Approval by the Medicines Control Council (MCC) of a combined single tablet containing two anti-retroviral drugs to treat HIV, Retrovir (AZT) and 3TC (lamivudine) has been met with skepticism because of the drug’€™s high cost to the patient.

AZT and 3TC have for the first time been combined in a single tablet in South Africa, named COMBIVIR. The drug has been available for several months in Europe and the United States.

Toby Kasper, spokesperson for Doctors without Borders (Medecins Sans Frontieres), welcomed the news, but said the price at which it was offered made a mockery of Glaxo Wellcome’€™s commitment to affordable medicines.

“We call on Government to urgently take steps, such as compulsory licensing, to allow South Africans access to generic anti-retroviral therapy,” Kasper said.

A generic version of Combivir is selling in India at R318 for one month’€™s supply while a month’€™s supply of AZT was selling at R300 and 3TC at R400 in the same country.

In South Africa, Combivir is likely to cost at least three times that amount for a month’s supply. Dr Peter Moore, Medical Director of Glaxo Wellcome South Africa, said patients were paying R1 500 per month for individual doses of AZT and 3TC while Combivir would sell for R1 000.

Glaxo Wellcome indicated that it was prepared to talk to the South African government around the pricing of Combivir.

The company recently secured a deal with Senegal in which the drug is being sold to the country at U$2 per day (about R400 per month).

Moore said the South African government was yet to express interest in securing a similar deal.
According to the pharmaceutical giant, the easy administration of a single film-coated tablet is one of the drug’s most significant benefits.

“Patients on anti-retroviral therapy have been beset with complicated dosing regimens and a need to take many pills every day. Forgetting to keep to strict dosage schedules can reduce the effectiveness of HIV treatments, leading to the emergence of a drug resistant virus and ultimately to treatment failure,” said Dr Moore.

Combivir is prescribed as a recommended dose of one tablet taken twice daily, with no food or drink restrictions.

It is formulated to be used as part of anti-retroviral combination therapy in the treatment of HIV-infected people over the age of 12 years.

3TC is an anti-HIV treatment in the same class of drugs as AZT. These drugs are called nucleoside analogs ‘€“ the body breaks down these drugs into chemicals that stop HIV from infecting uninfected cells in the body, but they do not help cells that have already been infected with the virus.

Studies have shown that using 3TC in combination with two other anti-HIV drugs can prevent the virus from getting resistant, and this has in turn helped people live longer and contract fewer opportunistic infections.

3TC has few side-effects, mainly nausea, vomiting, headaches and rare cases of hair loss.

AZT was the first drug approved for the treatment of HIV and is also used in combination with other anti-HIV drugs.

Combivir contains 300mg AZT and 150mg 3TC in a single pill.

The combination drug was granted approval and registration by the MCC last week and is expected to be available in local pharmacies by early next week. ‘€“ Health-e News Service