World Journal of AIDS, 2012, 2, 259-264
doi:10.4236/wja.2012.23034 Published Online September 2012 (http://www.SciRP.org/journal/wja) 1
Highly Active Antiretroviral Treatment (HAART) for the
Prevention of HIV Mother to Child Transmission (PMTCT)
at Roosevelt Hospital’s Infectious Diseases Clinic in
Guatemala: The Role of (LPV/r) Standard Dose
Carlos Mejia Villatoro¹, Maria Eugenia Luarte1, Guillermo Villatoro Natareno1, Julio Werner Juárez1,
Claudia Maria Rodríguez1, Aura Bertila Gonzalez1, Claudia Marleny Pérez1, Marisol Martinez2
1Infectious Diseases Unit, Roosevelt Hospital, Guatemala City, Guatemala; 2Medical Division, Abbott Laboratories, Chicago, USA.
Received July 2nd, 2012; revised August 3rd, 2012; accepted August 10th, 2012
ABSTRACT
Introduction: The transmission of HIV from mother to child is reported from 30% to 40% without any intervention [1].
When all the measures for prevention are implemented, in cluding treatment with HAART (Highly Active Antiretroviral
Treatment), the rate of infection can be reduced between 1% and 2% [2]. In Guatemala, the statistics demonstrated an
estimated of 20,000 women living with HIV virus infection during the period of 2009. In this scenario, mother to child
HIV transmission is an important public health fact. In preliminary reports, there is strong evidence of the impact of
preventing mother to child transmission with Lopinavir/Ritonavir in Guatemala is showing a small incidence of new
HIV infections and good to lerance [3,4]. Objective: To evaluate the effect of HAART with Lopinavir/Ritonavir on the
prevention of mother to child transmission (PMCT) in HIV-positive pregnant women at Roosevelt Hospital in Guate-
mala City. Methods: A retrospective cohort analysis study. The detection of pregnant HIV positive women and the fol-
low up period was from January 2003 to December 2009, and a total of 219 women completed the follow up time. The
HIV diagnosis and follow up for the ch ild was made with molecular testi ng an d antibody testing up to 18 months of age
or until testing was negative. Adherence was quantified by pill counts. The interventions where offered to all the
women in the cohort. Results: Regarding the pregnancy outcome, the study cohort gave a rate of abortion of 2.3%;
10.6% of preterm births and 79.6% normal births. Of the 202/219 children born, there was a 1.4% rate of transmission
(n = 3). The three infected children were born from mothers with high basal viral loads (50,000 C/mL or higher). There
were no serious adverse events related to antiretroviral therapy with Lopinavir/Ritonavir, with a 6.1% of non serious
adverse events, most of them of gastroin testinal type, and anemia. Conclusions: The rate of transmission of HIV from
mother to child was low in this population (1.4%), comparable to findings from similar studies [4]. Lopinavir/Ritonavir
was well tolerated in this cohort and no serious adverse events in this populatio n were reported.
Keywords: HIV; Antiretroviral; Pregnancy; Lopinavir-Ritonavir
1. Introduction
The prevalence of HIV/AIDS in Guatemala proves to be
the estimated of 0.9% in 2011 in the general population
[1]. From January 1984 to December 2010, the national
Guatemala STDs/HIV/AIDS program reported 22,647
cases of HIV/AIDS, of whom 38% (n = 8553) were
women. An important note is that 5% of the cases relate
to children under the age of 4 years. Mother to child
transmission (MTCT) represents 5.1% of the infections.
In pregnant women the prevalence is between 0.4 and
0.5%; in urban areas the range varies between 0.26 and
1.40%, at the rural areas between 0.13% and 0.16% [4,5].
Prevention of mother to child transmission (PMTCT)
programs have been implemented since 2002 in the na-
tional hospitals in Guatemala, at that time also has been
developing the first national guide for the management of
pregnant HIV positive women. Starting in 2005, the ser-
vices of PMTCT were expanded to cover also rural hos-
pitals; specially in those areas where greater number of
cases were reported, with the support of non-govern-
mental organizations (NGOs), the Global AIDS Founda-
tion UNICEF and other international organizations [6,7].
