Simplification to atazanavir/ritonavir monotherapy for HIV-1 treated individuals on virological suppression: 48-week efficacy and safety results
- Creators
- Castagna A.
- Spagnuolo V.
- Galli L.
- Vinci C.
- Nozza S.
- Carini E.
- Monforte A. D.
- Montella F.
- Antinori A.
- Di Biagio A.
- Rusconi S.
- Lazzarin A.
- Viscoli C.
- Parisini A.
- Prinapori R.
- Mazzotta F.
- Lo Caputo S.
- Di Pietro M.
- D'Arminio-Monforte A.
- Tincati C.
- Bini T.
- Merlini E.
- Puoti M.
- Moioli M.
- Montella M.
- Di Sora F.
- Ammassari A.
- Ottou S.
- Cauda R.
- Di Giambenedetto S.
- Galli M.
- Franzetti M.
- Rizzardini G.
- Capetti A.
- Cossarini F.
- Gianotti N.
- Mussini C.
- Guaraldi G.
- Others:
- Castagna, A.
- Spagnuolo, V.
- Galli, L.
- Vinci, C.
- Nozza, S.
- Carini, E.
- Monforte, A. D.
- Montella, F.
- Antinori, A.
- Di Biagio, A.
- Rusconi, S.
- Lazzarin, A.
- Viscoli, C.
- Parisini, A.
- Prinapori, R.
- Mazzotta, F.
- Lo Caputo, S.
- Di Pietro, M.
- D'Arminio-Monforte, A.
- Tincati, C.
- Bini, T.
- Merlini, E.
- Puoti, M.
- Moioli, M.
- Montella, M.
- Di Sora, F.
- Ammassari, A.
- Ottou, S.
- Cauda, R.
- Di Giambenedetto, S.
- Galli, M.
- Franzetti, M.
- Rizzardini, G.
- Capetti, A.
- Cossarini, F.
- Gianotti, N.
- Mussini, C.
- Guaraldi, G.
Description
Objectives: The objective of this study was to assess the 48-week virological efficacy of atazanavir/ritonavir (ATV/r) monotherapy vs. ATV/r along with two nucleoside reverse transcriptase (NRTIs) in HIV-1 treated individuals with HIV-RNA less than 50 copies/ml. Methods: A multicentre, randomized, open-label, noninferiority trial. HIV-1 treated individuals on ATV/r 300/100mg along with two NRTIs were randomized to receive ATV/r monotherapy or to maintain their antiretroviral regimen. The primary endpoint was the confirmed viral rebound (CVR: Two consecutive HIV-RNA >50 copies/ml) or treatment discontinuation for any reason. Individuals who experienced CVR on ATV/r monotherapy reintroduced NRTIs and discontinued the study if HIV-RNA was more than 50 copies/ml after 12 weeks since reintensification. Results: One hundred and three patients enrolled. By week 48, 11 patients in ATV/r arm and two in ATV/r along with twoNRTIs experienced CVR; four (8%) patients in ATV/r and eight (15%) in ATV/r along with twoNRTIs discontinued. At the 48-week primary efficacy analysis (re-intensification=failure), treatment success was73%inATV/r armand85%in ATV/r along with two NRTIs [difference 12.1%, 95% confidence interval (95% CI)27.8 to 2.1]. According to the analysis considering re-intensification is equal to success, treatment success was 92%in ATV/r armand 85%in the ATV/r along with twoNRTIs arm (difference 7.5%, 95%CI4.7 to 19.8). At CVR, no mutation was observed in ATV/r arm and reintensification with NRTIs was effective in all individuals. Overall, Grade 3-4 (P=0.003) and grade 3-4 drug-related (P=0.027) adverse events were less frequent in ATV/r arm. A significant increase in total and low-density lipoprotein (LDL)-cholesterol was observed as well as a significant improvement in high-density lipoprotein (HDL)- cholesterol, fasting glucose, liver fibrosis and alkaline phosphatase was observed in ATV/r monotherapy in comparison with ATV/r along with two NRTIs. Conclusion: ATV/r monotherapy treatment simplification showed lower virological efficacy in comparison with maintaining triple therapy; NRTIs reintroduction was effective in all the individuals.
Additional details
- URL
- http://hdl.handle.net/11567/995033
- URN
- urn:oai:iris.unige.it:11567/995033
- Origin repository
- UNIGE