HIV-AIDS Development in India - Essay Example

? HIV/AIDS in India Introduction The World Health Organization (WHO) defines Human Immunodeficiency Virus (HIV) as a virus that infects various cells in the human immune system, the most susceptible being the white blood cells referred to as the CD4 T-lymphocyte. WHO further defines AIDS on the other hand as a condition or stage of infection, which develops as a consequence of infection with the HIV virus when it enters the human body (WHO, 2010). In 2010, WHO redefined advancement of HIV infection to the AIDS stage as a fall of CD4 count to baseline level or below, or fifty percent fall from on-treatment peak value or constant CD4 count below 100 cells per cubic millimetre of blood (WHO, 2010). According to estimates by WHO and UNAIDS, approximately 34 million people are living with HIV although the degree of variance of the burden of the epidemic differs across countries and regions (UNAIDS, 2011). According to the same report, India has the uppermost populace infected with HIV/AIDS in the entire Asian region. According to studies that have been carried out in the country, the adult prevalence of HIV in India is estimated at 2.40 million people in 2009 (Pandey et al., 2012). There are various programs that have been initiated in India with targeted interventions that focus on the high-risk groups such as mothers and children and commercial sex workers (Bachani and Sogarwal, 2010) Although there is no cure for HIV, effective management is important in inhibiting the efficient replication of the virus, and in reducing viremia to levels that cannot be detected. The patient should also be provided with sufficient education and counselling in cases where antiretroviral treatment has been started in order to ensure adherence to drugs and medication. It is also important to ensure adequate training of health workers and successful intervention strategies are adopted in order to reduce the stigma and discrimination related to HIV and AIDS (Bharat, 2011; Sahay, Reddy and Dhayarkar, 2011). This paper aims to highlight one intervention that has been applied in the treatment and care of HIV/AIDS and how it has been evaluated. The objectives are to give an overview of the guidelines of administration of antiretroviral treatment (ART) in India and to finally outline an evaluation of ART in India while giving recommendations. Goals of RCT in India The major goals of the antiretroviral therapy program in India can be summarized as aiming to ensure that there is long-term provision of ART to all eligible patients. Secondly, the program strives to monitor and report treatment outcomes on a quarterly basis in addition to achieving individual drug commitment rates of 95 % or more. It is also the goal of the program to increase the life span patients so that 50% of those on ART are thriving a minimum of three years after initiation of the treatment. Lastly, the program aims at ensuring that 50% of patients on ART having jobs or return to their previous employments prior to starting the treatment (NACO India, 2007). (Guidelines of using RCT in India) When to Initiate Evidence based on randomized controlled trials (RCT) in India for starting the administration of antiretroviral therapy in patients with CD4 count of less than 350 cells per cubic millimetre of blood exist (Alvarez-Uria et al., 2012; Mrudula et al, 2012). Moreover, there have been adequate observational studies that demonstrate the effectiveness of ART in patients with a CD4 count of less than 500mm3 in reducing the number of AIDS-related deaths and clinical events including non-AIDS defining events. Most studies that have been carried out have consistently indicated the effectiveness of ART in the prevention of sexual transmission of HIV and this becomes useful in the decision of when to initiate ART in a randomized controlled trial (Cohen and Gay, 2010). Nonetheless, the benefits attributed to starting ART in the setting of acute HIV infection is very limited, therefore the initiation has to begin only in the context of clinical trial (Kumarasamy, Patel and Pujari, 2011). Before starting ART, it is important to prepare a patient despite the fact that no readiness measure has been clearly defined to predict adherence. During the preparation, there are some fundamental issues that need to be addressed including conceptual understanding of the treatment and its benefits, the significance of high level lifetime adherence to these drugs and the consequences that come with sub-optimal adherence. It is only after these initiatives and preparation process of the patient have been clearly executed that the treatment can be initiated (NACO India, 2007). What to start with In Indian setting, it is recommended that treatment should be started with a non-nucleoside reverse transcriptase inhibitor (NNRTI) based regimen given that it is more convenient, cost effective and has a lower prevalence of primary resistance