engleski

Toxicity Related Antiretroviral Drug Treatment Modifications in Individuals Starting Therapy in Croatia: a Cohort Analysis of Time Patterns, Gender and other Risk Factors

Background: Antiretroviral treatment (ART) modifications can occur for a number of reasons, including adverse drug effects. We investigated gender differences and other risk factors for ART toxicity modifications (ATM) during the first three years after initiation of ART in a closed cohort of patients in Croatia. Materials-Methods: We conducted a cohort study of ART naïve adults who started treatment in the period 1998-2007 in Zagreb. We calculate differential toxicity rates by the Poisson method. In multivariable analysis, we used a marginal discrete-time logistic regression model for repeated events for the outcome of modification due to drug toxicity. Results: Of 321 patients who started ART ; median age was 40 years, 19% were women, baseline CD4 <200 cells/mm3 in 71% and viral load >=100, 000 c/mL in 69%. There were 24 deaths. Overall 124 (39%) patients had >=1 ATM, and there were 176 episodes of ATM. The following toxicities caused ATM more often: lipoatrophy (22%), gastrointestinal symptoms (20%) and neuropathy (18%). Of individual drugs zidovudine was more frequently discontinued for toxicity reasons in women than in men (RR, 2.71, 95%CI 1.23-5.99). In multivariable analysis women were at greater risk for ATM (average HR, 1.89, 95%CI 1.27-2.81) because of the toxicity occurring during the first 3 months of therapy (HR, 3.08). Individuals taking an NNRT-based regiment compared to those taking a PI-based regimen had a higher average HR of ATM during the first three months of therapy (1.92, 95%CI 1.12-3.30). Individuals receiving ABC3TC and ZDV3TC had a lower average HR of ATM compared to patients on D4T3TC (0.21 and 0.41 respectively). Older age was also associated with ATM (average HR, 1.23 per 10 years). Conclusion: We found that factors related to ATM significantly vary over follow-up time and that female gender was an important risk for ATM.

HIV infection; Toxicity; Gender

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