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JAIDS Journal of Acquired Immune Deficiency Syndromes:
doi: 10.1097/QAI.0b013e318220787d
Supplement Article

Access to Second-Line Antiretroviral Therapeutic Regimens in Low-Resource Settings: Experiences From Cameroon

d'Almeida, Cristina MSc*; Essi, Marie-José PhD†; Camara, Mamadou PhD*; Coriat, Benjamin PhD*

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From *CEPN-CNRS, Université Paris 13 Nord, Paris, France; and †Faculté de Medicine de Yaoundê, Yaoundé, Cameroon.

Supported by ANRS.

The authors have no conflicts of interest to disclose.

Correspondence to: Prof Benjamin Coriat, PhD, Centre d'Economie de Paris Nord (CEPN), 99 Avenue Jean-Baptiste Clément, 94410—Villetaneuse, France (e-mail: coriat@club-internet.fr).

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Abstract

Cameroon is one of the few sub-Saharan countries engaged in the implementation of a universal public health policy on HIV/AIDS. In May 2007, second-line antiretroviral regimens were made available in the country; thanks to the joint participation of the Cameroonian government and the UNITAID/Clinton Foundation HIV/AIDS Initiative. This cooperation was achieved by means of a Memorandum of Understanding. The agreement aimed at providing free-of-charge access of 8 antiretroviral formulations. Nevertheless, only 1.9% of the estimated 16% patients that are presently in need of second-line regimens has access to these medicines. The main hindrances to achieving scaled-up access refer to the new institutional arrangements that are necessary for the demand and distribution of these medicines, the limiting conditions for the therapeutic monitoring of second-line treatments, at the national level and the governance of the Memorandum of Understanding itself.

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CONTEXT

The scaling-up access to antiretroviral therapy (ART) in Cameroon has considerably evolved after the implementation of the decentralization policy, in March 2001. This policy contributed to the institutional strengthening of all the constitutive levels of the National Essential Drugs Supply System1—SYNAME (Table 1). Another step forward was accomplished in May 2007. Thanks to the financial support of the Global Fund and the World Bank, a fresh institutional environment was created with the entering into force of the governmental engagement to providing universal and free-of-charge access to HIV/AIDS treatments.2,3As a consequence, the rapid increase in the number of patients that resulted from this initiative imposed additional skills from the National Essential Drugs and Consumables Supply Centre (CENAME) in negotiating affordable prices, and in identifying reliable and qualified suppliers. The agency opted for the implementation of a “generic-oriented” model, in which Indian generic manufacturers (most notably, Cipla, Rambaxy, and Hetero) were responsible for the supply of almost 90% of the procured medicines.4,5 Until now, the first-line therapeutic regimens are administered to 97.4% of the 64,638 individuals presently under ART.1,6

Table 1
Table 1
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However the increasing number of therapeutic failures and viral resistance7 among patients on ART required the introduction of second-line treatments. As the drugs comprised in the second-line protocols are all protected by intellectual property rights, the “generic-based” procurement model in use in the country proved to be not feasible.8 To overcome these obstacles, the Cameroonian government and the UNITAID/Clinton Foundation HIV/AIDS Initiative (CHAI) signed a Memorandum of Understanding (MoU) in the year 2007.9 However, 2 years after the implementation of the agreement, the access to second-line treatments remains incipient because only 1.9% of the estimated 16% patients that are presently in need of second-line regimens has access to these medicines.12 This article aims at presenting the Cameroonian experiences and lessons learned from the provision of second-line treatments through the MoU mechanism and at evaluating the difficulties (technical, financial, and institutional) confronted by SYNAME.

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METHODS

The methodology is based on on-site interviews performed before the relevant national institutions; data were acquired from semi-open questionnaires and exhaustive compilation of administrative and contractual documents employed to the setting-up of the Cameroonian HIV/AIDS Program and the MoU. Local studies aiming at assessing the current status of the HIV/AIDS therapeutic monitoring were held in 9 Cameroonian cities, from 2007 to 2009: Buéa, Limbé, Tiko (Southeast Province); Ebolowa, Nyete (South Province), Bamenda (Northweast Province), Bafoussam (West Province), Bertoua (East Province), and Douala (Littoral Province). A final consultation conducted in 2010 aimed at evaluating the access to monitoring assays in the different provinces.

