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S6 Isoniazid Pyridoxine Sulfam 1 Table of Contents 1. Summary statement of the proposal for inclusion ......................................................................... 2 2. Name of the focal point in WHO submitting or supporting the application ................................ 2 3. Name of the organization(s) consulted and/or supporting the application ................................. 2 4. International Non-proprietary Name (INN, generic name) of the medicine ............................... 2 5. Formulation proposed for inclusion; including adult and pediatric (if appropriate) .................... 2 6. International availability - sources, if possible manufacturers: ..................................................... 3 7. Whether listing is requested as an individual medicine or as representative of a pharmacological class ................................................................................................................................................ 3 8. Information supporting public health relevance ............................................................................ 3 8.1. Epidemiological information on disease burden ....................................................................................... 3 8.2. Assessment of current use ............................................................................................................................. 4 8.3. Target populations: ......................................................................................................................................... 4 9. Treatment details ........................................................................................................................... 5 9.1. Reference to existing WHO and other clinical guidelines: ....................................................................... 5 9.2. Dosage regimen and duration: ...................................................................................................................... 6 9.3. Need for special diagnostic or treatment facilities and skills: .................................................................. 6 10. Summary of comparative effectiveness in a variety of clinical settings ......................................... 7 10.1. Clinical Effectiveness: .................................................................................................................................... 7 10.2. Advantages of Fixed-dose combination ...................................................................................................... 9 10.3. Scored tablets ................................................................................................................................................... 9 11. Review of harms and toxicity: summary of the evidence on safety ............................................... 9 11.1. Estimate of total patient exposure to date .................................................................................................. 9 11.2. Description of adverse effects/reactions .................................................................................................... 9 11.3. Drug Interactions: ......................................................................................................................................... 10 11.4. Identification of variation in safety due to health systems and patient factors ................................... 10 12. Summary of available data on comparative cost and cost-effectiveness within the pharmacological class or therapeutic group. ................................................................................ 11 12.1. Range of costs of the proposed medicine ................................................................................................. 11 12.2. Comparative cost-effectiveness .................................................................................................................. 11 13. Summary of the regulatory status of the medicine ........................................................................ 11 14. Availability of pharmacopoeial standards ..................................................................................... 12 15. Proposed text for WHO model formulary ..................................................................................... 12 2 WHO MODEL LIST OF ESSENTIAL MEDICINES APPLICATION 1. Summary statement of the proposal for inclusion The fixed-dose combination of sulfamethoxazole 800mg and trimethoprim 160mg (co-trimoxazole, CTX), isoniazid (INH) 300mg, and pyridoxine (Vitamin B6) 25 mg, is proposed. It will prevent tuberculosis, toxoplasmosis, pneumocystosis, bacterial pneumonia, malaria, and isosporiasis; and reduce mortality and hospitalizations among adults and children living with HIV/AIDS (PLHIV). The individual products INH and pyridoxine and the combination product CTX (sulfamethoxazole and trimethoprim fixed dose combination) are listed as Essential Medicines. WHO has listed this fixed-dose combination of isoniazid, pyridoxine, sulfamethoxazole, and trimethoprim in the 10th Invitation for Expression of Interest for HIV medicinal products, and we therefore now propose its consideration for inclusion on the Essential Medicines List and the Essential Medicines List for Children. The principal reasons for requesting inclusion of a FDC (in adults and children) in the WHO Model List of Essential Medicines are as follows: Current WHO Consolidated Guidelines recommend both co-trimoxazole preventive therapy (CPT) and isoniazid preventive therapy (IPT) as part of the standard package of care available to PLHIV, on the condition that active TB has been excluded. In most settings CPT is recommended indefinitely while IPT is recommended for at least 6 months and for a longer duration for specific groups populations, settings or where evidence results in changing the balance of risk-benefit.[1] Co-trimoxazole (Sulfamethoxazole 800mg and trimethoprim160mg) preventive therapy (CPT) prevents Pneumocystis jirovecii pneumonia (PCP), cerebral toxoplasmosis, bacterial pneumonia, isosporiasis, malaria, and other co-infections in persons living with HIV (PLHIV). This has led to a significant morbidity and mortality benefit in clinical trials in low and high income countries. Isoniazid (300mg daily) preventive therapy (IPT) prevents active tuberculosis in HIV- infected persons, which decreases community cases of tuberculosis. Maximizing IPT coverage and adherence will enhance these individual and population benefits. Pyridoxine is recommended in all HIV-infected persons on INH to mitigate toxicity. It may be difficult for countries to procure and distribute pyridoxine with INH. Including it in the FDC ensures all patients on IPT are on concomitant pyridoxine, thereby preventing INH-induced toxicity. Several large trials have found fixed dose combinations improve compliance, particularly in individuals with chronic conditions.[2, 3] 2. Name of the focal point in WHO submitting or supporting the application Marco Vitoria, WHO/HTM/HIV/ATC 3. Name of the organization(s) consulted and/or supporting the application Clinton Health Access Initiative, Inc. (CHAI) 4. International Non-proprietary Name (INN, generic name) of the medicine Sulfamethoxazole/trimethoprim/isoniazid/pyridoxine 5. Formulation proposed for inclusion; including adult and pediatric (if appropriate) Combination tablet comprised of sulfamethoxazole 800 mg, trimethoprim 160 mg, isoniazid 300 mg, and pyridoxine 25 mg (CTX/INH/B6 FDC) for adult and adolescent patients (over 25 kg). The oval/capsule- shaped tablet is scored, enabling children between 14 kg and 25 kg to receive ½ tablet. 3 6. International availability - sources, if possible manufacturers: The fixed-dose combination of sulfamethoxazole 800mg and trimethoprim 160mg (co-trimoxazole, CTX), isoniazid (INH) 300mg, pyridoxine (Vitamin B6) 25 mg is manufactured by Cipla. Cipla Ltd. Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai-400013 7. Whether listing is requested as an individual medicine or as representative of a pharmacological class This FDC is proposed for the ‘Other Antibacterials’ category (6.2.2) 8. Information supporting public health relevance 8.1. Epidemiological information on disease burden Past surveys indicated that HIV infection increases the risk of TB 20-37-fold, depending on the severity of the HIV epidemic,[4] and in some countries in Sub-Saharan Africa up to 77% of new patients with TB have HIV [5]. In 2015, 6.4 million people with TB were notified to national TB programs (NTPs) and reported to WHO. Of these, just over 6.1 million had an incident episode of TB. The number of new and relapse TB cases notified and the notification rate per 100 000 population increased globally in 2013–2015, mostly explained by a 34% increase in notifications in India.[6] WHO estimated overall 10.4 million people developed TB in 2015, including 1.2 million PLHIV. TB was one of the top 10 causes of death worldwide in 2015, and was responsible for more deaths than HIV and malaria. In 2015, 1.8 million people died from TB, including 0.4 million among PLHIV.[7] The World Health Assembly, convened annually by WHO in Geneva, passed a resolution in May 2014 approving with full support new post-2015 Global TB Strategy with ambitious targets. While the overall goal of the WHO is to end the global tuberculosis epidemic, the Assembly endorsed the following milestone goals for 2025: 75% reduction in tuberculosis deaths (compared with 2015) 50% reduction
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