Switch to LPV/r Monotherapy Pilot Study - KalMo Study
This pilot study, known as the KalMo Study, explores the efficacy and safety of switching to LPV/r monotherapy in HIV patients. The study design, baseline characteristics, virologic outcomes, and conclusions are detailed, emphasizing the effectiveness and tolerability of LPV/r monotherapy through 96 weeks of treatment. Results show no resistance mutations, comparable CD4 changes, and a higher incidence of gastrointestinal adverse events in the monotherapy group. Switching to LPV/r monotherapy is shown to be effective, safe, and well-tolerated for HIV patients.
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author.If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
You are allowed to download the files provided on this website for personal or commercial use, subject to the condition that they are used lawfully. All files are the property of their respective owners.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author.
E N D
Presentation Transcript
Switch to LPV/r monotherapy Pilot LPV/r M03-613 LPV/r Mono KalMo OK OK04 KALESOLO MOST HIV-NAT 077
KalMo Study: Switch to LPV/r monotherapy Design Randomisation 1 : 1 Open-label W96 Continuation of current regimen with 2 NRTIs + (NNRTI or PI) N = 30 60 HIV+ 18 years On 2 NRTIs + (NNRTI or PI) > 6 months HIV-1 RNA < 80 c/mL > 6 months CD4 cell count > 200/mm3 N = 30 LPV/r 400/100 mg bid* * 533/133 mg bid for the first 2 weeks if on NNRTI at screening Endpoints Primary endpoint: proportion of patients with HIV-1 RNA < 80 c/mL at W96 (ITT, missing equals failure analysis) Secondary endpoints: virologic failure (2 consecutive HIV-1 RNA > 500 c/mL), AIDS-defining illnesses, CD4, safety, adverse events Nunes EP, HIV Clin Trials 2009;10:368-74 KalMo
KalMo Study: Switch to LPV/r monotherapy Baseline characteristics and patient disposition Triple therapy LPV/r bid monotherapy N = 30 39 45% 10% 538 40.5 33% 63% 6 1 (diarrhoea) 1 N = 29 40 31% 3% 510 43.4 37% 70% 3 0 1 Age, median years Female Hepatitis C co-infection CD4 cell count, median/mm3 Duration of ARV treatment, median months PI treatment at screening NNRTI treatment at screening Discontinuation by W48, n Discontinuation for adverse event Confirmed HIV RNA elevation Nunes EP, HIV Clin Trials 2009;10:368-74 KalMo
KalMo Study: Switch to LPV/r monotherapy Virologic outcome Other outcomes 1 virologic failure (confirmed HIV-1 RNA > 500 c/mL) in each group. No resistance mutation on genotype No difference in CD4 changes between groups GI adverse events more frequent in the monotherapy group: 24 vs 10 (p = 0.001) 5 patients in the triple therapy group underwent regimen changes due to drug-related toxicities Conclusion: switching to LPV/r monotherapy is effective, safe and well tolerated through 96 weeks ITT analysis HIV-1 RNA < 80 c/mL On-treatment analysis* % 96 96 100 86.7 80 75 50 25 0 Triple therapy LPV/r mono * Includes only patients who completed 96 weeks of follow-up without discontinuation for other reasons than virologic failure Nunes EP, HIV Clin Trials 2009;10:368-74 KalMo
