Quantification of ARVs for PMTCT. December 2005. Rwanda
Final Draft for Discussion. MSH/RPM Plus
QUANTIFICATION OF ARVS FOR PMTCT
December 2005 Rwanda
1. INTRODUCTION
The objective of this quantification is to estimate the needs of ARVs as well as the financial
contribution per program, in order to implement the recently approved PMTCT protocols.
Details on the new regimens can be found in section 2.
In these estimations, it has been assumed that Nevirapine in both solid and liquid formulations
will be still supported by Boehringer Ingelheim Pharmaceuticals donation, while the different
programs will need to support the procurement of AZT, 3TC, D4T and Ritonavir/Lopinavir in the
formulations required.
Costs of drugs have been estimated according to the prices of ARVs procured in June 2005, for
the Coordinated Procurement and Distribution System. However, drug prices and contribution per
program will need to be adjusted once the pro-forma invoices of the suppliers are available.
2. SUMMARY OF THE PMTCT PROTOCOLS
The new protocols for the mothers are as follow:

Pregnant women seeking antenatal care during the weeks 28-34 of pregnancy will
receive AZT 300mg BD until labor and one dose of NVP 200mg during labor. Then,
after delivery, they will receive a bi-therapy for 7 days, which could be AZT/3TC or
D4T/3TC in case of anemia (Hb<7gr/dl).

Pregnant women seeking antenatal care after week 34 will receive:
o In ARV sites, triple therapy until and during labor. This could be AZT/3TC/NVP
or alternatively 3TC/d4T/NVP in case of anemia. In case of toxicity to NVP, the
regimen should be adjusted as follows:
▬ For women with more than 32 weeks of pregnancy, NVP should be stopped
and they will continue with biotherapy.
▬ For women with less than 32 weeks of pregnancy, NVP will be replaced by a
protease inhibitor (Kaletra).
o In non-ARV site, the same protocol as for women seeking antenatal care between
28 and 34 weeks of pregnancy will be used.

Pregnant women seeking PMTCT services during labor will receive one dose of NVP
200mg during labor and AZT+3TC after birth during 7 days.
The new protocols for infants are as follows:


NVP one dose before 72 hours
AZT during one month
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Quantification of ARVs for PMTCT. December 2005. Rwanda
Final Draft for Discussion. MSH/RPM Plus
3. ESTIMATION OF ARV NEEDS
Procurement period
The calculations have been made in order to estimate the needs of ARVs for PMTCT for the
period January to July 2006, since it is expected that the new protocol will start in December
2005. In addition a three-month security stock has been added, which will cover the period
August to October 2006.
Estimation of number of new sites opening per month
According to data collected from April to September 2005 (see table below), the average number
of new PMTCT sites opening per month is 10.
Month
Number of Sites
April-05
150
Sept-05
199
Total Months
5
Average number of New Sites
Opened per Month
10
Estimation of mothers treated per site and month
In the absence of more accurate information, it has been assumed that the number of mothers
treated per month in each PMTCT site is constant over time, and that the number of mothers
treated per site is similar all over the country. The data available used for the estimations are:




Number of mothers treated during 2003 = 2,886
Number of sites opened in 2003 = 56
Number of mothers treated by the end of 2004 = 6,404
Number of sites operational by the end of 2004 = 120
Therefore, it can be estimated that each site treats an average number of 55 women per year,
which makes around 4.58 mothers treated per site and per month.
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Quantification of ARVs for PMTCT. December 2005. Rwanda
Final Draft for Discussion. MSH/RPM Plus
Estimation total mothers treated per month (January 2006 to October 2006)
The table below shows the total number of mothers that will be treated per month, with an
average increase of 10 new sites per month, and 4.58 mothers treated per month and per site.
Nov
05
Dec
05
Jan
06
Feb
06
Mar
06
Apr
06
May
06
Jun
06
Jul
06
Aug
06
Sep
06
Oct
06
Projected
PMTCT
Sites
208
218
227
237
246
256
266
275
285
294
304
314
Mothers
per Month
953
997
1041
1085
1129
1173
1217
1261
1305
1349
1393
1437
12,389 women to be treated
Estimation of total number of mothers treated for the procurement period (Jan to Oct 2006)
The total number of mothers treated for the period January to October 2006 can be estimated
from the table above, by aggregating the number of mothers treated per month, which makes a
total of 12,389.
Estimation of % of mothers seeking PMTCT services per week of pregnancy and average
number of days of treatment
The table below shows the distribution of mothers seeking treatment in PMTCT clinics according
to the week of pregnancy.
Week of Pregnancy
Mother Presents at
PMTCT Site
% of Mothers
Days of
treatment needed
according to
week
28
70
84
30
5
70
32
5
56
34
5
42
36
5
28
38
5
14
40
5
1
-3-
Groups of
mothers
Adjusted average
of number of days
of treatment for
each group
80%
84
15%
42
5%
1
Quantification of ARVs for PMTCT. December 2005. Rwanda
Final Draft for Discussion. MSH/RPM Plus
Since the number of days of treatment and therefore the drug requirements will depend on the
week when the treatment is started, for quantification purposes it has been considered always the
highest number of days of treatment in each group. Therefore, in average it can be concluded that:



