HCV Therapy Response Predicts Outcome in Co-Infected Patients

CROI: HCV Therapy Response Predicts Outcome in Co-Infected Patients
By Michael Smith, North American Correspondent, MedPage Today
Published: February 21, 2010
Reviewed by Barry S. Zingman, MD; Professor of Clinical Medicine, Albert Einstein College of Medicine, Bronx, NY and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner Earn CME/CE credit
for reading medical news
Action Points

* Explain to interested patients that HIV and hepatitis C co-infection is common.


* Note that this study showed that failure to respond to hepatitis C treatment increases the risk of HIV progression and mortality, separately from increased risk of liver-related complications.


* Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered preliminary until published in a peer-reviewed journal.

SAN FRANCISCO -- For people with both HIV and Hepatitis C, a poor response to hepatitis therapy markedly increased the risk of HIV progression and death, a researcher said here.

Previous research had shown that such patients were at increased risk of liver-related complications and death, according to Juan Berenguer, MD, of the Gregorio Marañon University Hospital in Madrid.

But analysis of outcomes for more than 1,400 co-infected patients at 20 clinical centers in Spain showed the same is true for outcomes not related to the liver disease, Berenguer told reporters at the Conference on Retroviruses and Opportunistic Infections.

In those who did not respond to therapy, he said, the risk of AIDS-defining conditions and non-liver death was significantly higher -- even though all patients in the study were on anti-HIV therapy and had fully suppressed virus.

Many studies have looked at the risks and benefits of various treatments, he said, but there is little data on long-term outcomes for people with both diseases.

To tease out some answers, he and colleagues looked at a large cohort of 1,428 patients treated with interferon and ribavirin between January, 2000 and July, 2007, Berenguer said. For this analysis, the researchers compared outcomes for those who did or did not achieve a so-called "sustained virological response."

A sustained virological response is a standard measure of response, defined as an undetectable serum level of Hepatitis C RNA 24 weeks after the completion of therapy.

Overall, he said, 36% of the patients had a sustained virological response. Compared with them, those who did not respond:

* Had a 3.6-fold greater risk of a new AIDS-defining condition, which was significant at P=0.008
* Had a 3.5-fold greater risk of non-liver-related death (P=0.019)
* Had a 3.3-fold greater risk of both (P=0.001)

After adjustment for covariates such as age, sex, hepatitis C genotype, and prior AIDS-defining illness, the risk of non-liver-related death lost significance, although the hazard ratio remained high at 2.6.

The risks of a new AIDS-defining condition or both AIDS and death remained high and significant, Berenguer said, (HR 3.24 and 2.86, respectively).

All told, he said, there were 24 non-liver-related deaths among the 908 patients who did not achieve a sustained virological response, compared with four among the 520 who did clear hepatitis C. At the same time, 34 of the nonresponders had a new AIDS-defining condition, compared with five of the responders.

The reason for the disparity is unclear, Berenguer said.

It may be that the increased risks are a function of poorer immune response that does not involve control of HIV, he said, since there was no significant difference between responders and nonresponders in suppression of HIV.

It may also be a result of chronic HIV viremia, he said.

The study is part of a range of research aimed at teasing out the natural history and effects of hepatitis C, according to David Thomas, MD, of Johns Hopkins University, who moderated a press conference at which the study was presented.

"Some people can recover from hepatitis C all by themselves," he said. "They just clear it out of the body and it's gone." Meanwhile, others respond to treatment, but many do neither, he said, although it has not been clear why not.

Thomas noted that HIV and hepatitis C are among the most prominent co-infections in the world. Berenguer's research outlines the risks for those co-infected patients who do not respond to hepatitis C treatment, he said.

The study was supported by the Fundación para la Investigación y la Prevención del SIDA en España.

Berenguer reported financial links with Roche and Schering-Plough.

Primary source: Conference on Retroviruses and Opportunistic Infections
Source reference:
Berenguer J, et al "Sustained virological response to interferon plus ribavirin reduces HIV progression and non-liver-related mortality in patients co-infected with HIV and HCV" CROI 2010; Abstract 167.