Highly active antiretroviral therapy (HAART) has
been shown over the past decade to have a great impact
in preventing MTCT in developed countries. The stan-

Highly Active Antiretroviral Treatment (HAART) for the Prevention of HIV Mother to Child Transmission (PMTCT)
at Roosevelt Hospital’s Infectious Diseases Clinic in Guatemala: The Role of (LPV/r) Standard Dose
260
dard of care to prevent mother to child transmission has
changed over the years, from single dose nevirapine
(NVP) to HAART. There are several specific evaluations
of large numbers of pregnant patients who have been
taken different HAART schemes, but there is still dis-
cussion about potential side effects of some of the anti-
retroviral drugs dur ing the pregnancy. The ver tical trans-
mission of HIV in children whose mothers were exposed
to various schemes of HAART has been reduced to less
than 1% - 2% [2,8,9], when using all of the associated
preventive measures that are considered effective ac-
cording to current scientific evidence. These measures
include: active detection of HIV infection in antenatal
care and at the time of delivery, timely initiation of
HAART during pregnancy and/or labor, emergency ce-
sarean section (ECS, clear efficacy in patients with viral
loads higher than 1000 copies/ml), prophylactic use of
antiretrovirals in the exposed children and avoidance of
breastfeeding when possible [8-10].
In this study, a cohort w ith more than 500 patients who
received HAART during the years of 2003-2010, inclu-
ding 219 pregnant women exposed to lopinavir/ritona-
vir (LPV/rtv), The results allowed the Guatemalan inves-
tigators to have a better understanding of the impact of
this drug, both in pregnant women and in their children
[9-11].
2. Methods
2.1. Study Design
Retrospective analysis of a Cohort of HIV positive pr eg-
nant women, from January 2003 to January 2010. All pa-
tients attended the Infectious Diseases Clinic from Roose-
velt Hospital, located in Guatemala City, Guatemala.
All pregnant women diagnosed with HIV infection
from January 2003 to January 2010were included. The
total number of LPV/rtv treated patients was 219.
Inclusion criteria: Any patient who received antiret-
roviral therapy during pregnancy by certain time, includ-
ing combined HAART with LPV/rtv, standard dose, for
at least 15 days prior to the resolution of the pregnancy.
Exclusion criteria: Patients who after the diagnosis
did not continue the follow up and in whom the devel-
opment of the newborn was unknown and/or patients
who did not re ceive HAART durin g pre gnancy.
Data sources: All data was obtained from the clinical
records from the patients, at the Infectious Disease Clinic,
from Roosevelt Hospital, in a retrospective time. Phar-
macy information was collected during each visit to de-
termine the level of adherence, and adverse events data
were obtained from the clinical records and a specific
database used for recording pharmacy events.
The evaluation of both acute and chronic adverse
events was based on the classification of the US Division
of Acquired Immunodeficiency Syndrome (DAIDS), at
the National Institute of Allergy and Infectious Diseases
(NIAD). All serious adverse events were reported within
24 hours of awareness, to Pharmacological vigilance au-
thorities. The adherence was calculated by pill counts in
each clinical visit by a pharmacist.
The research protocol was approved by the Committee
for Teaching and Research of the Roosevelt Hospital and
the Hospital authorities. The writing consent, was not
required given the retrospective nature of the study. All
data were tabulated and analyzed taking into account
patient confidentiality.
Data Analysis: The data collected were analyzed ac-
cording to the following scenarios that could have oc-
curred during pregnancy: 1) initial diagnosis of HIV in
pregnant women and initiation of antiretroviral therapy
during this period; and 2) diagnosis of pregnancy in
women who were already taking antiretroviral therapy.
All the pharmaceutical related information, including
tolerance, adherence rates, and incidence of adverse
events was obtained from the records of the patients. All
the data were tabulated and analyzed using descriptive
statistics. For assessment of risks, the relative risk ratio
(RR) was determined; and the chi square test was calcu-
lated for categorical variables to assess statistical signifi-
cance, with a 95% confidence. All analyses were done
using the EpiInf o 3.5.1 software.
Laboratory Testing: The serological diagnosis of the
patients, adults and children, was made according to the
national protocols from Guatemala.
The CD4 cell count was determined using FACSCoun t,
from Beckton Dickinson (San José, California). When
available, viral load was determined using COBAS Am-
pliprep/COBAS Taqman from Roche Molecular Diag-
nostics (Alameda, Californi a) version 1.0.
