While HIV advocates have for many years been asking for the removal of stavudine 40mg from the first line drugs after studies showed its ability to cause grave side-effects on number of patients, the government never took action.

A source at the Ministry of Health said they had ordered many stocks of the Stavudine 40mg, and the country was going to make major losses if it cancelled the contracts. Also, the patients were going to suffer as new combination had not been identified and modalities to shift them to the new regimen.

Now from a Fixed Dose Combination of Stavudine 40mg/ Lamivudine150mg /Nevirapine 200mg patients are being shifted to the less toxic combination of Stavudine 30mg /Lamivudine150mg/Nevirapine 200mg, according to Quantification of ARV drugs for Nascop ART Programme: 2007-2009, a report presented to the government late last year.

This also means all patients who are receiving stavudine 30mg will not be stepped–up to the 40mg has been the case in the past.

In fact, in the new drug forecast, this combination has been left out, with estimates showing that by end of this year, over 60,000 packs of the new combination will be consumed.

This transition was expected to be complete by January this year, but with ordering problems, this may not be possible. The report also wants patients being shifted to the new combination to go through clinical assessment to rule out lactic acidosis and peripheral neuropathy.

Stavudine is known to cause serious side-effects on some patients such as peripheral neuropathy, lipodystrophy and lactic acidosis, which are pronounced at higher dosing and after long-term use. Peripheral neuropathy or mitochondrial toxicity, which involves damage to the nerves that presents as tingling, numbness, or a sharp burning sensation in the feet, legs, or hands, are some of these.

Other people describe this pain as feeling like bolts of lightning shooting up and down the legs or electric shocks. While others find it difficult to wear shoes due to the numbness caused.  Such nerve damage is temporal and can be reversed if a person stops taking stavudine, or reduce the dose, HIV experts say.

The manufacturers of stavudine whose brand name is Zerit, say patients should be counseled that peripheral neuropathy occurs with greatest frequency in patients who have advanced HIV disease or a history of peripheral neuropathy, and that dose modification and/or discontinuation of Zerit may be required if toxicity develops.

Lactic acidosis, on the other hand is a buildup of lactic acid in the blood which may be caused by damage to the mitochondria.  When it happens, it can cause severe damage to the pancreas and liver and is usually manifested in weight loss, abdominal pain, and severe fatigue.

While Lipodystrophy results in changes in the body shape and blood chemistry that may result in the loss of fat in the legs, arms and face.  Reducing the dosage of stavudine has major impact on the reduction of these side-effects.

Because of the drug’s impressive efficacy in resorting the immune system’s CD4 cells, many countries have in the past favoured the reduction of the dosage from the 40mg to 30mg.

In May 2007, the World Health Organization (WHO), officially updated its treatment guidelines for resource limited countries, to recommend a 30mg twice daily dosage after several studies indicated reduced toxicity at low dosing stavudine or d4T.  The lower dosage has less rate of toxicity and side effects, but same efficacy levels as the 40mg.

Says the WHO report published last year: “The WHO Guidelines Development Group was persuaded of the need to recommend a reduced dose after accumulating reports of serious d4T-related toxicities in developing country treatment programmes, and the presentation of a meta-analysis of studies looking at the efficacy and safety of a reduced dose.”

WHO now requires all countries to start patients on stavudine 30mg irrespective of their weight.

Meanwhile, HIV experts are worried that lack of drug resistance surveillance systems could land this country in major problems. Currently, the country does not know the true status of drug resistance in the general population.

The only serious study around this issue is one that was commissioned by WHO. But this research considered only first time mothers who were presenting to antenatal clinics. The findings from this group indicated that the women had less than 5 percent resistance to certain ARV drugs, a rate defined by WHO as less threatening. But scientists say this can be deceiving especially for policy reasons.

While the resistance maybe due to being infected with a resistance HIV strain or developing resistance to certain ARVs drugs because of failure to adhere and comply with the treatment guidelines, the closest the country has come to knowing this factors is the number of people on second line treatment.

By end of last year, over 1,000 people were on second line treatment, meaning they had developed resistance to first line drugs or they had experienced serious side-effects occasioned by one or two of the drugs.

This means many of these people have developed HIV resistance strains. What is not clear is whether or not they are transmitting these trains to other people. That is why HIV pundits and people living with HIV/AIDS want the issue addressed immediately.

Promises by the government that Kenya Medical Research Institute (Kemri) or University of Nairobi would undertake such surveillance have just remained at that: promises.

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