Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Mohan Z Mani

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On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



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Professor and Head
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Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
ĎKnowledge is treasure of a wise man.í The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
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Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




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"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




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" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help oneís reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journalsĖNo manuscriptsĖNo authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2021 | Month : July | Volume : 15 | Issue : 7 | Page : OC01 - OC05 Full Version

Safety and Efficacy of Fixed Drug Combination Tenofovir, Lamivudine and Efavirenz to Prevent Transmission of HIV


Published: July 1, 2021 | DOI: https://doi.org/10.7860/JCDR/2021/48320.15076
Pramendra Sirohi, Anubhav Dabas, Hardeva Ram Nehara, Atma Ram Chhimpa, Mahesh Kumar Barodia, Rakesh Kumar

1. Senior Professor, Department of General Medicine, SP Medical College, Bikaner, Rajasthan, India. 2. Senior Registrar, Department of General Medicine, SP Medical College, Bikaner, Rajasthan, India. 3. Associate Professor, Department of General Medicine, SP Medical College, Bikaner, Rajasthan, India. 4. Assistant Professor, Department of General Medicine, SP Medical College, Bikaner, Rajasthan, India. 5. Senior Registrar, Department of General Medicine, SP Medical College, Bikaner, Rajasthan, India. 6. Senior Registrar, Department of General Medicine, SP Medical College, Bikaner, Rajasthan, India.

Correspondence Address :
Hardeva Ram Nehara,
77, Adrash Colony, Near Varsha Ritu, Ambedkar Circle, Bikaner, Rajasthan, India.
E-mail: drnehara@gmail.com

Abstract

Introduction: Mother-to-child transmission of HIV can occur during pregnancy, labour, or breastfeeding. The first-line regimen for prophylaxis in HIV infected pregnant women is combination of Tenofovir, Lamivudine and Efavirenz (TLE).

Aim: To evaluate the safety and efficacy of the TLE regimen in the Prevention of Mother-To-Child Transmission (PMTCT) of HIV.

Materials and Methods: The present hospital-based, retrospective cohort study was conducted at ART centre, Prevention of Parent to Child Transmission (PPTCT) centre, and Department of Medicine, SP Medical College, Bikaner from July 2016 to June 2019. HIV positive gravidas, on triple-drug regimen TLE (Tenofovir 300 mg, Lamivudine 300 mg, Efavirenz 600 mg) before conception and, those detected HIV reactive antenatally during study period were included in this study and started on TLE regimen. After delivery, these newborns were given syrup Nevirapine as per the PPTCT guidelines. Infants were tested with Rapid test and PCR for HIV, at six weeks, six months, 12 months, and 18 months of life.

Results: Out of 87 pregnant women, enrolled and delivered at the study institute, 85 were live births and two were stillbirths. Out of 85 live-born babies, four have died during infancy and two were lost to follow-up despite repeated counselling. Five babies were referred to nearby Anti-Retroviral Therapy (ART) centers. So, the study followed 74 babies out of which one girl child was found to be positive for HIV-1 at 18 months of age (transmission rate of HIV was 1.35 and efficacy of TLE 98.65%). No major adverse effects of TLE were noted and all women continued TLE.

Conclusion: The use of a triple-drug regimen (TLE) declined the risk of transmission of HIV from mother-to-child at negligible level, without drug resistance and with safety and tolerability as compared to single drug.

Keywords

Anti-retroviral therapy, Prevention, Transmission

According to WHO, approximately 37.9 million people were living with HIV and 1.7 million new infections and 7,70,000 people died from AIDS-related illnesses in 2018 (1). According to the National AIDS control organisation (NACO) report, an estimated 2.14 million people were living with HIV in India, out of which around 42% were females and children (<15 years) accounted for 6.54%. In India, an estimated 87.58 thousand new HIV infections occurred in 2017, and children <15 accounted for 4.3%. An estimated 22,677 pregnant women needed ART to PMTCT of HIV in 2017 in India (2).

Parent-to-child transmission is responsible for around 5% of HIV infection. It is the second most common mode of transmission of HIV after sexual transmission. In the absence of any interventions, HIV transmission from mother-to-child can be 15-45%. Mother-to-child transmission of HIV can occur during pregnancy, labour, or breastfeed¬ing. The prevalence of HIV in pregnant women was reported 0.5-3.3% in India. To reduce the burden of the disease by preventing the transmission from parent to child, in March 2014, the NACO started more efficacious multidrug ARV regimen in the national guidelines for the PMTCT of HIV program (3).

In the year 2015, WHO recommended antiretroviral therapy for all HIV positive pregnant women regardless of CD4 cell count and to continue ART lifelong. Infants born to HIV-infected mothers should also receive post-exposure antiretroviral prophylaxis (4). The recommended first-line regimen for ARV prophylaxis in HIV infected pregnant women is Teno¬fovir 300 mg+Lamivudine 300 mg+Efavirenz 600 mg (TLE), similar to nonpregnant adults. TLE regimen is preferred because of fewer side-effects, once-daily dosing schedule, increased adherence, and reduced risk of resistance (3),(4).

