IAS: Hepatitis C treatment should last for 48 weeks in HIV co-infected patients, study shows

HIV-positive patients co-infected with the hepatitis C virus (HCV) should be treated with anti-HCV therapy for 48, and not 28 weeks, according to the results of an Italian randomised controlled trial presented at the Third International AIDS Society Conference on HIV Pathogenesis and Treatment in Rio de Janeiro on July 25^th.

Treatment of HCV in co-infected patients with a combination of peginterferon alfa and ribavirin is known to be effective in clearing HCV infection in most patients. However, some uncertainty surrounds the optimal duration of therapy.

For patients with the varieties of HCV called genotypes 2 or 3, a course of anti-HCV therapy of 48 weeks is recommended. However, some experts have called this into question by advocating the use of HCV drugs for only 24 weeks, as is recommended for HIV-negative patients. In contrast, others have found that this shorter treatment results in an elevated risk of relapse after HCV therapy is stopped.

To examine the effect of treatment duration in HIV co-infected patients, researchers from Italy recruited 128 patients with CD4 cell counts above 200 cells/mm³ and HIV viral loads below 10,000 copies/ml, or who had been on highly active antiretroviral therapy for at least six months.

All of the patients had HCV infection confirmed by a blood test and a liver biopsy at least three years prior to the start of the study. Although it was restricted to those with genotypes 2 or 3, Massimo Puoti, presenting, claimed that almost all of the patients had genotype 3, as genotype 2 is very rare among HIV co-infected patients in Italy.

For the first 24 weeks, all of the patients received a combination of 180 µg peginterferon alfa 2a (Pegasys) once a week and ribavirin at a dose of 800 to 1200mg once a day, depending on body weight. At the end of this period, 74 of the 82 patients who had not dropped out of the study had become HCV-negative. These patients were then randomised either to receive a further 24 weeks of anti-HCV therapy or to remain off treatment.

Twenty-four weeks later, 15 (40%) of the 38 patients who stopped treatment after 28 weeks had relapsed, following detection of HCV in their blood.

In contrast, only two (10%) of the 20 patients who were still HCV-negative after completing 48 weeks of treatment had relapsed after 24 weeks. This was significantly lower than in the patients who were treated for 28 weeks (p = 0.02).

Using a multivariate analysis, the investigators calculated that the patients treated for 48 weeks were 5.46 times more likely to achieve a ‘sustained virological response’ (SVR), defined as persistent HCV negativity 24 weeks after the end of treatment.

Other factors that were significantly associated with SVR were and having a higher number of platelets in the blood (OR = 1.01; p = 0.019) and being HCV-negative after four weeks of treatment (odds ratio [OR] = 5.57; p

Dr Puoti acknowledged that his study included a high number of patients who discontinued therapy early. These drop-outs were mostly due to side-effects and intolerance of HCV therapy, with more than half of these patients relapsing to being HCV-positive after leaving the study.

However, he said that the incidence of side-effects was lower after the first 28 weeks of HCV treatment.

“These results suggest that the optimal duration of treatment in HIV-positive [patients] with HCV genotypes 2 or 3 is at least of 48 weeks,” he concluded.