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Background: Abacavir is considered as a potent and well tolerated drug but recent controversial data have raised questions concerning cardiovascular tolerability and virological efficacy in antiretroviral initial regimen with abacavir/lamivudine (ABC/3TC). Methods: Patients were selected from the Dat’AIDS french prospective cohort if they were prescribed a regimen containing ABC/3TC free or fixed dose combination for the first time between 01/01/2004 and 31/12/2007 before HLA screening recommendation or routine usage. All causes of treatment discontinuation were recorded, as well as immuno-virological and clinical data during follow-up. Results: Among the 1704 patients included in the study (male 69%, mean age 43 years) 407 (24%) were antiretroviral naive, 696 (41%) had viral load (VL) below detection on ARV treatment (switch), and 601 (35%) were on treatment with detectable VL (failure) at time of ABC/3TC initiation. Overall 565 patients (33%) discontinued ABC/3TC combination during follow-up, among them 26% have used ABC in the next regimen. Reasons for discontinuation were intolerance in 14% of the cases - including suspected hypersensitivity (HSR) in 7% of the overall population - treatment failure in 20%, and other causes in 39%. The median time to treatment discontinuation was 52 months for the overall population. After 2 years, the probability of receiving ABC/3TC was at 62%, 77%, and 60% respectively for the defined groups. Finally, the VL on treatment was below detection for 86%, 90%, and 71%, respectively. Conclusion: In this population ABC/3TC containing regimens were maintained with virological success for more than 2 years. Tolerance issues including HSR were the main reason for early discontinuation.

Tolerance and Durability of Abacavir/Lamivudine (Abc/3tc) Containing Regimens: Results from a large French Prospective Cohort