Re: DORAVIRINA
Inviato: lunedì 3 novembre 2014, 17:02
Un comunicato stampa di Merck annuncia il completamento con successo della sperimentazione di fase II della doravirina in pazienti naive e l'inzio del trial di fase III entro la fine di quest'anno.
I dati a 48 settimane sono stati presentati ieri da Josef Gatell al 12th International Congress on HIV Drug Therapy, in corso a Glasgow e confermano quelli ad interim di cui abbiamo già parlato (abstract #O434).
Fonte: Merck Announces Data from 48-Week Phase 2b Study of Investigational HIV Therapy Doravirine (MK-1439) in Treatment-Naive Patients
I dati a 48 settimane sono stati presentati ieri da Josef Gatell al 12th International Congress on HIV Drug Therapy, in corso a Glasgow e confermano quelli ad interim di cui abbiamo già parlato (abstract #O434).
- The primary safety analysis from the expansion phase of the study compared the incidence of central nervous system (CNS) adverse events (AEs) by Week 8 in patients who received doravirine 100 mg plus TDF/FTC (n=108) versus patients who received efavirenz with TDF/FTC (n=108). The results showed a significantly lower incidence of one or more of reported CNS AEs (all causality) among the doravirine-treated group compared to the efavirenz-treated group (22.2 % vs. 43.5 %, respectively; p<0.001). The most common (occurring in more than 5 percent of patients) CNS AEs in the doravirine-and efavirenz-treated groups, respectively, were dizziness (9.3 % vs. 27.8 %), insomnia (6.5 % vs. 2.8 %), abnormal dreams (5.6 % vs. 16.7 %) and nightmares (5.6 % vs. 8.3 %).
Interim results for this ongoing Phase 2b study, including the primary efficacy analysis for dose selection based on 24-week data from the dose-ranging cohort of the study, were previously presented at the 21st Conference on Retroviruses and Opportunistic Infections (CROI) in March 2014.
“This program underscores Merck’s ongoing commitment to the research and development of new therapeutic options for patients with HIV,” said Dr. Hedy Teppler, executive director, Infectious Diseases, Merck Research Laboratories. “We are encouraged by the antiviral activity and the overall tolerability profile of doravirine and look forward to initiating Phase 3 studies.”
Additional follow-up data through 48 weeks of treatment showed a 76 percent (n=126/166) overall virologic response rate (HIV RNA <40 c/ml) for all doravirine doses (25, 50, 100 and 200 mg) that is comparable to 71 percent (n=30/42) reported for patients administered efavirenz (600 mg). In addition, all treatment groups showed increased CD4 cell counts relative to baseline, consistent with the 24-week findings.
After 48 weeks of treatment, patients in the dose ranging part of the study who received doravirine demonstrated a lower overall incidence of drug-related adverse events (36.7%; n=166) than those who received efavirenz (57.1%; n=42). The most commonly reported drug-related clinical adverse events in the doravirine and efavirenz groups respectively were abnormal dreams (10.2% vs. 9.5%); nausea (7.8% vs. 2.4%); fatigue (7.2% vs. 4.8%); diarrhea (4.8% vs. 9.5%) and dizziness (3.0% vs. 23.8%). Doravirine-treated patients also had a lower incidence of laboratory abnormalities in routine clinical tests including increased total cholesterol (6.8% for doravirine vs. 31.6% for efavirenz) and LDL cholesterol (6.3% for doravirine vs. 18.4% for efavirenz).
Merck plans to initiate the first Phase 3 clinical trial of doravirine by the end of 2014, NCT02275780. The study will enroll treatment-naïve patients and compare the efficacy, safety and tolerability of doravirine and ritonavir-boosted darunavir, both in combination with other anti-retroviral therapy.
Fonte: Merck Announces Data from 48-Week Phase 2b Study of Investigational HIV Therapy Doravirine (MK-1439) in Treatment-Naive Patients