Low rate of adverse hepatic events associated with fosamprenavir/ritonavir-based antiretroviral regimens

HIV Clinical Trials

Volumn 9, Issue 5, 2008, Pages 309-313

  Pineda, Juan A ^a   Pérez Elías, Maria Jesús ^b   Peña, José Ma ^c   Luque, Isabel ^d   Rodríguez Alcantara, Felipe ^d   Aguirrebengoa, K ^e   Aleman R ^f   Alonso, C ^g   Orti, A ^h   Arazo, P ⁱ   Arrizabalaga, J ^j   Bachiller Luque, P ^k   Berdun, M A ^l   Baguena F ^m   Blanco, F ⁿ   Boix, V ^o   Blanquez, R M ^p   Cano, A ^q   Carmena, J ^r   Causse, M ^s   Clotet, B ^t   Cucurull, J ^u   Cuadrado, J Mo ^v   Chocarro, A ^w   Dalmau, D ^x   del Pozo, M A ^y   Domingo, P ^z   Echeverria S ^aa   Flores, J ^ab   Force, L ^ac   Frances A ^ad   Galindo, M J ^ae   Galvez J ^af   Galvez Ma C ^ag   Garcia J L ^ad   Guerrero, F ^ah   Gorgolas M ^ai   Gutierrez, F ^ad   Hayek, M ^aj   Hernandez J J ^ad   Hernandez J ^ak   Jusdado, J J ^al   Kindelan J M ^am   Knobel, H ^an   Lorenzo, J F ^ao   Llibre, J Ma ^ap   Lopez, J ^aq   Lozano, F ^a   Mallolas, J ^ar   Maradona, J A ^as   Marino Callejo A ^at   Marquez M ^au   Martin C ^av   Mascaro J ^aw   Miralles, P ^ax   Morano, L ^ay   Munoz A ^az   Ocampo, A ^ba   Ojea, R ^bb   Ortega, E ^bc   Oteo, J A ^bd   Pasquau, F ^be   Pasquau, J ^bf   Pedreira, J D ^bg   Pedrol, E ^bh   Peralta, G ^bi   Podzamcer, D ^bj   Portu Zapirain, J ^bk   Prada, J L ^ad   Prieto, A ^bl   Pujol, E ^bm   Pulido, F ^bn   Redondo, C ^bo   Ribera, E ^bp   Riera, M ^bq   Rodriguez R ^ad   Roca, V ^br   Rubio, R ^bn   Rubio, M ^ab   Sala, M ^bs   Santamaria J M ^bt   Sanz Moreno, J ^bu   Sanz, J ^bv   Silvarino R ^bw   Soriano, V ⁿ   Telenti, M ^bx   Terron J A ^ad   Viciana, P ^by   Vilades, C ^bz   Zarzalejos, J M ^ca   more..

^a HOSPITAL UNIVERSITARIO DE VALME   (Spain)

^b HOSPITAL RAMÓN Y CAJAL   (Spain)

^c HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^d GLAXOSMITHKLINE   (Spain)

^e HOSPITAL DE CRUCES   (Spain)

^f Canarias University Hospital   (Spain)

^g HOSPITAL UNIVERSITARI SANT JOAN DE REUS   (Spain)

^h Hospital Virgen de la Cinta   (Spain)

ⁱ Hospital Miguel Servert   (Spain)

^j Hospital Nuestra Senora de Aranzazu   (Spain)

^k HOSPITAL UNIVERSITARIO RÍO HORTEGA   (Spain)

^l UNIVERSIDAD SAN JORGE   (Spain)

^m Fundació Sanitaria D'Igualada   (Spain)

ⁿ Carlos III Hospital   (Spain)

^o H Gral de Alicante   (Spain)

^p Morales Messeguer Hospital   (Spain)

^q H General de Murcia   (Spain)

^r Hospital Peset   (Spain)

^s H Carlos Haya   (Spain)

^t HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL   (Spain)

^u Figueres Hospital   (Spain)

^v H San Juan de Alicante   (Spain)

^w HOSPITAL VIRGEN DE LA CONCHA   (Spain)

^x H Mutua de Tarrassa   (Spain)

