Sustained Response to Pegylated Interferon plus Ribavirin Reduces Liver Disease and Death in HIV Positive Patients

(A) Normal liver.

(B) Injured liver with fibrosis.

Research has shown that HIV positive people coinfected with hepatitis C virus (HCV) tend to experience more rapid liver fibrosis progression, and they also have a lower rate of sustained response to treatment.

In HIV negative people with hepatitis C, studies indicate that sustained virological response (SVR) to interferon-based therapy halts or slows fibrosis progression, but histological outcomes over time have not yet been extensively studied in coinfected people.

In a report at the 15th Conference on Retroviruses and Opportunistic Infections this week in Boston, Spanish researchers presented data from the GESIDA 3603 study, in which 711 HIV-HCV coinfected participants received hepatitis C treatment between January 2000 and December 2005. About 40% each received pegylated interferon alfa-2a (Pegasys) and pegylated interferon alfa-2b (PegIntron), while about 20% received conventional interferon. All patients also took ribavirin.

About three-quarters of study participants were men, with a median age of 41 years. Nearly two-thirds (63%) had difficult-to-treat HCV genotypes 1 or 4 and 39% already had advanced liver fibrosis (Metavir stage F3-F4) at study entry, another factor associated with poor treatment response. However, the patients had well controlled HIV disease overall, with a median CD4 count of 544 cells/mm3, 80% on HAART, and half with an HIV viral load under 50 copies/mL.

About one-third of study participants overall (31%) achieved SVR: 14% for genotypes 1 and 4; 46% for genotypes 2 and 3. Patients who either did not respond initially or relapsed during or after completion of treatment were classified as non-responders. Both sustained responders and non-responders were followed every 6 months for a median duration of about 20 months.

Results

• After adjusting for factors associated with an increased risk of death, including AIDS and baseline cirrhosis, patients who achieved SVR were significantly less likely to develop hepatocellular carcinoma (HCC), progress to decompensated liver disease, or require a liver transplant.

• Rates of adverse outcomes per 1000 person years in the sustained responder and non-responder groups were as follows:

• HCC: 0 vs 0.83;

• Decompensated liver disease: 0.23 vs 4.33;

• Liver transplantation: 0 vs 1.02;

• Liver-related death: 0.23 vs 1.65;

• All-cause death: 0.46 vs 3.12.

• Compared with sustained responders, non-responders had close to a 9-fold higher risk for all liver-related events combined (HR 8.92).

• Participants who achieved SVR had significantly lower rates of both liver-related death and all-cause mortality.

Conclusion

Based on these results, the investigators concluded that "the achievement of a sustained virological response after interferon-ribavirin therapy in HIV-HCV positive patients reduces liver-related complications and mortality."

2/8/08

Reference

Sustained Virological Response to Interferon plus Ribavirin Reduces Liver-related Complications and Mortality in HIV/HCV-co-infected Patients. J Berenguer, J Alvarez-Pellicer, J Lopez Aldeguer, and others. 15th Conference on Retroviruses and Opportunistic Infections. Boston, MA. February 3-6, 2008. Abstract 60.

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