FDCs: Fixing access problems

Yam Hin is 28 and lives in a rural city in China. Yam Hin is HIV positive, recently started antiretroviral treatment and currently travels three to four hours every fortnight to visit the HIV/AIDS clinic in Nanning.

The World Health Organization recommends a first-line treatment of three antiretroviral drugs: lamivudine (3TC), stavudine (d4T) or zidovudine (AZT), and efavirenz (EFV) or nevirapine (NVP). In many countries, fixed-dose combinations (FDC) of these ARVs are available. For example, one of the most commonly used AIDS drug combinations in developing countries is a triple FDC containing 3TC, d4T and NVP taken as one pill twice a day.

FDCs simplify treatment by significantly reducing the number of pills that need to be taken daily. As they are often made by generic companies, FDCs are also generally much cheaper than the single pills sold by originator companies.

Unfortunately for Yam Hin, triple FDCs are not available in China. So instead of taking two tablets per day using FDCs, Yam Him must take 10 pills a day. If he develops any opportunistic infections requiring additional treatments, this daily pill burden could more than triple. This will make it much harder for him to adhere to treatment -- which is critical as partial or erratic doses will lead to resistance and treatment failure.

Yam Hin has no access to triple FDCs because the pharmaceutical company GlaxoSmithKline currently holds patents on 3TC in China, and perhaps also holds other exclusive rights to it. This blocks the sale in the country of any single or combined tablet containing this drug.

GlaxoSmithKline does market 3TC in China -- but only combined with another drug, AZT, as a dual therapy FDC tablet, or in a dosage which is suitable for treating hepatitis B but not recommended for HIV/AIDS.

The lack of access to a generic triple FDC forces MSF and others to pay five times more for first-line ARV treatment in China than in Cambodia.

There are also obstacles to accessing other ARVs, such as efavirenz and d4T, which are both also used in first-line treatment. The first is under patent in China and is only available at a very high price, putting it out of reach of government treatment programmes and most patients. The second, d4T, is not available in the right dosages for treating people with low bodyweight.

The struggle for HIV/AIDS treatment access in China, let alone scaling-up of this treatment, has only just begun.