^y HOSPITAL CLÍNICO UNIVERSITARIO DE VALLADOLID   (Spain)

^z H Sant Pau   (Spain)

^aa H de Valdecilla   (Spain)

^ab HOSPITAL ARNAU DE VILANOVA   (Spain)

^ac Hospital of Mataro   (Spain)

^ad H Insular de las Palmas de Gran Canaria ^*  (Spain)

^ae Hospital Clinico Universitario   (Spain)

^af HOSPITAL UNIVERSITARIO VIRGEN MACARENA   (Spain)

^ag H de Torrecárdenas   (Spain)

^ah HOSPITAL UNIVERSITARIO PUERTA DEL MAR   (Spain)

^ai Jimenez Diaz Foundation   (Spain)

^aj HOSPITAL UNIVERSITARIO NUESTRA SEÑORA DE CANDELARIA   (Spain)

^ak HOSPITAL UNIVERSITARIO SAN CECILIO   (Spain)

^al HOSPITAL SEVERO OCHOA   (Spain)

^am HOSPITAL UNIVERSITARIO REINA SOFÍA   (Spain)

^an H del Mar   (Spain)

^ao HOSPITAL UNIVERSITARIO DE BURGOS   (Spain)

^ap Hospital Comarcal Sant Jaume de Calella   (Spain)

^aq HOSPITAL UNIVERSITARIO LA FE   (Spain)

^ar Servicio de Enfermedades Autoinmunes H Clinic   (Spain)

^as H Ntra Sra Covadonga   (Spain)

^at Universidad de La Coruña   (Spain)

^au H Virgen de la Victoria   (Spain)

^av H Ntra Sra de la Montaña   (Spain)

^aw Dr Josep Trueta University Hospital   (Spain)

^ax HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN   (Spain)

^ay Meixoeiro Hospital   (Spain)

^az HOSPITAL INFANTA CRISTINA   (Spain)

^ba HOSPITAL XERAL CÍES   (Spain)

^bb H de Pontevedra   (Spain)

^bc H Gral Univ   (Spain)

^bd H Provincial de la Rioja   (Spain)

^be Marina Baixa Hospital   (Spain)

^bf HOSPITAL UNIVERSITARIO VIRGEN DE LAS NIEVES   (Spain)

^bg HOSPITAL JUAN CANALEJO   (Spain)

^bh H de Granollers   (Spain)

^bi H Sierrallana   (Spain)

^bj H de Bellvitge   (Spain)

^bk HOSPITAL TXAGORRITXU   (Spain)

^bl H Santiago de Compostela   (Spain)

^bm Juan Ramon Jimenez Hospital   (Spain)

^bn HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^bo HOSPITAL UNIVERSITARIO VIRGEN DE LA ARRIXACA   (Spain)

^bp HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^bq Son Dureta Children's Hospital   (Spain)

^br H Clinico San Carlos   (Spain)

^bs Parc Tauli Health Corporation   (Spain)

^bt HOSPITAL DE BASURTO   (Spain)

^bu HOSPITAL UNIVERSITARIO PRÍNCIPE DE ASTURIAS   (Spain)

^bv HOSPITAL UNIVERSITARIO DE LA PRINCESA   (Spain)

^bw Hospital de San Eloy   (Spain)

^bx HOSPITAL UNIVERSITARIO CENTRAL DE ASTURIAS   (Spain)

^by HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO   (Spain)

^bz H Joan XXIII   (Spain)

^ca H Dr Negrín   (Spain)

more..

Author keywords

Fosamprenavir; Hepatitis; Liver toxicity

Indexed keywords

ABACAVIR; AMPRENAVIR; AMPRENAVIR PHOSPHATE; ATAZANAVIR; DIDANOSINE; EFAVIRENZ; EMTRICITABINE; ENFUVIRTIDE; HEPATITIS B SURFACE ANTIGEN; HEPATITIS C ANTIBODY; LAMIVUDINE; LOPINAVIR; NEVIRAPINE; PEGINTERFERON; RIBAVIRIN; RITONAVIR; SAQUINAVIR; STAVUDINE; TENOFOVIR; ZIDOVUDINE;