Definitions: Seroumreversion was considered in a
child, born from an HIV positive mother, with a rapid
test for HIV 12 positive, and with a follow up period
of 9 to 18 months until the rapid test became negative. At
this moment, a second test, in this case immune enzy-
matic, was done to confirm the negative result.
3. Results
Cohort Description: From January of 2003 to January
of 2010, 219 HIV-positiv e preg nant women, were treated
with LPV/rtv, of which 179/219 (81.7%) patients remain
in the program with regular follow-ups, after the preg-
nancy resolution, at the end of the year 2010. 3.7%
(8/219) were already HIV patients in HAART at the
moment of the pregnancy detection. All the other patients
were newly HIV diagnosed with the screening test in
antenatal care. The average age of the cohort was 26
years (range 16 - 43). Regarding educational status,
12.8% of the cohort reported to be illiterate; and 87% had

Highly Active Antiretroviral Treatment (HAART) for the Prevention of HIV Mother to Child Transmission (PMTCT)
at Roosevelt Hospital’s Infectious Diseases Clinic in Guatemala: The Role of (LPV/r) Standard Dose
261
less than 6 years of education.
Demographics: The average number of CD4+ cells/mL
was 329 (range: 2 - 1034). 70% of the women had more
than 200 CD4+ cells/mL. Viral load data was not avail-
able for the entire cohort. 187/219 had viral load (VL)
results available for analysis. The mean VL was 4.84
log10 copies/mL (range: Undetectable-6.26). 66% of the
patient had less than 50,000 copies/mL (4.68 log10). The
data are summarized in Table 1.
Antiretroviral Treatment History
All the patients in the cohort took antiretroviral treat-
ment, the main difference was the time of pregnancy in
which therapy began. It was found that 105/219 (48.4%)
of pregnant women began their follow-ups within the
first trimester of gestation, 67/219 (30.9%), started dur-
ing the second trimester and 45/219 (20.7%) in the third
trimester. ARV treatment was started from week 14 in
newly-diagnosed patients; treatment of the patients who
were already in ARV treatment was not interrupted, pa-
tients taking AZT-3TC + Efavirenz (EFV) were switched
to AZT-3TC of TDF-FTC + LVP/rtv.
The level of adherence (pills counts) was properly
registered for 71.8% (n: 156) of women. The average
level of adherence was 97.3%, based on compliance with
scheduled appointments and pill counts in each visit.
Women in whom the level of adherence could not be
registered did not have records because the y had bee n o n
therapy for less than a month.
Pregnancy outcomes: Out of the 219 pregnant wome n
in follow ups, n/219 (79.3 %) delivered at term infants,
n/219 (10.6%) delivered live preterm infants, x/219
(4.6%) delivered stillbirths and 5/219 (2.35%) had spon-
taneous abortions (Table 2). Mean gestational ag e of live
births was 36.8 weeks (range WX-40). All pregnancies
ended in an average of 36.8 weeks (range week 10-week
40); 79.3% of the women did not report any adverse
events during pregnancy. Registered adverse events were
as follows: 5 abortions 5/219, for a probability of 2.35 ×
every 100 births; 7/219 (3.2%) of the mothers reporteda
threat of premature birth. 2/179 (1.1%) of the children
died in the perinatal period; the mean age for preterm
infants was 31.3, (range w. 30 - 33) located between the
30 and 33 weeks of pregnancy (Table 3).
Table 4 describes pregnancy outcomes and calculated
HR ratios according to BL CD4+ cells (or CD4 closest to
delivery, which one?). A statistically significant rela-
tionship was found between CD4+ T cell count lower
that 200 and abortion, HR 4.8 times higher compared to
women with CD4+ T cell count > 200. In addition a sta-
tistically significant relationship was found between HIV
RNA VL > 50,000 c/mL at the time of HAART initiation
and the risk for stillbirth, and pr eterm deliveries, HR 3.08
when compared to women with HIV RNA VL < 50,000
c/ml. All other risk calculations were not statistically
significant.
Infant Outcomes: From 219 pregnancies, 92.2% of the
Table 1. Cohort description.