Early screening of antenatal mother, administration of ART and lifelong continuation, institutional delivery, follow-up and administration of ART to the infant and contraception are crucial for PMTCT of HIV (5). This study was designed to assess the socio-demographic variables, pregnancy outcome, safety, and efficacy of the TLE regimen for PMTCT in seropositive mothers.

Material and Methods

The present hospital-based, retrospective cohort study was conducted at ART centre, PPTCT centre, and Department of Medicine, SP Medical College, Bikaner from July 2016-June 2019. It is a tertiary care centre in northwestern Rajasthan (India). The study protocol was approved by the Institutional Review Board {No: F.29. (Acad) SPMC/2019/4160} and informed consent was taken from each study subject for initiation of the drug regime.

All the HIV-1 reactive pregnant females who had been taking ART regimen TLE before conception and continued during the antenatal and postnatal period formed the study population. The data belonged to July 2016-June 2019 and the analysis was done in December 2019. As this was a retrospective study, so all the available patient records were considered.

Inclusion criteria: HIV-1 reactive pregnant females who had taken Fixed Drug Combination (FDC) of TLE before delivery and babies born to them who had received syrup nevirapine as per the PPTCT guidelines (3).

Exclusion criteria: Those HIV-1 positive pregnant females who had refused to give syrup nevirapine to their babies and who didn’t give consent for testing the HIV status of their babies.

Study Procedure

Detailed proforma were filled from hospital records which included information regarding demo¬graphics, socioeconomic factors, obstetric history, history of a spouse, testing of spouse and previous children for HIV, ART status of spouse, and WHO staging of HIV/AIDS (2),(6). Socioeconomic status was determined in this study by the modified BG Prasad scale 2018 (7). Detailed investigations including complete blood count, plasma glucose, renal function, liver function, CD4 counts, HBsAg, HCV, etc., were done. Details about any minor (gastrointestinal) or major (haematological, pancreatitis, renal dysfunction, hepatotoxicity etc.,) adverse reactions to the TLE regimen were noted from hospital records. The mode of delivery and outcome of the baby was also noted.

Postexposure prophylaxis, in form of syrup nevirapine 2 mg/kg, was started within 6-12 hours of delivery and was continued for six weeks, if the mother was started on ART within 12 weeks of gestation; while it was continued up to 12 weeks if mother had started ART after 12 weeks of gestation. Mother was counselled and advised for the choice of alternative feed or breast-feed and contraceptive advice was given. After delivery, all infants were registered and serial screening was done for babies by PCR and rapid test for HIV at six weeks, six months, 12 months and 18 months of age. Samples in the form of Dried Blood Spots (DBS) and plasma were taken at the ICTC center of the institute.

Statistical Analysis

Quantitative and qualitative data were analysed at the end of the study period and the findings were used to evaluate the safety and efficacy of the TLE regimen for PMTCT in HIV reactive mothers and the possible contributory factors affecting HIV transmission to the baby.

Results

A total of 87 seropositive gravidas were enrolled and delivered in the same institute. The mean age of the study subjects was 25.4±3.66 and ranged from 19 to 39 years. The majority of them were illiterate (66.67%), were of socioeconomic class IV and V (53.47%), were residing in a rural area (62.07%), and were housewives (39.08%). In terms of WHO staging of HIV out of 87 subjects, 32 were in stage I, 24 were in stage II, 18 were in stage III and 13 were in stage IV disease, respectively. All of the women with stage III and IV disease were already diagnosed preconceptionally were on ART. Out of 87, 7 women (8.04%) had coexisting Hepatitis B infection and none had co-existing Hepatitis C infection. Out of 87 women, 68 (78.16%) had CD4 count of ≤500/mL and 19 (21.84%) had CD4 count of >500/mL. Voluntary testing of the spouse was done for 69 patients out of whom 64 couples were seroconcor¬¨dant and five couples were serodiscordant (Table/Fig 1).

In terms of parity, majority 36 (41.38%) were primipara. Total 33 (37.93%) women were preconceptionally diagnosed as HIV seropositive and already on the TLE regimen. Out of 87 women, 54 (62.07%) were diagnosed HIV reactive during the antenatal check as a part of the PPTCT program, out of which three (3.45%) started TLE regimen in first trimester, 26 (29.88%) in second trimester and 25 (28.73%) in third trimester. All women were compliant and took the TLE regimen regularly. No major adverse effects of drugs were noted except minor gastrointestinal side-effects and all women continued TLE regimen till last follow-up (Table/Fig 1).

