72-Week Treatment More Effective than 48 Weeks for Patients with Detectable HCV

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72-Week Treatment More Effective than 48 Weeks for Patients with

Detectable HCV Viral Load at Week 4

By Liz Highleyman

A majority of patients with chronic hepatitis C who ultimately

achieve sustained virological response (SVR) to treatment experience

an early decrease in HCV RNA and have undetectable viral load by

Week 4. Some studies suggest this response may be slower in HIV/HCV

coinfected individuals.

Some clinicians recommend discontinuing therapy to spare patients

additional side effects and expense if they have not achieved rapid

virological response by Week 4, but a subset of such patients do

eventually achieve sustained response.

As reported in the August 2006 issue of Gastroenterology, Spanish

researchers conducted a study to explore whether prolonged treatment

for 72 weeks can improve the chances of achieving SVR in patients

who still have detectable HCV RNA at Week 4.

The study included 510 HIV negative (HCV monoinfected) treatment-

naive patients treated with 180 mcg/week pegylated interferon-alfa2a

(Pegasys) plus 800 mg/day ribavirin. After 4 weeks of therapy, 326

patients who still had detectable HCV RNA were randomly assigned to

continue treatment for a total of 48 weeks (the standard duration of

therapy for individuals with genotype 1 HCV; n = 165) or 72 weeks (n

= 161).

The 184 patients with undetectable HCV RNA at Week 4 were allocated

into 2 groups on the basis of genotype and baseline viral load, and

were treated for a total of 24 weeks (the standard duration for

individuals with genotypes 2 or 3) or 48 weeks.

Results

The end-of-treatment response rates were similar in the Week 4 HCV

RNA detectable patients whether they were treated for a total of 48

or 72 weeks (about 60%).

However, the SVR rate (measured 24 weeks after the end of therapy)

was higher for those receiving treatment for 72 weeks compared with

48 weeks (45% vs 32%; P = 0.01).

Looking only at the genotype 1 patients with detectable HCV RNA at

Week 4, 44% of those treated for 72 weeks achieved SVR, compared

with 28% of those treated for 48 weeks (P = 0.003).

Among the Week 4 HCV RNA undetectable patients, SVR rates were 79%

in the arm treated for 24 weeks (i.e., genotype 2 or 3) and 64% in

the arm treated for 48 weeks (i.e., genotype 1).

The incidence of adverse events was similar in all groups.

Among the Week 4 HCV RNA detectable patients, treatment

discontinuation was more frequent in the arm treated for 72 weeks

compared with 48 weeks (36% vs 18%; P = 0.0004).

Conclusion

In conclusion, the authors wrote, " Extension of treatment with

peginterferon-alfa2a plus ribavirin from 48 to 72 weeks

significantly increases the rate of SVR in patients with detectable

viremia at Week 4 of treatment. "

This study adds to the evidence that tailoring hepatitis C treatment

on the basis of early virological response can produce improved

outcomes while minimizing unnecessary side effects. More research is

needed to determine optimal treatment duration for HIV/HCV

coinfected individuals.

08/29/006