scholarly journals Patent Pooling for Promoting Access to Antiretroviral Drugs (ARVs) – A Strategic Option for India

2010 ◽  
Vol 4 (1) ◽  
pp. 41-53
Author(s):  
Kanikaram Satyanarayana ◽  
Sadhana Srivastava

The current HIV/AIDS scenario in India is quite grim with an estimated 2.4 million people living with HIV/AIDS (PLHA) in 2008, just behind South Africa and Nigeria. The anti-retroviral drugs (ARVs) remain the main stay of global HIV/AIDS treatment. Over 30 ARVs (single and FDCs) available under six categories viz., NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), Protease inhibitors, the new Fusion inhibitors, Entry inhibitors-CCR5 co-receptor antagonists and HIV integrase strand transfer inhibitors. The major originator companies for these ARVs are: Abbott, Boehringer Ingelheim (BI), Bristol-Myers Squibb (BMS), Gilead, GlaxoSmithKline (GSK), Merck, Pfizer, Roche, and Tibotec. Beginning with zidovidine in 1987, all the drugs are available in the developed countries. In India, about 30 ARVs are available as generics manufactured by Aurobindo, Hyderabad, Andhra Pradesh; Cipla Limited, Goa; Emcure Pharmaceuticals, Pune, Maharashtra; Hetero Drugs, Hyderabad, Andhra Pradesh; Macleods Pharmaceuticals, Daman; Matrix Laboratories, Nashik, Maharashtra; Ranbaxy, Sirmour, Himachal Pradesh; and Strides Arcolab, Bangalore, Karnataka. The National AIDS Control Organization (NACO) set up in 1992 by the Govt. of India provides free ARVs to HIV positive patients in India since 2004. The drugs available in India include both single drugs and FDCs covering both first line and second line ARVs. Even while there are claims of stabilization of the disease load, there is still huge gap of those who require ARVs as only about 150,000 PLHA receive the ARVs from the Govt. and other sources. Access to ARVs therefore is still a cause of serious concern ever since India became fully Trade Related Aspects of Intellectual Property Rights (TRIPS)-complaint in 2005. Therefore, the Indian pharmaceutical companies cannot make generics for those for drugs introduced post-2005 due to product patent regime. Other concerns include heat stable, other better formulations and second line ARVs for adults and more drugs and formulations for paediatric groups, that are still to be widely available in India and other developing countries. To examine whether strong intellectual property (IP) protection systems are to be considered important barriers for the limited or lack of access to ARVs, we studied the patent profile of the ARVs of the originator companies within and outside India. We could record 93 patents in the United States Patent & Trademark Office (USPTO). The originator companies have been also aggressively filing and enforcing patents in India. There have been a few efforts by companies like Gilead and GSK to grant licenses to generic manufacturers in developing countries, ostensibly to promote access to ARVs through lower (two-tier) pricing. These steps are considered as too little and too late. There is an urgent need to look for alternative strategies to promote access to ARVs both linked to and independent of IPRs. Patent pooling as a viable strategy mooted by the UNITAID should be seriously explored to promote access to ARVs. India is ideally suited for trying out the patent pool strategy as most of the global requirement of affordable ARV drugs for HIV/AIDS treatment is sourced from Indian generic companies.

2019 ◽  
Vol 7 (02) ◽  
pp. 45-49
Author(s):  
Ranabir Salam ◽  
Sarita Bajaj ◽  
Nitin Kapoor ◽  
Banshi Saboo ◽  
Arundhati Dasgupta

