In parts of the developing world, particularly in Africa, the price of antiretroviral drugs has come down dramatically over the past four or five years. A generic combination of nevirapine, lamivudine and stavudine used for first-line therapy can be had for under $150 per year. While this is an effective and lifesaving combination that has enabled a half-million people to begin therapy, there are side effects associated with stavudine, and resistance to nevirapine can arise quickly if adherence is not near perfect. This means that, as the number of people going on first line therapy grows, the number of people who are failing or intolerant of those drugs is also growing, which, in turn, creates a growing need for second-line therapy.
There are many problems surrounding switching to a second regimen after the first and most affordable therapy is no longer useful, not the least of which is the cost of second-line -- typically much higher than first-line drugs.
For example, Kaletra, a first-line drug in the US and Europe, is considered second-line in the developing world because it has required refrigeration and no affordable generic version is available. Abbott Laboratories, the makers of Kaletra, recently brought to market a new version of the drug that does not require refrigeration, even in hot tropical climates. Abbott will sell the drug in Africa and in a few non-African developing countries at a no-profit price of $500 per year, or about $42 a month. Yet even this is too much for some national treatment programs to justify paying, and it does not seem likely the price will go much lower soon. Abbott says it is losing money at this rate, and no generic drug maker from India or elsewhere has developed a competing product that comes close to Abbott's $500 a year price.
In August 2006 Abbott announced that it would begin selling new Kaletra in the developing world under a new name: Aluvia. The heat-stable Aluvia lopinavir/ritonavir tablets would be identical to the new Kaletra tablets sold in the US and Europe except for a color change in the tablet coating: from yellow ochre to rose. Abbott also announced a new, lower price for sales to a list of lower-middle-income countries such as Ukraine and El Salvador. At $2,200 per year, however, this program may not bring relief to many of the increasing number of people who have run out of rope on their first drug regimen and are looking to Kaletra for a lifeline.
A group of treatment activists from the developing world recently met with Abbott in London to discuss the dismal situation for second-line therapy in their countries. Here are some excerpts from a country-by-country report on the availability of Kaletra for patients who are running out of options.
Moldova: We have Kaletra for only 10 people. Only one child takes Kaletra. By 2010 it is planned for 50 people. There is an urgent need for the drug because ARVs have been available for three years and there is now resistance. It is purchased by the Global Fund for $390/month. The government has no funds for purchasing Kaletra. We are concerned that when the Global Fund leaves the country in 2010, there will be no more drugs.
El Salvador: In some countries in Central America, Kaletra is now provided by the government. Before, we depended on relatives living in North America. Kaletra is used as a second-line drug in cases where there is resistance. Kaletra is prescribed only when clinical resistance has been diagnosed. But we don't have labs to demonstrate resistance.
Prescriptions are restricted because the costs are so high. No one is treated with Kaletra in El Salvador or Guatemala. Only 10% of those who need it can get Kaletra in Central America.
Ukraine: In Ukraine Kaletra is used as first-line. We have 200 patients on Kaletra but it is expensive. It is the only brand name drug being procured in Ukraine. The government first purchased it for post-exposure prevention. We don't care about the formulation but we have very high prices. The prices for the government and the Global Fund are different. Global Fund's Kaletra is cheaper than the government's. A package in Ukraine costs $370 dollars for the Global Fund, $420 for the government. Today we are planning procurement for 6th Global Fund round and they wanted to exclude Kaletra.
We have a lot of side effects and a lot of resistance so we are very interested in Kaletra monotherapy. In Ukraine we have 10 people on Kaletra monotherapy.
Paraguay: In Paraguay, Kaletra is provided to only 20 persons. Half are children and Kaletra is first-line for them. The cost is about $440 per month for one person. That consumes 25% of the budget for the national program. Monotherapy is used in the private sector if people can access their labs in Brazil or Buenos Aires. Kaletra has been available since 2003. Storage is a problem.
Croatia: In Southeast Europe there is some access to the old Kaletra. In Croatia we have 70 patients paying 403 Euros per month. There is a problem with access to Norvir in Croatia.
Suriname: Some people need to use Kaletra now, but the poor people can't buy it. Rich people can get it from Holland.
Zambia: Out of the 55,000 people on treatment in Zambia, currently 240 people are on second-line therapy and most depend on Kaletra. We have Kaletra but you need to take food with it. A new formulation that does not require food or refrigeration will be very good for countries like ours in Southern Africa. If people are hungry they won't take the drug until they have food. More than 80% of Zambians live on less than $1 a day. Buying drugs is more expensive than paying rent for most Zambians. HIV comes with job losses and to people who live where there is no electricity and refrigeration. Kaletra is mostly used in MSF (Doctors Without Borders) clinics or PEPFAR programs in the big towns. A doctor will not prescribe it for someone in a rural area. The cost of second line is $450-$500/month. If there is a new formulation then it is high time to find out how Abbott is planning to increase access to Kaletra so that it reaches the people who need it. PEPFAR gives free access to Kaletra, but if people must travel from another town and they must eat during their journey, then access to the drug is not really free.
India: As far as we know Kaletra is not available from the government in India. People only have access to Kaletra in India if they have money. We have 36,000 people on first line, but there is no second-line treatment for people on the government programs. Unofficially, about 10% of these people need second line. People don't know about Kaletra.
Uganda: I take Kaletra. Kaletra has been a total nuisance in my life: The food restrictions, the number of pills I must take every night and day. But it has worked very well for me. Most people don't have fridges. I'm looking forward to the new Kaletra but it must be accessible to people in rural areas. The price of $700 per year is very expensive. Why is this not the $500 they say they give to Africa?
China: China does not have any Kaletra. We only have what we can carry in.
Bulgaria: Bulgaria has Kaletra and it is reimbursed.
Russia: In Russia Kaletra is available and registered. The demand for second-line is not sufficient for the company to make it a priority. The price is also different between the government and Global Fund. Global Fund price is $290/month and it depends on the number of patients. Even this price is too expensive. The government tries to avoid Kaletra due to the high price.
Estonia: We have access to Kaletra in Estonia. Of 300 patients on second-line, 71 are on Kaletra. We only have the old formulation. The cost is about $6,000/year. Next year we need to put 2,000 patients on ARVs.
Peru: In Peru we introduced Kaletra in 2004. We got a price of $1.88 per day ($677/year) but in Peru it is free for the people. We have about 100 persons on Kaletra. We get generic Kaletra from Cipla. We have 500 people on the drug at 1.20 per pill.
Morocco: In Morocco, we started treatment early so second-line therapy is a big issue. We have Kaletra at the $500 access prices but it is still expensive for the Ministry of Health. It is free for the people. About 40 people take it. It is recommended for doctors to not prescribe it unless it is the only solution. So we try not to use it. We need the new heat stable version because we are a hot country. People travel in buses without air conditioning to get their medications. Getting to the clinics is a problem.
We buy Kaletra from Abbott in South Africa. We have benefited from the access prices since 2004 but $500/year is too much for a country like Morocco. We pay about $250/year for generic first-line therapy. This is a similar situation for other North African countries.
Cameroon: Our data says there are more than 3,000 people on ARVs and around 200 people on Kaletra. The price is a problem. The government decided not to apply for the next round of the Global Fund, so we are not sure what will happen if that support goes away. If we don't have that money, how can we access treatment? And we have so many people in rural areas. My village is 300km from Yaounde. How can people access these drugs? Everyday the need for treatment increases -- and the cost is the issue.