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once or twice daily kaletra?
Nov 4, 2003

Dr. Young,

Which one do you advocate in favor of?

Nelson

Once Daily Kaletra Vs Twice Daily Kaletra in Treatment-nave Patients

In a pilot study, the safety, tolerability, and antiviral activity of a once-daily Kaletra (lopinavir/ritonavir/LPV/r)-based regimen appeared comparable to that of a twice-daily LPV/r-based regimen.

Study 418 is a randomized, open-label comparison of LPV/r 800/200 mg QD (n=115) vs. LPV/r 400/100 mg BID (n=75), each dosed with once-daily Emtriva (emtricitabine/ FTC) and Viread (tenofovir DF/TDF).

Study Results

Median baseline viral load (VL) and CD4 count were 4.8 log10 copies/mL and 216 cells/mm3, respectively. Prior to Week 24, 15 (QD) and 12 (BID) patients discontinued, primarily due to adverse events (10 QD, 4 BID) or loss to follow-up or non-adherence (2 QD, 7 BID). Through 24 weeks, virologic responses were similar (see Table). The 95 CI for the difference in the Week 24 proportion of patients with HIV RNA <50 copies/mL (intent-to-treat) was (-14.3, 14.4).

Mean increases in CD4 count from baseline to Week 24 were 129 (QD) and 103 (BID) cells/mm3 (p=0.164). Diarrhea (10 QD, 3 BID, p=0.05) and nausea (7 in each group) were the most common moderate or severe, study drug-related AEs. 81 and 79 of patients had maximum total cholesterol or triglycerides values of Grade 0-1 (<240 mg/dL and <400 mg/dL, respectively).

Conclusions

Through 24 weeks, a QD regimen of TDF+ FTC + LPV/r resulted in similar virologic responses in antiretroviral-naive patients compared to the same regimen with LPV/r dosed BID. Both regimens were well tolerated, and diarrhea was the only AE reported more frequently in QD- vs. BID-treated patients.

11/03/03

Reference D Podzamczer and others. EFFICACY AND SAFETY OF ONCE-DAILY LOPINAVIR/ RITONAVIR VS. TWICE-DAILY LOPINAVIR/RITONAVIR IN ANTIRETROVIRAL-NAIVE PATIENTS: 24-WEEK RESULTS. Abstract F1/3. Program and Abstracts of the 9th European Conference on AIDS (9th EACS). October 25-29, 2003, Warsaw, Poland.

Response from Dr. Young

Nelson- There was an interesting presentation at the European AIDS Conference last week concerning a study that looked at lopinavir/ritonavir (Kaletra) once- versus twice-daily (in combo with tenofovir(Viread) and emtricitabine (Emtriva). This study presented analysis of the early 24 week data of treatment naive persons who received the combination and demonstrated that the two doses appear to perform similarly.

Now, does this mean that you should take Kaletra once-daily? I would think that given the preponderance of safety, efficacy and tolerability data on twice daily (up to 5 years in duration) that it would be very premature to conclude that Kaletra should be given once-daily for everyone. Indeed, I would caution people from thinking that 24 week data is comparable to 5 year effectiveness data-- since we are talking about HIV therapies that usually go past 24 weeks.

For selected persons who must have a once-daily protease inhibitor combination, we do have other tested drugs, like atazanavir (Reyetaz) and boosted fos-amprenavir (Lexiva) that have larger, more substantial data sets, this study with Kaletra adds to the knowledge about potential options for these persons. BY



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