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RESULTS

The MoU constituted an essential milestone as to allow for the introduction of second-line treatments in Cameroon. However, many challenges were faced by the local government to promoting the sustainability of this initiative, most notably: (1) problems in the governance and the implementation of the MoU itself; (2) the institutional arrangements that were necessary for the demand formation and distribution of these medicines; and (3) the limiting conditions for the therapeutic monitoring of second-line treatments at the national level.

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The Governance of the CHAI/Cameroonian Government Agreement

The CHAI/Cameroonian Government MoU was put into effect in May 25, 2007, allowing for successive prorogations for additional periods.9 The Agreement is limited to the provision of adult formulation of second-line ART. It comprises the free-of-charge provision of 5 individual antiretroviral (ARV) formulations and 3 fixed-dose combinations recommended by WHO (Table 2). All ARV drugs and fixed-dose combinations must satisfy the prequalification quality criteria required by WHO or otherwise by another competent Agency.

Table 2
Table 2
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According to the MoU, CHAI is committed to the capacity building strengthening of the Cameroonian government in the definition, quantification, and logistic management of the supplied ARV drugs. The Foundation is also committed to the enhancement of the country's capacity in the co-ordination of the multiple international financial initiatives established in Cameroon so as to avoid the waste or misuse of its financial resources in overlapping activities. Finally, CHAI might assure that the procurement of any additional ARV that is not comprised within the agreement will benefit from the most affordable price negotiated by the Clinton Foundation.9,10 It is important to underline that all activities performed by CHAI are funded by UNITAID.11

Regarding the responsibilities endorsed by the Cameroonian government,9 the country might make all efforts as to facilitate the registration of the supplied ARV drugs by the National Sanitary Agency. Also, it must bear the customs' clearance costs. The country is also engaged to assuring the gratuity of the second-line ARV drugs in all levels of the SYNAME distribution channel and to avoid any attempts of drug diversion. To prevent from any stock run-outs, the Cameroonian government is liable to formulate orders (3-month based) in advance to the Foundation. The country must also assure proper and safe storage conditions at all levels of the SYNAME chain and elaborate periodical reports, so as to provide updated information concerning the evolution of the cooperative agreement. Finally, the Agreement also establishes the country's commitment not to infringe any third parties' intellectual property.

In practice, as it will be shown below, the very limiting local conditions did not permit an effective implementation of all commitments assumed by the partners, turning into in a very limited number of patients benefiting from second-line treatments.

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Demand and Distribution

According to the information provided by the reference day-hospitals located at Yaoundé and Douala, approximately, 16% of the patients currently receiving first-line ART should undergo a therapeutic switch.12 The most prescribed therapeutic protocols includes the thermostable combination of lopinavir/r and abacavir and Tenofovir.13 Contrarily to first-line regimens, only few health units (provincial hospitals) benefiting from a better infrastructure and qualified human resources on their administration are able to estimate the demand for second-line treatments. The lack of an integrated information system concerning the profile of HIV/AIDS patients and the lack of adhesion by patients greatly hinder the assessment of the demand for these medicines.

In addition, some deficiencies in the supply chain of second-line medicines along the SYNAME can also be documented. This situation derives from 2 factors: first, there might be an uneven balance between the demand established at the centralized level (Ministry of Health's National Council for the Fight Against HIV/AIDS/The National Direction to Fight Diseases) and the demand at the provincial (Provincial Center for Treatment) level. The second reason is due to the fact that the requested amounts of treatments calculated at the decentralized level is often re-estimated and revised at higher decision-making levels, as a means to compensate stock run outs at different points of the SYNAME supply chain.

Finally it should be underlined that some financial unbalances have negatively impacted the distribution channels. As price negotiations and the identification of potential suppliers are exclusively performed by CHAI, the role of CENAME is limited solely to the storage of second-line ARVs. Consequently, some uncertainties concerning the bearing and the management of indirect costs (such as costs of transport and cost of local storage at the distribution points) arise from this situation. Such tensions have contributed to hinder the smooth functioning of the supply chain.

