. METHODS: This is a cohort-observational study. Inclusion criteria were: consecutive non-selected IIV patients in which antiretroviral treatment was indicated on medical grounds. The study was carried out from February 1990 to February 1996. We measured: a) poor compliance, when suspicion (by medical history, analytical data and administered drug control by the hospital pharmacy) more than a 25% of prescribed treatment was not taken; b) adverse events that obliged to discontinued the drug; and c) long-term therapy, when treatment acceptance and compliance and regular follow-up was stated. Statistics methods: Ji-square and Student's t- test. RESULTS: 567 patients were included, with a median follow up of 609 days. Male 413, female 154. Mean age: 32.9 years. Average CD4+ cells: 0.260 x 10(9)/L. There was a history of intravenous drug use (IDU) in 60.4% of cases and CDC classification group C (1993) 34.2%. Antiretroviral treatment was refused by 16.6% of patients, more frequently IDU patients (21.3%, p < 0.0001). There was a drop-out rate of 17.3%, with no differences among different groups. Poor compliance was found in 23% of cases, more frequently in IDU and group-C patients. Adverse events were observed in 22.6% of cases, more frequently in female (33.8%, p < 0.0004) and group C patients (28.6%, p < 0.04). The treatments used (AZT monotherapy, DDI monotherapy, AZT DDI and AZT + DDC) had no influence on compliance or follow-up. Long-term follow-up and compliance was achieved in 47.6% of patients, with a lesser degree in IDU (42.4%, p < 0.002) and group C patients (39.7%, p < 0.006). CONCLUSIONS:HIV-infectedpatients treated with antiretroviral agents, not enrolled in clinical trials, had similar rates of compliance that patients with other chronic diseases. Treatment refusal and poor compliance were more frequent in IDU patients, while adverse events were more frequent in patients with more advanced HIV infection stage.