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In Brief

tagline 2006 December

  • Stavudine Associated With Risk for Type-2 Diabetes
  • Generic Efavirenz/Tenofovir/FTC Combo
  • Compulsory License for Efavirenz in Thailand
  • Why Do People Still Die After Taking ARVs? Is it the Brand of Drugs?

Stavudine Associated With Risk for Type-2 Diabetes

By Simon Collins, HIV i-Base

The use of stavudine (d4T) has dramatically fallen in most Western countries, primarily due to high risk of lipoatrophy, and additive mitochondrial-related toxicity with other reverse transcriptase inhibitors. However, globally it remains one of the most widely ARVs prescribed first line therapy (in d4T/3TC/nevirapine), as the basis for the least expensive WHO-recommended fixed dose combinations (FDCs).

Further caution against use of d4T as a long-term treatment option was highlighted in an analysis of the use of d4T and the risk of diabetes mellitus (DM) from the D:A:D Study given in an oral presentation at the biannual Glasgow HIV conference by Stephane de Wit.

D:A:D is a prospective observational study of 23,437 HIV patients that has a focus on toxicity and safety issues relating to ARV treatment, including lipodystophy, cardiovascular risk and hepatotoxicity, and where diabetes mellitus (DM) is collected as a study endpoint.

The incidence of DM in the D:A:D study is comparable to that in HIV-negative populations, and this analysis aimed to identify whether specific antiretrovirals (ARV) were associated with new onset DM.

However, the rate of DM (/1000 PY) increased from 3.96 in those unexposed to d4T to 8.20 in those exposed for 2-3 years. No other ARV was significantly associated with DM after controlling for d4T use.

Time-updated total cholesterol, HDL-cholesterol, and triglycerides were all associated with DM. Adjusting for each of these separately reduced slightly the relationship between d4T and DM. While lipodystrophy was significantly associated with DM (1.37, p=0.008), adjustment for this did not modify the relationship between d4T and DM. This led the authors to conclude that "d4T potentially directly contributes to insulin resistance, rather than through lipodystrophy."

De Wit S, Sabin CA, Weber R et al. Relationship between use of stavudine and diabetes mellitus. 8th International Congress on Drug Therapy in HIV Infection, 12-16 November 2006, Glasgow. Oral abstract PL9.5

Generic Efavirenz/Tenofovir/FTC Combo

Indian generic drug maker Cipla has launched a new fixed dose combination pill called Viraday, a combination of efavirenz 600 mg, tenofovir 300 mg and emtricitabine 200 mg (a generic equivalent of Atripla). At a retail price of 5,200 rupees a month ($117), Viraday is expected to cost about 10-15% of the U.S. price for the brand name equivalent -- although it will still cost about 10-times more than a generic regimen containing nevirapine and stavudine. Gilead and Merck, the makers of Atripla, have not yet announced if their product will be made available in the developing world through Gilead's Access Program at a no-profit price.

Compulsory License for Efavirenz in Thailand

Thailand will issue a compulsory license for use by the government to improve access to efavirenz.

The price that patent holder Merck charges in Thailand (1,500 baht/month -- US $41) is double that charged by Indian generic manufacturers (800 baht/month -- US $22).

The compulsory license will apply both to import and local production of the drug. The Thai Government Pharmaceutical Organization (GPO), who manufacture antiretrovirals for use in Thailand, is developing its own production of efavirenz which is scheduled begin next year.

In the meantime, the compulsory license will allow Thailand to import generic efavirenz from India.

Why Do People Still Die After Taking ARVs? Is it the Brand of Drugs?

Email response to AIDS India e-forum:

I would like to bring in another angle why people face a problem or death even after on ARV treatment: It is lack of treatment literacy.

I mean to say many of the people living with HIV don't have required/sufficient knowledge about the treatment they are taking, but simply rely on the doctors who don't always have the time to explain. And we still see some doctors giving wrong prescriptions, e.g. 2 drugs instead of 3 or more.

Regarding particular brands: I am on ARVs (3TC+AZT+ NVP) for the last 4 years, and I have take all the brands that are available in India: Cipla, Ranbaxy, Hetero, Aurobindo, Strides et al; whatever is the cheapest for me -- it's not a problem.

I am on AZT, so I closely monitor my hemoglobin (Hb), and I'll take anything to improve Hb as I am prone to anemia. I am on NVP so I watch my liver and don't do things to hurt my LFTs.

We must scale up treatment literacy in order to have successful HIV treatment programs.

Loon Gangte
Delhi Network of Positive People