JVnet Forum posting** - April 22, 2004
Trang and Ngoc

(d4T or AZT) + 3TC + (NVP or EFV)

The five drugs, AZT, d4T, 3TC, NVP and EFV, can thus be considered the important basis for scaling up of ARV treatment in developing countries.

It is important to note that in the possible combinations, the third drug can be either NVP (nevirapine) or EFV (efavirenz).

We heard a joke from some people with HIV in HCM City, "You are not truly cool if you don't have all the 3 guys", with the 3 guys meaning HIV, hep B virus and hep C virus. This reflects the reality that the main HIV transmission routes in Viet Nam are related to intravenous drug use and commercial sex, and co-infection of "3 or 2 guys" is prevalent. This presents a challenge--combinations with NVP are not suitable for HBV (+) or HCV (+) patients with high liver enzymes, because NVP has liver toxicity.

On the other hand, TB infection and active TB is quite common in people with HIV, and NVP should not be co-administered with the TB drug rifampicin.

This means that the only option for HIV patients with high liver enzymes, and an important option for HIV patients with TB is to use EFV (efavirenz) instead of NVP (according to the above-mentioned recommendations).

At present, an important source of affordable ARV medicines in the world is generic triple therapy fixed-dose combinations (FDC), or 3 in 1 drugs in lay men's term (3 drugs in 1 pill). An important fact is that there are currently only generic 3 in 1 drugs with NVP, and none with EFV. To use a regimen including EFV, one would have to use stand-alone EFV.

EFV for adults come in 200mg and 600mg tablets. The adult dosage is 600 mg per day. The prices of these two kinds of tablets are being debated. Following is some information from the website of Medecins Sans Frontieres, an NGO with tremendous experience in this area:

In October 2002, Merck announced a price reduction for the 600mg formulation of EFV at 0.95USD per day (or 346.75USD per person per year), for low HDI (human development index) countries and for medium HDI countries with adult HIV prevalence of 1% or greater. This formulation allows patients to take one tablet of 600mg per day, instead of three tablets of 200mg. Also, its price is a reduction of 153.25USD per person per year, as compared to the price of using 200mg tablets, 3 tablets a day.

However, according to Medicins Sans Frontieres's newsletter of March 1, 2004, sixteen months after this announcement, Merck had officially registered this 600mg tablet in only seven countries. Many countries who are eligible to this price offer, therefore, in effect do not have access to this drug formulation with this price. Medecins Sans Frontieres is now trying to persuade Merck to reduce the price of the 200mg tablet to 0.32USD (so that it is equivalent to the 0.95USD per unit price of the 600mg tablet) and to register the 600mg formulation in developing countries. We will update JVNET when any results come of this.

Viet Nam falls in the category of medium HDI countries with adult prevalence less than 1%, which is eligible to a Merck offer of 2.10USD per tablet for EFV 600mg (equivalent to 767USD per person per year), and 0.84USD per tablet for EFV 200mg (equivalent to 920USD per person per year). Given these prices, a triple therapy regimen including EFV would be a lot more pricey than a triple therapy regimen with NVP (only 300-400USD per person per year if using generics, and even lower--140USD per person per year--if purchased through the Clinton Foundation).

EFV is also available as generics from India for 427-462 USD per person per year. However, these generics have not been pre-qualified by WHO, therefore cannot be purchased with funds from the Global Fund, the World Bank and UNICEF, or purchased through the Clinton Foundation. That's not to mention issues of patent barrier to EFV access in Viet Nam.

Will people with HIV who are co-infected with hepatitis B or C, or TB, have a real chance to access ARV treatment (with EFV in this case)?

Trang and Ngoc

PS: You can find more information on this topic from <http://www.accessmed-msf.org/prod/publications.asp?scntid=4320041 149507&contenttype=PARA>

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** JVnet, an email forum in Vietnam, was founded by Dr. Jamie Uhrig, currently moderated by Institute for Social Development Studies.

To post message on JVnet: send to jvnet@netnam.vn

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