Spotlight on access issues
This is a one-pill-a-day FDC, which makes it well-adapted to resource-poor settings.
WHO has advised countries to phase out stavudine (d4T)-based regimens because of their long-term irreversible side effects. Instead, zidovudine (AZT) or tenofovir-based (TDF) first-line regimens should be used, together with either lamivudine (3TC) or emtricitabine (FTC) and either efavirenz (EFV) or nevirapine (NVP).13
According to the WHO treatment guidelines, ‘FTC is an equivalent alternative to 3TC as it is structurally related, shares the same efficacy against HIV and hepatitis B virus (HBV) and has the same resistance profile’. This means this formulation is interchangeable with TDF/3TC/EFV.13, 29
There are currently two WHO-prequalified generic sources of TDF/FTC/EFV, and one WHO-prequalified source of TDF/3TC/EFV. This year the lowest WHO-prequalified generic price for this product is US$197, down from $219 in 2011. This is still higher than the lowest reported price for TDF/3TC/EFV ($172).
Based on WHO 2010 treatment guidelines for adults and adolescents, NVP was preferred over EFV, as a first-line treatment option for pregnant women.29 Recent WHO advice highlights the programmatic consequences of avoiding EFV use in pregnancy and supported its use as past of a simplified first-line treatment including among pregnant women and those of reproductive age.281
In July 2006, the originator version of TDF/FTC/EFV (marketed as ‘Atripla’) became the first multi-class antiretroviral drug approved by the US FDA. It was also the first collaboration between two US pharmaceutical companies combining patented HIV medicines into one product, as Gilead’s TDF and FTC are combined with Bristol-Myers Squibb’s EFV.282 Atripla is marketed in North America and Europe jointly by Gilead and BMS but in much of the developing world, marketing and distribution is handled by Merck.283
This combination is produced by Indian generic companies because none of the individual components is patented in India today. However, Gilead284 and BMS285 have applied for patents related to TDF, including the one specifically related to this combination.286 If these patents are granted in India, generic competition for this product may be affected.
In addition, given the limitations of Gilead’s voluntary licencing in India, countries not covered under these licences may face barriers in procuring TDF/FTC/EFV from the Indian manufacturers producing this FDC outside of the voluntary licence arrangements.
For full details on the patent status of TDF in India and Brazil, including the voluntary licence agreements signed by Gilead with generic companies and with the Medicines Patent Pool, as well as the Brazilian initiative for local production, please refer to the TDF drug profile. Additional information is also available on the FTC and EFV drug profiles.
In January 2012, the US FDA approved Gilead’s TDF for use in patients above the age of two.252 Approved formulations are a 40mg/gr oral powder and 150mg, 200mg, 250mg and 300mg tablets.
The approval of TDF use in children is a step forward as it opens up the possibility of aligning first-line ART for adults and children over three.29, 229 This would simplify treatment options for all and potentially simplify drug procurement for HIV programmes.