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 HIV and Coverage of the
th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2009)
 July 19 - 22, 2009, Cape Town, South Africa
 The material posted on HIV and about IAS 2009 is not approved by nor is it a part of IAS 2009.
Liver Toxicity Related to Raltegravir (Isentress) Is Uncommon among HIV Patients, including those with HIV-HCV Coinfection

HIV patients receiving the integrase inhibitor raltegravir (Isentress) seldom experience drug-related liver toxicity, even if they are coinfected with hepatitis C virus (HCV), according to a poster presentation at the 5th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention (IAS 2009) last month in Cape Town, South Africa.

By Liz Highleyman

Raltegravir (Isentress)

Raltegravir has generally demonstrated good safety and tolerability in clinical trials, which typically have recruited HIV patients without serious underlying conditions such as liver disease. Therefore, HIV positive patients with chronic viral hepatitis B or C represent a large group for whom the tolerability of raltegravir still remains to be assessed.

Researchers at Hospital Carlos III in Madrid, Spain, which treats many HIV-HCV coinfected individuals, evaluated liver toxicity among antiretroviral treatment-experienced patients who started raltegravir between December 2005 and January 2009.

Out of a total 311 patients who started the drug during this period, the present analysis included 126 HIV monoinfected and 92 HIV-HCV coinfected participants. Most (80%) were men, the mean age was 46 years, the median CD4 cell count was 400 cells/mm3, and 64% had plasma HIV RNA < 50 copies/mL.

At baseline, month 1, and every 3 months thereafter, the investigators analyzed clinical data, laboratory parameters, and liver stiffness (a method of estimating extent of liver damage using the transient elastometry, or FibroScan, method).

Liver toxicity was classified according to baseline alanine aminotransferase (ALT) values. Any toxicity was defined as > 1.25-fold above the upper limit of normal (31 IU/L) in patients with normal ALT at baseline, or 1.25 times the baseline level in those who started with elevated ALT. Grade 3 (serious) hepatotoxicity was defined as ALT increases > 3.5-fold the normal or baseline level, while grade 4 (severe or life-threatening) liver toxicity was defined as > 5-fold the normal or baseline level.


10 (7.9%) HIV monoinfected patients developed any degree of liver toxicity after starting raltegravir, compared with 23 (25%) HIV-HCV coinfected patients (P < 0.001).
Only 3 patients -- all of them coinfected -- experienced grade 3 or 4 hepatotoxicity.
This occurred at 1 month in 1 patient and at 15 months in the other 2 patients with serious hepatotoxicity.
In all 3 of these patients, other factors related to liver damage were also involved.
A multivariate analysis revealed that HIV-HCV coinfection was the only independent variable associated with any degree of liver toxicity (P = 0.03).
The main reasons for raltegravir discontinuation were poor adherence (n=5), virological failure (n=3), and headache (n=1).

"Elevations in liver enzymes are rarely seen in HIV patients treated with raltegravir-containing regimens," the investigators stated. "They are uniformly mild and no cases of grade 3-4 hepatotoxicity could be attributed to raltegravir in our patients, 40% of whom were coinfected."

Based on these findings, they concluded, "The good hepatic safety profile of raltegravir should be added to its overall good tolerability. Raltegravir may be an interesting option in HIV-HCV coinfected patients."

Hospital Carlos III, Infectious Diseases Department, Madrid, Spain.


A Mena, F Blanco, M Córdoba, and others. Hepatic safety profile of raltegravir in HIV patients with chronic hepatitis C. 5th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention (IAS 2009). July 19-22, 2009. Cape Town, South Africa. Abstract WePeB230.















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