80% of the mothers seeking antenatal care will be between 28 and 34 weeks of
pregnancy, needing 84 days treatment.
15% of the mothers seeking antenatal care will be between 34 and 40 weeks of
pregnancy, needing 42 days treatment.
5% of the mothers will seek antenatal care at delivery, needing 1 day of treatment.
Assumptions

Percentage of anemic mothers. Since there is no data available on actual prevalence of
anemia in pregnant women in Rwanda, for this quantification it has been assumed that 35%
of anemia in pregnant women, based in two sources:
o The document Elaboration de la Politique Nationale de Nutrition (December,
2004) states that according to a survey done by the Ministry of Health in 1996,
the rate of anemia of pregnant women was 10.6%. However, this rate seems not
to be very realistic since Sub-Saharan countries show rates 3 times higher1.
o The study The prevalence and Factor Associated with Pregnancy at CHK,
(March 2002), estimates a rate of anemia of 32.4% among 380 pregnant women
seeking antenatal care. Since the population of CHK may not be representative of
rural areas, it has been assumed that the rate of anemic women in the country
might be a bit higher.

Percentage of pregnant women < 60 kg. According to a study carried out by TRAC in the
Gitega health center, Kicukiro health center and Muhima hospital, it has been estimated that
38% of pregnant women’s weight is below 60kg and 62% is above 60kg. This percentage has
been used to calculate needs for D4T 30mg and D4T 40mg for anemic mothers.

Toxicity to NVP. There is no data available on toxicity to NVP in Rwanda. However, several
studies2 have found that women with CD4 >350 have higher risk to develop toxicity to NVP.
Data collected during 2004 on pregnant women from Kicukiro Health Centre suggest that
around 16% of the pregnant women who are HIV positive will have a CD4 count > 350 (see
table below). According to the protocols, since not all HIV positive pregnant women will
have a NVP-based regimen, it has been estimated that around 2.5% from the total number of
women will need to be changed to the Kaletra based regimen.
L’Enquête nationale de nutrition, menée en 1996 par le Ministère de la Santé, a dépisté 43,1 %
de taux de prévalence de l’anémie (Hgb < 11 g) chez les enfants de 0 à 5 ans et 10,6 % chez les
femmes enceintes. Le taux de prévalence de 10,6 % chez les femmes enceintes est 3 fois plus
bas que celui généralement observé dans les pays de l’Afrique sub-saharienne et semble peu
refléter la réalité. Elaboration de la Politique Nationale de Nutrition. December 2004. p.6
2
Ask references to TRAC.
1
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Quantification of ARVs for PMTCT. December 2005. Rwanda
Final Draft for Discussion. MSH/RPM Plus
Data from Kicukiro Health Clinic (2004)
Number of women in
PMTCT
97
CD4 < 250
% Women in PMTCT
76%
CD4 between 250 and 350
10
8%
CD4 > 350
20
16%
Total
127
100%

Number of infants treated. Data from the TRAC gathered during 2004 suggest that every 100
mothers treated to prevent the transmission of HIV to the child, only 84.5 infants are treated
(2,939 mothers treated versus 2,490 infants). This suggests that there are a number of children
who do not receive the treatment after birth. For the estimations in this exercise it has been
agreed to consider that the PMTCT services will improve, and that the number of children
receiving treatment will be equal to the number of mothers (= 12,389), assuming that only
one baby will be born from each mother.

