Tags

Type your tag names separated by a space and hit enter

Twice-daily amprenavir 1200 mg versus amprenavir 600 mg/ritonavir 100 mg, in combination with at least 2 other antiretroviral drugs, in HIV-1-infected patients.
BMC Infect Dis. 2003 Jun 10; 3:10.BI

Abstract

BACKGROUND

Low-dose ritonavir (RTV) boosts plasma amprenavir (APV) exposure. Little has been published on the efficacy, tolerability, and safety of APV 600 mg/RTV 100 mg (APV600/RTV) twice daily (BID) compared to APV 1200 mg BID (APV1200).

METHODS

ESS40011 was a 24-week, multicenter, open-label, clinical trial in which antiretroviral therapy-naïve and -experienced HIV-1-infected adults were randomized 3:1 to receive either APV600/RTV BID or APV1200 BID, in combination with > or = 2 non-protease inhibitor antiretroviral drugs. Non-inferiority of the APV600/RTV regimen to the APV1200 regimen was established if the 95% lower confidence limit for the difference in proportion of patients achieving HIV-1 RNA <200 copies/mL at week 24 with APV 600/RTV minus APV1200 was > or =-0.12. Late in the conduct of the trial, patients not yet completing 24 weeks of therapy were given the option of continuing treatment for an additional 24-week period.

RESULTS

211 patients were randomized, 158 to APV600/RTV and 53 to APV1200. At week 24, APV600/RTV was similar to or better than APV1200 (HIV-1 RNA <200 copies/mL in 62% [73/118] vs 53% [20/38] of patients; intent-to-treat: observed analysis). In the APV600/RTV arm, significantly more patients achieved HIV-1 RNA <50 copies/mL (48% [57/118] vs 29% [11/38] with APV1200, P = 0.04), and greater mean reduction from baseline in HIV-1 RNA was observed (-2.21 vs -1.59 log10 copies/mL, P = 0.028). The two treatment arms were similar with respect to mean overall change from baseline in CD4+ count, frequency of drug-related grade 1-4 adverse events, and frequency of discontinuing treatment due to adverse events (most commonly nausea, diarrhea, vomiting or fatigue; 7% vs 8%), although a lower proportion of patients in the APV600/RTV arm experienced drug-related oral/perioral paresthesia (2% vs 8%). Eleven (73%) of 15 patients who had HIV-1 RNA <200 copies/mL at week 24 and chose to continue study treatment maintained this level of virologic suppression at follow-up 24 weeks later.

CONCLUSIONS

APV600 RTV BID was similar to or better than APV1200 BID in virologic response. Virologic results in a small number of patients who continued treatment for 24 weeks post-study suggest that virologic suppression with APV600 RTV BID is durable.

Authors+Show Affiliations

University of South Florida, College of Medicine, Tampa, Florida, USA. jnadler@hsc.usf.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

