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Efficacy and safety of pegylated interferon plus ribavirin in HIV and hepatitis C virus-coinfected patients with advanced immunosuppression
Clin Infect Dis. 2009 Oct 15;49(8):e84-91.
Efficacy and safety of pegylated interferon plus ribavirin in HIV and hepatitis C virus-coinfected patients with advanced immunosuppression.
Mira JA, Gutiérrez-Valencia A, Gil Ide L, Merino D, Rivero A, Ríos-Villegas MJ, Delgado M, González-Serrano M, Collado A, Torres-Tortosa M, Omar M, López-Ruz MA, Macías J, Arponen S, Pineda JA.
Unidad de Enfermedades Infecciosas, Servicio de Medicina Interna, Hospital Universitario de Valme, Hospital Universitario Virgen del Rocío, Sevilla, Spain.
BACKGROUND: The aim of this study was to assess the efficacy and safety of pegylated interferon (IFN) plus ribavirin (RBV) in human immunodeficiency virus (HIV) and hepatitis C virus (HCV)-coinfected patients with severe immunodeficiency in a clinical cohort. BACKGROUND. A total of 542 HIV-infected patients receiving treatment with pegylated IFN plus RBV from June 2001 through April 2007 were included in this study. The outcome variables were sustained virologic response (SVR) rate and the emergence of AIDS-defining events during HCV infection therapy. SVR rates among patients with a CD4 cell count 250 cells/mm(3). The association between SVR and potential predictors was analyzed. RESULTS: Ten (26%) of 39 individuals with a baseline CD4 cell count 250 cells/mm(3) and 198 (39%) of 503 with baseline CD4 cell counts >or=250 CD4 cells/mm(3) achieved SVR (P = .09). In a nested case-control study with populations matched at a 1:2 ratio, the SVR rate was 26% in the CD4 cell count 250 cells/mm(3) group and 32% in the CD4 cell count >250 cells/mm(3) group (P = .5). Baseline CD4 cell count (250 cells/mm(3) vs >250 cells/mm(3)) was not associated with SVR in the multivariate analysis. Two (5%) individuals in the CD4 cell count 250 cells/mm(3) group experienced opportunistic events during follow-up. In the CD4 cell count 250 cells/mm(3) group, severe hematological toxicity and pegylated IFN or RBV dosage reductions occurred in 16 (41%) and 12 (31%) patients, respectively. In the CD4 cell count >250 cells/mm(3) group, severe hematological toxicity and pegylated IFN or RBV dosage reductions occurred in 29% (P = .1) and 20% (P = .1) of patients, respectively. CONCLUSIONS: The efficacy of pegylated IFN plus RBV in HIV-HCV-coinfected patients with advanced immunosuppression is substantial and not significantly different to that observed in the overall coinfected population. HCV therapy is generally safe in the population of coinfected patients with advanced immunosuppression.
PMID: 19772388 [PubMed - indexed for MEDLINE]
Publication Types, MeSH Terms, SubstancesPublication Types:
Research Support, Non-U.S. Gov't
MeSH Terms:
Adult
Antiviral Agents/adverse effects
Antiviral Agents/therapeutic use*
CD4 Lymphocyte Count
Female
HIV Infections/complications*
HIV Infections/drug therapy*
Hepatitis C, Chronic/complications*
Hepatitis C, Chronic/drug therapy*
Humans
Immunocompromised Host
Interferon Alfa-2b/adverse effects
Interferon Alfa-2b/therapeutic use*
Male
Polyethylene Glycols/adverse effects
Polyethylene Glycols/therapeutic use*
Ribavirin/adverse effects
Ribavirin/therapeutic use*
Treatment Outcome
Viral Load
Substances:
Antiviral Agents
Polyethylene Glycols
peginterferon alfa-2b
Ribavirin
Interferon Alfa-2b
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Joey, thanks for taking the time to answer my question. Your information confirms some things for me and puts the question to rest. Much appreciated.
I was pulled from treatment on Oct. 27th 2008. I ended up in hospital early December with a perforated appendix which I recovered from rather quickly. They kept me on the antibiotics until around Dec. 23rd when my levels finally inched up just enough to take me off. They didn't test CD4 count after that. They kept testing lymphocytes instead and considered that there would be a co-relation between increased lymphocytes and an improved CD4 count so didn't test the latter. Battled deep and dark depression almost immediately post treatment that lasted 3-4 months and finally lifted.
Long-term side effects - have hypothyroid - Hashimoto's. That's permanent but manageable. Other than that, I'd say no other lingering side effects.
Long-term side effects - have hypothyroid - Hashimoto's. That's permanent but manageable. Other than that, I'd say no other lingering side effects.
Hi Trish,
Your t-cells (CD4) really got hit hard from that trial. Normal range is 600 - 1,000. HIV positive people are considered to have AIDS when their t-cells drop below 200. Below that level with HIV, you start to have risks of opportunistic infections such as karposi's sarcoma and pneumacystis pneumonia (sp?).
