Here is a paper in AIDS on the use of a generic three drug regimen on the border.
The generic formulation used is not WHO prequalified.
[him] moderator
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Advantages of low-cost generic tenofovir instead of D4T for first-line antiretroviral therapy in Burma: a 2-year experience.
AIDS. 2010 Jun 19;24(10):1606-7
Authors: Moore S, Myint MM, Galau NH
PMID: 20539097 [PubMed - in process]
Many third world AIDS treatment programs are
contemplating an ‘upgrade’ to a less toxic long-term
alternative to D4T. Few programs are aware that an Food
and Drug Administration (FDA)-certified generic equivalent
of Atripla (Bristol-Myers Squibb & Gilead Sciences,
LLC, Foster City, California, USA) is now available for
US$ 15 per month. We have used this alternative for
2 years in Burma. It is cost-effective and has several
advantages over the cheaper D4T regimen now used in
resource-poor countries.
Burma (Myanmar), a poor country with 55 million
people, has the worst untreated epidemic of HIV in Asia.
It has poor health statistics, but by best estimates, there are
between 240 000 and 500 000 people living with HIV.
The problem is worse along the borders with China,
Thailand, and India and contributes greatly to crossborder
epidemics in those countries.
The border region of Kachin state in northern Burma
has the ingredients for the ‘perfect storm’ for an HIV
epidemic. Here, heroin costs less than US$ 1 per fix, and
there are large numbers of intravenous drug users. There
are many gambling casinos with sex workers. Customers
are Chinese and Burmese jade miners and teakwood
workers and the sex workers are local wives and mothers
by day.
There is no Global Fund or PEPFAR support for HIV
treatment in Burma and only 16 000 end-stage patients
have been started on treatment, mostly by one nongovernment
organization (NGO), MSF-Holland.
In August 2007, a grant from the Chicago-based Ann &
Robert H. Lurie Foundation was used to start an HIV
treatment program organized by the BritishNGO, Health
Unlimited, along the border with China. The treatment
effort took a new approach in this rural, high-prevalence
area. Instead of relying on expensive laboratory equipment
and frequent follow-up visits to detect signs of
toxicity, we focused our limited resources on outreach
rapid testing by mobile teams in rural villages. Those
testing positive were referred to a central clinic for
staging. Initially, without a CD4 machine, patients were
staged clinically and stage 3 or 4 patients were started on
treatment after two counseling sessions. Examinations,
symptom reviews, and adherence counseling (without
laboratory monitoring) were done every 3 months
thereafter. Now, a new CD4 machine allows treatment
to be started at CD4 cell count of 350 cells/ml and
monitored every 6 months.
An inexpensive generic form of tenofovir 300/emtricitabine
200/efavirenz 600 was used as first-line therapy.
This new combination has recently become available
from Matrix, a totally owned subsidiary of the American
generic company, Mylan, for 50 cents per day. Atripla (the
branded equivalent) is produced by Bristol-Myers Squibb
& Gilead Sciences, LLC and is now the most common
first-line AIDS treatment in the United States and
Europe. But it costs US$ 55–65 a tablet. Even the
discounted price (US$ 4–10 per tablet) offered to poor
countries is too high for many programs in the developing
world, when D4T costs a fraction of that.
But the advantages of tenofovir overD4Tare important: at
50 cents a day, it still costs twice as much as the D4T
combination, but those costs can be offset by less need for
laboratorymonitoring.Without D4T, AZT, or nevirapine
in the regimen, only symptoms and signs of side-effects
need be done. Hemoglobin, liver function, and creatinine
laboratory monitoring was not done (studies show
tenofovir renal toxicity to be less than 1%). It is easier
for patients to take one pill per day. Tenofovir has a more
favorable resistance profile. Clinically,we have not seen any
of the neuropathy or lipodystrophy that occur with D4T.
The annual costs of our program have been US$ 276 per
patient including all antiretroviral therapy (ART), OI
drugs, CD4 testing, Burmese salaries, and running costs
for the program.
During the rapid 2-year scale-up, 10 100 people have
been tested for HIVand 1430 positives have been staged,
840 have been started on ART. Seventy percent were
between the ages of 25 and 39 and 61% were men. Sexual
transmission was likely in two out of three patients.
Tuberculosis, peniciliosis, and cryptococcus were the
most common presenting OIs. Pneumocystis, Kaposi
sarcoma, and toxoplasmosis were almost never seen. Four
percent have been lost to follow-up and 9% have died in
the first 2 years. Two patients had to change regimens
because of (efavirenz) nightmares.
The major advantages of using generic tenofovir in this
rural setting were the simplicity for patients and no
requirement for frequent laboratory tests and clinic visits.
Most importantly, the long-term toxicity from D4Twas
not seen. A much larger international effort should be
funded to treat the 100 000–150 000 Burmese end-stage
AIDS patients who now need ART to survive.
Stephen Moore, Myo M. Myint and Naw H. Galau,
Numripan Clinic, Laiza, Kachin State, Myanmar.
Correspondence to Stephen Moore, MD, MPH,
1909 Rock Street (Apt 4), Mountain View, CA
94043, USA.
Received: 22 January 2010; revised: 8 February 2010;
accepted: 17 February 2010.
