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[e-drug] Access to Kaletra in developing countries

E-DRUG: Access to Kaletra in developing countries
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[E-drug does not normally discuss patient cases, but this case from Ethiopia 
has maybe some general interest points. WB]

Dear e-druggers,

I present a case to share with you on a person living with HIV and on ARV 
treatment.

The drugs for the first regimen were zidovidine lamivudine and nelfinavir 
(viracept). At the time the therapy started the drugs were obtained from the 
black market which was the only option. In the middle there was problem in the 
availability nelfinavir (Viracept) and it was shifted to efavirenz (Stocrin). 
Then the Ethiopian government started antiretroviral therapy as a program in 
selected sites but unfortunately efavirenz was not available in the program and 
the physician shifted to nelfinavir a year ago. 

After four months, the therapy CD4 started to decline and before 15 days the 
viral load was extremely high indicating that resistance had developed. The 
doctors suggested that the only option that is left to be to use lamuvidine, 
viread and combination of lopinavir and ritonavir (Kaletra).

I discussed this issue with e-drugger Dr Valeria whom I have known on e-drug to 
help on this issue. She responded quickly and helped a lot on the issue. I 
would like to thank her for the effort that she exerts to help me find the 
right track. The Abbott Labs have got a program for these drugs for people 
living in poor countries with a price with no profit. I have send message-about 
the case but they have not responded yet. I am afraid that the programs in 
Ethiopia may not include these drugs.

Dear e-druggers at this point I would like to raise two questions:

First what alternatives are available for the case mentioned above other than 
the new PI?  

Second on how people in developing countries who are in need of these drugs 
could get access to the drugs if the drugs are not included in the existing 
programs? I feel that this could be question of thousands living in poor 
countries 

Finally I would like to summarize some tips which could have relevance with the 
case I mentioned above.

HIV reproduces itself very quickly and when reproducing often makes slight 
mistakes. So each new generation, or new strain, of HIV differs slightly from 
the one before. These tiny differences in the structure of HIV are called 
mutations. Some of the mutations occur in the parts of HIV which are targeted 
by anti-HIV drugs. So although you have some HIV that continues to be affected 
by the drugs, you have other strains of HIV that are not affected by the 
anti-HIV drugs as effectively as before. This HIV is called drug resistant HIV, 
and it is then able to reproduce unaffected by the drugs.

When someone has drug resistant HIV (commonly referred to as drug resistance), 
the amount of HIV in the blood rises and the risk of the person becoming ill 
increases. Drug resistance is one of the main reasons why antiretroviral 
treatment fails. If resistance to the current drug treatment is developed, this 
usually means that the drug regime needs to be changed.

The anti-HIV drugs work the best when used the first time. This is one of the 
reasons why it has to be considered carefully whether a change of treatment is 
necessary or not. The combination of anti-HIV drugs other than the first or 
second treatment is called salvage therapy. It is also referred as second-line, 
third-line or rescue therapy.

Monitoring the viral load carefully is an important part of treatment. There 
are different opinions about the 'right time' to change the treatment if your 
viral load is rising. Some doctors recommend changing the treatment as soon as 
the viral load starts to rise. Others recommend monitoring the overall trend of 
the viral load before making a decision to change. Changing the drugs earlier 
rather than later, could mean running out of treatment options quicker. But 
changing later, means there is a danger of developing resistance to certain 
drugs. This can seriously limit your future treatment options. The changes that 
can be made to the drug regime will depend on the drugs already being used, the 
CD4 count and your general health.

Many people start their salvage therapy with much higher levels of viral load 
than previous treatments. This puts more pressure on the new combination to 
work. Each combination used lessens the chance of maintaining a low viral load 
because of the possibility of developing resistance to the drugs. The choice of 
new treatment should always depend on what caused the previous one to fail.

New antiretroviral drugs (drugs in existing classes with activity against 
resistant strains, or new drug classes with novel mechanisms of action) 
including those available on expanded access or through clinical trials may be 
used.

According to release from Abbot in a study of individuals with extensive 
nucleoside analogue and protease inhibitor experience (but no prior NNRTI 
experience) and virologic recurrence on treatment, changing to a regimen 
including lopinavir/r and efavirenz resulted in viral load suppression at week 
24 in the majority of participants.The effectiveness of regimens containing 
lopinavir/r in patients with prior NNRTI experience and failure of a protease 
inhibitor-containing regimen is unknown.

Data from the randomized, uncontrolled, prospective Phase II study of 100 
treatment-naove patients taking Kaletra in combination with lamivudine (3TC) 
and stavudine (d4T) show that of 17 patients out of 27 patients who met the 
criteria for resistance testing with resistance data available through 252 
weeks, none demonstrated evidence of resistance to lopinavir (0/17) or 
stavudine (0/17). Three patients (3/17) Demonstrate damivudine esistance. 

In addition, 64 percent of patients (64/100) had an undetectable viral load 
(HIV RNA less than 50 copies per milliliter) and 67 percent (67/100) had HIV 
RNA less than 400 copies per milliliter, using an intent-to-treat (ITT) 
analysis, which categorizes any patient who does not complete the study as a 
treatment failure. Of the 68 patients remaining on treatment (OT) at week 252, 
94 percent (64/68) of patients had an undetectable viral load and 99 percent 
(67/68) had HIV RNA less than 400 copies per milliliter.

With regards

Menassie Kifle
Ethiopia
menassie2002@yahoo.com

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