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Response-guided therapy may be effective for patients coinfected with HIV/HCV

Issue: May 2009

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A sustained virologic response was achieved by 55% of patients coinfected with HIV and hepatitis C virus who received response-guided therapy.

Researchers evaluated 60 patients who were given individualized treatment with pegylated interferon alfa-2b at a rate of 1.5 mcg/kg per week plus weight-based ribavirin at 800 mg to 1,400 mg per day.

Patients who achieved a viral load <50IU/mL at week four completed 24 weeks of therapy.

Patients who did not reach such a rapid virologic response were evaluated again at 12 weeks. The researchers defined an early virologic response as a hepatitis C virus (HCV) RNA level less than 600 IU/mL. Patients who attained an undetectable viral load at 24 weeks but who had a decrease in the viral load equal to or greater than 2 log₁₀ and an HCV RNA level equal to or greater than 600 IU/mL were defined as having a partial response. Patients who achieved a partial response were treated for 60 weeks.

The primary endpoint was the percentage of patients who reached HCV RNA levels less than 50 IU/mL 24 weeks after the end of treatment.

In the HCV genotype 1 group, a sustained virologic response was achieved by 11 of 25 (44%) patients and a rapid virologic response was achieved by four of 25 (16%) patients. For patients with genotype 4, there was a sustained virologic response in three of 11 (27%) patients and a rapid response in one of 11 (9%) patients. In patients with genotype 3, 19 of 24 (79%) had a sustained response and 14 of 24 (58%) had a rapid response.

Patients with genotype 3 and low pretreatment HCV RNA levels were significantly more likely to achieve a sustained virologic response. At 48 weeks, there was a 46% relapse rate among patients with genotypes 1 and 4 who first achieved undetectable viral loads at week 12.

Crespo M. Clin Infect Dis. 2009;48:1152-1159.

Many clinicians are using response-guided therapy of hepatitis C virus infection to determine treatment duration in patients who are HIV seronegative. Patients with a rapid virologic response, defined as HCV RNA < 50 IU/ml by week 4, are treated for shorter durations. A genotype 1-infected patient with a RVR may be treated for only 24 weeks, as opposed to 48 weeks, while patients with genotype 2 or 3 and a RVR may be treated for only 12 weeks. For patients coinfected with HIV, response-guided therapy has not been well-studied and 48 weeks of treatment is recommended for all.

This small, randomized study by Van den Eynde et al. addressed this issue. Regardless of genotype, patients whose HCV RNA level was less than 50 IU/ml at week 4 were treated for only 24 weeks. Seventeen of these 19 patients had a sustained virologic response. All five RVR patients with either genotype 1 or 4 had a SVR. Further, the SVR rate in the 24-week group was similar to that seen in the 48-week group. Prior studies have shown a high relapse rate in coinfected patients with genotypes 2 or 3 who were treated for only 24 weeks. These data suggest that response guided therapy, as opposed to genotype-based duration, may be an option for HIV-HCV coinfected patients. This strategy may be useful for patients with genotype 2 or 3, since only one of 13 patients relapsed.

In other words, patients who are coinfected with HIV and HCV genotype 2 or 3 and have a rapid response may be offered 24 weeks of therapy. More data are needed before considering this approach in HIV-positive patients coinfected with genotype 1 or 4.

Overall, the rate of SVR in this coinfected population was much higher than has been reported in studies conducted, at least in part, in the United States. Reasons for this improvement are not clear, but may, in part, be explained by the race or ethnicity of the subjects. Black patients respond poorly to HCV therapy, regardless of coinfection status.

Clinicians who treat HCV in HIV coinfected patients are eager to see data on the efficacy of several new compounds, such telaprevir and boceprevir, in this population. Some physicians caring for black patients coinfected with HIV and genotype 1 HCV are holding off therapy until new, better therapies are available.

– Stephen Smith, MD

Infectious Disease News Editorial Board member