12795812

Citation

Nadler, Jeffrey P., et al. "Twice-daily Amprenavir 1200 Mg Versus Amprenavir 600 Mg/ritonavir 100 Mg, in Combination With at Least 2 Other Antiretroviral Drugs, in HIV-1-infected Patients." BMC Infectious Diseases, vol. 3, 2003, p. 10.
Nadler JP, Gathe JC, Pollard RB, et al. Twice-daily amprenavir 1200 mg versus amprenavir 600 mg/ritonavir 100 mg, in combination with at least 2 other antiretroviral drugs, in HIV-1-infected patients. BMC Infect Dis. 2003;3:10.
Nadler, J. P., Gathe, J. C., Pollard, R. B., Richmond, G. J., Liao, Q., Griffith, S., Lancaster, C. T., Hernandez, J. E., & Pappa, K. A. (2003). Twice-daily amprenavir 1200 mg versus amprenavir 600 mg/ritonavir 100 mg, in combination with at least 2 other antiretroviral drugs, in HIV-1-infected patients. BMC Infectious Diseases, 3, 10.
Nadler JP, et al. Twice-daily Amprenavir 1200 Mg Versus Amprenavir 600 Mg/ritonavir 100 Mg, in Combination With at Least 2 Other Antiretroviral Drugs, in HIV-1-infected Patients. BMC Infect Dis. 2003 Jun 10;3:10. PubMed PMID: 12795812.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Twice-daily amprenavir 1200 mg versus amprenavir 600 mg/ritonavir 100 mg, in combination with at least 2 other antiretroviral drugs, in HIV-1-infected patients. AU - Nadler,Jeffrey P, AU - Gathe,Joseph C, AU - Pollard,Richard B, AU - Richmond,Gary J, AU - Liao,Qiming, AU - Griffith,Sandy, AU - Lancaster,C Tracey, AU - Hernandez,Jaime E, AU - Pappa,Keith A, AU - ,, Y1 - 2003/06/10/ PY - 2003/02/20/received PY - 2003/06/10/accepted PY - 2003/6/11/pubmed PY - 2004/7/31/medline PY - 2003/6/11/entrez SP - 10 EP - 10 JF - BMC infectious diseases JO - BMC Infect Dis VL - 3 N2 - BACKGROUND: Low-dose ritonavir (RTV) boosts plasma amprenavir (APV) exposure. Little has been published on the efficacy, tolerability, and safety of APV 600 mg/RTV 100 mg (APV600/RTV) twice daily (BID) compared to APV 1200 mg BID (APV1200). METHODS: ESS40011 was a 24-week, multicenter, open-label, clinical trial in which antiretroviral therapy-naïve and -experienced HIV-1-infected adults were randomized 3:1 to receive either APV600/RTV BID or APV1200 BID, in combination with > or = 2 non-protease inhibitor antiretroviral drugs. Non-inferiority of the APV600/RTV regimen to the APV1200 regimen was established if the 95% lower confidence limit for the difference in proportion of patients achieving HIV-1 RNA <200 copies/mL at week 24 with APV 600/RTV minus APV1200 was > or =-0.12. Late in the conduct of the trial, patients not yet completing 24 weeks of therapy were given the option of continuing treatment for an additional 24-week period. RESULTS: 211 patients were randomized, 158 to APV600/RTV and 53 to APV1200. At week 24, APV600/RTV was similar to or better than APV1200 (HIV-1 RNA <200 copies/mL in 62% [73/118] vs 53% [20/38] of patients; intent-to-treat: observed analysis). In the APV600/RTV arm, significantly more patients achieved HIV-1 RNA <50 copies/mL (48% [57/118] vs 29% [11/38] with APV1200, P = 0.04), and greater mean reduction from baseline in HIV-1 RNA was observed (-2.21 vs -1.59 log10 copies/mL, P = 0.028). The two treatment arms were similar with respect to mean overall change from baseline in CD4+ count, frequency of drug-related grade 1-4 adverse events, and frequency of discontinuing treatment due to adverse events (most commonly nausea, diarrhea, vomiting or fatigue; 7% vs 8%), although a lower proportion of patients in the APV600/RTV arm experienced drug-related oral/perioral paresthesia (2% vs 8%). Eleven (73%) of 15 patients who had HIV-1 RNA <200 copies/mL at week 24 and chose to continue study treatment maintained this level of virologic suppression at follow-up 24 weeks later. CONCLUSIONS: APV600 RTV BID was similar to or better than APV1200 BID in virologic response. Virologic results in a small number of patients who continued treatment for 24 weeks post-study suggest that virologic suppression with APV600 RTV BID is durable. SN - 1471-2334 UR - https://www.unboundmedicine.com/medline/citation/12795812/Twice_daily_amprenavir_1200_mg_versus_amprenavir_600_mg/ritonavir_100_mg_in_combination_with_at_least_2_other_antiretroviral_drugs_in_HIV_1_infected_patients_ L2 - https://bmcinfectdis.biomedcentral.com/articles/10.1186/1471-2334-3-10 DB - PRIME DP - Unbound Medicine ER -