Hi Eki: Congratulations on your initial 4.9 log drop in the first week! I'm a data oriented person so it's exciting to see you are receiving weekly viral load tests during the initial Incivek treatment period.
There are many reasons why a viral load may go up, but before I speculate, recommend getting a week 3 viral load test to help determine the validity of the week 2 test result. In the meantime, here are some initial thoughts to ponder.
Maybe the same laboratory was not used for your week 2 test.
Maybe they did not draw enough blood to ensure a valid test. My lab always needed to fill two tubes.
Maybe your week 2 test result is an outlier -- an aberration.
Can you get a week 3 viral load test? A week 3 test may help understand the week 2 test result or it may help us discount the week 2 result as an abnormality. Cheers, GB
Please dont worry about this slight variation. In terms of viral load, they go by "logs" (one of the experts can tell you about that measurement, I can be a bit of a bimbo) But those two vl #'s are almost the same result, only 46 vl points is insignificant, I would guess.
I didn't take a vl test until 4 weeks, but at two weeks, I got a lab test, that showed my liver enzymes as almost in normal range, compared with the super high range they were before. Then, at 4 weeks, my enzymes were normal, and my vl went und. So 4 weeks is a better indicator, and some dont clear until 8 weeks, or 12.
Try to have a look around, and read other peoples' stats, on their profiles.
I cant remember, did you post what your AST/ALT was, prior to treatment, at one week, and two weeks?
Hi Again Eki: The other labs may help understand if the week 2 viral load test result is an abnormality. In addition to the liver enzymes Bo mentioned, which I can see are trending downward, it might be helpful to see your hemoglobin. Might be best to post your complete CBC results and your comprehensive metabolic panel results (pre-treatment, week 1, and week 2). Maybe post it here on the open forum or maybe in your journal -- let us know if you post the results in your journal so we can go look at them. Cheers, GB
Hi Eki: I can understand your data posting, Might help to add your hemoglobin and WBC test results. Oh, maybe the week 1 viral load test is the outlier. Even if the week 1 test result was reported incorrectly, you are still making awesome progress. Of course, which data point may be the outlier is speculation until we get the week 3 viral load test result. Cheers, GB
Hi Eki. Thanks for the additional data. The data you provided are about what I would have expected to see in my own data when I was on triple therapy.
While there are many of these data categories I don't understand, given the categories I do understand, I don't see anything that alarms me. I assume your doctor was not alarmed by your CBC & complete metabolic panel results.
So, suggest we wait for the week 3 data before continuing our analysis. Cheers, GB
Any predictions about your viral load at this point are nothing more than speculation, there is no data to compare it to, the drug co's do have response guided therapy and futility rules in place.
2.7.1 Duration of Treatment in Treatment-Naive Subjects
In subjects who have had no previous treatment for HCV (treatment-naive), treatment with telaprevir must be initiated in combination with Peg-IFN and RBV and administered for 12 weeks.
• Subjects with undetectable HCV RNA at Weeks 4 and 12 receive an additional 12 weeks of Peg-IFN and RBV alone for a total treatment duration of 24 weeks
• Subjects with detectable HCV RNA at either Weeks 4 or 12 receive an additional 36 weeks of Peg-IFN and RBV alone for a total treatment duration of 48 weeks
HCV-RNA levels should be monitored at Weeks 4 and 12 to determine treatment duration.
Treatment with telaprevir should be discontinued in subjects who do not have an adequate viral response during treatment.
2.7.2 Duration of Treatment—Previously Treated Subjects
In subjects who have had previous treatment for HCV, treatment with telaprevir must be initiated in combination with Peg-IFN and RBV and administered for 12 weeks. Subjects who had a partial response to previous treatment (partial responders) or minimal response
(null responders) to Peg-IFN plus RBV receive an additional 36 weeks of Peg-IFN and RBV treatment alone for a total treatment duration of 48 weeks.
In subjects who had relapse after previous treatment to Peg-IFN plus RBV, a responseguided regimen is recommended.
• Subjects with undetectable HCV RNA at Weeks 4 and 12 of telaprevir-based treatment receive an additional 12 weeks of Peg-IFN and RBV alone for a total treatment duration of 24 weeks
• Subjects with detectable HCV RNA at either Weeks 4 or 12 of telaprevir-based treatment receive an additional 36 weeks of Peg-IFN and RBV alone for a total treatment duration of 48 weeks
Telaprevir must be dosed with Peg-IFN and RBV to prevent treatment failure.
Treatment-Naïve and Prior Relapse Patients
HCV-RNA Undetectable (Target Not Detected) at Weeks 4 and 12
Triple Therapy INCIVEK, peginterferon alfa and ribavirin First 12 weeks Dual Therapy peginterferon alfa and ribavirin Additional 12 weeks, Total Treatment Duration 24 weeks
HCV-RNA Detectable (1000 IU/mL or less) at Weeks 4 and/or 12 Triple Therapy INCIVEK, peginterferon alfa and ribavirin First 12 weeks Dual Therapy peginterferon alfa and ribavirin Additional 36 weeks, Total Treatment Duration 48 weeks
Prior Partial and Null Responder Patients
All Patients Triple Therapy INCIVEK, peginterferon alfa and ribavirin First 12 weeks Dual Therapy peginterferon alfa and ribavirin Additional 36 weeks, Total Treatment Duration 48 weeks
Treatment Futility Rules: All Patients
HCV-RNA Week 4 or Week 12: Greater than 1000 IU/mL
Action Discontinue INCIVEK and peginterferon alfa and ribavirin (INCIVEK treatment complete at 12 weeks)
Week 24: Detectable
Action Discontinue peginterferon alfa and ribavirin
2.3 Discontinuation of Dosing
Patients with inadequate viral response are unlikely to achieve SVR, and may develop treatment-emergent resistance substitutions [see Microbiology (12.4)]. 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).
HCV-RNA levels should be monitored at weeks 4 and 12 and as clinically indicated. Use of a sensitive real-time RT-PCR assay for monitoring HCV-RNA levels during treatment is recommended. The assay should have a lower limit of HCV-RNA quantification equal to or less than 25 IU/mL and a limit of HCV-RNA detection of approximately 10-15 IU/mL. For the purpose of assessing response-guided therapy eligibility, an “undetectable” HCV-RNA result is required; a confirmed “detectable but below limit of quantification” HCV-RNA result should not be considered equivalent to an “undetectable” HCVRNA result.
Hi Eki: For your benefit, and the benefit of anyone reading this thread, I want to make it clear that I am not a medical provider nor am I a medical researcher.
I enjoy engaging in discussions concerning data. However, trending a person's actual data should not be used to suggest a medical course of action nor should it be used to make actual medical decisions.
In essence, what I'm saying is the MedHelp statement at the bottom of each page applies. The MedHelp disclaimer states, in part, that our communication "should not be interpreted as medical advice or a diagnosis of any health or fitness problem, condition or disease; or a recommendation for a specific test, doctor, care provider, procedure, treatment plan, product, or course of action."
In your case, I believe your medical decisions should be made using the guidance hrsepwrguy provided above. I think you understand that, but I wanted to emphasize that point just in case you didn't. Cheers, GB
As cando put it..don't stress about this lack of viral drop at week 2, as it is of little significance
As hrsep has copied you the info. it is the 4 week PCR that will give you the indication of "early repsonse"
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