Rapid HCV Clearance after 4 Weeks on Pegylated Interferon Plus Ribavirin Is the Best Predictor of Sustained Virological Response

It is recognized that low pre-treatment HCV RNA level and rapid virological response (RVR), or clearance of the virus after 4 weeks on interferon-based treatment, predict a greater likelihood of sustained virological response (SVR; continued undetectable viral load 24 weeks after completion of therapy) in HIV negative people with chronic hepatitis C.

At the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy last week in Chicago, Spanish researchers presented results of a study to assess what factors are associated with sustained response among HIV-HCV coinfected individuals in the PRESCO trial.

PRESCO is a prospective, open-label, multicenter trial evaluating the safety and efficacy of 180 mcg/week pegylated interferon alpha-2a (Pegasys) plus 1000-1200 mg/day weight-based ribavirin. The study included 389 HIV-HCV coinfected participants: 49% with genotype 1, 38% with genotype 3, 12% with genotype 4, and less than 1% with genotype 2.

Patients with genotypes 1 or 4 received treatment for either the standard duration of 48 weeks or an extended 72-weeks course; those with genotypes 2 or 3 were treated for either the standard 24 weeks or an extended 48 weeks. Participants discontinued therapy if they did not achieve at least a 2 log decrease in HCV RNA by Week 12.

Results

• Overall, 49.6% of treated patients achieved SVR:

- 35.6% with genotype 1;
- 72.4% with genotypes 2 or 3;
- 32.6% with genotype 4.

• RVR was the best predictor of SVR, regardless HCV genotype.

• Only for genotype 1 patients, HCV RNA below 500,000 IU/ml was independently associated with SVR.

• Among genotype 3 patients, the positive predictive value of SVR was 90%.

• Extension of therapy from 24 to 48 weeks did not increase the likelihood of SVR.

• The positive predictive value of SVR for patients with RVR was 69% for genotype 1 and 83% for genotype 4.

Conclusions

"RVR at week 4 of therapy is the best predictor of cure from chronic hepatitis C in HIV positive patients," the researchers wrote. "Patients with HCV [genotype] 3 with RVR may benefit from only 24 weeks of therapy with weight-based ribavirin plus pegylated interferon."

Hosp. Carlos III, Madrid, Spain; Hosp. Arquitecto Marcide, El Ferrol, Spain; Hosp. Clínico, Valencia, Spain; Hosp. Son Dureta, Palma de Mallorca, Spain; Fundación de Alcorcón, Madrid, Spain; Hosp. Univ., Salamanca, Spain; H. Txagorritxu, Vitoria, Spain; H. Virgen de la Victoria, Málaga, Spain.

09/25/07

Reference
L Martin-Carbonero, M Nunez, A Marino, and others. Clearance of Serum HCV-RNA at Week 4 is the Best Predictor of Sustained Virological Response to Pegylated Interferon Plus Ribavirin in HIV-Infected Patients with Chronic Hepatitis C. 47th Interscience Conference on Antimicrobial Agents and Chemotherapy. Chicago, September 17-20, 2007. Abstract V-1896.