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Pegasys/RBV 16 vs 24 Weeks for Genotype 2 & 3
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"Randomized multicenter study comparing 16 vs 24 weeks of combination therapy with peginterferon alfa-2a plus ribavirin in patients chronically infected with genotype 2 or 3"
Reported by Jules Levin
Michael Wagner reported results from this pilot study at AASLD. Studies report that 24 or 48 weeks therapy with peginterferon plus RBV results in 80-85% SVR for genotypes 2/3. But there has been discrepant results on virologic relapse in HCV-3 infected patients with high pretreatment viremia. In this study patients received Pegasys + RBV 1000/1200 mg/day and were stratified by baseline HCV RNA (<600,000 IU/mL>). Patients with <600,000 IU/mL were randomized to 16 (group A) or 24 weeks therapy (group B). Patients with >600,000 IU/mL received 24 weeks therapy (group C).
The authors summary: Patients infected with HCV genotype 2 achieve excellent (early, end of treatment and) sustained viral response rates following therapy for 16 or 24 weeks. Similar response rates are observed in patients infected with genotype 3 and a pre-treatment viremia <800,000 IU/ml who achieve an early viral response at week 4. SVR rates in patients with HCV genotype 3 and a viral load >800,000 IU/ml are generally lower: treatment duration 16 weeks: 55%; treatment duration 24 weeks 68%. Author conclusions: The present pilot study suggests that 16 weeks of combination therapy with peginterferonb alfa-2a and ribavirin are sufficient in HCV G2 & G3 <800,000 IU/ml) infected patients. The situation in HCV G3 (>800,000 IU/ml) infected patients requires data from larger studies, the optimal duration of therapy is not yet defined. The ACCELERATE Study is an international, multicenter, randomized trial of 1469 patients with HCV genotypes 2 & 3. Patients will receive Pegasys + RBV 800mg/day for 16 weeks or 24 weeks.
Patients were treatment-naive chronically infected with genotype 2 or 3. The primary study endpoint was sustained viral response in patients treated for 16 or 24 weeks. Secondary endpoints included viral response at week 4 of therapy, tolerability & safety.
BASELINE
| Grp A | Grp B | Grp C | | Genotype | | | | | 2 | 27 | 27 | 8 | | 3 | 72 | 73 | 92 | | Viremia | 1.7x | 1.8x | 1.8x106 |
RESULTS
Early Viral Response (HCV RNA <600 IU/mL) at Week 4
97% (37/38) for genotype 2; 92% (103/112) for G3.
End of treatment (ETR) & SVR (HCV genotypes 2 & 3 combined)
Group A 16 weeks:
94% ETR (67/71)
82% SVR (58/71)
Group B 24 weeks:
86% ETR (59/69)
81% SVR (56/69)
Group C:
69% ETR (9/13)
39% SVR (5/13)
SVR B vs C: p=0.003
End-Of-Treatment Viral response (groups A, B, C combined)
HCV-2 <800,000 IU/mL: 85%
HCV-2 >800,000 IU/mL: 96%
HCV-3 <800,000 IU/mL: 93%
HCV-3 >800,000 IU/mL: 82%
SUSTAINED VIRAL RESPONSE
(groups A, B, C combined)
HCV-2 <800,000 IU/mL: 92% (10/13)
HCV-2 >800,000 IU/mL: 92% (24/26)
HCV-3 <800,000 IU/mL: 85% (50/59)
HCV-3 >800,000 IU/mL: 59% (32/54)
HCV-3 <800 vs >800 p=0.0031
SVR according to tx group, genotype and viremia
HCV-2 A <800,000: 100% (6/6)
HCV-2 B <800,000: 100% (6/6)
HCV-2 A >800,000: 92% (12/13)
HCV-2 B >800,000: 92% (12/13)
HCV-3 A <800,000: 93% (27/29)
HCV-3 B <800,000: 84% (21/25)
HCV-3 >800,000: 55% (12/22)
HCV-3 >800,000: 68% (17/25)
ADVERSE EVENTS
| Grp A | Grp B | Grp C | | 16 wks | 24 wks | 24 wks | | Flu-like symptoms | 52% | 47% | 15% | | Fatigue | 36% | 44% | 62% | | Pruitis | 27% | 33% | 31% | | Headache | 26% | 30% | 54% | | Anorexia | 22% | 26% | 31% | | Alopecia | 21% | 25% | 23% | | Asthenia | 17% | 26% | 15% | | Pain | 13% | 22% | 46% | | Dyspnea | ? | 21% | 31% | | Insomnia | 13% | 22% | 39% |
PREMATURE WITHDRAWALS
Group A was very low or 0
Group B had a few for AE & 5 or 6 for non-safety reasons
Group C had only a few for non-safety reasons.
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