gms | German Medical Science

Aims: Raltegravir (RAL) has shown considerable potency and safety in several clinical trials. We evaluate the efficacy of raltegravir containing antiretroviral (ARV) regimens in HIV+ patients with several treatment failures in "real life".

Methods: Cohort of consecutively enrolled patients switching to a raltegravir containing ARV regimen until Dezember 2008. The drug was prescribed in patients with virologic failure under previous ARV combination. Data were recorded at baseline and during 52 weeks of follow-up.

Results: A total of 55 patients were analysed. Baseline characteristics were as follows: mean age was 47 (range 31–64) years, female 16,3 %, mean time on ARV´s: 12,3 (5–20) years; CDC group C was n=27 (49,1%), B n=17 (30,3%) and A n= 11 (19,6%). Baseline HIV-RNA and CD4+ counts were [median (IQR)]: 4,38 (1,04–5,2) log 10 copies/ml and 254 (2-846) cells/µl, respectively. Most frequently concomittantly used new protease inhibitor was darunavir (24 pts.=44%), 10 pts. had maraviroc (18%), 7 pts. etravirine (13%) and 4 pts. T-20 (7%) combined as an active antiretroviral with raltegravir. 14 pts. (25,4%) received only RAL as a new compound. The tolerabillity and safety was generally well. After 4 weeks 17 pts. (30%) presented a suppresed viral load <40 copies/ml; 45 % (25 pts.) at wk 12 and 58,2% (32 pts.) at wk 24. The mean CD4+ count increased to 317/µl (wk 4), 351/µl (wk 12) and 384/µl at wk 24. In June 2009 48 pts. (87,3%) were still on their RAL combination, 7 pts. stopped their ARV regime due to virolocic failure and/or lack of compliance. 38 pts. reached wk 52 at June 2009, data from 34 pts. were available. 23 pts. were <40 copies/ml (51,1% NC=F) at wk 52, mean CD4+ count was 368/µl.

Conclusion: Although the overall efficacy of RAL containing regimens in HIV multi-experienced patients was encouraging, in comparison to the favourable study-results (60% <40 copies7ml), in real life it seems more difficult to replicate these results.