Basal CD4 Basal viral load
Month of pregnancy in
which started HAART <200 >200 Total % <50,000 >50,000 Total %
1 to 3 months 21 84 105 48.4 79 15 94 50.3
4 to 6 months 28 39 67 30.9 37 18 55 29.4
7 to 9 months 14 31 45 20.7 26 12 38 20.3
Total 63 154 217 100 142 45 187 100
Average 128 (SD:
191 cells/uL) 411 (SD: 193.7 cells/uL) 329 (SD: 194.3 cells/uL)- 10,235 (SD: 14,441 cp/mL)243,741 (SD: 377,289 cp/mL) 66,426 (SD: 209,403 cp/mL)-
Range 2 - 199 201 - 1034 2 - 1034 - Undetectable
- 48400 50,021 - 1,840,000 Undetectable - 1,840,000 -
Table 2. General outcomes of pregnancy in HIV women with HAART.
Adverse events Deaths Alive Total %
Infected children 03/219 3 1.4%
Abortion 05/219 5 2.3%
Stillbirth 10/219 10 4.6
Premature birth 07/219 7 7 3.2%
Normal birth 2 after birth 170 172 79.3%
Lethality 17/219 17

Highly Active Antiretroviral Treatment (HAART) for the Prevention of HIV Mother to Child Transmission (PMTCT)
at Roosevelt Hospital’s Infectious Diseases Clinic in Guatemala: The Role of (LPV/r) Standard Dose
262
Table 3. Pregnancy outcomes and r i sk determination.
Adverse Outcome <200 T CD4
cells >200 T CD4 cells % RR VL < 50,000 cp/mLVL > 50,000 cp/mL % RR
Abortion 3 2 11.1 4.8
(CI 95%: 1.62 - 14.65)2 1 10.7
1.85
(CI 95% 0.71 - 4.82)
APP 1 6 15.6
0.78
(CI 95%: 0.11 - 5.36 ) 1 3 14.3
0.6
(CI 95% 0.10 - 3.50)
Still birth 10 22.2 0 2 6 28.6 3
(CI 95% 1.27 - 7.08)
Premature bi rth 4 19 51.1 0.96
(CI 95%: 0.27 - 3.36 ) 8 5 46.4
3.08
(CI 95% 1.02 - 9.24)
Total 8 37 100 - 17 11 - -
Table 4. Mother to child transmission rate in relation to diverse parameters.
Parameter Outcome
Not infected Infected Total
Adherence of the mother
More than 95% 134 1 135
Less than 95% 21 - 21
Not available 61 2 63
Maternal Viral load
<1000 67 - 67
1001 to 10,000 26 - 26
10,000 to 50,000 48 1 49
50,001 and 100,000 15 - 15
>100,000 28 2 30
Time of HAART during pregnancy
<4 weeks 21 - 21
4 to 12 weeks 43 - 43
>12 weeks 152 3 155
Gestational age at birth
Abortion 5 - 5
Preterm birth 13 - 13
Normal birth 198 3 201
HIV infection determination using viral load
<1 month 8 - 8
1 - 4 months 160 3 163
>4 months 15 - 15
Not available 33 - 33
Antibody seroumreversion
6 - 12 months 64 - 64
12 - 18 months 46 - 46
>18 months 5 - 5
Not available 101 3 104

Highly Active Antiretroviral Treatment (HAART) for the Prevention of HIV Mother to Child Transmission (PMTCT)
at Roosevelt Hospital’s Infectious Diseases Clinic in Guatemala: The Role of (LPV/r) Standard Dose
263
children were born alive. Of the 202 born children, 12%
were born from mothers with baseline viral load >
100,000 c/mL and 33% from mothers with Bl VL be-
tween 50,000 and 100,000 c/mL. Regarding additional
interventions for preventing transmission, 96% of chil dr en
were delivered by caesarean section, 92.6% received
zidovudine (AZT) during labor, 100% of children re-
ceived oral suspension of AZT, and 99% were bottle fed
(Table 4).
The calculated mortality in the post neonatal period
was 2.94%. Of the total of live births, 1.4% were identi-
fied as infected, 7.8 per cent were transferred to other
clinics for their follow-ups as not infected, and 81.3%
completed the follow-ups with serore version of anti-
bodies. All children with negative results for HIV RNA
during the first six months of life were confirmed as
negative with antib odies, at the end of fo llow-up between
12 months and 18 months of life (Tables 3 and 4).
Tolerance to ARV therapy was good; only 6.1% of pa-
tients treated with LPV/rtv reported adverse events. All
adverse events were not serious and predominantly of
gastrointestinal type. There were no serious adverse
events or adverse events affecting adherence or requiring
changes to the scheme of treatment, with the exception of
anemia related to zidovudine (AZT).As per published
guidelines (Ref) EFV at the beginning of pregnancy was
switched to Lopinavir/rtvfor its potential teratogenic ef-
fects.