The average weight of new born has been estimated to be 3kg.
Needs of ARVs for Mothers
The table below shows the results on the requirements of ARVs for the treatment of mothers in
PMTCT programs.
PACK UNIT
NUMBER OF
TABLETS
NUMBER OF BOXES
AZT 300mg tab
60
1,082,270
18,038
NVP 200mg tab
60
166,627
2,777
LPV/r tab
180
24,975
139
AZT+3TC tab
60
216,615
3,610
D4T 30+3TC+NVP tab
60
221,460
3,691
D4T 40+3TC+NVP tab
60
361,320
6,022
D4T 30 mg caps
56
44,296
791
D4T 40mg caps
56
72,296
1,291
3TC tab
60
116,639
1,944
PRODUCT
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Quantification of ARVs for PMTCT. December 2005. Rwanda
Final Draft for Discussion. MSH/RPM Plus
Needs of ARVs for Infants
The table below shows the results on the requirements of ARVs for the treatment of infants in
PMTCT programs.
Days
ml
Waste
per
Infant
Total
ml
ml per
Bottle
2
30.5
26.8
100.0
1
1
0.4
1
Dose
(ml/kg)
Infant
Weight
Daily
dose
AZT
Syrup
0.4
3
NVP
Syrup
0.2
3
Bottles
Numbers
of infants
to be
treated
Numbers
of bottles
100
1
12,389
12,389
20
0.05
12,389
619
1. In the case of AZT syrup, a bottle of 100 ml will be enough to treat each infant. Since it is not
possible to break bottles and the treatment will be most likely followed at home, it has been
therefore estimated that it will be needed one bottle of AZT syrup for children treated
(=12,389).
2. For the case of NVP syrup, each child will receive an only dose of treatment, which is most
likely to be administered in the health center or hospital. Since it is expected that wastage of
liquid will occur, it has been estimated that for each child treated it will be needed an average
on 1ml of syrup, making a total number of 619 bottles.
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Quantification of ARVs for PMTCT. December 2005. Rwanda
Final Draft for Discussion. MSH/RPM Plus
4. ESTIMATION OF QUANTITIES TO BE ORDERED AND COSTS FOR PMTCT
Estimation of Quantities to be ordered and Total Costs
The table below shows the quantities to be ordered taking into account the quantities in stock and
quantities on order. The final column shows the cost of the product, according to the prices
gathered from the suppliers in the last procurement placed. These prices will be updated once proforma invoices from suppliers are received.
Pack prices
Total needs (
tablets or ml)
Stock on
hand
(end of
September)
Stock on
order
Quantity to
order
( bottles and
boxes)
Total prices
AZT 300mg/ tab
$15.47
1,082,270
0
0
18,038
$279,085.08
AZT syrup/ml
$7.70
1, 238,863
0
0
12,389
$95,441.98
D4T30+3TC+NVP/ tab
$13.32
221,460
0
0
3,691
$49,167.26
D4T40+3TC+NVP/tab
$14.49
361,320
0
0
6,022
$87,243.56
AZT+3TC/ tab
$16.05
216,615
0
0
3,610
$57,944.55
D4T 30mg /caps
$3.46
44,296
0
0
791
$2,735.43
D4T 40mg/ caps
$3.48
72,296
0
0
1,291
$4,490.70
3TC 150mg/ tab
$5.72
116,639
0
0
1,944
$11,128.33
LPV/r /tab
$47.67
24,975
0
0
139
$7,077.34
NVP syrup/ml
Free
12,389
0
2,400
500
N/A
NVP 200mg/tab
Free
166,627
0
3,000
2,727
N/A
TOTAL COST
$594,314.22
Prices per Box or Bottle of Product3
AZT+3TC
$
16.05
AZT 300 mg
$
15.47
D4T 30mg
$
3.46
AZT syrup
$
7.70
D4T 40mg
$
3.48
D4T30+3TC+NVP
$
13.32
3TC
$
5.72
D4T40+3TC+NVP
$
14.49
Ritionavir/lop
$
51.01
AZT+3TC
$
16.05
3
Prices used according to the procurement placed in June 2005. Need to be adjusted.
-7-
Quantification of ARVs for PMTCT. December 2005. Rwanda
Final Draft for Discussion. MSH/RPM Plus
Estimation of Contribution per Program according to Number of Sites
The following table shows the contribution per program based on the number of sites that each
program is supporting. It has been assumed that the % of sites that each program will support will
be maintained over the following months. Adjustments could be made if more accurate
information regarding targets and ceilings on patients and number of sites is facilitated by the
different contributors.
# of Sites
% of Total
Contribution
per program
USD
COAG (TRAC/CDC)
2
1%
$5,973.01
Concern (Global Fund)
1
0.5%
$2,986.50
E.P.R (FHI / IMPACT)
1
0.5%
$2,986.50
EGPAF
18
9.0%
$53,757.07
FHI
25
12.6%
$74,662.59
Global Fund
107
53.8%
$319,555.89
IntraHealth
19
9.5%
$56,743.57
MSF Belgique
2
1.0%
$5,973.01
OMS
5
2.5%
$14,932.52
UNICEF
16
8.0%
$47,784.06
AVSI
1
0.5%
$2,986.50
MAP
1
0.5%
$2,986.50
Med. M (Global Fund)
1
0.5%
$2,986.50
199
100%
$594,314.22
Total
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Quantification of ARVs for PMTCT. December 2005. Rwanda
Final Draft for Discussion. MSH/RPM Plus
5. OBSERVATIONS AND RECOMMENDATIONS
A successful implementation of the new PMTCT protocols will require to put in place a good
monitoring system to gather systematically information from the sites on mothers developing
toxicity to NVP, and on % of mothers seeking PMTCT services with anemia.
In addition, it will be also necessary to gather data on the number of mothers under each of the
different regimens, in order to monitor the adherence of the clinicians to the new protocols. If
clinicians do not adhere to the protocols, the theoretical estimations of drugs based on population
data will not correspond to real consumption.
More accurate information concerning the number of mothers and infants expected to be treated
by site and program will allow a better estimation of the contribution by program. Although the
average number of mothers treated by site might provide enough information to estimate national
needs of ARVs for PMTCT, this information is insufficient in order to develop a plan for
distribution of products by site and by program.
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