Study of the Gastrointestinal Tolerance of a New Tablet Formulation of the Lopinavir/Ritonavir Antiretroviral in HIV-Infected Patients

BACKGROUND:Preliminary studies suggest that the new film-coated tablet formulation of lopinavir/ritonavir (LPV/r-fct) could cut down the rate of adverse gastrointestinal symptoms of the conventional lopinavir/ritonavir soft gelatine capsules (LPV/r-sgc). OBJECTIVE:To ascertain the difference in the...

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Bibliographic Details
Published in:	Journal of acquired immune deficiency syndromes (1999) Vol. 50; no. 3; pp. 294 - 298
Main Authors:	Sa´ez de la Fuente, Javier, Granja, Virginia, Escobar, Ismael, Collada de la Fuente, Elena, Moreno, Victor, Rubio, Rafael
Format:	Journal Article
Language:	English
Published:	Hagerstown, MD Lippincott Williams & Wilkins, Inc 01-03-2009 Lippincott Williams & Wilkins Lippincott Williams & Wilkins Ovid Technologies
Subjects:	Adult Aged Antiretroviral drugs Biological and medical sciences Digestive system Drug Combinations Drug therapy Female Fundamental and applied biological sciences. Psychology Gastrointestinal Tract - drug effects HIV HIV Infections - drug therapy HIV Protease Inhibitors - administration & dosage HIV Protease Inhibitors - adverse effects Human immunodeficiency virus Human viral diseases Humans Infectious diseases Lopinavir Male Medical sciences Microbiology Middle Aged Miscellaneous Pharmacology Prospective Studies Pyrimidinones - administration & dosage Pyrimidinones - adverse effects Ritonavir - administration & dosage Ritonavir - adverse effects Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Virology Immunopathology Antiretroviral agent Microbiology Ritonavir Toxicity Lopinavir Retroviridae AIDS Immune deficiency Lentivirus Virology Infection Virus drug-related toxicity HIV Viral disease Antiviral Human immunodeficiency virus
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Summary:	BACKGROUND:Preliminary studies suggest that the new film-coated tablet formulation of lopinavir/ritonavir (LPV/r-fct) could cut down the rate of adverse gastrointestinal symptoms of the conventional lopinavir/ritonavir soft gelatine capsules (LPV/r-sgc). OBJECTIVE:To ascertain the difference in the rate of adverse gastrointestinal symptoms in patients who switch from LPV/r-sgc to LPV/r-fct. METHODS:An uncontrolled, open, prospective study including a pre/post comparison using the Gastrointestinal Symptom Rating Scale (GSRS) modified to the characteristics of the protease inhibitors. RESULTS:Seventy patients were included, with a mean time of treatment, with the new formulation of 77 days [confidence interval (CI) 95%70 to 84]. The total GSRS score was 26.96 (CI 95%25.02 to 28.89) in the prechange survey and 26.27 (CI 95%24.08 to 28.47) in the postchange survey, with a mean difference of 0.69 points (CI 95%−1.18 to 2.55, P = 0.47). None of the questions obtained the objective of a difference of at least 2 points, previously set as a clinically significant difference. Only 1 patient dropped the study due to gastrointestinal toxicity. CONCLUSIONS:Our study has unearthed no clinically significant differences in the gastrointestinal tolerance profile of (LPV/r-sgc) and (LPV/r-fct), measuring this tolerance level by application of the GSRS scale.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23
ISSN:	1525-4135 1944-7884
DOI:	10.1097/QAI.0b013e3181989a74