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Tenofovir Bolsters Response to IFN/RBV in People With HCV/HIV
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15th Conference on Retroviruses and Opportunistic Infections
February 3-6, 2008
Boston
Mark Mascolini
Tenofovir (TDF) regimens including 3TC of FTC almost doubled the chance of sustained virologic response (SVR) to pegylated interferon plus ribavirin in HCV/HIV-coinfected GeSIDA 50/06 trial participants [1]. AZT-containing regimens lowered the chance of SVR 40%.
This retrospective analysis of the 35-site GeSIDA 50/06 results compared 238 people who took TDF with 3TC or FTC and 481 patients who took AZT, d4T, or abacavir with 3TC. The investigators excluded people who took ddI or who combined TDF with AZT, d4T, or abacavir. The antiretroviral regimen always included abacavir, a nonnucleoside, or a protease inhibitor, and everyone in this analysis took pegylated interferon plus ribavirin.
Compared with people not taking TDF, those who did had used more antiretrovirals (median 7.16 versus 5.87 drugs, P = 0.000), had a lower pretreatment CD4 count (535 versus 602, P = 0.003), had a higher AST/ALT ratio (0.84 versus 0.77, P = 0.04), had a higher red cell count (4.46 vs. 4.04 cells x 10(6)/mm(3), P = 0.000), and were more likely to have lipodystrophy (30.3% versus 22.9%, P = 0.033). (Earlier work correlated an AST/ALT ratio of 1.0 or higher with cirrhosis in people with HCV-related chronic liver disease but without HIV.[2])
Intention-to-treat analysis in which antiretroviral changes meant failure figured that TDF takers had a higher SVR rate than those not taking TDF (39.1% versus 26.4%, P = 0.001, difference 12.7%, 95% confidence interval [CI] 5.35 to 20.05). Univariate analysis determined that seven factors raised or lowered the odds of attaining SVR:
· TDF during HCV therapy (raised odds): SVR 42.4%, no SVR 33.4%, P = 0.014
· AZT before and during HCV therapy (lowered odds): SVR 30.6%, no SVR 41.2%, P = 0.005
· HCV genotype 2 or 3 versus 1 or 4: SVR 60.9%, no SVR 19.3%, P = 0.000
· Never drinking alcohol: SVR 61.8%, no SVR 50.8%, P = 0.021
· Higher baseline AST/ALT ratio: SVR 0.71, no SVR 0.86, P = 0.000
· HCV load below 500,000 IU/mL: SVR 49.5%, no SVR 32.2%, P = 0.000
· HIV load below 50 copies/mL: SVR 95.6%, no SVR 91.1%, P = 0.048
Multivariate analysis adjusting for HCV genotype, HCV and HIV load, AST/ALT ratio, and alcohol history determined that taking TDF with 3TC or FTC independently raised chances of SVR 70% (odds ratio [OR] 1.70, 95% CI 1.05 to 2.27, P = 0.03), while taking AZT with 3TC cut SVR odds 40% (OR 0.60, 95% CI 0.37 to 0.99, P = 0.05).
Five other factors independently raised or lowered chances of SVR:
· HCV genotype 2 or 3 versus 1 or 2: OR 6.22, 95% CI 4.10 to 9.43, P = 0.000
· HCV load below 500,000 IU/mL: OR 1.82, 95% CI 1.19 to 2.78, P = 0.006
· HIV load below 50 copies/mL: OR 2.68, 95% CI 1.08 to 6.66, P = 0.034
· Never drinking alcohol: OR 4.65, 95% CI 1.40 to 15.45, P = 0.012
· Higher AST/ALT ratio (lowered odds): OR 0.19, 95% CI 0.08 to 0.44, P = 0.000
References
1. Gonzalez-Garcia J,Berenguer J, Condes J, et al. The use of tenofovir plus 3TC/FTC is associated with an improved response to pegylated interferon plus ribavirin in HIV-HCV co-infected patients receiving HAART: the GESIDA 50/06 study. 15th Conference on Retroviruses and Opportunistic Infections. February 3-6, 2008. Boston. Abstract 783.
2. Giannini E, Risso D, Botta F, et al. Validity and clinical utility of the aspartate aminotransferase-alanine aminotransferase ratio in assessing disease severity and prognosis in patients with hepatitis C virus-related chronic liver disease. Arch Intern Med. 2003;163:218-224.
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