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Limiting Conditions for the Therapeutic Monitoring of Second-Line Regimens

Another major problem lies in the incipient conditions concerning the therapeutic monitoring of patients under ART. On one hand, the lack of infrastructure and human resources does not permit on-time assessment of the persons in need of treatment switch. On the other hand, the MoU (and the agreements previously established with international donors) does not comprise the supply of monitoring assays.

The current eligibility criteria to the identification of therapeutic failures and treatment switches is based upon the counting of patient's CD4 cells (CD4 < 200 cells/μL), and clinical monitoring (stage 3 and 4, defined by WHO).14 CD4 count tests are partially (85.7%) subsided by the Cameroonian government; the unitary cost for this test varying from 13 to 18 Euros (an average of 21,000 FCFA). The viral load tests are not subsided by the Cameroonian government and are charged at 39 Euros to 57 Euros (an average of 36,000 FCFA) per patient.15 The access to CD4 count is therefore restricted to few provincial hospitals and remains very costly to the vast majority of patients.

As a result, the public health authorities are not in condition to perform a complete and reliable assessment of the therapeutic failures and viral resistance cases at national level. Moreover, the procurement procedure employed for the acquisition of CD4 equipments and kits are held by 2 different institutions (CD4 kits by CENAME, and equipments by Ministry of Health's National Council for the Fight Against HIV/AIDS). This division can result in suboptimal procurement prices and in inefficiencies in the use and maintenance of these equipments.

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DISCUSSION AND CONCLUSION

Beside the evident successful outcomes resulting from the national strategies addressing the scaling-up of access to second-line treatments, the Cameroonian experience points out some sensitive points. The challenges can be summarized as follows:

(1) The high dependency of the Cameroonian government upon the international financial mechanisms represents a major and continuous threat to the sustainability of the national response to the HIV/AIDS. In practice, the provision of second-line drug has restricted the role of CENAME to the simple storage of the medicines provided by CHAI. As a result, the Agency was not apt to improve its competency as a negotiator and market analyzer in the supply of second-line drugs. It has to be noticed that, in effect, CHAI was not able to fulfill its commitments in this domain. Future negotiations should address this very important issue.

(2) Regarding the supply chain management, the special protocols implemented for the access to second-line treatments have yielded a series of inefficiencies concerning the storage, and the direct and indirect cost sharing along SYNAME. As to promote sustainability in the provision of first-line and second-line ARV drugs, one might envisage a more integrated and harmonized supply chain model. Similarly, a better coordination between the centralized and decentralized levels of SYNAME has to be achieved, as to avoid stock run-outs and bottlenecks in the distribution channel.

(3) Local authorities and international financing agencies should take into account the strong complementarities between second-line ARVs and monitoring tests, as to promote efficient national strategies for the scaling-up of second-line ARVs. Future versions of the MoU addressing the provision of second-line drugs should consider also the provision of monitoring assays, which are not yet covered within the gratuity policy implemented by the Cameroonian government. For the vast majority of the PLWHAs in low-resource settings, the access to these essential tests still remains a luxury. This situation is in line neither with the present status and evolution of the pandemic nor with the 2010 version of the WHO adult treatment guidelines for a public health approach.

To date, access to second-line therapeutic regimens still stands as very insufficient and inefficient t in Cameroon, as it is limited to only 1.9% of the HIV/AIDS patients in care and treatment and a clear margin of progress exists. We can expect that the experience herein presented and the lessons drawn from it might contribute to future improvements in the performance of the national strategies addressed to scaled-up access to second-line treatments.

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ACKNOWLEDGMENTS

The authors thank ANRS for sponsoring this research (grant # 12108). They would like to thank Dr. Patricia Mouné too for her invaluable contribution concerning the understanding of the SYNAME circuit and the strategic role played by CENAME in the enhancement of the national capacity for drug procurement and distribution, in the course of the last 3 years of our research.

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REFERENCES

1. Republic of Cameroon. Plan Strategique National de Lutte contre le VIH/SIDA: 2006-2010. Available at: http://www.ilo.org/wcmsp5/groups/public/—ed_protect/—protrav/—ilo_aids/documents/legaldocument/wcms_126706.pdf.

2. Republique du Cameroun, Ministère de la Santé Publique, “Décision N 0457/MSP/CAB du 30 juin 2006, Fixant le Prix du Paquet Subventionné du Bilan Pré-Thérapeutique et du Bilan Semestriel de Suivi des Personnes Vivant avec le VIH/SIDA sous Antirétroviraux au Cameroun.”

