3rd International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 23-26 October 2001, Athens, Greece

COMPARATIVE ADVERSE EFFECTS OF DIDANOSINE BUFFERED TABLETS (VIDEX) AND ENTERIC COATED CAPSULES (VIDEXEC)

Antiviral Therapy 2001; 6(Suppl. 4):34 (abstract no. 46)

SK Chuck and D Areff
Grady Infectious Disease Program, Atlanta, Ga., USA

BACKGROUND: Anecdotally, Videx is poorly tolerated resulting in decreased quality of life and sub-optimal adherence. VidexEC advantages are decreased dosing frequency, pill burden (1 versus 2-4/day), and gastrointestinal (GI) adverse effects.

OBJECTIVE: To document differences in tolerability and adherence associated with switching from Videx tablets to VidexEC capsules.

METHODS: Patients on VidexEC for >4 weeks with previous Videx use were included. Patient surveys were completed with a review of pharmacy and medical records. Switching reasons, frequency preference, and adherence were examined. Overall tolerability, satisfaction, and frequency, severity and bothersomeness of adverse effects were evaluated.

RESULTS: Twenty-four patients (23 male; 41±7 years old; 71% African American; 71 % men who have sex with men; CD4 405±263; HIV RNA 3783±11011) were included with advanced disease [67% >3 antiretrovirals; often double protease inhibitors (PI)]. Videx and VidexEC durations were 24±18 months (range: 3-60) and 7±2 months (range: 1-10), respectively. Fewer pills, ease of taking, more effective, less overall side-effects and physician recommendation were important reasons to switch. Satisfaction with dosing regimen, ease of taking and effects on daily activities, CD4 and HIV RNA were noted. Forty-six percent of patients noted increased energy. Adherence: 75% stated that decreasing to daily for one antiretroviral is very helpful; 45% Videx and 4% VidexEC had monthly or more frequent missed doses. Responses for VidexEC missed doses were: 79% never and 92 % none in the last month. Adverse effects: 75% stated Videx had disagreeable taste. GI effects occurred less frequently on VidexEC; weekly or daily nausea/vomiting (33 versus 0%), bloating/gas pain (25 versus 8%), appetite loss (16 versus 0%), and diarrhoea (42 versus 12 %). Improved frequency of bloating/gas pain or loss of appetite and nausea/vomiting/diarrhoea were seen in 29-38 and 63-67%. Improved nausea/vomiting/diarrhoea severity was noted in 33-40 %. Bothersomeness decreased in 50 and 80% for diarrhoea and nausea/vomiting, respectively. Neuropathy was unchanged with the switch; 33-50% prevalence with 20% daily frequency, very severe in 25-33%, and bothersome in 50-58%. Thirty-three, 43 and 43% experienced decreases in neuropathy frequency, severity and bothersomeness, respectively.

CONCLUSIONS: Together, an easier dosing regimen and better tolerability with less frequent, less severe and less bothersome adverse effects are likely explanations for improved adherence with VidexEC.

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