Of the total 87 gravidas, 79 (90.81%) were delivered by vaginal delivery, and 8 (9.19%) by caesarean section due to obstetric indications. Out of these 87 deliveries, two were stillbirth and four babies died in the infantile period due to diarrhoea, acute respiratory illness, malnutrition, and unknown reason respectively. The mean birth weight of infants delivered was 2.61±0.45 kg. Out of 85 live births, 30 babies were low birth weight (<2.5 kg), 78 (91.76%) were breastfed and seven (8.13%) were top-fed. Two women lost to follow-up, even after repeated counseling and five babies were referred to nearby ART centers. So the study followed 74 infants for mean follow time of 18 months. In these 74 babies, 73 were negative for HIV and one girl child tested positive for HIV during follow-ups at 18 months of age (transmission rate was 1.35% and efficacy of TLE 98.65%) (Table/Fig 2).

Discussion

The United Nations program on HIV/AIDS reported that 82% of pregnant women living with HIV had access to antiretroviral medicines to prevent transmission of HIV to their child in 2018 (1). All HIV infected pregnant women have to be detected and provided with timely ART in order to reduce mother to child transmission and ultimately to eliminate paediatric HIV (8). According to the latest guidelines of ACOG, the treatment of HIV-infected pregnant women with combined ART can achieve a 1-2% or lower risk of mother-to-child transmission if the maternal viral load of 1000 copies/ml or less can be sustained, independent of the route of delivery (9). This study was aimed to evaluate the safety and efficacy of the TLE regimen in the PMTCT of HIV. The efficacy of TLE was found to be 98.65% with no without major adverse effects.

The mean age of the study subjects was 25.4±3.66 and ranged from 19 to 39, similar to previous studies (10),(11). In this study, majority of the women (66.67 %) were illiterate, similar to study done by Saha S at al., (12). A higher illiteracy rate in this study may be explained by the fact that the majority of women were from low socioeconomic class (53.47 %). Illiterate women are susceptible to HIV/AIDS because of the inability to have adequate knowledge for protection from sexually transmitted diseases (13). Poverty and illiteracy increase susceptibility to HIV/AIDS particularly in developing countries like India (13),(14),(15),(16).

In terms of parity, 34.48% of women were nullipara, 41.38% were primipara, 24.14% were multipara, similar to previous studies (10),(14). A family obligation, social pressures like the stigma of infertility and inability to terminate the pregnancy seems to be important for the repeated pregnancies in seropositive women (9),(13). Out of 87 women, 54 women were detected seropositive in the present pregnancy as part of PPTCT while 33 women were diagnosed precon¬¨ceptionally. Of these, 14 women were diagnosed as a part of the PPTCT program during previous pregnancies, 11 women were detected after the husband was diagnosed as seropositive, while eight women were detected seropositive while being investigated for other medical conditions. Hence, 78.16% of the total subjects were diagnosed due to the reach of the PPTCT program. In contrast, a study done by Daver RG and Chhabra M. showed that 64.5% of cases were diagnosed as part of the PPTCT program and Izzo l et al., reported that 43.1% of patients were detected antenatally, whereas 53.9% were detected preconceptionally (11),(16). As antenatal clinics are a woman’s first point of contact with the health care system in developing countries, HIV testing integrated with such clinics is the main reason for the detection of HIV in women who would not otherwise get tested.

In this study, out of 69 couples 64 (92.75%) were sero¬concordant, and five (7.25%) were serodiscordant. Daver RG and Chhabra M. and Darak S et al., reported 64.5% vs 30.1% and 79.4% vs 7.7% sero¬concordant and serodiscordant couples, respectively in their studies (11),(17). In a study from India, Shah I reported prevalence of serodiscordance among HIV infected pregnant women of 6.7% (18). Serodiscordance was found which could be because the spouses were in the window period.

In this study, majority of women 68 (78.16%) had a CD4 count of ≤500/mL, similarly to other previous studies (5),(17). Contrary to this in study done by Onoya D et al., majority of women had CD4 count >500/mL (19). In this study, 33 (37.93%) women were already on ART, and majority of women started ARV in the second and third trimester. Hence, a large number of patients have started ARV regimen as a result of the PPTCT pro¬¨gram, minimising the risk of transmission signifi¬¨cantly. This finding is similar to a study done by Daver RG and Chhabra M. where 30.1% of women were already on ART and 41.57% of women started ARV in the second trimester. Similarly, in study done by Gupta A et al., 39.4% of gravidas were found seropositive during antenatal check-up (5). Izzo l et al., reported that 75% and 42.8% women were already on ART, and 25% and 57.2% women started ARV during pregnancy in Italian and migrant population respectively (16). Early start of ARV related with the reduction of peri¬¨natal morbidity and mortality for seropositive mothers (4). Those patients who started ARV late in pregnancy, the total duration of ARV received were less than those who started earlier, thereby increasing the chances of vertical transmission (11). In contrast, a study conducted by Berhan Z et al., in Ethiopia reported that 63.4% of the women were already on ART and 30.3% were started ARV as a part of the PMTCT program and 6.2% women not received ARV, with 10.1% transmission rate as 19.1% infants not received ARV prophylaxis at birth (20).

