I could not believe that there are persons who have been detected at end of treatment and then achieved SVR 24. According to Gilead, for Harvoni, UND is NOT the measure of SVR. They are using a LLOQ of 25 and are defining SVR as a quant rna number of less than 25, not UND. At the time of trials with Harvoni the LLOQ have been 25 IU/ml, now they have updated to 25 and 15. This is from their prescribing document describing how SVR was defined in the trials:
"All three Phase 3 trials evaluated efficacy of HARVONI (one fixed-dose tablet of 90 mg of ledipasvir and 400 mg of sofosbuvir administered once daily) with or without ribavirin. Treatment duration was fixed in each trial. 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. The assay had a lower limit of quantification (LLOQ) of 25 IU/mL. Sustained virologic response (SVR) 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 posttreatment period after achieving HCV RNA less than LLOQ at end of treatment."
The data of one person:
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result: Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22
48 wk post tx: UNDETECTED SVR48
Male, Fibro F1. Geno 1b. ALT 67 before treatment Viral load 5 million. My huge viral load replicates in my nervous system as I suffer anxiety.
Started Twinvir 12/12/15.
ALT 17 at 2 weeks
Viral Load UND at 2 weeks
ALT 13.5 at 7 weeks EOT
ALT 10.5 at 15 weeks EOT
ALT 13 at 27 weeks EOT, VL UND, Cured