in the Indian population (Kumarasamy, Patel and Pujari, 2011). This is in contrast to initiating treatment with a protease inhibitor based regimen which has similar potency but more expensive and has shown higher levels of primary resistance in the population. Efavirenz (EFV) and Nevirapine (NVP) In cases where a patients are simultaneously using rifampicin or have a preference for the once-daily regimen, or if the CD4 count is more than 250 cells per cubic millimetre in women and more than 400 cells per cubic millimetre in men, then it is recommended that Efavirenz (EFV) be used initially. On the other hand, even if the CD4 count is more that the above stated in women, if they are planning pregnancies or have underlying severe psychiatric illness, then nevirapine is preferred over the other drugs (Campbell et al., 2011). Tenofovir(TDF)/Emtricitabine (FTC) or Lamivudine As a backbone, Tenofovir/Emtricitabine or Lamivudine is the most preferred since in addition to having similar virologic response to zidovudine (AZT)/lamivudine (3TC), it has been linked with comparatively lower levels of toxicity especially in women. Furthermore, TDF/XTC is advantageous as it has a lower pill burden being a one daily pill when combined with EFV (Pujari et al., 2011). Other advantages include better sequencing options after failure of first line regimen, can be administered simultaneously in cases of underlying HBV infections that have not been diagnosed, and have been proven to be very cost-effective in India (Bender et al., 2010). The use of tenofovir has been consistently linked to renal and bone toxicity which therefore calls for additional research that would characterize the incidence and risk factors to be carried out in India (Kumarasamy, Patel and Pujari, 2011). Special Cases For women who are planning pregnancy or are found to be pregnant during the initiation of ART, AZT/3TC is better preferred although there has been evident association with higher short term haematological and long term morphological and metabolic toxicities (Agarwal, 2010). Stavudine (d4T) should however be totally avoided if possible due the long term toxicity associations it has exhibited which cannot often be reversed. In first line regimen, boosted protease inhibitor together with nucleoside reverse transinptases (NRTs) backbone should be preferred as the third drug in particular circumstances (Saravanan et al., 2012). At this point, it is important to note that some ARV combinations portray less severe potency or have the ability to relate with other prescriptions that are used. Varied lab assays need to be performed in order to make an informed choice of the suitable drug regimen prior to initiation of therapy and on subsequent follow up. This also has the advantage of helping in identifying early toxicities and efficiency of the drug regimens. Figure 1 First line regimen: What to start with Preferred TDF/XTC/EFV or NVP Alternative AZT/3TC/EFV or NVP Consider (only in special situations) ABC/3TC/EFV Use only when no other options available D4T/3TC/EFV or NVP To be avoided if possible d4T Virologic Monitoring The usefulness of virologic monitoring has come under considerable debate due to the fact that trials have indicated no significant advantage in using viral loads to appraise treatment response particularly in regard to disease progression and death in comparison to immunological and clinical appraisal. Moreover, before the decision to switch a drug or stop administration is made, the use of CD4 criteria to determine failure indicating virologic failure has poor positive predictive value and low sensitivity. (Ingole at el., 2013; Rawizza et al.,, 2011) Nonetheless, the failure to perform virologic monitoring is associated with late documentation of failure due to the fact that the period between virologic and immunologic failure can be up to numerous months or even years. This has the potential of leading to the virus being exposed to a deteriorating regimen that consequently amplifies the resistance and further cross resistance which could lead to compromising future regimens. Therefore, after virologic suppression has been achieved, it is preferable to perform viral load monitoring at least once annually. Relying on immunologic failure criteria to determine treatment failure in patients leads to unnecessary switching to more expensive second line therapy which adds to the cost and may lead to development of resistance to second line agents for patients who do not have access to third line agents. Therefore, in resource-limited settings like India for patients where virologic monitoring is possible to be performed on a more frequent basis such as two to four times annually, it is recommended to perform CD4 count monitoring on an annual basis as long as a good immunologic response has been achieved. (Vallabhaneni et al., 2013) When to switch The most common reason that generally necessitates regimen change during