Aa
Viral Load Went Up with Incivek
I'm in week 3 of triple therapy on Friday. Here is my viral load:
Before treatment: 7.7 million
1 week test: 93
2 week test: 139
Why would it go up? I'm kind of worried about that.
Before treatment: 7.7 million
1 week test: 93
2 week test: 139
Why would it go up? I'm kind of worried about that.
You have to be under 1,000 at week 4, and that is the first VL that counts. I'm sure you will be.
Advocate1955
Advocate1955
Hi Eki.
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"
Good luck..
Will
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"
Good luck..
Will
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
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
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.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562.pdf
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).
Laboratory Tests
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.
http://pi.vrtx.com/files/uspi_telaprevir.pdf .
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.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562.pdf
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).
Laboratory Tests
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.
http://pi.vrtx.com/files/uspi_telaprevir.pdf .
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
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
Hi Sent, Like this?
Component Standard Range 2/22/2012 4/20/2012 4/27/2012
WBC 4.0-10.0 1000/mm3 5.0 5.1 4.4
RBC 4.60-6.10 mill/mm3 5.03 4.89 4.65
Hgb 13.7-17.5 gm/dL 15.2 14.8 14.1
Hct 40.0-50.0 % 43.5 42.7 40.5
MCV 79.0-95.0 um3 86.5 87.3 87.1
MCH 26.0-32.0 pgm 30.2 30.3 30.3
MCHC 32.0-36.0 % 34.9 34.7 34.8
RDW 12.0-14.0 % 12.7 13.2 13.2
MPV 9.4-12.4 fL 10.4 10.3 10.2
Plt Count 140-370 1000/mm3 158 122 L 129 L
Segs 34-71 % 67 72 H 66
Lymphocytes 19-53 % 25 18 L 24
Monocytes 5-12 % 6 8 7
Eosinophils 1-7 % 2 1 1
Abs Neutrophils 1.6-7.0 1000/mm3 3.4 3.7 2.9
Imm Gran Abs 0.0-0.1 1000/mm3 0.1
Abs Lymphs 0.8-3.1 1000/mm3 1.3 0.9 1.0
Abs Monos 0.2-0.8 1000/mm3 0.3 0.4 0.3
Abs Eosinophils 0.0-0.5 1000/mm3 0.1 0.1 0.1
Imm Gran % 0-1 % 1
Diff Type Automated Automated Automated
Component Standard Range 2/22/2012 4/20/2012 4/27/2012
WBC 4.0-10.0 1000/mm3 5.0 5.1 4.4
RBC 4.60-6.10 mill/mm3 5.03 4.89 4.65
Hgb 13.7-17.5 gm/dL 15.2 14.8 14.1
Hct 40.0-50.0 % 43.5 42.7 40.5
MCV 79.0-95.0 um3 86.5 87.3 87.1
MCH 26.0-32.0 pgm 30.2 30.3 30.3
MCHC 32.0-36.0 % 34.9 34.7 34.8
RDW 12.0-14.0 % 12.7 13.2 13.2
MPV 9.4-12.4 fL 10.4 10.3 10.2
Plt Count 140-370 1000/mm3 158 122 L 129 L
Segs 34-71 % 67 72 H 66
Lymphocytes 19-53 % 25 18 L 24
Monocytes 5-12 % 6 8 7
Eosinophils 1-7 % 2 1 1
Abs Neutrophils 1.6-7.0 1000/mm3 3.4 3.7 2.9
Imm Gran Abs 0.0-0.1 1000/mm3 0.1
Abs Lymphs 0.8-3.1 1000/mm3 1.3 0.9 1.0
Abs Monos 0.2-0.8 1000/mm3 0.3 0.4 0.3
Abs Eosinophils 0.0-0.5 1000/mm3 0.1 0.1 0.1
Imm Gran % 0-1 % 1
Diff Type Automated Automated Automated
omponent Standard Range 2/22/2012 4/20/2012 4/27/2012
Glucose 70-115 mg/dL 70 78 82
Bun 6-20 mg/dL 10 12 15
Creatinine 0.67-1.17 mg/dL 0.72 0.84 0.84
Sodium 136-145 mmol/L 137 139 142
Potassium 3.5-5.1 mmol/L 4 3.9 4
