In wake of Tivicay approval, MSF asks, 'when will people in developing countries have access?'

As the US Food and Drug Administration approved the new HIV drug Tivicay (dolutegravir) late Monday (The Pharma Letter August 13), international medical humanitarian organization Medecins Sans Frontieres (MSF) questioned when people in developing countries would be able to access this promising new drug.

Studies have shown dolutegravir, a drug from the potent new integrase inhibitor class of drugs, to be well-tolerated and extremely effective in stopping replication of the HIV virus, with a high barrier to HIV resistance. Given its advantages over drugs in the same class and those widely used today, dolutegravir will likely become part of first-line therapy in wealthy countries, says MSF. However, it is still unclear whether people across the developing world will have access to dolutegravir, as initial indications from the drug’s producer ViiV Healthcare, a joint venture of GlaxoSmithKline (LSE: GSK), Pfizer (NYSE:PFE) and Shionogi (TYO: 4507) to enable affordable access have not been encouraging.

“Based on studies to date, dolutegravir holds important advantages for use in developing countries, but as treatment providers, our biggest concern is what the price will be,” said Manica Balasegaram, executive director of MSF’s Access Campaign, adding: “A promising new drug will only translate into more lives saved if it is affordable, so that people who need it have access.”