Doh – I kinda ‘got’ the VL testing thing, but now I’m all confused again !

Will ask for the simple version again 4 weeks into treatment, to make sure GP does the right test & and so I can understand the results

So, to recap;
1. You should have a complete liver function test and RNA Quantitative just before beginning treatment.
2. You should have a complete liver function test and RNA Quantitative at around 2-4 weeks.
3. Then just an RNA Qualitative at say, EOT.
4. Then an RNA Qualitative at 12 weeks after EOT.
5. Then one more just to be sure at 24 weeks.
Is this right?

Right on.

I told you Jeanmarc,

The lab have saved the money by doing only quantitative. <12 means UND

The way I understand it, ‘Quantitative’ testing determines the actual number per ml of bloodborne virus. However, it is only accurate between 12 and 10,000,000. The ‘Qualitative’ testing is far more accurate, but can only determine present/not present. So you use quantitative to see how you’re doing until <12, then do qualitative to see if it goes all the way down to undetected. (zero). Dr. Freeman?

Investigating many patients cured at others forums, being UND or < LLOQ (<15) is insignificant. Even patients that have been detected at EOT but < LLOQ have been cured. At the time of trials with Harvoni the LLOQ have been 25 IU/ml, now they have updated to 25 and 15. Other patients on Harvoni have been UND at 4 weeks and then detected at 6 weeks followed with UND at 8 weeks and still cured with three months treatment. From Gilead Page: HARVONI was administered once daily by mouth in these trials. For subjects who received ribavirin (RBV), the RBV dosage was 1000 mg per day for subjects weighing less than 75 kg or 1200 mg per day for subjects weighing at least 75 kg. RBV dose adjustments were performed according to the RBV labeling. Serum HCV RNA values were measured during the clinical trials using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System in ION-3, ION-1, ION-2, SIRIUS and ION-4 studies or the COBAS AmpliPrep/COBAS Taqman HCV test (version 2.0) in ELECTRON-2, and 1119. The COBAS TaqMan HCV test (version 2.0) for use with the High Pure System has a lower limit of quantification (LLOQ) of 25 IU per mL and the COBAS AmpliPrep/COBAS Taqman HCV test (version 2.0) has a LLOQ of 15 IU per mL. Sustained virologic response (SVR12) was the primary endpoint and was defined as HCV RNA less than LLOQ at 12 weeks after the cessation of treatment. Relapse was a secondary endpoint, which was defined as HCV RNA greater than or equal to LLOQ with 2 consecutive values or last available post-treatment measurement during the post-treatment period after achieving HCV RNA less than LLOQ at end of treatment.