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  AIDS 2002 Barcelona
Barcelona, Spain July 7-12 2002
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Kaletra Once Daily; Efavirenz in Patients with Highly Advanced HIV
  Kaletra Once A Day
Once daily Kaletra (800mg lopinavir/200mg ritonavir) is being compared to the standard dose of Kaletra (400/100) twice daily in 38 treatment-naive individuals. All patients also received d4T/3TC. This is a small pilot study; baseline viral load is 4.6 log in each group (50,000) and CD4 is 250. After 72 weeks of therapy 74% in the once daily Kaletra group vs 58% in the twice daily Kaletra group had <50 copies/ml of viral load (ITT noncompleter=failure). 2 of 19 patients in the once daily group discontinued vs 6of 19 in the twice daily group. The most common study-drug related adverse events of at least moderate severity were diarrhea, nausea, and asthenia, while the most common lab abnormality was lipid elevations. 2 patients were reported to have triglycerides over 750 in each of the two treatment groups. And 1 patient was reported to have >300 cholesterol in each of the treatment groups. They did not report lipid elevations below those levels. Only 3 of 38 patients discontinued the study due to adverse events. On average the Kaletra blood level was lower at the end of the dosing period (trough) for patients on the once daily regimen than the twice daily regimen. There were a number of individuals with lower troughs in the once daily group, while none of the patients receiving the twice daily regimen had low trough levels.
Efavirenz vs Single PI in Patients with <100 CD4s
Spanish researchers reported study results for patients with advanced HIV (<100 CD4s) who received either an efavirenz regimen or a PI regimen (indinavir or nelfinavir). Comparing efavirenz to Kaletra in these types of patients might be more interesting. This was a retrospective (look back) at severely immunosuppressed patients who had received either an EFV or single PI regimen. Several studies show that increasingly patients are first being diagnosed with HIV after they have advanced HIV. Individuals are increasing showing up at clinics with late stage HIV. This obviously makes treatment more difficult and response to therapy is not as good. So, this study looks at these types of patients.
These patients were from 3 clinics in Madrid & Barcelona who were treatment-naive and had CD4s <100. They received 2 nukes with either EFV or a PI and had at least 1 followup visit. The patients receiving the PI regimen started therapy in 1997 and the patients getting the NNRTI regimen started in 1999. About 80% were men, 38 years old. Interestingly, patients were mostly IVDUs & heterosexuals: 36-46% were IVDUs, 14-21% men who have sex with men, and 28-37% heterosexual.
These patients had advanced HIV. Average cd4s were very low (34-39). HIV viral load was very high 350,000 in EFV group & 254,000 in the PI group. 50-60% had CDC C3 HIV disease, more advanced. 10-20% of patients had TB, 17% had PCP, 11-15% had esophogeal candida, and other AIDS defining diagnosis.
Patients received AZT/3TC or d4T/3TC in combination with either efavirenz or a PI: nelfinavir (46%), indinavir (34%), ritonavir (14%). Some patients took d4T/ddI, and 12 took RTV/IDV or RTV/SQV. There are 92 patients in the EFV group and 218 in the PI arm.
Treatment discontinuations. 23% in the PI group discontinued due to an adverse event vs 8% in the EFV arm. 12.8% in the PI arm experienced viral failure vs 4.3% in the EFV arm.
After 24 months of therapy, 70% in the EFV had <400 copies viral load (n=36) vs 45% (n=208) in the PI arm (ITT:NC or change not due to simplification=failure). Using a less stringent analysis (ITT: NC=failure, change of regimen ignored) 75% in EFV arm and 55% in PI arm had <400 copies. They did not report perecent of patients with less than 50 copies of viral load.
Time to treatment failure (ITT: non-completer or change=failure) was significantly better in the EFV patients. CD4 increases were generally better in the EFV group. Study limitations are that it is non-randomized, retrospective study. Results might be different with boosted PI regimen such as Kaletra.