antitroviral therapy in Indian patients is drug toxicity. There is an array of toxicities that are linked to ART usage, some of which are acute and also particular drugs can lead to chronic toxicities. The toxicities associated with use of ART range from mild and self-limited ones to those that can cause fatalities and prove to be irreversible. Therefore, it is crucial to promptly caution the patients of the risks associated with the therapy and a discussion with the patient regarding these issues should form part of the preparation process prior to the initiation of ART (Pujari et al., 2011). In a study in among HIV infected patients in Southern India initiated on first-line ART, the most common antiretroviral toxicity the researchers observed was lactic acidos, anaemia and peripheral neuropathy which were all attributable to stavudive (D4T) and azitothymidine (AZT). Peripheral neuropathy was mainly caused by the first-line regimens containing stavudine while anaemia was mainly reported due to regimens that contained zidovidine of AZT/3CT/NVP and AZT/3CT/EFV. Other toxicities that necessitate regimen change after first-line ART initiation include central nervous system toxicities, lipodystrophy, nausea and vomiting and hepatoxicity which is mostly as a result of (NVP)-containing regimens of D4T/3TC/NVP and AZT/3TC/NVP (Keiser et al., 2009). The other reasons that may require switching of regimens include death, treatment failure, non-adherence to antiretroviral therapy and a desire for pregnancy (Sivadasan et al, 2009). Patient care and support The continuing HIV epidemic in India has resulted in a lot of people being in need of good patient care and support services. Firstly, adequate nutrition is essential for maintaining good health and survival of HIV-infected individuals. Good nutrition is important because it helps in maintenance of the desired body weight for sufficient energy level, productivity and overall well being of HIV patients on antiretroviral therapy. Good nutrition also minimizes the health complications that arise due to HIV such as diarrhea, muscle wasting weight loss and fever. Most importantly, it is vital in developing strong immune system by providing the required vitamins and minerals in the diet. Moreover, nutrition also helps to support the effective action of treatment of opportunistic infections and antiretroviral therapy (Duggal, Chugh and Dughal, 2012). Comprehensive care for and support should include voluntary counseling and testing from health care providers, psychological support to patients living with HIV/AIDS, social support from families and communities in order to cope with the consequences of the sickness. There should be adequate support to ensure that those on ART treatment adhere to the medication in order to prolong life. Non-medication: alternatives to ART A considerable number of Indians living with HIV/AIDS do not access antiretroviral treatment due to various reasons including the cost of the drugs, beliefs or due to the overburdening of public hospitals which limits them from receiving adequate care. Therefore, some patents seek out alternative medicine such as Ayurdeva therapy, a much practiced traditional Indian medical system which incorporates dietary regulation, sleep and sexual activity modification, and herbal and mineral supplements in order to achieve good health. However, NACO and the Government of India continue to skeptically approach the use of this therapy to treat HIV/AIDS patients since the safety and quality of drugs are not assured (Thomas, 2013). Other forms of traditional Indian medicine and homeopathy that are widely practiced in the country to curb HIV/AIDS include Unani medicine balance among humors (blood, phlegm, yellow bile and black bile) is required for maintenance of health, Siddha medicine, homeopathy, yoga and naturopathy, a belief in the healing power of nature by trusting in the body's inherent wisdom to heal itself, identify and treat the causes (MOHFW India). Mother-Child Treatment It should be noted that pregnancy is a very special case which presents an inimitable opportunity for health managers of HIV/AIDS to prevent transmission of the virus using different interventions. Managing HIV in pregnant mothers is a two-pronged initiative and includes management of the mother’s HIV status and the inhibition of transmission of the virus from the mother to the child. In as much as the indications for ART and the selection of the choice of drug to be used in pregnant mothers is similar to those in non-pregnant women, the selection of the drug regimen for pregnant women should take into consideration various points.