Docs Recommend Curbing Treatment Length for Some HCV Patients
by John C. Martin
Article Date: 08-10-05

When it comes to the length of time that people with hepatitis C should remain
on treatment, the current consensus among medical experts is that those strains
other than genotype 1 should be treated for a total of 24 weeks.1 Of course,
patients are monitored throughout treatment, and if a predefined plunge in viral
levels is seen by the 12th week of treatment, patients are classified as having
achieved an early virologic response to therapy, or EVR.2 Those who achieve an
EVR, experts contend, are likely to achieve a sustained virologic response, or
SVR—continual undetectable levels of the virus in the blood for at least 24
weeks following the end of treatment.2,3 Thus, treatment for these individuals
can be halted earlier in that event.

Shorter Treatment May be Possible
Now, a group of Italian doctors claims that people with the less common genotype
2 or 3 strains of the hepatitis C virus can halt treatment 12 weeks later if no
presence of the virus has been detected by the fourth week of therapy.4 "Twelve
weeks of treatment" for those patients "is as effective as 24 weeks," they
contend.

The most common strain of HCV in the United States is genotype 1. As many as
three-quarters of HCV patients are infected with this strain, estimates state.
This strain is also more resistant to treatment and outcomes are usually poorer
than genotypes 2 and 3. Thus, it is recommended that genotype 1 patients undergo
treatment for 48 weeks.1

The study team tested their shorter treatment hypothesis in a clinical trial
involving 283 patients infected with genotype 2 or 3 HCV. Each was randomly
assigned to receive a standard 24-week regimen of PEG-Intron (peginterferon
alfa-2b) plus ribavirin. Doses used in the study included 1 microgram of
PEG-Intron per kilogram of body weight once per week and 1000 – 1200 mg of
ribavirin once per day, based on body weight. In all, 70 patients were assigned
to the standard 24-week treatment schedule. The remaining 213 patients took the
same doses of pegylated interferon and ribavirin for either 12 or 24 weeks,
depending on whether they had cleared the virus by the fourth week of treatment.
Those who had, ended treatment at week 12, and those who didn't, continued
treatment until week 24.

Early Treatment Success Noted
Among patients adhering to the standard 24-week treatment schedule, 45 of 70 (64
percent) achieved non-detectable levels of HCV by the fourth week. That's
compared to 133 of 213 patients (62 percent) in the group taking combination
therapy for either 12 or 24 weeks. Thus, the difference between the groups was
just 2%, the researchers pointed out.

When the study team then assessed how many patients achieved an SVR in the
study, 53 of them (76 percent) in the standard duration group did so, compared
to 164 patients (77 percent) in the group given the variable regimen. Again, the
differences between the two groups were very slight.

Benefits of Shorter Treatment
Further, "fewer patients in the variable-duration group receiving the 12-week
regimen had adverse events and withdrew [from the trial] than in the group
receiving the 24-week regimen," they wrote.

About 3 percent of the patients who received the standard 24-week treatment
duration relapsed, compared to approximately 9 percent of those in the group
with the variable treatment schedule. "Overall, the sustained virologic response
was 80% among patients with HCV genotype 2 and 66 percent among those with
genotype 3," wrote the study group.

Based on these findings, it's apparent that "a shorter course of therapy over 12
weeks with peginterferon alfa-2b and ribavirin is as effective as a 24-week
course for patients with HCV genotype 2 or 3 who have a response to treatment at
4 weeks," they concluded.

1. Vrolijk JM, de Knegt RJ, Veldt BJ, Orlent H, Schalm SW. The treatment of
hepatitis C: history, presence, and future. Neth J Med 2004 Mar;62(3):76-82.
2. Davis GL. Monitoring of viral levels during therapy of hepatitis C.
Hepatology 2002 Nov;36(5 Suppl 1):S145-51.
3. Fried MW. Viral factors affecting the outcome of therapy for chronic
hepatitis C. Rev Gastroenterol Disord 2004;4 Suppl 1:S8-S13
4. Mangia A, Santoro R, Minerva N et al. Peginterferon alfa-2b and ribavirin for
12 vs 24 weeks in HCV genotype 2 or 3. N Engl J Med 2005 Jun 23;352(25):2609-17.






Sandra Tara Balduf (Ane)

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