title: 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.
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 alpha-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 pretreatment samples. The bDNA assay apparently failed to detect low viral titres. Interferon 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.
authors.affiliation: Central Laboratory of The Netherlands Red Cross Blood Transfusion Service, Amsterdam.
authors.forename: D
authors.initials: D
authors.lastname: Bresters
authors.forename: H T
authors.initials: HT
authors.lastname: Cuypers
authors.forename: H W
authors.initials: HW
authors.lastname: Reesink
authors.forename: E P
authors.initials: EP
authors.lastname: Mauser-Bunschoten
authors.forename: H M
authors.initials: HM
authors.lastname: van den Berg
authors.forename: W P
authors.initials: WP
authors.lastname: Schaasberg
authors.forename: J C
authors.initials: JC
authors.lastname: Wilber
authors.forename: M S
authors.initials: MS
authors.lastname: Urdea
authors.forename: P
authors.initials: P
authors.lastname: Neuwald
authors.forename: P N
authors.initials: PN
authors.lastname: Lelie
mesh_terms: D000410:Alanine Transaminase / Q000097:blood; D018076:DNA, Complementary / Q000235:genetics; D004279:DNA, Viral / Q000235:genetics; D006467:Hemophilia A / Q000150:complications; D002836:Hemophilia B / Q000150:complications; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006526:Hepatitis C / Q000150:complications / Q000628:therapy* / Q000821:virology*; D006521:Hepatitis, Chronic / Q000150:complications / Q000628:therapy / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D009693:Nucleic Acid Hybridization; D016133:Polymerase Chain Reaction / Q000379:methods; D012367:RNA, Viral / Q000097:blood* / Q000235:genetics; D011994:Recombinant Proteins; D014766:Viremia / Q000150:complications / Q000628:therapy / Q000821:virology
chemical_list: D018076:DNA, Complementary; D004279:DNA, Viral; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D000410:Alanine Transaminase