AbstractIn India, the prevalence of HIV infection among adults (15–49 years) is estimated at 0.26%. The total number of people living with HIV (PLHIV) in India was estimated at 21.17 lakhs in 2015. There has been a declining trend in the mortality rate of HIV-infected patients on antiretroviral therapy (ART). With HIV becoming a chronic manageable disease, metabolic complications like diabetes mellitus (DM) and dyslipidemia are coming to the forefront. Generally, protease inhibitors (PI) are implicated in metabolic derangement; however, nucleoside reverse transcriptase inhibitors (NRTI) like stavudine can also cause diabetes. Among HIV-infected patients, the prevalence of diabetes is reported to range from 2 to 19%, so there is strong case for screening of diabetes among HIV-infected cases. The South Asian Consensus Guidelines recommend that both fasting and postprandial glucose values should be checked at screening and during monitoring of therapy. National AIDS Control Organization (NACO) recommends fasting plasma glucose with value ≥ 126 mg% diagnostic of diabetes mellitus. HbA1c may underestimate the degree of hyperglycemia in HIV-infected individuals and may not be a good diagnostic tool. Lifestyle modification is recommended as part of treatment. Metformin should be used with caution in HIV patients. Concomitant use of metformin with non-nucleoside reverse transcriptase inhibitors (NNRTI) can cause lactic acidosis. Thiazolidinediones should be the drug of choice in HIV, particularly in patients with lipodystrophy. Insulin secretagogues (meglitinides and sulfonylureas) are safe but may not be effective in the presence of severe insulin resistance. There are concerns regarding the use of gliptins in HIV-infected patients as they have molecular targets on immune cells. Insulin should be the drug of choice for HIV-infected patients with marked hyperglycemia (HbA1c > 9%), ketonuria, severe liver disease, or severe kidney disease. SGLT2 inhibitor may increase the risk of urinary tract infection and genital mycotic infections in HIV-infected diabetics. Regarding the use of ART among HIV patients with diabetes, NACO guidelines recommend that Tenofovir, lamivudine, and efavirenz should be used as first-line ART for all new patients, except known cases of severe diabetes, severe hypertension, or renal disease. Tenofovir, lamivudine, and lopinavir/ritonavir should be used as first line in women ever exposed to single dose Nevirapine in the past and also for all confirmed HIV-2 or HIV-1 & 2 coinfected patients. HIV infected with diabetes mellitus and microalbuminuria or proteinuria need Abacavir-based regimen (Abacavir + Lamivudine + Efavirenz). There is some suggestion that PI-based regimes should be avoided in patients at high risk of developing diabetes, for example, those with a history of gestational diabetes, positive family history of diabetes, or impaired glucose tolerance on screening.


RSC Advances ◽  
2016 ◽  
Vol 6 (3) ◽  
pp. 2119-2130 ◽  
Author(s):  
Hugo Vite-Caritino ◽  
Oscar Méndez-Lucio ◽  
Héctor Reyes ◽  
Alberto Cabrera ◽  
Daniel Chávez ◽  
...  

Medicinal chemistry, computational design and biological screening have advanced pyridin-2(1H)-one derivatives as a promising class of non-nucleoside reverse transcriptase inhibitors for the treatment of HIV/AIDS.


2019 ◽  
Vol 1 (1) ◽  
pp. 64-81
Author(s):  
Ani Anggriani ◽  
Ida Lisni ◽  
Olga Susana Liku

ABSTRACT The Human Immunodeficiency Virus (HIV) continues to be a major global public health issue, which targets the human immune system. The using of ARVs in the treatment of HIV / AIDS increased life expectancy for PLHIV (People With HIV / AIDS). This study aims to determine the description of the using of ARV drugs in outpatients of the HIV / AIDS Clinic and assessed their suitability with established treatment standards. This research was carried out in a descriptive non-experimental manner, with data collection carried out retrospectively, used patient prescription data from April to December 2017. The results of quantitative studies showed 87% were male patients, and the largest age group was 20-29 years (39%) . Class of antiretroviral drugs used were Nucleoside / Nucleotide Reverse Transcriptase Inhibitors (NRTIs), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Protease Inhibitors (PI), with a combination of antiretroviral drugs most was the combination of first-line tenofovir + lamivudine + efavirenz (69%) while the second-line drug zidovudine + lamivudine + lopinavir / ritonavir  was 1%. The most commonly used comorbid drug was cotrimoxazole. For qualitative data, the accuracy of combination and dose of ARV drugs was 100% in accordance with Permenkes No. 87/ 2014, with 79% of patients adhered to antiretroviral treatment every month. The potential for most ARV drug interactions with other drugs for the moderate category was zidovudin + cotrimoxazole (11%) which occured pharmacokinetically by decreasing renal clearance of zidovudine and glucuronide metabolites. In conclusion, the pattern of used of ARV drugs had met the standard of Permenkes No.87/2014, with the most used were the first line combination of tenofovir + lamivudine + efavirenz.


