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Coinfected Patients Can Respond Better Than previously Observed
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Preliminary results from the PRESCO Study conducted in Spain suggest that if you hand-pich coinfected patients to study you may achieve higher viral response rates. The week 24 viral response rates are higher in PRESCO than observed in larger coinfection studies. Extended duration of therapy will be explored in this study in order to reduce relapse rates. We could've expected these results. If you treat patients with high CD4s, low viral load, higher RBV doses, no cirrhotic patients, no alcohol use, & no psych illnesses, you most certainly should expect much better response rates. An important take-home message is if you have these characteristics your chances of a good viral response to peginterferon+RBV are high. If you were to look at these patient types in APRICOT I'm sure you see this kind of superior response.
Choosing the Right HCV-Coinfected Patients to Treat
Combined report from: By Paul E. Sax, MD (AIDS Clinical Care); aidsmap; Clinical Care Options; hivandhepatitis.
Patients in the Spanish PRESCO Study are showing better viral responses in preliminary analysis than seen in the larger coinfection studies. Patients in this study used higher doses of ribavirin (1000-1200 mg) than in APRICOT or RIBAVIC, and all study patients had >300 cd4s. Median CD count is 562 cells. Eligibility criteria include high liver enzymes. Exclusion criteria include psychiatric illness, alcohol abuse, ddI use, and cirrhosis. Patients in this trial are treated with 180 microgram/week pegylated interferon (IFN)-a combined with ribavirin (RBV) (1,000 mg/day if body weight < 75 Kg or 1,200 mg/day if >75 Kg). Extended treatment (48 weeks for genotypes 2/3 and 72 weeks for genotypes 1 / 4) will be compared with standard treatment (24 weeks for HCV-2/3 and 48 weeks for HCV-1 / 4) in this trial. The higher ribavirin doses may improve sustained viral responses. And the extended duration of therapy may address higher relapse rates sometimes observed in coinfected patients.
Pegylated interferon with ribavirin has been established as the treatment of choice for patients coinfected with HIV and hepatitis C virus (HCV). However, the rate of sustained virologic response in these patients has been disappointing compared with that seen in HCV-monoinfected patients. The rates have been particularly low (15% to 20%) among patients with HCV genotype 1. Now, data from Marina Nunez and colleagues suggest that careful patient selection could improve these rates.
Nunez presented interim data at ICAAC on 181 HIV/HCV-coinfected patients in Spain who were receiving pegylated interferon alfa-2a (180 g/week) and ribavirin (1000-1200 mg/day). All patients had baseline CD4 counts >300 cells/mm3 and no cirrhosis or active alcohol abuse. End of treatment viral response rates for genotype 1 are 61% (43/71) On Treatment & 50% Intent-To-Treat (43/87). For genotypes 2/3, 87% (61/70) ETR (OT) & 85% (61/71) ITT. These results so far look better than observed in larger studies and suggest that selectively picking patients for treatment can yield better viral response rates.
There was, however, a high rate of treatment discontinuation due to adverse events (18 patients) and other causes (ten patients), 23% of patients withdrawing from the study before completing 24 weeks of treatment.
Dose reductions in pegylated interferon were required in 35 patients, and 41 individuals reduced their dose of ribavirin.
Comment: These encouraging results suggest that our immunologically healthiest HIV/HCV-coinfected patients can achieve higher virologic response rates than previously reported. However, these findings need to be confirmed with longer follow-up. Previous studies have shown that coinfected patients have higher rates of virologic rebound (relapse) than HCV-monoinfected patients do, even after achieving suppression with 48 weeks of treatment.
Writer Mark Mascolini reported: Núñez also learned that ribavirin levels foretell both early responses and anemia.[14] Two variables independently predicted at least a 100-fold drop in HCV RNA by Week 4: A ribavirin plasma level above 2.7 µg/mL raised the virologic response odds 1.9 times (95% confidence interval (CI), 1.2-3.2; P = .004), and infection with HCV genotype 3 raised the odds 52.9 times (95% CI, 6.8-439; P < .001). People who crossed the 2.7-µg ribavirin threshold also had a higher risk of hemoglobin values below 2 mg/dL (odds ratio, 9.5; 95% CI, 3.4-26.8; P < .001). The Carlos III group believes these results paint ribavirin in a new light: Instead of merely easing HCV relapse rates, it may help interferon clear HCV early.
Nunez M et al. Efficacy and safety of PegInterferon-a2a plus ribavirin (PegIFN+RBV) for the treatment of hepatitis C in HIV co-infected patients: The PRESCO trial. Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, October 2004. Abstract V-1148.
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