Chloride 98-107 mmol/L 100 101 105
Bicarbonate 22-29 mmol/L 26 28 28
Calcium 8.6-10.5 mg/dL 8.7 8.5 L 9.5
Total Protein6.0-8.0 g/dL 7.2 7.1 7.5
Albumin 3.5-5.2 g/dL 4.5 4.4 4.5
Bilirubin, Tot <1.2 mg/dL 0.8 2.4 H 1.8 H
AST (SGOT) 0-40 U/L 36 29 23
ALT (SGPT) 0-41 U/L 48 H 29 17
Alkaline Phos 40-129 U/L 82 83 87
Glucose 70-115 mg/dL 70 78 82
Bun 6-20 mg/dL 10 12 15
Creatinine 0.67-1.17 mg/dL 0.72 0.84 0.84
Sodium 136-145 mmol/L 137 139 142
Potassium 3.5-5.1 mmol/L 4 3.9 4
Chloride 98-107 mmol/L 100 101 105
Bicarbonate 22-29 mmol/L 26 28 28
Calcium 8.6-10.5 mg/dL 8.7 8.5 L 9.5
Total Protein6.0-8.0 g/dL 7.2 7.1 7.5
Albumin 3.5-5.2 g/dL 4.5 4.4 4.5
Bilirubin, Tot <1.2 mg/dL 0.8 2.4 H 1.8 H
AST (SGOT) 0-40 U/L 36 29 23
ALT (SGPT) 0-41 U/L 48 H 29 17
Alkaline Phos 40-129 U/L 82 83 87
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
No need to stress over that, it's one of the reasons they don't do weekly testing. Its the 4 week test that really counts. To much worring is no good for you...... Hang in there.
omponent Standard Range 2/22/2012 4/20/2012 4/27/2012
Glucose 70-115 mg/dL 70 78 82
Bun 6-20 mg/dL 10 12 15
Creatinine 0.67-1.17 mg/dL 0.72 0.84 0.84
Sodium 136-145 mmol/L 137 139 142
Potassium 3.5-5.1 mmol/L 4.0 3.9 4.0
Chloride 98-107 mmol/L 100 101 105
Bicarbonate 22-29 mmol/L 26 28 28
Calcium 8.6-10.5 mg/dL 8.7 8.5 L 9.5
Total Protein 6.0-8.0 g/dL 7.2 7.1 7.5
Albumin 3.5-5.2 g/dL 4.5 4.4 4.5
Bilirubin, Tot <1.2 mg/dL 0.8 2.4 H 1.8 H
AST (SGOT) 0-40 U/L 36 29 23
ALT (SGPT) 0-41 U/L 48 H 29 17
Alkaline Phos 40-129 U/L 82 83 87
Glucose 70-115 mg/dL 70 78 82
Bun 6-20 mg/dL 10 12 15
Creatinine 0.67-1.17 mg/dL 0.72 0.84 0.84
Sodium 136-145 mmol/L 137 139 142
Potassium 3.5-5.1 mmol/L 4.0 3.9 4.0
Chloride 98-107 mmol/L 100 101 105
Bicarbonate 22-29 mmol/L 26 28 28
Calcium 8.6-10.5 mg/dL 8.7 8.5 L 9.5
Total Protein 6.0-8.0 g/dL 7.2 7.1 7.5
Albumin 3.5-5.2 g/dL 4.5 4.4 4.5
Bilirubin, Tot <1.2 mg/dL 0.8 2.4 H 1.8 H
AST (SGOT) 0-40 U/L 36 29 23
ALT (SGPT) 0-41 U/L 48 H 29 17
Alkaline Phos 40-129 U/L 82 83 87
Aha, more good news! Your enzymes were in the normal range range by one week, and are even lower now, at the 2 week mark : )
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
BTW, thank you both for your calming words. This forum (and you in particular) is proving indispensable to me.
2/22 - AST (SGOT) 36 ALT (SGPT) 48
Week 1 Test: AST (SGOT) 29 ALT (SGPT) 29
Week 2 Test: AST (SGOT) 23 ALT (SGPT) 17
Week 1 Test: AST (SGOT) 29 ALT (SGPT) 29
Week 2 Test: AST (SGOT) 23 ALT (SGPT) 17
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?
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 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
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
Have an Answer?
You are reading content posted in the Hepatitis C Community
Learn about this treatable virus.
Getting tested for this viral infection.
3 key steps to getting on treatment.
4 steps to getting on therapy.
What you need to know about Hep C drugs.
How the drugs might affect you.
These tips may up your chances of a cure.
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
