|
12th Annual Conference of the British HIV Association29 March–1 April 2006, Brighton, UK |
A 48-WEEK-STUDY OF TENOFOVIR (TDF) OR LAMIVUDINE (3TC) OR A COMBINATION OF TDF AND 3TC FOR THE TREATMENT OF CHRONIC HEPATITIS B IN HIV/HEPATITIS B VIRUS (HBV) CO-INFECTED INDIVIDUALS
HIV Med 2006; 7(Suppl. 1):4 (abstract no. O16)
R Jones1, Mark Nelson1, Sanjay Bhagani2, Martin Fisher3, Clifford Leen4, Gary Brook5, Surdalia Mandalyia1, G Reilly6, D Pillay7 and G Mathews1
1 Chelsea and Westminster NHS Trust, London, 2 Royal Free Hospital, London, 3 Royal Sussex County Hospital, Brighton, UK, 4 Western General Hospital, Edinburgh, 5 Central Middlesex Hospital, London, 6 Gilead Sciences, Cambridge, 7 University College London, London, UK
BACKGROUND: Optimal therapy of HBV in HIV-infected individuals remains unclear.
METHODS: Multicentre open-label randomised study of TDF versus 3TC versus TDF+3TC as part of HAART in individuals with active HBV either without previous 3TC-experience or in the presence of 3TC. Primary endpoint was HBV DNA reduction via DAVG analysis at 24 weeks. In the 3TC arms, TDF was added at 24 weeks for naïve subjects and could be added at 24 weeks in experienced subjects.
RESULTS: 59 of 78 subjects were randomised prior to alterations in the BHIVA guidelines.
| 3TC-experienced | 3TC naïve | |||||
| ARM (n) | TDF (12) | 3TC (9) | TDF/3TC (11) | TDF (10) | 3TC (11) | TDF/3 TC (6) |
| Median baseline HBV DNA(log copies/ml) |
7.7 | 8.2 | 7.7 | 8.2 | 7.5 | 8.2 |
| Median ALT IU/l (range) | 48 | 61 | 62 | 77 | 66 | 35 |
| Median change in HBV DNA(24 weeks) | -3.41 | -0.82 | -3.93 P<0.001 | -4.66 | -3.31 | -5.03 P=0.045 |
| Median change in HBV DNA (48 weeks) | -3.07 | -2.50 | -4.50 | -5.41 | -4.55 | -6.23 |
| HBV DNA <400 copies/ml(24 weeks) | 2 | 0 | 4 | 4 | 4 | 3 |
| HBVDNA <400 copies/ml (48 weeks) | 4 | 1 | 6 | 3 | 7 | 2 |
| Normalisation ALT (<37 IU/l) (48 weeks) | 7 | 5 | 8 | 7 | 9 | 5 |
| HbeAg negative (48 weeks) | 2 | 0 | 3 | 3 | 5 | 2 |
CONCLUSION: At 24 weeks in 3TC-naïve subjects, combination therapy with TDF was superior. There was no statistical difference between TDF alone and 3TC. In 3TC-experienced subjects, there was no benefit in continuing with 3TC alone; adding or switching to TDF was superior. This study supports current guidelines of combination therapy in 3TC-naïve subjects. 3TC-experienced subjects should add TDF or switch to TDF depending on 3TC activity against HIV.
2006-03-29
O16
Copyright © 2006 - British HIV Association (BHIVA) Reproduction of this abstract (other than one copy for personal reference) must be cleared through the BHIVA Organising Secretariat 1 Mountview Court, 310 Friern Barnet Lane, London N20 0LD