Background and Summary

Prolonged infection with hepatitis C virus (HCV) can lead to liver damage and, eventually, death. The combination of interferon-alpha and ribavirin has enabled as many as 40% of patients with HCV infection to recover. This rate of success was observed in people without HIV.

To investigate the effect of this combination in people living with both HCV and HIV, researchers in Paris conducted a study on 20 people with HCV-HIV co-infection. Fifty per cent of the subjects recovered from HCV infection after six months of interferon and ribavirin therapy. The combination was generally well tolerated, although some subjects experienced side effects. Further comments on the results of this study appear at the end of this article.

Study details

Researchers enrolled 20 subjects (three females, 17 males) co-infected with HCV and HIV. At the start of the study, the subjects had the following characteristics:

• 90% were injection drug users.
• 80% had never used interferon-alpha.
• No subject had been exposed to ribavirin.
• The average CD4+ count was 350 cells.
• The average viral load was about 6,000 copies.

Use of anti-HIV drugs was as follows:

• 11 subjects were taking two nucleoside analogues (nukes).
• Six subjects were taking two nukes and a protease inhibitor.
• Three subjects were not taking any anti-HIV medication.

All subjects received the following drugs for six months:

• Ribavirin, between 1,000 and 1,200 mg each day.
• Interferon, 3 million units injected under the skin three times weekly.

Results - liver enzymes

Levels of liver enzymes in the blood are often higher than normal when liver damage occurs. Subjects in this study all had high levels of the following liver enzymes:

• ALT (analine aminotransferase)
• AST (aspartate aminotransferase)
• GGT (gamma glutamyl transferase)

After three months of combination anti-HCV therapy, levels of these liver enzymes fell significantly. By the sixth month, ALT levels had fallen, on average, to near normal and AST levels fell by 50%. GGT levels, although significantly decreased, were still higher than normal.

Results - HCV

In 50% of subjects (called "responders" by the doctors), technicians could not detect any HCV by the sixth month of the study.

Results - CD4 counts and HIV

The average CD4+ count fell from 350 to 285 cells by the sixth month of the study. This decrease was statistically significant; that is, not likely due to chance alone. This probably occurred because of the combined toxicity of interferon and ribavirin. Levels of HIV remained relatively stable during the study and no subject developed AIDS.

Responders and non-responders

Only 50% of subjects were able to recover from HCV infection despite having received combination anti-HCV therapy. None of the following factors had any impact on the effectiveness of combination therapy:

• Age
• Extent of liver damage
• ALT levels
• HCV levels
• CD4+ cell count

The most important factor to influence the outcome of therapy was the type of HCV present in the subjects. For example, all five subjects infected with HCV genotype 3a recovered. Those subjects infected with HCV genotypes 1a, 1b and 4 did not always respond to therapy however.

Side effects

Overall, the doctors reported that subjects tolerated therapy. The following side effects were caused by ribavirin however:

• nausea
• low levels of red blood cells

These side effects cleared when subjects stopped taking ribavirin. In two cases, doctors had to reduce the daily dose of ribavirin to 600 mg because of side effects.

Future research into the treatment of HCV should involve:

• Continued monitoring of subjects to find out if the recovery seen in short-term studies is sustained.
• Is 600 mg/day of ribavirin as effective as 1000 mg/day?
• The fact that only 50% of subjects recovered from HCV when given interferon and ribavirin means that more effective therapies that cause fewer side effects are urgently needed.

REFERENCE

1. Landau A, Batisse D, Van Huyen JPD, et al. Efficacy and safety of combination therapy with interferon-alpha2b and ribavirin for chronic hepatitis C in HIV-infected patients. AIDS 2000;14:839-844.

20000501
CATE10702

Copyright © 2000 - TreatmentUpdate. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Editor, The Canadian AIDS Treatment Information Exchange, 555 Richmond St. West, Suite 505, Box 1104, Toronto, ON, M5V 3B1 • Phone: 416-203-7122 • Toll Free: 1-800-263-1638 • Fax: 416-203-8284  http://www.catie.ca.

ÆGiS is made possible through unrestricted grants from Boehringer Ingelheim, Elton John AIDS Foundation, iMetrikus, Inc., the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2000. This material is designed to support, not replace, the relationship that exists between you and your doctor.

ÆGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1990, 2000. ÆGiS & the Sisters of Saint Elizabeth of Hungary. All materials appearing on ÆGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of ÆGIS, or the party credited as the provider of the content.