Comparison of quantitative cDNA‐PCR with the branched DNA hybridization assay for monitoring plasma hepatitis C virus RNA levels in haemophilia patients participating in a controlled interferon trial

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Abstract
The branched DNA (bDNA) assay was compared with a semi‐quantitative cDNA‐polymerase chain reaction (cDNA‐PCR) assay for monitoring HCV RNA levels in plasma in 17 haemophilia patients participating in a controlled a‐interferon trial. Good correlation between the HCV RNA levels as detected by the two assays was observed, with a correlation co‐efficient of 0.83 (P < 0.0001) and 0.90 (P < 0.0001) at week 0 and 24, respectively. Hepatitis C virus RNA (HCV RNA) levels could be assessed with the bDNA assay in 14/17 (82 percent) HCV cDNA‐PCR positive pre‐treatment samples. The bDNA assay apparently failed to detect low viral titres. (riterferon treated patients (n = 11) showed either a complete response, being a large reduction in HCV RNA level to below the detection limit of the HCV cDNA‐PCR assay (6/11) or no significant reduction in HCV RNA level (5/11). A “partial” virological response was not observed. The changes in HCV RNA plasma levels in non‐responders during interferon (IFN) treatment were similar to the (small) natural fluctuations in viral load observed in controls (untreated patients). Although the bDNA assay was not as sensitive as cDNA‐PCR, given its user friendliness and quantitative results, it is concluded that it is a useful test for monitoring HCV RNA levels in patients treated with interferon. However, patients who are non‐reactive in the bDNA assay have to be retested by cDNA‐PCR because low viral titres are not detected by the bDNA assay.