(WHO, 2010). According to existing NACO guidelines, the recommendations for ART drugs are divided into categories which depend on the antiretroviral status of the mother prior to initiation of treatment (Bendle et al., 2012). Firstly, AZT should be included as one of the components of the regimen in cases where there are no outright conflicts to its usage. Secondly, EFV if possible needs to be sidestepped during first trimester of pregnancy due to the risk of teratogenicity that is associated with the medication. Moreover, whenever NVP is used and the CD4 count of the mother is determined to be more than 250 cells per cubic millimetre of blood, there should be proximal monitoring of liver function (Bendle et al., 2012). In situations where women who are already undergoing the ART therapy become pregnant, there should adequate consideration of the benefits and risks of the ART in the initial trimester. Such advantages include the decline in the risk of developing resistance and a fall in the risk to the mother while the risks of continuing with the ART include the potential for ARV becoming toxic to the foetus. The current RCT guidelines in India demand that all HIV-positive women be referred to the ART center in order to be registered into care for a comprehensive screening to be done to determine their eligibility to undergo ART therapy. For pregnant women who are infected with HIV, the CD4 count should be assessed in regard to the national guidelines and be jointly managed by the ART center and the antenatal team of health workers for any obstetric concerns (NACO India, 2007). Evaluation of ART in India Although antiretroviral treatment has significantly reduced the rates of mortality due to HIV-related complications, the adherence rate to ART (70%) is still below the required levels to ensure an optimal treatment effect (Mhaskar, 2013). Antiretroviral therapy in India still continues to face a number of significant challenges and barriers. The most notable issue that is of great concern to the implementation of a comprehensive Indian ART program is the societal stigma that is associated with HIV/AIDS and the consequent discrimination at all levels of the society (India HIV/AIDS Alliance, 2009). It has been noted that more often than not, this discrimination even emanates from health service providers in India, a situation that greatly discourages any patient living with the disease to seek help from relevant bodies (India HIV/AIDS Alliance, 2009). This has the consequence of leading to patients fearing disclosing their HIV status, making the situation worse for most of them. Lack of adherence to antiretroviral therapy has been reported in India, with the highest non-adherence rates being reported in the rural places. Adherence to ART is strikingly dependent on individual behaviour and some of the reasons that have been cited by patients for non-adherence include such factors as distress caused by the side effects of drugs being used, lack of proper awareness and non-belief in treatment, substance abuse and lack of confidence. In addition, patient adherence to antiretroviral treatment is found to be dependent on the relationship that exists between the patient and the health care provider of ART (Sahay, Reddy and Dhayarkar, 2011). A study carried out in Mumbai, India reported that viral containment was linked to patient reported adherence (Walshe et al., 2010) Recommendation and Conclusion Although impact antiretroviral drugs have had in reducing the rates of mortality related to HIV infections has been tremendous, their effectiveness is gradually becoming under threat due to the severe adverse effects and the rising levels of drug resistance. On a more positive note though, there have been progress in the understanding of the virus and the dynamics of its replication, insights that have greatly led to identification of new sites for the action of these drugs. There is renewed involvement of stakeholders including clinical investigators, industry, federal government, patient advocates and clinical trial networks in the process of developing new drugs that ensure that HIV/AIDS is adequately managed. This has resulted in new HIV therapies and new therapeutic strategies coming up continuously in the market, making the disease as yet another chronic manageable both in India and globally. To make ART programs in India more successful and effective there should be further exerted efforts on the part of all parties to address such issues as illiteracy, public awareness and the continuous limited access to basic knowledge and information on health matters especially HIV/AIDS (India HIV/AIDS Alliance, 2009). References Agarwal, D., Chaube, L., Rai, M., Chakravarty, J., Sundar, S., & Agrawal, N. R. (October 01, 2010). High incidence of zidovudine induced anaemia in HIV infected patients in eastern India. Indian Journal of Medical Research, 132, 10, 386-389. Alvarez-Uria, G., Midde, M., Pakam, R., Kannan, S., Bachu, L., & Naik, P. K. (May 21, 2012). 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Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: Recommendations for a public health approach. Geneva: World Health Organization. Read More

 

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