Opis Zaradi nadaljnje ocene razmerja med koristjo in tveganjem je predlagatelj Odboru za zdravila za uporabo v humani medicine (CHMP) v pregled predložil 48- tedenske podatke o varnosti in učinkovitosti potekajočih študij Protokol 018 (Multicentrična, dvojno slepa, randomizirana s placebom nadzorovana študija, ki pri bolnikih, okuženih z virusom HIV, z dokazano odpornostjo na vsaj eno zdravilo iz vsake od 3 skupin zdravil, ki se uporabljajo za peroralno protiretrovirusno zdravljenje, vrednoti varnost in protiretrovirusno učinkovitost MK- 0518 v kombinaciji z optimiziranim osnovnim zdravljenjem (OBT; “ Optimized Background Therapy ”) v primerjavi z optimiziranim osnovnim zdravljenjem samim) in Protokol 019 (Multicentrična, dvojno slepa, randomizirana s placebom nadzorovana študija, ki pri bolnikih, okuženih z virusom HIV, z dokazano odpornostjo na vsaj eno zdravilo iz vsake od 3 skupin zdravil, ki se uporabljajo za peroralno protiretrovirusno zdravljenje, vrednoti varnost in protiretrovirusno učinkovitost MK- 0518 v kombinaciji z optimiziranim osnovnim zdravljenjem (OBT; “ Optimized Background Therapy ”) v primerjavi z optimiziranim osnovnim zdravljenjem samim).
Description To further support the benefit risk assessment, the MAH has provided the CHMP with the 48-week safety and efficacy data from the ongoing Phase III Protocol 018 (A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV- Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies) and Protocol 019 (A Multicenter, Double-Blind, Randomized, Placebo- Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies) for review.