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UntitledProposed lists of priority essential medicines for HIV
UNITAID Secretariat/WHO proposal
Proposed lists of priority essential medicines for HIV
Adults: missing essential medicines – medicine/form
Rationale from current
or Model List
Stand-alone thermostable formulations of ritonavir or in combination with other protease inhibitors (PIs) Tenofovir (TDF)-based triple combinations plus efavirenz (EFV) or nevirapine (NVP) plus lamivudine (3TC) Zidovudine (AZT)-based triple combinations plus lamivudine or emtricitabine plus abacavir (ABC) or tenofovir e.g.
AZT/3TC/ABCAZT/FTC/ABCAZT/3TC/TDFAZT/FTC/TDF Alternative dual combinations based on lamivudine Possible valuable second-line triple combinations based on lamivudine or emtricitabine plus tenofovir and a once-daily boosted PI (e.g. ATV/r, LPVr) Possible valuable second-line dual and triple combinationsAlternative dual combinations based on lamivudine or emtricitabine plus didanosine enteric coated (ddI)ddI/3TCddI/FTCTriple combinations based on lamivudine or emtricitabine plus didanosine enteric-coated and a once-daily boosted PI (e.g. ATV/r, LPVr)LPVr/ddI/3TCLPVr/ddI/FTCATV/r/ddI/FTCATV/r/ddI/3TC NOTE: The WHO adult treatment guidelines will be revised in 2009. The revision will consider the potential use of newer products. Consult the WHO web site for more details.
Priority paediatric products
Recommended priority antiretroviral products for infant MTCT prevention
Recommended priority antiretroviral products required for treatment
MSF proposals for additional missing essential
medicines for adults for the UNITAID patent
pool initiative as at 23-03-2009
Proposals by MSF for additional medicines for adults for the UNITAID
patent pool initiative
Reasons for inclusion
More effective and less resistance development than LPV/R. Indicated in international guidelines for treatment experienced patients. Need ritonavir boosting.
A new class. Indicated for treatment experienced, multi class resistant patients. Can be used in treatment naïve patients but not in international guidelines for this indication. Very well tolerated. An important advancement in HIV-1 treatment option.
A new class. Indicated for treatment experienced/multi- resistant patients with only CCR5 tropism. HIV-1 subtype C virus seems to carry majority of CCR5 receptors. Use of maraviroc in African subtypes limited. Active against mutant NNRTI resistant HIV strains. Non-nucleoside reverse transcriptase inhibitor (NNRTI) Undergoing Phase III study. Not yet commercialized but promising drug as it is potent, and can be used once daily (with low dose (25 mg.) Undergoing Phase II-III with a booster GS-9350. Potential The only booster commercially available with other PIs Non ARV booster. Entering phase II-III studies. Developed for combination with elvitegravir, and potentially with elvitegravir, TDF and FTC.
Non ARV booster. Only preclinical study done. Fixed-dose combinations
1. Heat-stable boosted PI (combined with ritonavir)
Validated for fi rst-line and treatment-experienced patients. Advantage of FDC is once daily dosing.
Reasons for inclusion
Alternative PI for treatment-naïve or experienced patients. Can be used once or twice daily.
Potent PI with main indication for salvage or second-line regimens. Can be used once or twice daily.
2. Heat-stable PI plus NRTIS for secon d-line
Component of second-line regimens in current WHO guidelines and expert meeting on second lines (2008). LPV/r can be given once daily in PI naïve patients.
All didanosine (ddI)-containing combinations are suggested. All didanosine (ddI)-containing combinations are suggested. Co-blisters are needed at the moment as can only be manufactured in buffered tablets or with enteric coating. 3. FDC for fi rst-line combinations
Currently recommended fi rst-line. Interesting combination but NVP is usually given twice daily at least in the fi rst 3–6 months.
Exists in co-formulation and is widely used as fi rst-line internationally. More sources needed (only orginator’s available now).
MSF proposal for additional children’s essential medicines for the UNITAID
patent pool initiative as at 23-03-2009
Reason for inclusion
MSF proposal for urgent studies in children
Reason for urgent need for studies in children
Accelerate testing in children below 3 years old Accelerate testing in children below 6 years old
TABLETS MIDAMOR ® (AMILORIDE HCl) DESCRIPTION Amiloride HCl, an antikaliuretic-diuretic agent, is a pyrazine-carbonyl-guanidine that isunrelated chemically to other known antikaliuretic or diuretic agents. It is the salt of a moderatelystrong base (pKa 8.7). It is designated chemically as 3,5-diamino-6-chloro- N -(diaminomethylene)pyrazinecarboxamide monohydrochloride, dihydrate and has