4. Discussion
The results of our cohort of patients identified by a regu-
lar screening program in a resource limited country
demonstrate that such programs are feasible and can pro-
vided access to high quality regular care to HIV-1 posi-
tive pregnant women. The patients in this cohort be-
longed to a Hispanic, mestizo population in Central
America, and attended a tertiary referral hospital in Gua-
temala City. This model resulted in a successfu l program
in which treatment with HAART including a PI (lopi-
navir/r) was implemented [12,13].
Antiretroviral therapy has proven to be a fundamental
intervention in the prevention of the transmission of
HIV-1 from mother to child. As demonstrated since the
1990s in the ACTG 076 study, the use of AZT adminis-
tered both from pregnancy and during childbirth to the
mother and in the postpartum to the baby, showed a re-
duction of 68% of the risk of transmission. The use of
triple therapy, which includes drugs such as NPV, and
subsequently protease inhibitors starting with nelfinavir
and then followed by LPV/rtv, has become the standard
of management. Such combination regimens have suc-
ceeded in decreasing the transmission rate to less than
1% - 2% in the majority of tertiary referral centers
around the world [11,13-15].
In this study, has been demonstrated good maternal
and pediatric outcomes with the use of triple therapy that
included LPV/rtv in a low income country. Despite some
challenges associated with educational and social aspects
of the participating women, those were addressed with
the use of a multidisciplinary team. This cohort represents
a successful PMCTC program. The incidence of infected
children was lower than 2%, and a high proportion of
women (79%) had no adverse pregnancy outcomes.
There are few publications with large numbers of
pregnant women who have been treated with LPV/rtv,
standard dose, during pregnancy. That is an important
contribution of this study, given that 219 pregnant
women receiving ARV combination, involving LPV/rtv,
without evidence of increase in the number of adverse
reactions compared to published reports. Also, compar-
ing to the national statistics, there was not an increase in
the number of abortions, stillbirth or premature labor in
this cohort. Also, it is important to note th at the tolerabil-
ity and safety of LPV/rtv was adequate in this cohort; no
treatment failure due to intolerance or toxicity was been
observed, and most adverse events were of gastro-intest-
inal type, were mild to moderate, were self limited or at
most required use of antiemetics [16-18].
Regarding the two children that died after the n eonatal
period; both deaths were attributed to several gastrointes-
tinal community acquired infections and were felt not to
be related to the PMTCT program.
On the individual analysis of the three infected chil-
dren, several aspects are important. It is importan t to note
that two of the children were twins; therefore, HIV
transmission occurred in only two mothers. In the three
cases, the mothers had baseline CD4+ cell counts higher
than 200 cells/uL, but the mother of the twins presented
with a baseline viral load of 1,840,000 cp/mL (6.26 log)
and the other one with 48,000 cp/mL (4.68 log). In the
case of the twins, the viral load higher than 6 logs sug-
gests a recent infection, and the mother also reported
suboptimal adherence to the HAART. In the other case,
the infection was unexpected because the mother re-
ported good adherence and had a low baseline viral load.
In the three cases, the same post delivery measures were
provided: AZT after delivery and artificial feeding. No
viral loads controls after beginning of ARV treatment
were performed.
This study had several limitations: 1) although not all
women had CD4+ cell counts measured at every visit,
the available information was useful to classify the
women in various risk groups, as shown in the Table 4.
Not all the women had CD4 cell counts, not all the
women had viral loads, although p ill counts are a reason-

Highly Active Antiretroviral Treatment (HAART) for the Prevention of HIV Mother to Child Transmission (PMTCT)
at Roosevelt Hospital’s Infectious Diseases Clinic in Guatemala: The Role of (LPV/r) Standard Dose
264
able measure of adherence, no other adeherence meas-
ures were used, and there was no control arm.
This is an important perspective for a low income
country; it shows that triple combination therapy with a
PI is feasible and better than alternative interventions
such as single dose nevirapine, that can led to higher lev-
els of infections and antiretroviral resistance. The favor-
able maternal and pediatric outcomes and the positive
safety and tolerability of the regimens reported in this
cohort in this setting should be replicated by other
groups.
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