Gilead has announced it will sell its nucleotide analogue tenofovir (Viread) at `no profit` in Africa and 15 other least developed nations from early next year.
Gilead will sell tenofovir at a price set to cover the cost of production and distribution – the `no profit` cost – and will supply it directly to treatment programmes, bypassing third party suppliers who may bump up costs or cause delays.
However, Gilead is not able to say what that price will be – although it has calculated the cost of production, it is still wrestling with the cost of supply, which may represent a considerable portion of the price.
The company intends to provide a dedicated website for the programme, which is due to be launched in the first quarter of 2003. Treatment programmes will be able to apply online, by e-mail fax or post, and Gilead will provide technical assistance in filling out the application form. Applications will be reviewed by an expert panel to ensure that programmes have the technical expertise and facilities to provide antiretroviral treatment.
Amy Flood of Gilead emphasised that the price reduction would be available to any treatment programme in the nominated countries, including companies providing health care for employees, as long as the programme could sustain provision of treatment.
"We'll need to know that they have funds available for more than one month of treatment, but not necessarily out to years and years of secured funding - we recognise the realities.", she told aidsmap.
Programmes will be assessed by local experts, ideally in the specific country, Amy Flood went on, and they will compare feasibility with existing local standards of monitoring and provision of care.
Deal for middle income countries awaited
Outside Africa, the price reduction will only be available in two countries where HIV treatment is required by substantial numbers of people, Haiti and Cambodia (see below for complete list).
The deal does not cover the Caribbean, Eastern Europe, Thailand, India, or Central America – all regions where the current US price tag of around $4100 a year will put tenofovir out of reach. The Pan Caribbean Partnership Against HIV/AIDS of the Caribbean Community, for example, is seeking a price of $540 for a triple regimen, to make therapy affordable not only for Haiti (included in the Gilead offer) but Guyana and Jamaica too (excluded from the offer). Even the more wealthy countries in the region, such as the Bahamas, can only afford combination therapy that costs $1800, placing tenofovir beyond their reach.
However, Amy Flood told aidsmap that a price cut for middle income countries was being considered. "We are focussing on the least developed countries first and hope to have more to say on pricing for middle income countries in the first quarter of next year."
Gilead has not yet looked at participating in the regional deal with six companies negotiated by the Pan-Caribbean Partnership, Amy Flood said.
Tenofovir in resource-limited settings
Gilead’s decision to reduce the price of tenofovir widens the range of options for first-line regimens in Africa, and makes it plausible that affordable second-line regimens containing tenofovir could be assembled where other, affordable nucleoside analogues can be obtained.
Current WHO guidelines recommend the use of zidovudine/lamivudine (AZT/3TC) or stavudine/lamivudine (d4T/3TC) with either efavirenz or nevirapine as first line therapy, or alternatively, a triple nucleoside regimen of AZT, 3TC and abacavir. Less is known about the use of didanosine and lamivudine together, and the use of zidovudine/didanosine may best be deferred for use in second line therapy after d4T/3TC, the guidelines suggest.
Tenofovir can be combined with all antiretrovirals apart from ddI with no interactions. However, tenofovir increases ddI levels, and this interaction could lead to adverse effects, especially if ddI is taken at the same time of day as tenofovir and within two hours of a meal.
A triple regimen containing tenofovir, stavudine and either efavirenz or nevirapine would be a plausible option after first line treatment with Trizivir, (abacavir/AZT/3TC), whilst first line use of tenofovir with 3TC and efavirenz or nevirapine could spare AZT and ddI for combination with abacavir in a second line regimen.
Tenofovir may be particularly useful in resource-limited settings where first-line regimens have contained 3TC, due to the effect of 3TC resistance on response to tenofovir. The M184V mutation associated with 3TC treatment failure increases susceptibility to tenofovir, and appears to preserve susceptibility to tenofovir in the presence of AZT-associated mutations.
However tenofovir’s biggest attractions in resource-limited settings are likely to be its once-daily dosing and its lack of interactions with tuberculosis treatments, suggesting that the drug will be compatible with Directly Observed Therapy programmes that administer TB and HIV treatment together.
Least developed nations
The 15 least developed nations outside Africa are: Afghanistan; Bangladesh; Bhutan; Cambodia; Haiti; Kiribati; Laos; Maldives; Myanmar; Nepal; Samoa; Solomon Islands; Tuvalu; Vanuatu, and Yemen.
Further information on this website
Tenofovir - drug overview and summary of research.
Antiretroviral treatment in resource-limited settings - overview of key issues.