Oral Abstract Presentations|
Clinical Trials in Resource-Limited Settings
Session Day and Time: Thursday 4 - 6:15 pm
Presentation Time: 5:30
Room: Ballroom C
Background: Production of antiretrovirals by generic manufacturers has reduced prices to around 1 USD/day. Because concerns have been raised that generic medicines may not be equivalent to proprietary therapeutics, we evaluated the safety, tolerability, and effectiveness of generic HAART in an HIV care center in India.
Methods: YRG CARE is an HIV referral center in South India providing care for over 4,000 PLHA. A retrospective cohort review was conducted to identify patients (pts) on Indian-manufactured generic HAART combinations for at least 12 weeks (wks). Review included assessment of documented OIs, CD4 counts and adverse events (AEs). Anemia, diarrhea, headache, and/or nausea on therapy were recorded as AEs, as were rash occurring within 6 wks and hepatitis within 12 wks of initiating therapy. Analysis included Wilcoxon signed-rank test to compare paired CD4 counts within pts and Mann-Whitney test to compare change in CD4 count from baseline between ART naive and experienced pts.
Results: From May 2000 to present, 286 pts (89% male, 95% acquired heterosexually, median age 33) reflecting 178 person-yrs experience, have been on a generic HAART regimen for at least 3 months. Pts were on generic HAART containing NVP in combination with AZT/3TC, d4T/3TC or d4T/ddI. Sixty-four (64) patients (23%) had been on a prior ART without generic NVP. The median CD4 count at HAART initiation was 120 cells/mm3(range 2–623).Median rise in CD4 count after 6 mos of therapy was 159 cells/mm3 (n = 89, p < 0.001) and remained stable at 159 cells/mm3 for the next 6 mos (n = 49, p < 0.001). Median CD4 rise from baseline was greater in pts who were ART naïve than in pts who had prior dual nucleoside therapy (n = 51, p = 0.011). Pts who started generic HAART below a CD4 of 100 cells/mm3 were more likely to develop an OI (n = 31, p < 0.001).Twenty-six percent (26%) of pts developed side effects of rash (10.5%), anemia (6.6%), diarrhea (4.9%), hepatitis (4.6%), or peripheral neuropathy (4.5%). One (1) pt developed SJS. Fifty (50) pts (17%) discontinued HAART, 29 (10%) due to side effects. No pt expired due to drug toxicity.
Conclusion: In this cohort, generic based HAART was safe, well tolerated and effective at increasing CD4 count in advanced pts, comparable to the experience of proprietary HAART. Increasing access to generic HAART could be an effective means to use limited resources to provide needed treatment in areas where the epidemic continues to rapidly expand.