Many patients with advanced HIV/AIDS can fall prey to the infection, cytomegalovirus (CMV) which will if untreated, lead to total and irreversible blindness in a very short space of time – sometimes just weeks.
Blindness caused by CMV is preventable, but the most available treatments are invasive and far from ideal – injections directly into the affected eye or intravenous, twice-daily treatment requiring a long stay in hospital.
There is a better medicine available – an oral medication, valganciclovir, produced by Roche. This drug is patented in China and the company charges US$ 10,000 for a four-month supply – simply too expensive for the vast majority of people most at risk of going blind. It's a similar situation in both India and Thailand – both middle- income countries where the product is patented. While the manufacturer offers discounts to the poorest countries – mainly in sub-Saharan Africa – middle-income countries including China are offered no such discount and are charged the same as wealthy countries.
Dr. Peter Saranchuk has worked in China in both of MSF's HIV projects – in Nanning and the recently closed XiangFan project treating patients with HIV/AIDS. He describes his experiences in treating CMV and the frustration of seeing patients suffer because the best medicines are unaffordable.
What happens to patients with CMV?
If CMV infection attacks the person's retina and is left untreated, they will become blind over a period of weeks to months. This blindness is irreversible. CMV infection can also attack other parts of the person's body, such as the gastro-intestinal system or brain. Such systemic CMV infection is serious, and without treatment, will progress and invariably result in death in a person whose immune system is weakened by HIV.
How do you treat CMV in the MSF clinics in China?
In MSF's Xiangfan project, the treatment for CMV retinitis (infection of the retina) involved weekly injections of the medication ganciclovir, directly into the patient's eye or eyes if both were affected. The injections would usually be given for three to four months, depending on how quickly the person's immune system could be restored with medications to fight HIV. As you can imagine, patients did not like to receive these injections, and would sometimes not return for the rest of their needed treatment. Additionally, there was a risk that other infections could be introduced to the eye during this procedure and the eye could bleed.
In MSF's Nanning project, instead of eye injections, a person is usually admitted to hospital for a prolonged course of the medication foscarnet, given intravenously. The hospitalisation lasts many weeks, and costs thousands of dollars for a single patient. Since few patients can afford such treatment, MSF covers the cost for people attending our Nanning clinic. But poor CMV/HIV patients in other Chinese settings usually receive no treatment and simply go blind.
An oral version of the treatment is available – what are the advantages of oral valganciclovir over the other treatments you have mentioned?
Oral valganciclovir is by far the best treatment available for CMV disease. Of course, as an oral medication, patients are much more likely to adhere to their full four month treatment and not default as when faced with the ordeal of direct injection of other drugs into their eyes. The oral medication also tackles the virus causing disease elsewhere in the person's body and not just locally as is the case with the directly-injected gancyclovir. And using oral valganciclovir means that the patient can usually be treated on an outpatient basis and does not have to be hospitalised.
With such obvious advantages, why is treatment with oral valganciclovir restricted?
The product, produced by the pharmaceutical company Roche, is available for purchase in China, but the company charges the same amount as to customers in rich countries: each tablet costs about 275 RMB (or about US$ 40). Since a treatment for CMV disease usually consists of 264 tablets given over four months, this means a total cost of over US$ 10,000 just for the oral medication.
So unfortunately, the outrageous cost of this medicine prohibits its use in the people who need it most. The exorbitant price has also prevented the introduction of screening programmes in HIV clinics for CMV retinitis because nobody wants to screen for a disease when the treatment is out of reach financially.
“After my first injection... when I left the clinic the wind was blowing very hard and my eyes felt as if they were going to explode. I just could not hold my tears. I kept having pain for the whole week and before the pain was gone, I had to receive another injection."
Dou, a CMV patient from XiangFan in Central China.
How viable are the treatment alternatives to oral valganciclovir for patients in China?
The main treatment alternative is a lengthy hospital stay for daily intravenous medications (ganciclovir or foscarnet), which results in a similarly shocking cost for treatment. If the patient and/or his family is unable to afford this – and they often go into serious debt trying to do so – the patient goes without treatment, as the cost of health care is usually the responsibility of the individual. MSF has thus far provided the treatment for free to patients with CMV disease in our Nanning clinic and previously in our Xiangfan clinic, as well. But we need to see the price for valganciclovir, drop drastically and very soon, in order to continue preventing unnecessary blindness and death in our patients suffering from CMV retinitis and systemic disease.
Roche offers discount prices for its product in the poorest countries but not in China?
That's correct. Right now, there is no company discount that we can access in China. For treatment to be accessible to patients who would benefit most from its use in many different settings around the world, a four-month treatment with valganciclovir should cost no more than US$ 500.
Monopoly position shuts out more affordable treatments
The pro-drug valganciclovir manufactured by Roche is patented in China. This means that Roche enjoys a monopoly position on the drug which will last until the patent expires in 2015. Until then, there can be no competition in those countries from generic companies to drive down the price of this medication. Meanwhile, many more will be denied the best treatment that could save their sight.
MSF approached Roche and asked them to make the drug more affordable for CMV patients everywhere. Roche came back with an offer of around US$ 2,000 per treatment at current exchange rates – still way beyond reach for most patients in developing countries.
Further, the offer is restricted to use for MSF and other NGOs – governmental sector health programmes are excluded from the deal. In addition, the lower price applies only in the least developed countries and sub-Saharan Africa.
What lies behind Roche’s unyielding position is the intent to protect its market for this drug in countries where it is used both for prophylaxis and in the treatment of CMV in transplant patients. The market for this is considerable – on average seventy thousand organ transplants are carried out each year.