Experience with darunavir in HIV-infected adults enrolled in a US expanded access program: results from a single center.
OBJECTIVE
A multicenter, international, expanded access program (EAP) was initiated in October 2005 for patients failing multiple antiretroviral regimens. The primary objective was to provide early access to darunavir (DRV) (PREZISTA) co-administered with low-dose ritonavir (DRV/r) for antiretroviral-experienced patients who failed multiple regimens and had limited treatment options; the secondary objective was to gather additional DRV/r safety information.


METHODS
Following initiation of DRV/r 600/100 mg bid, patients were evaluated at baseline, Weeks 4 and 12, and every 12 weeks thereafter for changes in CD4 cell counts and HIV-1 RNA levels. Safety and tolerability were also evaluated.


RESULTS
Results from patients treated at a single US EAP center in Houston, Texas (N = 38; mean age 47 years; 92% male; 60% Caucasian, 24% Black, 16% Hispanic) are presented. At time of analysis, 38 and 23 patients completed 12 and 24 (+/- 1) weeks of therapy, respectively. At Weeks 12 and 24, the mean change in viral load (VL) from baseline was -1.96 log(10) copies/mL (n = 38) and -2.17 log(10) copies/mL (n = 22), and 54% and 50% of patients achieved HIV-1 RNA < 50 copies/mL, respectively. Mean CD4 cell count increased by 109 cells/mm(3) from baseline to Week 24. DRV/r was generally safe and well tolerated. Most adverse events (AEs) were mild to moderate in severity (nine events considered possibly related to DRV); neither of the two serious AEs was considered related to DRV/r.


CONCLUSIONS
Although this study reflects results from only a small cohort of patients at a single center, among this community-based population of highly treatment-experienced patients, DRV/r 600/100 mg bid provided clinically meaningful decreases in VL, an undetectable rate similar to that seen in the POWER studies, and was well tolerated with infrequent AEs.
Gathe
Joseph
J
Therapeutic Concepts, Houston, TX 77004, USA. drgathe@josephgathe.com
D000328:Adult; D000368:Aged; D044966:Anti-Retroviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D000069454:Darunavir; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D015497:HIV-1 / Q000187:drug effects*; D006801:Humans; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D016730:Program Development; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D019562:Viral Load
D044966:Anti-Retroviral Agents; D017320:HIV Protease Inhibitors; D013449:Sulfonamides; D000069454:Darunavir