I am not sure how your immune system might have been impacted being HIV negative but I assume t-cells at 93 also meant a very weakened immune system with you being susceptible to many types of infections. The SOC HCV tx really impacts t-cells - mine dropped from around 800 to around 300 my last round of treatment but after a month post tx, they were back over 500. Did you get another CD4 test post tx? I would imagine yours rebounded very quickly.
Great that you wound up with SVR in spite of tx being cut short. Do you have any long-term side effects still?
Joey
Your t-cells (CD4) really got hit hard from that trial. Normal range is 600 - 1,000. HIV positive people are considered to have AIDS when their t-cells drop below 200. Below that level with HIV, you start to have risks of opportunistic infections such as karposi's sarcoma and pneumacystis pneumonia (sp?).
I am not sure how your immune system might have been impacted being HIV negative but I assume t-cells at 93 also meant a very weakened immune system with you being susceptible to many types of infections. The SOC HCV tx really impacts t-cells - mine dropped from around 800 to around 300 my last round of treatment but after a month post tx, they were back over 500. Did you get another CD4 test post tx? I would imagine yours rebounded very quickly.
Great that you wound up with SVR in spite of tx being cut short. Do you have any long-term side effects still?
Joey
I have a question you might be able to answer for me. My treatment was on a Phase IIb clinical trial for R1626. That trial was pulled across the board due to adverse effects on the immune system. Everybody was at different stages of treatment when it got pulled. Some were 5 weeks away from finishing, others managed to be done when it got pulled and so on. For me, I was at 34 weeks when it got pulled.
One of the things they started monitoring towards the later part of my treatment was my CD4 count. There started to be some real concerns about that. Up until that point, nobody had mentioned CD4 count and it wasn't being actively monitored. Other white counts were, as R1626 was known have an impact there. I'd never heard of CD4 counts until then. Mine went down to 102 and then 93. They were sitting at about that point when I got pulled from the trial. They had me on antibiotics at that point that were bloody expensive - about $700 for a bottle about 350ml at most. My hepatologist got the trial sponsor to cover the cost of that thankfully.
I notice in the above information, it mentions CD4 counts constantly. I read up as much as I could on CD4 counts at the time all this was going on trying to understand it. Posted on the HIV forum and didn't get much response. I wanted to know what the role of CD4 counts were and what levels were considered safe - you can drop pretty low on your ANC count and still be okay but what I wanted to know at the time was what the data is on CD4 counts. I did find information that seemed to indicate that my CD4 count was not that great and of cause for concern but nothing that was able to make me feel definitively that my impression of that was accurate.
Wondering if you can add anything to my understanding of that? I do have SVR so I'm very glad for that. I think it would simply help put certain things in perspective. When I got pulled from the trial, it was a big deal for me at the time as I had to figure out whether I go "rogue" and find a different doctor and complete the 48 weeks off the trial - or accept the opinion of my treatment team that it was time to stop. I did stop at the 34 weeks and fortunate to have SVR and not have to second-guess that decision - but still would like to know if the criteria upon which I based that decision at the time was accurate. Know what I mean?
Trish
One of the things they started monitoring towards the later part of my treatment was my CD4 count. There started to be some real concerns about that. Up until that point, nobody had mentioned CD4 count and it wasn't being actively monitored. Other white counts were, as R1626 was known have an impact there. I'd never heard of CD4 counts until then. Mine went down to 102 and then 93. They were sitting at about that point when I got pulled from the trial. They had me on antibiotics at that point that were bloody expensive - about $700 for a bottle about 350ml at most. My hepatologist got the trial sponsor to cover the cost of that thankfully.
I notice in the above information, it mentions CD4 counts constantly. I read up as much as I could on CD4 counts at the time all this was going on trying to understand it. Posted on the HIV forum and didn't get much response. I wanted to know what the role of CD4 counts were and what levels were considered safe - you can drop pretty low on your ANC count and still be okay but what I wanted to know at the time was what the data is on CD4 counts. I did find information that seemed to indicate that my CD4 count was not that great and of cause for concern but nothing that was able to make me feel definitively that my impression of that was accurate.
Wondering if you can add anything to my understanding of that? I do have SVR so I'm very glad for that. I think it would simply help put certain things in perspective. When I got pulled from the trial, it was a big deal for me at the time as I had to figure out whether I go "rogue" and find a different doctor and complete the 48 weeks off the trial - or accept the opinion of my treatment team that it was time to stop. I did stop at the 34 weeks and fortunate to have SVR and not have to second-guess that decision - but still would like to know if the criteria upon which I based that decision at the time was accurate. Know what I mean?
Trish
Thanks for posting this. I am HIV positive and when I did my first round of tx 6 years ago, my physician wouldn't treat anyone for HCV unless they had high t-cells. It shows how research and opinions on treatment keep changing. I recall when SVR was only considered after 2 years of being UND. It is interesting how some people on this site quote one study like it is absolutely conclusive given how relatively new HCV research is.
Good to see that people with low t-cells have a decent shot at SVR. But tx really whacks down the t-cells - mine dropped from the 800 range down to about 300 each round of tx but moved back up after tx.
Good to see that people with low t-cells have a decent shot at SVR. But tx really whacks down the t-cells - mine dropped from the 800 range down to about 300 each round of tx but moved back up after tx.
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