3. Republique du Cameroun, Ministère de la Santé Publique, “Décision N 176/MSP/CAB du 10 avril 2007, Fixant la nouvelle tarification des Protocoles de Prise en Charge des Personnes Vivant Avec le VIH/SIDA par les Médicaments Antirétroviraux (ARV) et les Médicaments pour les Infections Opportunistes au Cameroun.”

4. Camara M, d'Almeida C, Essi MJ, et al. Du passage à l'Échelle à la Gratuité. Les Politiques d'Acquisition et de Distribution des Médicaments Antirétroviraux dans le Contexte de la Décentralisation au Cameroun. In: Eboko F, Abé C, Laurent C, eds. Accès Décentralisé au Traitement du VIH/Sida: Évaluation de l'Expérience Camerounaise. Paris, France: ANRS; 2010:95-112.

5. Camara M, d'Almeida C, Orsi F, et al. Procurement policies, governance models and availability of ARVs in some African Francophone Countries: An Overview. In: Coriat B, ed. The Political Economy of HIV/AIDS in Developing Countries. TRIPS, Public Health Systems and Free Access. London, UK: Edward Elgar Publisher; 2008:225-254.

6. CENAME-Centrale Nationale d'Approvisionnement en Medicaments et Consommables Medicaux Essentiels, “Catalogue des Antiretroviraux—ARV”, Juin 2009.

7. Kouanfack C, Montavon C, Laurent C, et al. Low levels of antiretroviral-resistant HIV infection in a routine clinic in cameroon that uses the World Health Organization (WHO) public health approach to monitor antiretroviral treatment and adequacy with the WHO recommendation for second-line treatment. Clinical Infectious Diseases. 2009;48:1318-1322.

8. Orsi F, Camara M, Coriat B. AIDS, TRIPS and ‘TRIPS plus’: The case for developing and less developed countries. In: Andersen B, ed. Intellectual Property Rights: Innovation, Governance and the Institutional Environment. London, UK, Oxford Press University; 2005:70-108.

9. Clinton Foundation and Cameroon; “Protocole d'Accord entre l'Initiative de la Fondation Clinton contre le VIH/SIDA et le Gouvernement du Cameroun pour La Fourniture des Traitements de Deuxième Ligne contre le VIH/SIDA pour les Adultes”, Mai 2007.

10. REDORBIT, “Mylan's Matrix Selected by the Clinton HIV/AIDS Initiative and UNITAID as the Primary Supplier of Five Second-Line and Seven Pediatric HIV/AIDS Treatments”, April 2009. Available at: www.redorbit.com.

11. Clinton Foundation (2009). “Supply of UNITAID-Financed Pediatric and/or Adult Second-Line Antiretrovirals for period of March 2010-February 2011”. Available at: http://www.clintonfoundation.org/files/chai_unitaid_2010_arv_supplier_letter.pdf.

12. d'Almeida C, Camara M, Essi MJ, et al. L'expérience Camerounaise d'Accès aux Thérapies de Seconde Ligne. In: Eboko F, Abé C, Laurent C, eds. Accès Décentralisé au Traitement du VIH/Sida: Évaluation de l'Expérience Camerounaise. Paris, France: ANRS; 2010:113-132.

13. Republique de Cameroun- Ministère de la Santé Publique; “Vers l'Accès Universel aux Traitements et Soins en Faveur des Adultes et Enfants Vivant avec le VIH/SIDA au Cameroun—Rapport de Progrès N 12”, Mars 2009.

14. ANRS; “Évaluation du Programme Camerounais d'Access aux Antirétroviraux: Impact sur la Prise en Charge et les Conditions de Vie de la Population Infectée par le VIH (EVAL)”, Juin 2009.

15. Laurent C, Kouanfack C, Vergne L, et al. Antiretroviral drug resistance and routine therapy, cameroon. Emerging Infection Diseases. 2006;12:1001-1004.

Keywords:

Cameroon; Clinton Foundation; HIV/AIDS; Memorandum of Understanding; second-line treatments; UNITAID

© 2011 Lippincott Williams & Wilkins, Inc.

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