Your case manager is correct. If there are people on the Incivek regime on the forum ,continuing past week 4 with VL >1000 ,,they should not be according to the drug labeling.
Discontinuation of Dosing
Patients with inadequate viral response are unlikely to achieve SVR, and may develop treatment-emergent resistance substitutions. Discontinuation of therapy is recommended in all patients with (1) HCV-RNA levels of greater than or equal to 1000 IU/mL at Treatment Week 4 or 12; or (2) confirmed detectable HCV-RNA levels at Treatment Week 24 (see Table 2).
Table 2: Treatment Futility Rules: All Patients
Week 4 or Week 12: Greater than 1000 IU/mL Discontinue INCIVEK and peginterferon alfa and ribavirin (INCIVEK treatment complete at 12 weeks)
Week 24: Detectable Discontinue peginterferon alfa and ribavirin
You are seeing people who are only on interferon and ribavirin. They have different stopping rules.They stop you at 4 weeks if your viral load is not under 1000 so that resistance does not develop.
Thank you, willbb and SusieS2010.
I am still fairly new to the forum (Hep. C having been diagnosed in July 2011) so I am still trying to sort things out and make sure I know the correct information. I am also on pins and needles because I had my 4 week draw on Monday and I am waiting for the results. Obviously I am afraid my viral load may be over 1000. I really want to get rid of this virus so I am trying to learn as much as possible.
i am also waiting on the 4 week result. i asked the doc why 1000? she said that in the clinical trials they had a few patients that had viral loads in the hundreds and went on to clear. if your viral load is over 1000 incivek is not going to work for you, according to one doc.
Pooh & coeric:
strict adherence to the futility stopping rules for protease inhibitor–based triple therapy can reduce the risk of expanding resistant viral variants. According to the approved labeling information for telaprevir in the United States and Europe,[1,2] patients with HCV RNA > 1000 IU/mL at treatment Weeks 4 or 12 must discontinue all therapy. In addition, the US prescribing information recommends that any patient with detectable HCV RNA at treatment Week 24 must also discontinue all therapy, whereas the European prescribing information recommends discontinuing therapy if HCV RNA is detectable at Weeks 24 or 36 (Table 2).
Summary: Important Considerations to Avoid Resistance-Associated Variants
Paul J. Pockros, MD:
In the meantime, there are various approaches that physicians treating patients with currently available regimens should take to minimize the likelihood of developing/expanding resistance-associated variants and to reduce the impact of resistance when it does occur:
1. Educate patients on the importance of regimen adherence and implement programs that support and promote drug adherence
2. Maintain strict adherence to futility stopping rules for the currently approved direct-acting antiviral agents according to the package inserts to reduce the expansion and further evolution of resistance-associated variants
Thanks so much for the responses. I am just so anxious about the results of my Monday blood draw. I so much want to be able to continue treatment and I am just afraid that my viral load may be 1000 or above. Maybe I am jumping the gun on worrying, but this is such a crucial result that I cannot help it.
coeric: I hope we are both below a thousand or UND. Then we too can join in the celebrations.
just got the call. although this test does not have as low of limit detection as i might like. i am still taking it. You're next pooh.
Component Your Value Standard Range Units
HEPATITIS C QUANT PCR <18 < 18 IU/mL
69,000,000 IU/mL = Positive, above linear quantitation range of assay
Assay LOD = 18 IU/mL Assay LOQ = 43 IU/mL
This HCV RNA real-time PCR assay utilizes the Roche Ampliprep and TaqMan 96
technology. A positive result should be coupled with clinical indicators
for diagnosis/treatment. An HCVPCR result of <18 IU/mL does not exclude
Hepatitis C Virus involvement in a disease process. This test has been
approved by the U.S. Food and Drug Administration.