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

J Med Virol. 1994 Jul;43(3):262-8. doi: 10.1002/jmv.1890430313.

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Alanine Transaminase / blood
  • DNA, Complementary / genetics
  • DNA, Viral / genetics
  • Hemophilia A / complications
  • Hemophilia B / complications
  • Hepacivirus / genetics
  • Hepacivirus / isolation & purification*
  • Hepatitis C / complications
  • Hepatitis C / therapy*
  • Hepatitis C / virology*
  • Hepatitis, Chronic / complications
  • Hepatitis, Chronic / therapy
  • Hepatitis, Chronic / virology
  • Humans
  • Interferon alpha-2
  • Interferon-alpha / therapeutic use*
  • Male
  • Nucleic Acid Hybridization
  • Polymerase Chain Reaction / methods
  • RNA, Viral / blood*
  • RNA, Viral / genetics
  • Recombinant Proteins
  • Viremia / complications
  • Viremia / therapy
  • Viremia / virology

Substances

  • DNA, Complementary
  • DNA, Viral
  • Interferon alpha-2
  • Interferon-alpha
  • RNA, Viral
  • Recombinant Proteins
  • Alanine Transaminase