Prolonged Treatment of HIV/HCV Coinfected Patients Without Early Virological Response

Past research has shown that early virological response (EVR) to interferon-based therapy at 12 weeks is a good predictor of eventual sustained virological response (SVR) in both hepatitis C virus (HCV) monoinfected patients and HIV/HCV coinfected individuals.

The aim of the current study was to assess the efficacy and safety of an extended course of treatment with pegylated interferon plus ribavirin in coinfected patients who did not achieve EVR.

Participants received 180 mcg/week pegylated interferon alfa-2a (Pegasys) plus 800 mg/day ribavirin for 12 weeks.

Patients who achieved EVR at week 12 continued on therapy for an additional 12 or 36 weeks, depending on genotype. Those who did not achieve EVR were randomly assigned to either complete the standard course of therapy (a total of 24 weeks for genotypes 2 or 3, and 48 weeks for genotypes 1 or 4), or to continue on treatment for 72 weeks (extension arm).

Results

110 patients were included in the study (mean age 38.7 years, mean weight 68 kg, 74% males, 74% on HAART, mean CD4 cell count 564 cells/mm³)

. 51 patients had genotype 1 HCV, 44 had genotype 2 or 3, and 15 had genotype 4; 53 participants had HCV viral loads above 800,000 IU/mL.

Overall, 63.6% of patients achieved EVR:

- 51% with genotype 1;- 88.6% with genotype 2 or 3;- 33.3% with genotype 4.

The overall end-of-treatment response rate was 52.7%:

- 47.2% with genotype 1;- 68.2% with genotype 2 or 3;- 26.7% with genotype 4.

The overall SVR rate was 41.8%:

- 37.3% with genotype 1;- 54.6% with genotype 2 or 3;- 20% with genotype 4.

Only one patient allocated to the extended arm achieved SVR.

Overall, 32.7% of patients discontinued treatment prematurely, but the drop-out rate in the extension arm was 68%.

The negative predictive value of EVR at week 12 was 97.5%.

Conclusion

The authors concluded that this study "shows no benefit of extending therapy in patients without EVR at week 12." They added that, "Measures to improve adherence to HCV antiviral therapy should be considered when new approaches based on extended periods of treatment are investigated."

7/21/06

Reference
D Fuster, R Planas, and J Gonzalez. Results of a study of prolonging treatment with pegylated interferon-alpha2a plus ribavirin in HIV/HCV coinfected patients with no early virological response. Antiviral Therapy 11(4): 473-482. 2006.