In June, pharmaceutical company ViiV Healthcare is expected to debut one of the world’s newest antiretrovirals (ARV), dolutegravir, in South Africa’s private sector for about R720 per month excluding VAT and dispensing fees, reports Health-e News.
In a 2012 study conducted among about 830 people, a dolutegravir-based combination that included the ARVs abacavir and lamivudine beat South Africa’s current three-in-one combination ARV in effectiveness and tolerability. Patients on the dolutegravir-based combination treatment also had a lower incidence of side effects like psychiatric, skin and gastrointestinal disorders.
According to ViiV Healthcare global medical director, Jan van Lunzen, the drug’s long-release formulation also helps protect patients against the development of drug resistance. Patients who had skipped several one or two doses would retain concentrations of the drug in their blood high enough to control the virus even 72 hours after they missed their medication, Van Lunzen is quoted in the report as saying. Van Lunzen added that the drug can be taken with or without food – this is just one reason why the drug might be ideal for South Africa’s public sector.
However, Van Lunzen said he expects it will be at least two years before generic dolutegravir formulations will be registered with South African drug regulator, the Medicines Control Council. The Treatment Action Campaign is expected to call for the Medicine Control Council to fast-track approval of these producers.
A doctor who has seen the benefits of dolutegravir in his own patients, Van Lunzen said ViiV Healthcare is keen to see generic production ramped following a 2014 licensing agreement with the UN-backed organisation the Medicines Patent Pool. Under the agreement, ViiV Healthcare would grant royalty-free, voluntary licenses to generic manufacturers to produce adult and paediatric formulation of dolutegravir for at least 67 countries, including South Africa.
The report says the agreement is not unlike the deal signed between the pool and pharmaceutical company AbbVie in December that allowed generic manufacturers to produce its combination ARV Aluvia for countries including South Africa.
The agreement followed months of Aluvia shortages due to AbbVie’s alleged inability to keep pace with South Africa’s demand. AbbVie’s patents prevented other companies from selling the drug in South Africa. But AbbVie’s agreement with the pool may be a reminder that licenses are only one hurdle in the road to generic and even local manufacture of drugs and ultimately to making sure drugs end up in patient hands.
Background: Dolutegravir (DTG; S/GSK1349572), a once-daily, unboosted integrase inhibitor, has shown rapid & durable antiviral responses, with favorable tolerability. Methods: SINGLE, a double-blind, double-dummy, non-inferiority phase III study in therapy-naïve adults with HIV-1 RNA ≥1000 c/mL, randomized subjs to DTG 50 mg + ABC/3TC QD or TDF/FTC/EFV QD. Primary endpoint: proportion of subjs with HIV-1 RNA ≥1,000 c/mL, randomized subjs to DTG 50 mg + ABC/3TC QD or TDF/FTC/EFV QD. Primary endpoint: proportion of subjs with HIV-1 RNA <50 c/mL at week 48 (FDA Snapshot, ITT-Exposed). Tolerability, safety, & viral resistance evaluated. Results: 833 enrolled (84% males; 32% non-white); groups similar at BL. At Week 48, 88% of DTG + ABC/3TC and 81% of TDF/FTC/EFV subjects had HIV-1 RNA <50 c/mL confirming non-inferiority. Using pre-specified testing procedure, statistical superiority was concluded (p=0.003). Both Time to Suppression and Change from BL in CD4 favored DTG arm and were significant. Protocol defined virological failure: 4% on each arm. No INI or NRTI resistance observed on DTG arm, vs. 1 NRTI RAM and 4 NNRTI RAMs on TDF/FTC/EFV. Conclusion: DTG + ABC/3TC was highly effective and better tolerated through 48 weeks than TDF/FTC/EFV single-tablet regimen.