Open AccessUnboosted atazanavir with lamivudine/emtricitabine for patients with long‐lasting virological suppression
Author(s) -
Carbone Alessia,
Galli Laura,
Bigoloni Alba,
Bossolasco Simona,
Guffanti Monica,
Maillard Miriam,
Carini Elisabetta,
Salpietro Stefania,
Spagnuolo Vincenzo,
Gianotti Nicola,
Lazzarin Adriano,
Castagna Antonella
Publication year - 2014
Publication title -
journal of the international aids society
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.724
H-Index - 62
ISSN - 1758-2652
DOI - 10.7448/ias.17.4.19811
Subject(s) - medicine , atazanavir , emtricitabine , lamivudine , ritonavir , viral load , gastroenterology , human immunodeficiency virus (hiv) , virology , pharmacology , antiretroviral therapy , chronic hepatitis , virus
Unboosted atazanavir (ATV) including regimens have been investigated as a ritonavir‐sparing simplification strategy. No data are available on removal of one NRTI in subjects effectively treated with unboosted atazanavir+2NRTIs. We present the 48‐week virological efficacy and safety of unboosted atazanavir plus lamivudine (3TC) or emtricitabine (FTC) (lamivudine/emtricitabine/Reyataz © , LAREY Study). Materials and Methods Single arm, prospective, pilot study on HIV‐treated patients, HBsAg negative, with HIV‐RNA<50 cps/mL since at least 2 years, who switched from ATV+2NRTIs to ATV 400 mg QD +3TC or FTC. Virological failure was defined as 2 consecutive values of HIV‐RNA>50 cps/ml; viral blip was defined as a single HIV‐RNA value>50 cps/ml not subsequently confirmed. Results as median (IQR). Changes between baseline (BL) and week 48 assessed by the Wilcoxon signed rank test. Results Forty patients enrolled: 75% males, 51 (47–54) years, 14% HCV co‐infected, infected with HIV since 16 (9–21) years, on antiretroviral therapy since 13 (5–16) years, with a nadir CD4+ of 254 (157–307) cells/mm 3 , virologically suppressed since 4.2 (2.2–5.4) years; 53 patients switched from a tenofovir (TDF)‐based regimens; ATV was associated with 3TC in 83% patients. No virological failures or discontinuations were observed; three patients had a single viral blip in the range 50–250 copies/mL; CD4+ increased from 610 (518–829) cells/mm 3 at BL to 697 (579–858) cells/mm 3 at week 48 [48‐week change: 39 (−63/+160) cells/mm 3 p=0.081]. Three clinical events were observed (one herpes zoster, one pneumonia, one syphilis) in absence of renal lithiasis, AIDS‐defining or drug‐related events or death. Overall, significant 48‐week amelioration of ALP [BL: 83 (71–107) mg/dL; 48‐week change: −15 (−27/−8) mg/dL p<0.0001] and CKD‐EPI [BL: 100 (86–108) ml/min/1.73 m 2 ; 48‐week change: 1.5 (−3/+8) ml/min/1.73 m 2 , p=0.042] were observed. Patients switching from TDF (Table 1) significantly improved CD4+, lymphocytes, hepatic profile, renal profile and ALP; these patients had also a modest but significant decrease in haemoglobin. Conclusions Switch from an unboosted atazanavir‐based regimen to ATV+3TC or FTC regimen was effective and safe in this small sample, supporting the hypothesis of a potential two‐steps de‐intensification (removal of ritonavir and removal of one NRTI) in patients on long‐lasting virological suppression.