Long-Term Treatment With Subcutaneous T-20, a Fusion Inhibitor, in HIV-Infected Patients: Patient Satisfaction and Impact on Activities of Daily Living

Currently, all approved agents for HIV therapy target one of two viral enzymes: reverse transcriptase or protease. Clinical studies have shown that current agents are highly effective when used in combination; however, many patients are unable to tolerate these agents or develop virologic failure through incomplete viral suppression and the emergence of drug-resistant strains. The synthetic peptide T-20 is a novel antiretroviral agent that inhibits the fusion of HIV with target cell membranes.

HIV-infected adults who had previously received T-20 in short-term (< one month, with the exception of one patient who had received T-20 for 36 weeks) clinical trials without experiencing any drug-related toxicity that resulted in study withdrawal were eligible for the current study. There were no restrictions on absolute CD4+ cell counts or on previous treatment with approved therapies. T-20 50 mg was self-administered in twice-daily, subcutaneous injections. The impact of this mode of administration on patients' ability to conduct normal activities of daily living (ADL) and comply with a T-20 treatment regimen was assessed as part of a 48-week, open-label, single-arm rollover phase II trial.

Seventy previously treated patients received T-20 in combination with an average of five oral antiretroviral agents. Patients' opinions on the impact of T-20 on ADL and the ease of use of subcutaneous T-20 and choice to continue therapy were assessed by two questionnaires completed at baseline and week 48 (or study withdrawal). ADL were measured using a Likert-type scale based on established instruments with questions added to assess HIV-specific issues, such as privacy and sexuality.

Among the 55 patients who completed both baseline and final questionnaires, 41 completed 48 weeks of treatment and 14 prematurely withdrew from the study (11 because of virologic failure and three because of voluntary withdrawal). There were no significant differences noted in individual baseline questionnaires between those patients who completed final questionnaires and those who did not, in terms of number of years since diagnosis, self-assessment of health and impact of current therapy on ADL.

Relative to other HIV/AIDS drugs, T-20 had little impact on ADL, with the majority of patients (54 percent to 96 percent) agreeing (somewhat or strongly) that "relative to my other HIV/AIDS drugs subcutaneous injections have not limited my daily activities." Over 75 percent of patients agreed with statements that vigorous and moderate activities (walking uphill/climbing stairs, preparing meals/bathing/using the toilet, working/attending school, intimacy, social relationships and family life) had not been affected. For the ability to travel away from home, personal appearance and privacy of health status, 54 percent, 62 percent and 62 percent of patients agreed the therapy did not interfere.

Patients found the injections relatively easy to perform with more than 47 percent of patients stating that each aspect of the injections (ease of injection, storage, reconstitution, and disposal of sharps) was very easy or easy. If offered the chance, 98 percent of patients who completed 48 weeks of treatment stated that they would choose to continue with T-20. The most common reasons for this were the perceived effectiveness of T-20 and lack of side effects.

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