New Treatment Opportunity: Valganciclovir

1. New Treatment Opportunity: Valganciclovir Arax Bozadjian, PharmD International AIDS Conference Kuala Lumpur, Malaysia June 2013

2. Outline • Current Treatment Options • Advantages and Disadvantages of existing forms of treatment • Price Analysis Assumptions • Price Analysis-Oral Valganciclovir • Price Analysis-Intraocular Ganciclovir • Barriers to scaling up treatment of CMV retinitis with oral therapy • Overcoming barriers to enable access to oral therapy

3. Current Treatment Options • Ganciclovir • Systemic Injection • Intravitreal Injection • Intraocular Injection • Intraocular Implant • Valganciclovir • Oral tablet

4. Advantages and Disadvantages

5. Price Analysis Assumptions • For the oral therapy we used two scenarios for the time frames: • Induction phase: 3 weeks (Dose: 2 tablets twice daily) • Maintenance phase: 9 weeks and 24 weeks (Dose: 2 tablets daily) • For the intraocular injection we used the following time frames: • Induction phase: 6 weeks (Dose: 0.05ml or 2.5 mg daily) • Maintenance phase: 22 weeks (Dose: 0.05ml or 2.5 mg daily) • The sources of our pricing is procurement reported prices, as well as private market prices CDC,IDSA Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected adults and adolescents 2009

6. Price analysis-Oral Valganciclovir The dosing for oral Valganciclovir 450 mg for the treatment of CMV retinitis is as follows: • Induction Phase: 3 weeks = 84 tablets • Maintenance Phase Scenario 1: 9 weeks = 126 tablets • Maintenance Phase Scenario 2: 24 weeks = 336 tablets • Total Number of tablets = 210 (Scenario 1) or 420 (Scenario 2)

7. Price analysis-Oral Valganciclovir

8. Price analysis-Intraocular Ganciclovir • Assuming 100 patients are in our clinic, and the single dose is 0.05 ml (2.5 mg) • The cost of 1 vial of Ganciclovir from a procurement agent in Europe is $ 35 USD • The need based upon above scenario is approximately 4 vials (1900mg ÷ 500 mg) • Approximately 4 vials are needed to treat 100 patients at our clinic • 4 vials x 35 USD per vial = 140 USD to treat 100 patients

9. Barriers to Scaling Up Treatment of CMV retinitis with Oral Therapy • Currently, there is insufficient demand for Valganciclovir due to: • Patients under-diagnosed for CMV retinitis • Lack of normative clinical guidance on CMV retinitis (for screening and treatment) • Lack of donor interest in opportunistic infections • Current high costs of oral therapy as compared to the intraocular injection • No demand, hence no supply

10. Overcoming Barriers to enable Access to Oral Therapy • Global Level: • WHO to rapidly issue evidence-based treatment guidelines • Enabling generic competition for additional quality-assured and affordable sources of Valganciclovir • Negotiation with the originator company to reduce the price of Valganciclovir • Donors to include diagnosis and treatment of CMVr as a component of basic HIV package of care

11. Thank You Questions and Comments? Arax.Bozadjian@geneva.msf.org