In this study, no major adverse effects of ARV were noted except minor GI side-effects and all women continued TLE regimen till last follow-up. While Daver RG and Chhabra M. reported one case of tenofovir induced Nephritis and Gallant JE et al., reported two cases of acute renal failure and 2 patients with rash in their studies where TLE was used (11),(21). Hence, this study suggests that TLE appears to be better option for HIV reactive pregnant women.

In this study, 90.81% of women delivered vaginally while 9.19% were delivered by cesarean section due to obstetric indications. This finding was similar to the studies by Lussiana C et al., (22). In study done by Gupta A et al., 66% infants were delivered by caesarean section and 44% by vaginal delivery and 2 infants found HIV reactive during follow-up and both were delivered by caesarean section (5). While Daver RG and Chhabra M. and Thorne C et al., reported 31.2% and 37% of caesarean, and 68.8% and 63% vaginal delivery respectively (11),(23). In this era of triple-drug therapy, vaginal delivery is the safer option for HIV reactive women, with minimal risk of mother to child transmission.

Out of 87 women who delivered, there were 85 live births and two stillbirths. Out of 85 living born babies, four babies died in the infantile period. HIV reactive women, especially with advanced disease, have higher rates of pregnancy loss and neonatal mortality. Excess neonatal mortality in HIV reactive women may be due to low birth weight and prematurity (22),(24). Out of 85 live births, 30 (35.3%) babies were low birth weight (<2.5 kg). Daver RG and Chhabra M. and Leroy V et al., reported 91.76% and 25.5% low birth weight baby, respectively (11),(25). Less number of low-birth weight babies in this study may be explained by the fact that most of the women in this study were in WHO stage I and II, as severity of disease increases as WHO staging increases from stage I to stage IV (6). Kim HY et al., found a positive association between an advanced maternal HIV disease with adverse pregnancy outcomes (26). Out of 85 live borns babies, 78 (91.76 %) were breastfed and seven (8.13%) babies were top-fed. This finding is similar to study by Edward M and Mofenson LM (27). In study done by Daver RG and Chhabra M 75% babies were breastfed and 25% babies were top-fed (11). In study done by Dash M et al., 82.6% babies were breastfed and 17.4% babies were on replacement feeding (28). In the year 2009, WHO recommended babies of HIV-positive mothers can have a benefit of breastfeeding with very little risk of becoming infected with HIV (29). In first six months of infant’s life exclusive breastfeeding is associated decreased risk of HIV transmission compared to breastfeeding along with top-feeding (29).

Out of 74 infants followed, 73 were negative for HIV and one tested positive for HIV during follow-ups with a transmission rate of 1.35% and efficacy rate of the TLE regimen 98.65%. One baby who was found to be HIV reactive whose DBS 1, DBS 2 and final confirmation by HIV PCR technique at 18 months of age came out to be positive for HIV-1. HIV reactive baby was a girl and born to the mother who was already taking TLE regimen for last five years before pregnancy and was breast-fed. There may be poor adherence to treatment. Moreover, pregnant who were diagnosed antenatally were diagnosed coincidently and in early stage of disease as a part of the PPTCT program with better immune status than those who were already on ART. This can be the reason that there was no mother to child transmission occurred in antenatally detected women. Gupta A et al., Daver RG and Chhabra M, and Sumithra S and Manonmani R, reported 95.35%, 100%, and 93.3%, efficacy rate respectively of TLE regimen to prevent mother to child transmission of HIV in seropositive pregnant women (5),(11),(30).

Limitation(s)

Few limitations of this study need mention. First, the retrospective nature of the study design which may introduce bias. Second, the data used were tertiary care facility-based and might not be true presentation of the community.

Conclusion

Vertical transmission is the predominant way children become infected with HIV worldwide. With improved access to ARV HIV can be significantly eliminated. The pregnant women should be offered universal screening because appropriate interventions with early initiation of ART can reduce mother to child transmission to a negligible level. In this study, the use of the TLE regimen led us to astonishing results with safety and efficacy rate of 98.65%. Fixed dose combination of TLE in pregnant women showed clear benefits for maternal health and reduction in perinatal transmission. The emerging drug resistance can be reduced with FDC-TLE compared to single dose nevirapine.

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DOI and Others

10.7860/JCDR/2021/48320.15076

Date of Submission: Dec 29, 2020
Date of Peer Review: Mar 16, 2021
Date of Acceptance: Apr 12, 2021
Date of Publishing: Jul 01, 2021

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. NA

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