754 - Abstract (11th CROI)

Session 104 Poster Abstracts
Systemic and Organ Complications of HIV-1 and Antiretroviral Therapies
Monday, 1:30 - 3:30 pm
Poster Hall

754

Low-grade Symptoms Worsen Quality of Life for HIV-infected Individuals in Antiretroviral Therapy Clinical Trials
S Mannheimer*¹, J Matts², C Child³, M Chesney⁴, E Telzak⁵, A Wu⁶, G Friedland⁷, and the Terry Beirns Community Programs for Clinical Research on AIDS (CPCRA)
¹Harlem Hosp./Columbia Univ., New York, NY, USA; ²CPCRA Statistical and Data Monitoring Ctr., Minneapolis, MN, USA; ³Univ. of California, San Francisco, USA; ⁴Natl. Ctr. for Complementary and Alternative Med., NIH, DHHS, Bethesda, MD, USA; ⁵Bronx Lebanon Hosp. Ctr., Albert Einstein Coll. of Med., Bronx, NY, USA; ⁶Johns Hopkins Univ., Baltimore, MD, USA; and ⁷Yale Univ. Sch. of Med., New Haven, CT, USA

Background: Quality of life is an important outcome in the treatment of HIV. While the most severe symptoms (grade 4) are associated with higher mortality, little is known about the impact of less severe symptoms on clinical outcome.

Methods: Participants who completed at least 1 month of follow-up in 1 of 2 prospective, randomized antiretroviral therapy (ART) clinical trials for ART-naīve (CPCRA 058) or -experienced participants (CPCRA 057) were included in this cross-protocol analysis to assess if symptoms lower quality of life. Self-reported symptoms were assessed by a standardized NIH/DAIDS scale of adverse events (0 = none, 4 = most severe) at baseline, 1, 4, 8, and 12 months. Quality of life was measured at the same times using the validated SF-12. Quality of life physical and mental component summary scores were calculated using standard methods. Data were analyzed using ANOVA.

Results: Of 1095 participants, 20% were women, 53% African American, 16% Latino, 16% injection drug users, 29% had AIDS, mean age 39 years; mean baseline CD4 count 230 cells/mm³, mean baseline HIV RNA 4.95 log₁₀ copies/mL; and 89% were ART-naīve. Symptoms were common: 70% at 12 months reported at least 1 symptom; <5% were severe (grade 3 to 4). The mean quality of life summary scores by symptom status (- or +) at baseline and at 12 months among the 512 participants with 12 months of data are shown in the table below:

Quality of Life	-/-	+/-	-/+	+/+	p
Physical	54.7	50.9	49.4	45.3	<0.001
Mental	48.7	46.2	44.0	43.6	<0.001

Having symptoms (mostly mild-to-moderate) was strongly associated with lower quality of life scores. Similar findings were seen at 1, 4, and 8 months (p <0.001). Participants who developed symptoms at 12 months after having none at baseline (-/+) had a decrease in quality of life (mean DPCS -3.2 from baseline to 12 months), while all other participants had improved quality of life (mean DPCS +2.4 to +7.2), p<0.001. An inverse relationship was seen between the number of symptoms and quality of life: mean physical component scores were 52.3, 48.8, 48.7, 43.9, and 39.5 for participants reporting 0, 1, 2, 3, or >3 symptoms at 12 months (p <0.001); similar findings were seen for mental component scores (mean score 47.1 if 0 symptoms vs 39.8 if >3, p <0.001).

Conclusions: The presence of symptoms had a deleterious effect on quality of life for these ART clinical trial participants. Most symptoms were mild to moderate (grade 1 or 2). These findings highlight the significance of symptoms experienced by participants receiving ART.

Keywords: symptoms; quality of life; antiretroviral therapy