Background : hyperglicaemia and diabetes are related with liver fibrosis progression and hccin hcv mono and hiv co-infected patients (pts).atz and drv based treatment seem to have less metabolic toxicity.A retrospective analysis of master cohort has be done to compare the safety and the impact on liver fibrosis of cART based on atz/r, unboosted atz and drv/r in HIV/HCV pts. Materials & Methods : HIV/HCV Ab+ patients starting for the first time ATZ/r 300/100mg QD (group 1) or unboosted ATZ 200 mg BID (group 2), or DRV/r 800/100 mg QD or 600/100 BID (group3),enrolled in the observational Italian MASTER database, were included. Socio demographic variables and clinical and laboratory data were collected during follow up. Liver fibrosis has estimated using FIB-4 formula. The mean difference between the final and the initial value of each variable along the therapeutic cycle was submitted to ANOVA using the therapeutic scheme as explanatory variable. The HIV-RNA was log 10 -transformed, to ameliorate its distribution. The variables changes under the treatment were submitted to pairwise comparison between therapeutic groups. The impact of study drugs on HIV-RNA and CD4 cell count variation were tested adjusting for confounding variables (baseline HIV-RNA, CD4 cell count, sex and age) using the AIPW estimator 'augmented inverse- probability weighting', probit model. Results: Six hundred-eighty-nine pts were included: 466 in group 1, 89 in group 2 and 134 in group 3.The median years of follow up were 2,07 (1,0;3,7) in group 1;2,8(1,6;4,2) in group 2 and 1,7(0,1;2,5) in group 3. Baseline characteristics were similar in 3 groups; but LDL cholesterol plasma level (ANOVA p 0.023),HIV- RNA (p 0.006) and T CD4 cell count(p 0.002) differ among groups. ANOVA on the variation between final and initial value shown that triglycerides decreased more in group 1 [-15.4 mg/dl (- 25.44; -5.38)p0.03] and 2 [-25,9 mg/dl(- 48.8; -3.06)p0.02]; glycaemia[-4.15 mg/dl (- 8.32;0.03)p0.05] and GGT [-3.,3 mg/dl (IC95% -69.3;-5.32)p0.022] decreased significantly in group 2. The difference between paired treatments (1vs2; 3vs2; 3vs1) revealed that glycaemia was significantly increased with DRV/r vs unboosted ATZ [5.9(0.46;11.34)p0.03] and reduced with unboosted ATZ vs ATZ/r [- 5.10 mg/dl (-9.59;-0.42)p0.03]. A mild increase in CD4 ell count (+ 47 cell/mm3) is evident with ATZ/r vs unboosted ATZ(p0.04).HIV-RNA decreased more in pts treated with ATZ/r or DRV/r vs unboosted ATZ (p0.01).Fib 4 lowered during treatment with ATZ/r [- 0.34(-0.6;- 0.03)p0.03] Conclusions: In the real clinical setting DRV/r and ATZ based treatment are the most used among HIV/HCV co-infected pts. Boosted or unboosted ATZ based regimens could have more metabolic advantages and liver fibrosis seems to be reduced on unboosted ATZ. A stronger viral control is provided by boosted protease inhibitors than unboosted ATZ based regimen.
Atazanavir/rit(atz/r),unboosted atazanavir (atz) or darunavir/rit(drv/r):metabolic safety and liver fibrosis in hiv/hcv coinfected patients (master cohort)
C. Mengoli;D. Segala;S. Costarelli;
2015
Abstract
Background : hyperglicaemia and diabetes are related with liver fibrosis progression and hccin hcv mono and hiv co-infected patients (pts).atz and drv based treatment seem to have less metabolic toxicity.A retrospective analysis of master cohort has be done to compare the safety and the impact on liver fibrosis of cART based on atz/r, unboosted atz and drv/r in HIV/HCV pts. Materials & Methods : HIV/HCV Ab+ patients starting for the first time ATZ/r 300/100mg QD (group 1) or unboosted ATZ 200 mg BID (group 2), or DRV/r 800/100 mg QD or 600/100 BID (group3),enrolled in the observational Italian MASTER database, were included. Socio demographic variables and clinical and laboratory data were collected during follow up. Liver fibrosis has estimated using FIB-4 formula. The mean difference between the final and the initial value of each variable along the therapeutic cycle was submitted to ANOVA using the therapeutic scheme as explanatory variable. The HIV-RNA was log 10 -transformed, to ameliorate its distribution. The variables changes under the treatment were submitted to pairwise comparison between therapeutic groups. The impact of study drugs on HIV-RNA and CD4 cell count variation were tested adjusting for confounding variables (baseline HIV-RNA, CD4 cell count, sex and age) using the AIPW estimator 'augmented inverse- probability weighting', probit model. Results: Six hundred-eighty-nine pts were included: 466 in group 1, 89 in group 2 and 134 in group 3.The median years of follow up were 2,07 (1,0;3,7) in group 1;2,8(1,6;4,2) in group 2 and 1,7(0,1;2,5) in group 3. Baseline characteristics were similar in 3 groups; but LDL cholesterol plasma level (ANOVA p 0.023),HIV- RNA (p 0.006) and T CD4 cell count(p 0.002) differ among groups. ANOVA on the variation between final and initial value shown that triglycerides decreased more in group 1 [-15.4 mg/dl (- 25.44; -5.38)p0.03] and 2 [-25,9 mg/dl(- 48.8; -3.06)p0.02]; glycaemia[-4.15 mg/dl (- 8.32;0.03)p0.05] and GGT [-3.,3 mg/dl (IC95% -69.3;-5.32)p0.022] decreased significantly in group 2. The difference between paired treatments (1vs2; 3vs2; 3vs1) revealed that glycaemia was significantly increased with DRV/r vs unboosted ATZ [5.9(0.46;11.34)p0.03] and reduced with unboosted ATZ vs ATZ/r [- 5.10 mg/dl (-9.59;-0.42)p0.03]. A mild increase in CD4 ell count (+ 47 cell/mm3) is evident with ATZ/r vs unboosted ATZ(p0.04).HIV-RNA decreased more in pts treated with ATZ/r or DRV/r vs unboosted ATZ (p0.01).Fib 4 lowered during treatment with ATZ/r [- 0.34(-0.6;- 0.03)p0.03] Conclusions: In the real clinical setting DRV/r and ATZ based treatment are the most used among HIV/HCV co-infected pts. Boosted or unboosted ATZ based regimens could have more metabolic advantages and liver fibrosis seems to be reduced on unboosted ATZ. A stronger viral control is provided by boosted protease inhibitors than unboosted ATZ based regimen.I documenti in SFERA sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
