Efficacy of a dual therapy based on darunavir/ritonavir and etravirine in ART-experienced patients.
BACKGROUND
Nucleoside reverse transcriptase inhibitors (NRTI)-sparing regimens have been studied in antiretroviral therapy (ART)-naïve patients but data with ART-experienced are scarce. NRTI-sparing regimens may be an option in patients with toxicities and for simplification reasons.


METHODS
Retrospective multicentre analysis including ART-experienced patients starting treatment with darunavir/ritonavir and etravirine (DRV/r 800 mg/100 mg QD or 600 mg/100 mg BID and ETV 400 mg QD or 200 mg BID) with at least six months of follow-up. Primary endpoint was proportion of patients with VL<50 copies/mL at 48 weeks with an ITT analysis (missing or switch equals failure). Secondary endpoints were safety, CD4 count and lipid changes over 48 weeks.


RESULTS
Seventy-five patients were included of whom 44 (58.6%) had HIV RNA<50 copies/mL. Baseline characteristics: median age 50 years (IQR 34-65), 72% males, 93% Caucasians, 38.6% hepatitis C, and 45.4% with CDC C stage. Median HIV duration and time on ART were 20 (IQR 7-28) and 14 years (IQR 5-21) respectively. Reasons for switching were virologic failure in 27 (36%), simplification in 25 (33.3%), toxicity in 20 (26.6%) and other 3 (4.1%). Most of them received DRV/r and ETV QD. Thirty-nine patients had NNRTI resistance mutations [28 K103N (37.3%), 6 Y181I/C (8%), 3 G190A (4%)] and 29 patients had ≥1 primary PI mutations. Main analysis (ITT) showed that 67 (89.3%) had a VL undetectable at 24 weeks (95% CI 83.1-95.5) and 57 (76%) at 48 weeks (95% CI 68.4-83.6). On treatment analysis showed that 94.3% and 89% had a viral load<50 copies at 24 and 48 weeks, respectively. 11 (14.6%) patients discontinued the regimen (three virologic failures, three switching to darunavir/ritonavir monotherapy, two to salvage regimen and three due to toxicity). No significant changes in CD4+ count and lipid changes were observed at 48 weeks.


CONCLUSIONS
Dual therapy with Darunavir/ritonavir and etravirine is an efficacious and safety option in ART-experienced HIV patients even in patients on virologic failure.
HIV Unit, Internal Medicine, Hospital La Paz, IdiPAZ, Madrid, Spain.
Jose Ignacio
JI
Bernardino
HIV Unit, Internal Medicine, Hospital La Paz, IdiPAZ, Madrid, Spain.
Francisco Xavier
FX
Zamora
Servicio Enfermedades Infecciosas, Hospital Carlos III, Madrid, Spain.
Eulalia
E
Valencia
Servicio Enfermedades Infecciosas, Hospital Carlos III, Madrid, Spain.
Victoria
V
Moreno
nfectious Diseases Unit, Internal Medicine, Hospital Clinico Universitario, Madrid, Spain.
Jorge
J
Vergas
nfectious Diseases Unit, Internal Medicine, Hospital Clinico Universitario, Madrid, Spain.
Maria Jesus
MJ
Tellez
nfectious Diseases Unit, Internal Medicine, Hospital Clinico Universitario, Madrid, Spain.
Vicente
V
Estrada
HIV Unit, Internal Medicine, Hospital La Paz, IdiPAZ, Madrid, Spain.
Juan
J
Gonzalez-Garcia