Short-term effect of ritonavir-boosted atazanavir in hepatitis B and/or C co-infected, treatment-experienced HIV patients.
OBJECTIVE
To describe the short-term, liver safety, immunological, and virological outcome in HIV subjects according to their hepatitis co-infection status after switching to ritonavir-boosted atazanavir (ATV/r)-based therapy.


METHODS
Rates of treatment discontinuation, changes in liver enzyme values, viral load, and CD4+ T-cell counts responses from patients included in the Bristol-Myers Squibb Atazanavir Early Access Program (BMS ATV EAP) were evaluated in hepatitis C and/or B co-infected patients (co-infected) and non-co-infected.


RESULTS
A total of 304 subjects with known HCV and/or HBV status from 55 centers were included in the analysis: 180 co-infected and 124 HIV non-co-infected. Accumulated follow-up until study closure was 762 and 551 person-months in the co-infected and non-co-infected subjects, respectively. The proportion of discontinuations through Month 6 was 9.4% (co-infected) and 5.6% (non-co-infected). Discontinuations due to elevated liver enzymes [1.7% (co-infected) and 0% (non-co-infected)] and due to scleral icterus/jaundice [4.4% (co-infected) and 3.2% (non-co-infected)] were low and similar between groups. Only three subjects (1%) discontinued due to virological failure. Successful virological outcome (viral load <500 copies/mL or a decrease >1 log(10)) was observed in 74% of subjects in each group. CD4+ T-cell count changes were +51 (co-infected) and +53 cells/mm3 (non-co-infected).


CONCLUSIONS
Short-term effectiveness and liver safety in HCV and or HBV co-infected patients changing to an ATV/r-based regimen was similar to that observed in non-co-infected patients.
Pérez-Elías
María Jesús
MJ
Servico de Enfermedades Infecciosas, Hospital Ramón y Cajal, Madrid, Spain. mjperez@telefonica.net
Gatell
Jose María
JM
Flores
Juan
J
Santos
Jesús
J
Vera-Médez
Francisco
F
Clotet
Bonaventura
B
Moreno
Ana
A
Pérez-Molina
Jose-Antonio
JA
Vendrell
Belén
B
Serrano
Oscar
O
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D000069446:Atazanavir Sulfate; D001663:Bilirubin / Q000097:blood; D018791:CD4 Lymphocyte Count; D004359:Drug Therapy, Combination; D005260:Female; D006678:HIV / Q000254:growth & development; D015658:HIV Infections / Q000188:drug therapy* / Q000201:enzymology / Q000821:virology*; D017320:HIV Protease Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016174:Hepacivirus / Q000254:growth & development; D006515:Hepatitis B virus / Q000254:growth & development; D019694:Hepatitis B, Chronic / Q000201:enzymology / Q000821:virology*; D019698:Hepatitis C, Chronic / Q000201:enzymology / Q000821:virology*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D009842:Oligopeptides / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D019438:Ritonavir / Q000009:adverse effects / Q000627:therapeutic use*
D017320:HIV Protease Inhibitors; D009842:Oligopeptides; D011725:Pyridines; D012367:RNA, Viral; D000069446:Atazanavir Sulfate; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D019438:Ritonavir; D001663:Bilirubin