2017 ◽  
Vol 41 (S1) ◽  
pp. S697-S698
Author(s):  
S. Nascimento ◽  
M. Mendes ◽  
C. Solana ◽  
M. Croca ◽  
J. Reis

IntroductionHIV (human immunodeficiency virus) infection is related to several neuropsychiatric complications, such as dementia, encephalopathy, psychosis, as well as, opportunistic infections of the central nervous system (CNS). The discovery of antiretroviral therapy (ART) has limited these conditions and extended the life span of infected patients into a chronic illness, but it is also associated with neuropsychiatric adverse effects.ObjectivesTo review the literature on the most common neuropsychiatric complications of the ART, since it can be difficult to distinguish drugs toxicity, the effects of the virus, immune system and psycho-social events.MethodsThe authors have conducted an online search in PubMed with the terms: “Psychiatry”, “HIV”, “adverse effects” and “antiretroviral drugs” from 2011 until 2016. From the outcome were collected, analyzed and summarized the articles considered to be relevant.ResultsThe antiretroviral therapy (ART) are associated with a numerous adverse effects on the central and peripheral nervous systems, as well as, metabolic, gastrointestinal, cardiac, and other toxicities. The neuropsychiatric effects are common and highly variable, including depression, cognitive impairment and sleep disturbance. The nucleoside reverse transcriptase inhibitors and the non-nucleoside reverse transcriptase inhibitors are one of the two classes of antiviral drugs most frequently associated with neuropsychiatric complications.ConclusionsThe occurrence of new-onset conditions related to ART makes it difficult to determine the association between psychiatric disorders and ART adverse effects, and given the fact that patients commit to lifelong therapy, as well as, they can diminish quality of life; it makes these assessment important in treating these conditions.Disclosure of interestThe authors have not supplied their declaration of competing interest.


2019 ◽  
Vol 1 (1) ◽  
pp. 22
Author(s):  
Indana Eva Ajmala ◽  
Laksmi Wulandari

TB and HIV have a very close relationship since the development of AIDS. Through a significant reduction in cellular immunity, HIV affects the pathogenesis of tuberculosis, thereby increasing the risk of TB in HIV co-infected individuals. In 2006, there were an estimated 9.2 million new TB cases worldwide, there were 710.00 in patients with HIV and 500,000 cases with MDR-TB. Sensitivity to TB associated with cytokine production by T lymphocytes (IFN gamma and TNF are like alpha). During HIV infection, IFN gamma production declined dramatically in line with the decrease in CD4 T lymphocytes This leads to an increased risk of developing reactivation or reinfection Mycobacterium tuberculosis. Clinical symptoms of pulmonary TB in people living with HIV are often non-specific. Clinical symptoms often found are fever and significant weight loss. The other symptoms usually associated with extrapulmonary TB. Antiretrovirals are drugs that inhibit HIV replication. The main priority in patients co-infected with TB-HIV is a start of TB therapy, followed by cotrimoxazole and ARV. ARV treatment recommendation on co-infection tuberculosis is starting ARV therapy to all people living with HIV with active TB, regardless of CD4 cell count. Antiretroviral therapy start as soon as possible after TB treatment can be tolerated, as soon as 2 weeks and no more than 8 weeks. Regimen set by WHO for first-line regimen containing two nucleoside reverse transcriptase inhibitors (NRTIs) plus one non-nucleoside reverse transcriptase inhibitors (NNRTIs). In the co-infection of TB-HIV nucleoside was elected WHO recommended Zidovudine (AZT) or tenofovir disoproxil fumarate (TDF), in combination with lamivudine (3TC) or emricitabine (FTC). For NNRTI, WHO recommends efavirenz (EFV) or nevirapine (NVP).


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