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Second-line Treatment in Urgent Demand
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Meng Lin relies on friends to post him drugs from overseas every month medicine he needs to stay alive.

Meng is HIV-positive. As a former entrepreneur from Beijing, he can afford second-line anti-retroviral treatment, so he's lucky because he estimates they cost 160,000 yuan (US$19,500) a year. But the key drugs he needs for second-line treatment are still unavailable in China.

Even though he's more fortunate than most Chinese HIV/AIDS patients, he still feels troubled when his supply drops to eight to 10 days. If he runs out of the drugs or develops resistance to these new drugs, he will have no chance to lead his life.

"At the beginning, I used drugs that were available in China (for first-line treatment), but I quickly suffered side effects, so I started on Kaletra (a key second-line treatment drug) in 2004," said Meng, 38, who learnt he was HIV-positive in 1995.

Meng is also the head of ARK of Love, a Beijing-based informational support network for people suffering from HIV/AIDS.

About 650,000 people in China live with HIV, and first-line treatment is available, but only one in four who need HIV drugs received them in 2005, according to a report by the United Nations agency UNAIDS.

"The Chinese Government has promised to provide free anti-retroviral treatment to every HIV/AIDS patient who is officially registered," Ministry of Health spokesman Mao Qun'an said.

Most of the country's HIV/AIDS sufferers are still not registered, and it is difficult to give them timely testing and treatment without knowing where they are and how they are getting on with the virus, Mao said.

About 20 kinds of drugs are available worldwide for first-line treatment that doctors use in combination "cocktails" to treat various patients. The central government has been buying five kinds of first-line drugs and lamivudine for patients since early 2003. Now they are permitted to be produced in China.

But even the people who have enjoyed the treatment have many difficulties. Many of them, after taking the first-line drugs for a certain time, usually about three years, develop a resistance to them. Others, like Meng, develop side effects. And still others don't adhere well to the programme prescribed for them.

They are the ones who need second-line drugs, which cost seven to 28 times more than the first-line drugs.

Adherence and rural care

In China, at least 70 per cent of HIV/AIDS sufferers live in rural areas, where the number of doctors lags and the quality of medical service is quite poor.

Meng said when the government started its free treatment programme in early 2003, some village doctors, who didn't know about the programme, gave the drugs to patients and told them to take them in whatever way they wanted.

There are no reliable statistics on how many patients across China have given up first-line treatment. But some Beijing doctors who travelled to Central China's Henan Province, which gets the most government-funded drugs, estimated that about 30 to 40 per cent of the infected villagers had given up the first-line treatment.

Neither are there Ministry of Health statistics on how many patients in China need second-line cocktail treatment. According to global figures from Medecins Sans Frontieres (MSF, known in English as Doctors Without Borders), "we estimate that 15 to 20 per cent of our patients will need second-line treatment," said Amine Dahmane, medical co-ordinator in Beijing.

MSF has 51 projects in 31 countries, treating nearly 70,000 AIDS patients. At the end of last year, 6 per cent of all the patients who have had first-line treatment for three years need second-line cocktails, MSF said.

"From MSF projects in China (around 400 patients), we actually have around 10 to 15 patients (2.5-3.75 per cent) who need or might need second-line treatment soon," Dahmane said.

MSF is currently treating three patients on second-line therapy on the mainland, she said, with the drugs being bought from Hong Kong or other places.

"We have seen from our international experience in South Africa that after four years, about 16 per cent of patients need second-line therapy assuming the patients have had good adherence," said Suerie Moon, a senior adviser with MSF in Beijing.

The World Health Organization recommends doctors use a combination of three or four drugs in a second-line cocktail. Some of the drugs are already available in China, but they are not the key components of the treatment.

Doctors must have at least one of these key drugs, called protease inhibitors, to construct a second-line cocktail. Among them are lopinavir/ritonavir (LPV/r, produced by Abbott Laboratories, near Chicago, under the brand name Kaletra), atanazavir (ATV) and saquinavir (SQV).

That is why everyone is so interested in getting access to LPV/r, Dahmane said.

What is interesting is that the drug ritonavir, abbreviated simply as "r," is also needed for other second-line combinations (for example, ATV/r, which stands for atazanavir/ritonavir and SQV/r, which stands for saquinavir/ritonavir), Moon said. But if "r" is not available, then they cannot use ATV or SQV and they must use LPV/r.

Abbott also controls ritonavir, she said, and by not making it available in China now, the laboratory also automatically blocks the possibility of choosing an alternative to LPV/r.

"We are currently in discussions with the Ministry of Health in China regarding access to Abbott's HIV medicines," said Tracy Sorrentino, international media spokeswoman for Abbott.

Negotiations are continuing, but a deal is not expected anytime soon, said Hao Yang, deputy director of the Disease Control Bureau of the Ministry of Health.

One important problem of the negotiation is the price of the drugs, Hao said.

It will cost 20,000 yuan (US$2,400) a year for second-line treatment, which most HIV/AIDS sufferers, who live in rural and remote areas and have to depend on drugs given by the government, cannot afford.

Reuters reported that Abbott was asking US$1,000 for a one-year course, but the Chinese Government's top price was US$400.

"A few very fortunate Chinese patients may be able to travel to regions such as Hong Kong or Thailand to get some of the necessary drugs, but it's extremely expensive," Dahmane said.

For most patients, they must simply go without treatment.

The Kaletra that Abbott used to sell needs to be refrigerated and must be taken after a meal. The recommended dosage was six tablets a day. Abbott now sells a new, non-refrigerated version of Kaletra in the United States and Europe, where health ministries have approved it.

"Abbott is working to register this new formulation in developing and developed countries around the world. Abbott is working on its submission to China and plans to file as soon as possible," Sorrentino said.

But even if the talks with Abbott do bring the drugs for the second-line treatment to China, the issue of the quality of rural medical service remains.

Zhang Fujie, director of the Care and Treatment Department of the China Center for Disease Control and Prevention, said: "If the quality of the doctors and their working conditions are kept at the same low level where they are now, which means they cannot ensure that the patients will have good adherence to treatment, it will be useless even we have the latest drugs."

(China Daily December 1, 2006)

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