ADULT; ARTICLE; DRUG SAFETY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; HEPATITIS B; HEPATITIS C; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERBILIRUBINEMIA; INCIDENCE; LIVER FIBROSIS; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; MIXED INFECTION; PRIORITY JOURNAL;

ADULT; CARBAMATES; FEMALE; HEPATITIS C; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HUMANS; LIVER; MALE; MIDDLE AGED; PHOSPHORIC ACID ESTERS; RITONAVIR; SPAIN; SULFONAMIDES;

EID: 57149087059     PISSN: 15284336     EISSN: None     Source Type: Journal    
DOI: 10.1310/hct0905-309     Document Type: Article

References (14)

1. Soriano V, Puoti M, Garcia-Gascó P, et al. Antiretroviral drugs and liver injury. AIDS. 2008;22:1-13.
2. Gathe JC Jr, Ive P, Wood R, et al. SOLO: 48-week efficacy and safety comparison of once-daily fosamprenavir/ritonavir versus twice-daily nelfinavir in naive HIV-1-infected patients. AIDS. 2004;18:1529-1537.
3. Eron J Jr, Yeni P, Gathe J Jr, et al. The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: A randomised non-inferiority trial. Lancet. 2006;368:476-482.
4. Pavel S, Burty C, Alcaraz I, et al. Severe liver toxicity in postexposure prophylaxis for HIV infection with a zidovudine, lamivudine and fosamprenavir/ritonavir regimen. AIDS. 2007;21:268-269.
5. Norris D, Patel L, Rizzardini G, et al. Efficacy and safety of fosamprenavir/ritonavir (FPV/r) BID or lopinavir/ritonavir (LPV/r) BID in antiretroviral treatment-naive subjects co-infected with hepatitis B (HBV) or C (HCV) and HIV (The KLEAN Study). In: Program and abstracts of the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2007); July 22-25, 2007; Sydney, Australia. Abstract MOPEB059.
6. De Jesus E, Gladysz A, Vera J, et al. Long term safety in HCV/HBV co-infected HIV ART naïve adults treated with fosamprenavir/ ritonavir. In: Program and abstracts of the 3th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2005); July 24-27, 2005; Rio de Janeiro, Brazil. Abstract TuPe1.1C03.
7. Pérez-Elías MJ, Sanchez-Conde M, Soriano V, et al. Fosamprenavir (GW433908)/ritonavir in subjects infected by HIV: Efficacy and safety results from the Spanish Expanded Access Program. Enferm Infecc Microbiol Clin. In press.
8. Sulkowski MS, Mehta SH, Chaisson RE, Thomas DL, Moore RD. Hepatotoxicity associated with protease inhibitor-based antiretroviral regimens with or without concurrent ritonavir. AIDS. 2004;18:2277-2284.
9. Macías J, Girón-González JA, González-Serrano M, et al. Prediction of liver fibrosis in HIV/ HCV-coinfected patients by simple noninvasive indexes. Gut. 2006; 55:409-414.
10. Pineda JA, García-García JA, Aguilar-Guisado M, et al. Clinical progression of Hepatitis C Virus-related chronic liver disease in Human Immunodeficiency Virus-infected patients undergoing highly active antiretroviral therapy. Hepatology. 2007;46:622-630.
11. Aranzabal L, Casado JL, Moya J, et al. Influence of liver fibrosis on highly active antiretroviral therapy-associated hepatotoxicity in patients with HIV and hepatitis C virus coinfection. Clin Infect Dis. 2005;40:588-593.
12. Labarga P, Soriano V, Vispo ME, et al. Hepatotoxicity of antiretroviral drugs is reduced after successful treatment of chronic hepatitis C in HIV-infected patients. J Infect Dis. 2007;196:670-676.
13. Al-Mohri H, Murphy T, LU Y, Lalonde RG, Klein M. Evaluating liver fibrosis progression and the impact of antiretroviral therapy in HIV and hepatitis C coinfection using a non-invasive marker. J Acquir Immune Defic Syndr. 2007; 44:463-469.
14. Macías J, Mira JA, López-Cortés LF, et al. Antiretroviral therapy based on protease inhibitors as a protective factor against liver fibrosis progression in patients with chronic hepatitis C. Antivir Ther. 2006;11:839-846.