Safety and efficacy of adefovir dipivoxil in patients infected with lamivudine-resistant hepatitis B and HIV-1.
OBJECTIVE
Adefovir dipivoxil (10 mg once-daily) was added to antiretroviral therapy including lamivudine in 35 HIV/HBV co-infected patients.


METHODS
Parameters evaluated included alanine aminotransferase (ALT), HBV DNA and serological markers, HIV-1 RNA, and CD4+ cell count.


RESULTS
Twenty-nine patients (83%) completed 144 weeks. Serum HBV DNA declined from a baseline 9.76 log10 copies/mL (median) to 4.68, 5.24, and 5.90 log10 copies/mL at weeks 48, 96, and 144, respectively (P<0.0001 at all time points). Seven patients (25%) achieved HBV DNA<2.3 log10 copies/mL. No adefovir-associated resistance mutations in HBV DNA polymerase or HIV-1 reverse transcriptase were detected. ALT declined from 81 IU/L (median) at baseline by -16.0, -44.5, and -46.0 IU/L at week 48, 96 and 144, respectively (P=<0.05, respectively), and normalized in 71% of patients (20 of 28) by week 144. Two patients developed antibodies against HB 'e' antigen by week 48. No serious adverse events related to adefovir dipivoxil occurred during the study, and HIV-1 RNA and CD4+ cell counts were stable.


CONCLUSIONS
Treatment with adefovir dipivoxil for 144 weeks was well tolerated and resulted in significant and sustained reductions in HBV DNA and ALT in HIV/HBV co-infected patients. Efficacy increased with treatment duration, with no loss of viral suppression.
Benhamou
Yves
Y
Groupe Hospitalier Pitie-Salpetriere, Service de d'Hépato-Gastroentérologie, Paris, France. ybenhamou@teaser.fr
Thibault
Vincent
V
Vig
Pamela
P
Calvez
Vincent
V
Marcelin
Anne-Genevieve
AG
Fievet
Marie-Hélène
MH
Currie
Graeme
G
Chang
Chuy G
CG
Biao
Lu
L
Xiong
Shelly
S
Brosgart
Carol
C
Poynard
Thierry
T
D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy* / Q000821:virology; D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D024882:Drug Resistance, Viral; D005260:Female; D005500:Follow-Up Studies; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics; D006515:Hepatitis B virus / Q000235:genetics / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D063065:Organophosphonates / Q000627:therapeutic use*; D010865:Pilot Projects; D016133:Polymerase Chain Reaction; D011446:Prospective Studies; D012367:RNA, Viral / Q000032:analysis; D016896:Treatment Outcome
D000998:Antiviral Agents; D063065:Organophosphonates; D012367:RNA, Viral; D019259:Lamivudine; D000225:Adenine; C106812:adefovir dipivoxil