Background:  Zimbabweans with AIDS-related Kaposi’s sarcoma (AIDS/KS) present with great tumor burdens and advanced immunosuppression. Chemotherapy alone does not increase survival compared to supportive care. The present study evaluated the hypothesis that co-formulated abacavir (ABC)+lamivudine (3TC)+zidovudine (ZDV) increases survival compared to chemotherapy alone during initial treatment of AIDS/KS in a resource limited setting.
Methods:  Prospective evaluation of open-label ABC+3TC+ZDV in Zimbabweans with AIDS/KS. Entry criteria included documented HIV-1 infection and histological documentation of KS. All participants were naïve to ART and did not have chemotherapy or radiation therapy within 45 days prior to study entry. An a priori planned intention-to-treat analysis was conducted to compare survival of study participants with historical controls and to identify potential predictors of survival during the first 48 weeks of treatment.

Results:  In this study, 62 men and 28 women with AIDS/KS were treated with ABC+3TC+ZDV. Adjunctive chemotherapy was given to 32 participants, at the discretion of their care provider. Among the subjects, 4 (4%) had localized cutaneous KS, 42 (47%) had aggressive cutaneous or lymphatic KS, and 44 (49%) had evidence of palatal or visceral KS. Median CD4⁺ lymphocytes increased from 134 mm^–3 at baseline to 204 mm^–3 at 48 weeks (p <0.001). Week 48 plasma HIV-1 RNA was <400 copies/mL for 39 of 48 (81%) specimens tested. The hazard ratio for death at 48 weeks was 0.12 (95%CI 0.07 to 0.22; p <0.0001) for study participants compared to historical controls with similar AIDS/KS disease stage treated with chemotherapy without ART in a previous clinical trial at the University of Zimbabwe. Death was not associated with sex, age, KS stage, baseline hemoglobin, baseline CD4⁺ cell count, or CD4⁺ cell change from baseline. The odds of death for participants who used adjunctive chemotherapy during the first 48 weeks of ART was 0.13 (95%CI 0.02 to 1.0; p = 0.03) compared with ART alone.

Conclusions: Co-formulated ABC+3TC+ZDV provides a survival benefit compared to chemotherapy alone in Zimbabweans with advanced AIDS/KS. The trend toward decreased odds of death among persons treated with adjunctive chemotherapy suggests an added benefit when chemotherapy and ART are used in combination.